Albiglutide instruction

Name: Albiglutide

  • Albiglutide albiglutide drug
  • Albiglutide effects of albiglutide
  • Albiglutide side effects
  • Albiglutide side effects of albiglutide
  • Albiglutide injection
  • Albiglutide drug
  • Albiglutide 50 mg
  • Albiglutide how to use
  • Albiglutide weight loss
  • Albiglutide and weight loss
  • Albiglutide albiglutide side effects
  • Albiglutide albiglutide dosage
  • Albiglutide dosage
  • Albiglutide missed dose
  • Albiglutide mg
  • Albiglutide names
  • Albiglutide drugs like

Albiglutide Interactions

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with albiglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Side Effects of Albiglutide

Serious side effects have been reported with albiglutide. See the “ Albiglutide Precautions” section.

Common side effects of albiglutide include the following:

  • diarrhea
  • nausea
  • injection site reactions

This is not a complete list of albiglutide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Albiglutide Overview

Albiglutide is a prescription medication used to control blood glucose (sugar) in people with type 2 diabetes.

Albiglutide belongs to a group of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. These help to normalize blood sugar levels by causing the pancreas to release insulin when blood sugar levels are high.

This medication comes in an injectable form. Albiglutide is given under the skin (subcutaneously), once-weekly, on the same day each week.

Common side effects of albiglutide include diarrhea, nausea, and injection site reactions.

Albiglutide Drug Class

Albiglutide is part of the drug class:

  • Other blood glucose lowering drugs, excl. insulins

Albiglutide Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Albiglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Albiglutide may affect the way some medicines work and some other medicines may affect the way albiglutide works.

Especially tell your doctor if you take:

  • insulin, or any other anti-diabetes medicines
  • birth control pills that are taken by mouth (oral contraceptives)
  • digoxin Lanoxin)
  • warfarin (Coumadin, Jantoven)
  • simvastatin (Zocor)

This is not a complete list of albiglutide drug interactions. Ask your doctor or pharmacist for more information.

How should I use albiglutide?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Albiglutide comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Albiglutide is injected under the skin. You will be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

You may use albiglutide with or without food.

The albiglutide prefilled injection pen comes in a strength of 30 milligrams (mg) or 50 mg. The pen contains powder medicine and a liquid that must be mixed before you give the injection. Each pen strength has a certain “wait” time to allow the powder to completely dissolve after mixing. The 30-mg pen needs 15 minutes of wait time, and the 50-mg pen needs 30 minutes of wait time Mixed medicine must be used within 8 hours.

If you are using the injections at home, be sure you understand how to properly mix the medicine. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Do not mix albiglutide together with insulin in the same injection.

Albiglutide is usually given only one time per week. Use the medicine on the same day each week if possible. Allow at least 4 days to pass between doses.

Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Each single-use injection pen is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor’s advice.

Storing unopened injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any albiglutide not used before the expiration date on the medicine label.

You may also store injection pens at room temperature, away from moisture and heat, for up to 4 weeks before use.

Do not freeze albiglutide, and throw away the medication if it has become frozen.

Albiglutide side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • symptoms of pancreatitis–severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • signs of a thyroid tumor–swelling or a lump in your neck, trouble swallowing, a hoarse voice, or if you feel short of breath;

  • low blood sugar–headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or

  • signs of a kidney problem–little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

  • nausea, diarrhea;

  • cough, cold or flu symptoms;

  • back pain; or

  • pain, swelling, or irritation where medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Albiglutide Dosage and Administration

General

  • Perform regular monitoring (e.g., blood glucose determinations, HbA1c) to determine therapeutic response.1

Administration

Administer by sub-Q injection using a prefilled injection pen.1

If a dose is missed, administer it as soon as possible within 3 days after the missed dose, followed by resumption of the regular weekly schedule.1 If it has been more than 3 days since the missed dose, skip the dose and resume the regular schedule with the next scheduled dose.1

Administer albiglutide and insulin as separate injections in patients receiving both medications; do not mix insulin and albiglutide.1 May inject albiglutide and insulin in the same body regions; do not administer injections adjacent to each other.1

Sub-Q Administration

Administer by sub-Q injection once weekly, on the same day each week, at any time of day without regard to meals.1 If changing the day of weekly administration, allow at least 4 days to elapse between doses.1

Administer into abdomen, thigh, or upper arm; rotate sites.1

Reconstitution

Reconstitute prefilled injection cartridge pens according to manufacturer’s instructions prior to use.1 12 If stored in the refrigerator, allow pen to sit at room temperature for 15 minutes before reconstitution.1

To reconstitute albiglutide lyophilized powder, hold the clear cartridge upright displaying the number “1” in the window, then twist the cartridge several times in the direction of the arrow (clockwise) until the number “2” is displayed.1 12

Gently rock the pen side to side (like a windshield wiper) 5 times to mix, and allow pen to stand for 15 minutes (30-mg pen) or 30 minutes (50-mg pen) to dissolve completely.1 12 Do not shake pen.1 12 After 15 or 30 minutes, gently rock pen side to side 5 additional times to ensure complete mixing.1 12

Alternative instructions for healthcare professionals allowing for faster reconstitution provided in the manufacturer’s labeling.1

Attach manufacturer-supplied needle and prime by twisting the pen as directed until the number “3” is displayed in the cartridge window.1 12

Reconstituted solution should be clear and yellow, and contains 30 or 50 mg of albiglutide per 0.5 mL.1 12 Use within 8 hours of reconstitution prior to attaching the needle; after the needle is attached and primed, use immediately to prevent solution drying and clogging the needle.1 12

Dosage

Adults

Diabetes Mellitus Sub-Q

30 mg once weekly.1 May increase dosage to 50 mg once weekly if glycemic response is inadequate.1

Special Populations

No special population dosage recommendations.1

Use caution when initiating albiglutide or escalating dosage in patients with renal impairment.1 (See Renal Impairment under Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Parenteral

Powder for Injection, for subcutaneous use

30 mg

Tanzeum (available as prefilled single-use injection pen with sterile water for injection diluent, and needle)

GlaxoSmithKline

50 mg

Tanzeum (available as prefilled single-use injection pen with sterile water for injection diluent, and needle)

GlaxoSmithKline

What do I need to tell my doctor BEFORE I take Albiglutide?

  • If you have an allergy to albiglutide or any other part of albiglutide.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Acidic blood problem, type 1 diabetes, pancreas swelling, or stomach or bowel problems.
  • If you are pregnant.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take albiglutide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Albiglutide) best taken?

Use albiglutide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Take with or without food.
  • Take the same day each week.
  • This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
  • Do not shake.
  • Use your dose within 8 hours after mixing.
  • Use your dose right away after you put the needle on the pen.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • This medicine is yellow after mixing. Do not use if the solution changes color.
  • Wash your hands before and after use.
  • Move site where you give the shot each time.
  • Do not mix this medicine in the same syringe with insulin.
  • Give albiglutide at some other site from where you gave your insulin if you are also getting insulin.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
  • Attach new needle before each dose.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If you miss your dose by more than 3 days, skip the missed dose. Take your next dose on your normal day.
  • Do not take 2 doses at the same time or extra doses.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Albiglutide?

  • Store in a refrigerator. Do not freeze.
  • Store in original container.
  • This medicine may be stored at room temperature for up to 4 weeks before use.
  • Do not use if it has been frozen.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Pharmacology

Albiglutide is an agonist of human glucagon-like peptide-1 (GLP-1) receptor and augments glucose-dependent insulin secretion and slows gastric emptying.

Distribution

Vd: 11 L

Metabolism

Degradation to small peptides and individual amino acids by proteolytic enzymes.

Time to Peak

3 to 5 days

Half-Life Elimination

~5 days

Dosing Renal Impairment

eGFR ≥15 to 89 mL/minute/1.73 m2: No dosage adjustment necessary; use caution when initiating or escalating doses.

eGFR 10%:

Endocrine & metabolic: Hypoglycemia (combination therapy; 3% to 17%)

Gastrointestinal: Diarrhea (13%), nausea (11%)

Local: Injection site reaction (11% to 18%, including erythema at injection site , hypersensitivity reaction at injection site , rash at injection site , itching at injection site)

Respiratory: Upper respiratory tract infection (14%)

1% to 10%:

Cardiovascular: Atrial fibrillation (1%)

Endocrine & metabolic: Increased gamma-glutamyl transferase (2%)

Gastrointestinal: Gastroesophageal reflux disease (4%), vomiting (4%)

Immunologic: Antibody development (non-neutralizing; 6%)

Infection: Influenza (5%)

Neuromuscular & skeletal: Arthralgia (7%), back pain (7%)

Respiratory: Cough (7%), pneumonia (2%)

edrugswiki.com

Applies to the following strengths: 50 mg; 30 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Diabetes Type 2

Initial dose: 30 mg subcutaneously once a week
-If glycemic response is inadequate, may increase to 50 mg subcutaneously once a week
Maintenance dose: 30 or 50 mg subcutaneously once a week

Comments:

-This drug is not recommended as first-line therapy because of uncertain relevance of the rodent C-cell tumor findings to humans; prescribe only to patients for whom the potential benefits are considered to outweigh the potential risk.
-This drug has not been studied in patients with a history of pancreatitis; consider alternative therapies
-The dose of concomitantly administered insulin or insulin secretagogues may need to be reduced when starting therapy in order to decrease the risk of hypoglycemia.
-This drug has not been studied in combination with prandial insulin.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Renal Dose Adjustments

Mild, moderate, or severe renal impairment (eGFR 15 to 89 mL/min/1.73m2): No adjustment recommended; use caution when initiating or escalating doses
-eGFR less than 15 mL/min/1.73m2: No data available

Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions

Liver Dose Adjustments

No dose adjustment recommended

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Albiglutide. It includes communication plan. For additional information: www.fda.gov/REMS

US BOXED WARNING: RISK OF THYROID C-CELL TUMORS

-Carcinogenicity of this drug could not be assessed in rodents, but other glucagon-like peptide-1 (GLP-1) receptor agonists have caused thyroid C-cell tumors in rodents at clinically relevant exposures. Human relevance of GLP-1 receptor agonist induced C-cell tumors in rodents has not been determined. It is unknown whether this drug causes thyroid C-cell tumor, including medullary thyroid carcinoma (MTC) in humans.
-This drug is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Counsel patients regarding the potential risk of MTC with the use of this drug and inform them of the symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with this drug.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-For subcutaneous use only into the abdomen, thigh, or upper arm region; do not give IV or IM
-Administer subcutaneously once a week at any time of the day, without regard to meals; give on the same day each week
-Never share a pen between patients, even if the needle is changed, due to risk for transmission of blood-borne pathogens

Missed dose:

-If a dose is missed, administer as soon as possible if it is within 3 days of the missed dose, then resume usual dosing schedule
-If a dose is missed, and it is more than 3 days after the missed dose, skip the missed dose and resume usual dosing schedule

Administration day may be changed if the last dose was administered 4 or more days earlier

Storage requirements: Store in original carton until use; do not freeze; discard if frozen

-Unopened (not in use): Store in the refrigerator (36F to 46F )
-Pens may be kept at room temperature below 86F (30C) for up to 4 weeks
-Once reconstituted, must use within 8 hours

Reconstitution/preparation techniques:

-The lyophilized powder contained within the Pen must be reconstituted prior to administration
-Patients should receive proper training from their healthcare provider prior to first use
-Product labeling should be consulted for specific instructions; instructions may also be found at www.TANZEUM.com

General:

-This drug has not been studied in patients with a history of pancreatitis, alternative therapy should be considered in these patients.
-This drug should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis; this drug is not a substitute for insulin.
-This drug is not recommended as a first-line therapy in patients with type 2 diabetes mellitus as the relevance of rat thyroid C-cell tumor findings to humans is uncertain.
-Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with this drug.
-This drug has not been studied in combination with prandial insulin.
-This drug has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients.

Monitoring:

-Blood glucose and hemoglobin A1C measurements should be measured periodically to assess efficacy.
-Observe for signs and symptoms of pancreatitis.
-Observe for signs and symptoms of thyroid tumors.
-Renal: Monitor renal function in patients with renal impairment reporting adverse gastrointestinal reactions

Patient advice:

-Patients should understand the potential risk of medullary thyroid cancer with the use of this drug and should be instructed to report symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness).
-Patients should be familiar with proper use, storage, and disposal of pen. Patients should be familiar with self-management practices of diabetes including recognition and management of hypoglycemia.
-Patients should be advised to never share a pen with another person, even if the needle is changed as sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens
-If using this drug together with insulin, administer as separate injections. Injections may be administered in the same body region but should not be adjacent to each other; patients should be instructed to rotate injections sites.
-Patients should be instructed to stop this drug and contact their healthcare provider for the occurrence of severe abdominal pain that may radiate to the back with or without vomiting.
-Patients should be instructed to seek medical advice during periods of stress, such as fever, trauma, infection, or surgery as medical management of diabetes may change.
-Inform patients that hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
-Patients should be aware of signs and symptoms of hypoglycemia and how it should be managed; patients should be advised to take precautions to avoid hypoglycemia while driving and using machines.

www.drugs.com
Albiglutide Overview

Reviewed: January 14, 2013

Updated: March 18, 2016

Albiglutide is a prescription medication used to control blood glucose (sugar) in people with type 2 diabetes.

Albiglutide belongs to a group of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. These help to normalize blood sugar levels by causing the pancreas to release insulin when blood sugar levels are high.

This medication comes in an injectable form. Albiglutide is given under the skin (subcutaneously), once-weekly, on the same day each week.

Common side effects of albiglutide include diarrhea, nausea, and injection site reactions.

How was your experience with ?

Albiglutide Cautionary Labels

Albiglutide is a prescription medication used to control blood glucose (sugar) in people with type 2 diabetes

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Albiglutide may be found in some form under the following brand names:

  • Tanzeum

Side Effects of Albiglutide

Serious side effects have been reported with albiglutide. See the “ Albiglutide Precautions” section.

Common side effects of albiglutide include the following:

  • diarrhea
  • nausea
  • injection site reactions

This is not a complete list of albiglutide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Albiglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Albiglutide may affect the way some medicines work and some other medicines may affect the way albiglutide works.

Especially tell your doctor if you take:

  • insulin, or any other anti-diabetes medicines
  • birth control pills that are taken by mouth (oral contraceptives)
  • digoxin Lanoxin)
  • warfarin (Coumadin, Jantoven)
  • simvastatin (Zocor)

This is not a complete list of albiglutide drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with albiglutide including the following:

  • Acute pancreatitis. Tell your healthcare provider right away if you have some or all of the following symptoms of acute pancreatitis:
    • severe pain in your stomach area (abdomen) that will not go away
    • vomiting
    • pain that may go from your abdomen to your back
  • Hypoglycemia. Tell your healthcare provider right away if you have some or all of the following symptoms:
    • dizziness or light-headedness
    • sweating
    • confusion
    • headache
    • blurred vision
    • slurred speech
    • shakiness
    • fast heart beat
    • anxiety, irritability, or mood changes
    • hunger
    • feeling jittery

Talk with your healthcare provider about how to treat low blood sugar.

  • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
  • Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may result in loss of fluids (dehydration) which may worsen kidney problems.
  • Allergic reactions. Stop using albiglutide and get medical help right away if you have any symptoms of an allergic reaction. Do not use albiglutide if you have had an allergic reaction to albiglutide or any of the other ingredients in it. Symptoms of a severe allergic reaction with albiglutide may include:
  • swelling of your face, lips, tongue, or throat
  • problems breathing or swallowing
  • severe rash or itching
  • fainting or feeling dizzy
  • very rapid heartbeat

Do not take albiglutide if you:

  • are allergic to albiglutide or to any of its ingredients
  • or your family has a history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Albiglutide Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of albiglutide, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking albiglutide, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to albiglutide or to any of its ingredients
  • severe stomach or intestinal problems
  • previously had pancreatitis
  • you or your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC)
  • you have an endocrine system cancer called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • have or have had problems with your pancreas, kidneys, or liver 
  • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or
    problems with digesting food
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Albiglutide and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Albiglutide falls into category C.There are no well-controlled studies that have been done in pregnant women. Albiglutide should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Albiglutide and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if albiglutide crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using albiglutide.

Take albiglutide exactly as prescribed.

This medication comes in an injectable form. Albiglutide is given under the skin, once every seven days (weekly), on the same day each week.

Albiglutide may be administered at any time of day and may be taken with or without food.

Albiglutide is injected under the skin (subcutaneously) in the abdomen, thigh, or upper arm region.

The day of weekly administration may be changed if necessary as long as the last dose was administered 4 or more days before.

If you miss a dose, take your missed dose of medicine within 3 days after your scheduled day, then return to your scheduled day for your next dose. If more than 3 days have passed since your usual scheduled day, wait until your next regularly scheduled day to take the injection of albiglutide. Do not take two doses of albiglutide at the same time.

Albiglutide pen

Your healthcare provider must teach you how to inject albiglutide before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist.

  • If stored in a refrigerator, allow to sit at room temperature for 15 minutes before starting.
  • The albiglutide pen has medicine powder in 1 compartment and water in another compartment. You will need to mix them together by twisting the pen, then wait for 15 minutes for the medicine and water to fully mix.
  • Do not mix insulin and albiglutide together in the same injection.
  • Albiglutide is injected under the skin (subcutaneously) in the abdomen, thigh, or upper arm region. Do not inject albiglutide into a vein or muscle.
  • Change (rotate) your injection site with each injection (weekly).

General Information

Follow your healthcare provider’s instructions for diet, exercise, and how often to test your blood sugar. If you see your blood sugar increasing during treatment with albiglutide, talk to your healthcare provider because you may need to adjust your current treatment plan for your diabetes.

Talk to your healthcare provider about how to manage high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia), and how to recognize problems that can happen with your diabetes.

Never share your albiglutide with another person. You may give an infection to them, or get an infection from them, and albiglutide may harm them.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on how you respond to this medication.

The recommended dose of albiglutide used to control blood glucose (sugar) in people with type 2 diabetes is 30 mg once every seven days (weekly). The dose can be administered at any time of day, with or without meals.

If you take too much albiglutide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Too much albiglutide can cause your blood sugar to drop quickly and you may have symptoms of low blood sugar. You may need medical treatment right away.

  • Store albiglutide pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Patients may store albiglutide pens at room temperature not to exceed 86°F (30°C) for up to 4 weeks prior to use.
  • Store albiglutide pens in the original carton until use.
  • Do not freeze. If the liquid in the pen is frozen, throw away the pen and use another pen.
  • Do not use past the expiration date.
  • Use within 8 hours after reconstitution.
  • Keep this and all medicines out of the reach of children.

WARNING: RISK OF THYROID C-CELL TUMORS

Tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists. It is unknown whether albiglutide causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Albiglutide should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (a disease where patients have tumors in more than one gland in their body and that predisposes them to MTC).

www.rxwiki.com
BOXED WARNING(What is this?) • Carcinogenicity of albiglutide could not be assessed in rodents, but other glucagon-like peptide-1 (GLP-1) receptor agonists have caused thyroid C-cell tumors in rodents at clinically relevant exposures. Human relevance of GLP-1 receptor-agonist-induced C-cell tumors in rodents has not been determined. It is unknown whether TANZEUM causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans . • TANZEUM is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of TANZEUM and inform them of the symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with TANZEUM . Close HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TANZEUM safely and effectively. See full prescribing information for TANZEUM.
TANZEUM (albiglutide) for injection, for subcutaneous use
Initial U.S. Approval: 2014

• Carcinogenicity of albiglutide could not be assessed in rodents, but other glucagon-like peptide-1 (GLP-1) receptor agonists have caused thyroid C-cell tumors in rodents at clinically relevant exposures. Human relevance of GLP-1 receptor-agonist-induced C-cell tumors in rodents has not been determined. It is unknown whether TANZEUM causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. (5.1, 13.1) • TANZEUM is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors. (4.1, 5.1)

Contraindications (4)

8/2017

Warnings and Precautions (5.4)

8/2017

Warnings and Precautions, Acute Kidney Injury (5.5)

12/2017

TANZEUM is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)

Limitations of Use:

• Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. ( 1, 5.1) • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. ( 1, 5.2) • Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1) • Not for patients with pre-existing severe gastrointestinal disease. ( 1) • Has not been studied in combination with prandial insulin. ( 1) • Administer once weekly at any time of day, without regard to meals. ( 2.1) • Inject subcutaneously in the abdomen, thigh, or upper arm. ( 2.1) • Initiate at 30 mg subcutaneously once weekly. Dose can be increased to 50 mg once weekly in patients requiring additional glycemic control. ( 2.1) • If a dose is missed, administer within 3 days of missed dose. ( 2.1) • See Full Prescribing Information and Patient Instructions for Use for reconstitution of lyophilized powder and administration. ( 2.4, 2.5, 17)

For injection: 30 mg or 50 mg in a single-dose Pen. (3)

• TANZEUM is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. ( 4) • TANZEUM is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or any of the product components. ( 4, 5.4) • Thyroid C-Cell Tumors: See Boxed Warning. ( 5.1) • Acute Pancreatitis: Discontinue promptly if suspected. Do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. ( 5.2) • Hypoglycemia: Can occur when used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Consider lowering sulfonylurea or insulin dosage when starting TANZEUM. ( 5.3) • Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., angioedema) have occurred. Discontinue TANZEUM and promptly seek medical advice. ( 5.4) • Acute Kidney Injury: Postmarketing cases of worsening renal function and acute renal injury, some requiring hemodialysis, have occurred. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions and advise patients to avoid fluid depletion. ( 5.5) • Macrovascular Outcomes: There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with TANZEUM. ( 5.6)

Adverse reactions reported in ≥5% of patients treated with TANZEUM and more frequently than in patients on placebo were upper respiratory tract infection, diarrhea, nausea, injection site reaction, cough, back pain, arthralgia, sinusitis, and influenza. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

TANZEUM delays gastric emptying. May impact absorption of concomitantly administered oral medications. (7)

• Pregnancy: TANZEUM may cause fetal harm; only use if potential benefit justifies potential risk to fetus. ( 8.1) • Acute Kidney Injury: No dosage adjustment recommended. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. ( 5.5, 8.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2017

Close FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE

TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus .

Limitations of Use:

• TANZEUM is not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans. Prescribe TANZEUM only to patients for whom the potential benefits are considered to outweigh the potential risk . • TANZEUM has not been studied in patients with a history of pancreatitis . Consider other antidiabetic therapies in patients with a history of pancreatitis. • TANZEUM is not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis. TANZEUM is not a substitute for insulin in these patients. • TANZEUM has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of TANZEUM is not recommended in patients with pre-existing severe gastrointestinal disease . • TANZEUM has not been studied in combination with prandial insulin. Close 2 DOSAGE AND ADMINISTRATION

2.1 Dosage

The recommended dosage of TANZEUM is 30 mg once weekly given as a subcutaneous injection in the abdomen, thigh, or upper arm region. The dosage may be increased to 50 mg once weekly if the glycemic response is inadequate.

TANZEUM may be administered at any time of day without regard to meals. Instruct patients to administer TANZEUM once a week on the same day each week. The day of weekly administration may be changed if necessary as long as the last dose was administered 4 or more days before.

If a dose is missed, instruct patients to administer as soon as possible within 3 days after the missed dose. Thereafter, patients can resume dosing on their usual day of administration. If it is more than 3 days after the missed dose, instruct patients to wait until their next regularly scheduled weekly dose.

2.2 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin

When initiating TANZEUM, consider reducing the dosage of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia .

2.3 Reconstitution of the Lyophilized Powder

The lyophilized powder contained within the Pen must be reconstituted prior to administration. See Patient Instructions for Use for complete administration instructions with illustrations. The instructions may also be found at www.TANZEUM.com. Instruct patients as follows:

Pen Reconstitution

a) Hold the Pen body with the clear cartridge pointing up to see the in the number window. b) To reconstitute the lyophilized powder with the diluent in the Pen, twist the clear cartridge on the Pen in the direction of the arrow until the Pen is felt/heard to “click” into place and the is seen in the number window. This mixes the diluent with the lyophilized powder. c) Slowly and gently rock the Pen side-to-side 5 times to mix the reconstituted solution of TANZEUM. Advise the patient to not shake the Pen hard to avoid foaming. d) Wait 15 minutes for the 30-mg Pen and 30 minutes for the 50-mg Pen to ensure that the reconstituted solution is mixed.

Preparing Pen for Injection

e) Slowly and gently rock the Pen side-to-side 5 additional times to mix the reconstituted solution. f) Visually inspect the reconstituted solution in the viewing window for particulate matter. The reconstituted solution will be yellow in color. After reconstitution, use TANZEUM within 8 hours. g) Holding the Pen upright, attach the needle to the Pen by pushing it straight down until there is a click and the needle snaps into place. Gently tap the clear cartridge to bring large bubbles to the top.

See Dosage and Administration (2.5) for important administration instructions, including the injection procedure.

Alternate Method of Reconstitution (Healthcare Professional Use Only)

The Patient Instructions for Use provide directions for the patient to wait 15 minutes for the 30-mg Pen and 30 minutes for the 50-mg Pen after the lyophilized powder and diluent are mixed to ensure reconstitution.

Healthcare professionals may utilize the following alternate method of reconstitution. Because this method relies on appropriate swirling and visual inspection of the solution, it should only be performed by healthcare professionals.

a) Follow Step A (Inspect Your Pen and Mix Your Medication) in the Instructions for Use. Make sure you have: • Inspected the Pen for in the number window and expiration date. • Twisted the clear cartridge until appears in the number window and a “click” is heard. This combines the medicine powder and liquid in the clear cartridge. b) Hold the Pen with the clear cartridge pointing up and maintain this orientation throughout the reconstitution. c) Gently swirl the Pen in small circular motions for at least one minute. Avoid shaking as this can result in foaming, which may affect the dose. d) Inspect the solution, and if needed, continue to gently swirl the Pen until all the powder is dissolved and you see a clear yellow solution that is free of particles. A small amount of foam, on top of the solution at the end of reconstitution, is normal. • For 30-mg Pen: Complete dissolution usually occurs within 2 minutes but may take up to 5 minutes, as confirmed by visual inspection for a clear yellow solution free of particles.  • For 50-mg Pen: Complete dissolution usually occurs within 7 minutes but may take up to 10 minutes. e) After reconstitution, continue to follow the steps in the Instructions for Use, starting at Step B: Attach the Needle.

2.4 Important Administration Instructions

Instruct patients as follows:

• The pen should be used within 8 hours of reconstitution prior to attaching the needle. • After attaching the supplied needle, remove air bubbles by slowly twisting the Pen until you see the in the number window. At the same time, the injection button will be automatically released from the bottom of the Pen. • Use immediately after the needle is attached and primed. The product can clog the needle if allowed to dry in the primed needle. • After subcutaneously inserting the needle into the skin in the abdomen, thigh, or upper arm region, press the injection button. Hold the injection button until you hear a “click” and then hold the button for 5 additional seconds to deliver the full dose.

When using TANZEUM with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject TANZEUM and insulin in the same body region but the injections should not be adjacent to each other.

When injecting in the same body region, advise patients to use a different injection site each week. TANZEUM must not be administered intravenously or intramuscularly.

Close 3 DOSAGE FORMS AND STRENGTHS

TANZEUM is supplied as follows:

• For injection: 30-mg lyophilized powder in a single-dose Pen (pen injector) for reconstitution. • For injection: 50-mg lyophilized powder in a single-dose Pen (pen injector) for reconstitution. Close 4 CONTRAINDICATIONS • Medullary Thyroid Carcinoma

TANZEUM is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) .

• Hypersensitivity

TANZEUM is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components. Serious hypersensitivity reactions including angioedema have been reported with TANZEUM.

Close 5 WARNINGS AND PRECAUTIONS

5.1 Risk of Thyroid C-Cell Tumors

Carcinogenicity of albiglutide could not be assessed in rodents due to the rapid development of drug-clearing, anti-drug antibodies . Other GLP-1 receptor agonists have caused dose-related and treatment–duration-dependent thyroid C-cell tumors (adenomas or carcinomas) in rodents. Human relevance of GLP-1 receptor-agonist-induced C-cell tumors in rodents has not been determined. It is unknown whether TANZEUM causes thyroid C-cell tumors, including MTC, in humans .

Across 8 Phase III clinical trials , MTC was diagnosed in 1 patient receiving TANZEUM and 1 patient receiving placebo. Both patients had markedly elevated serum calcitonin levels at baseline. Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

TANZEUM is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of TANZEUM and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TANZEUM. Such monitoring may increase the risk of unnecessary procedures, due to the low specificity of serum calcitonin testing for MTC and a high background incidence of thyroid disease. Significantly elevated serum calcitonin may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

5.2 Acute Pancreatitis

In clinical trials, acute pancreatitis has been reported in association with TANZEUM.

Across 8 Phase III clinical trials , pancreatitis adjudicated as likely related to therapy occurred more frequently in patients receiving TANZEUM (6 of 2,365 ) than in patients receiving placebo (0 of 468 ) or active comparators (2 of 2,062 ).

After initiation of TANZEUM, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, promptly discontinue TANZEUM. If pancreatitis is confirmed, TANZEUM should not be restarted.

TANZEUM has not been studied in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

5.3 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin

The risk of hypoglycemia is increased when TANZEUM is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Therefore, patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting .

5.4 Hypersensitivity Reactions

Serious hypersensitivity reactions (including angioedema and generalized pruritus and rash with dyspnea) have been reported with TANZEUM. If hypersensitivity reactions occur, discontinue use of TANZEUM; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous hypersensitivity reaction to TANZEUM .

Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with TANZEUM.

5.5 Acute Kidney Injury

There have been postmarketing cases of worsening renal function and acute kidney injury in patients treated with TANZEUM, some of which required hemodialysis. Some of the postmarketing events were reported in the absence of gastrointestinal adverse reactions and in patients without known underlying renal disease.

In a trial of TANZEUM in patients with renal impairment , the frequency of such gastrointestinal reactions increased as renal function declined . Because these reactions may worsen renal function, use caution when initiating or escalating doses of TANZEUM in patients with renal impairment and/or in those reporting severe gastrointestinal symptoms. Advise patients treated with TANZEUM of the potential risk of dehydration in relation to gastrointestinal side effects and to take precautions to avoid fluid depletion .

5.6 Macrovascular Outcomes

There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with TANZEUM.

Close 6 ADVERSE REACTIONS

The following serious reactions are described below or elsewhere in the prescribing information:

• Risk of Thyroid C-Cell Tumors • Acute Pancreatitis • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin • Hypersensitivity Reactions • Renal Impairment

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pool of Placebo-Controlled Trials

The data in Table 1 are derived from 4 placebo-controlled trials. TANZEUM was used as monotherapy in 1 trial and as add-on therapy in 3 trials . These data reflect exposure of 923 patients to TANZEUM and a mean duration of exposure to TANZEUM of 93 weeks. The mean age of participants was 55 years, 1% of participants were 75 years or older and 53% of participants were male. The population in these studies was 48% white, 13% African/African American, 7% Asian, and 29% Hispanic/Latino. At baseline, the population had type 2 diabetes for an average of 7 years and had a mean HbA1c of 8.1%. At baseline, 17% of the population in these studies reported peripheral neuropathy and 4% reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR >60 mL/min/1.73 m2) in 91% of the study population and moderately impaired (eGFR 30 to 60 mL/min/1.73 m2) in 9%.

Table 1 shows common adverse reactions excluding hypoglycemia associated with the use of TANZEUM in the pool of placebo-controlled trials. These adverse reactions were not present at baseline, occurred more commonly on TANZEUM than on placebo, and occurred in at least 5% of patients treated with TANZEUM.

Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Patients Treated with TANZEUMa

  a Adverse reactions reported include those occurring with the use of glycemic rescue medications which included metformin (17% for placebo and 10% for TANZEUM) and insulin (24% for placebo and 14% for TANZEUM).   b See below for other events of injection site reactions reported.

Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal complaints occurred more frequently among patients receiving TANZEUM (39%) than patients receiving placebo (33%). In addition to diarrhea and nausea (see Table 1), the following gastrointestinal adverse reactions also occurred more frequently in patients receiving TANZEUM: vomiting (2.6% versus 4.2% for placebo versus TANZEUM), gastroesophageal reflux disease (1.9% versus 3.5% for placebo versus TANZEUM), and dyspepsia (2.8% versus 3.4% for placebo versus TANZEUM). Constipation also contributed to the frequently reported reactions. In the group treated with TANZEUM, investigators graded the severity of GI reactions as “mild” in 56% of cases, “moderate” in 37% of cases, and “severe” in 7% of cases. Discontinuation due to GI adverse reactions occurred in 2% of individuals on TANZEUM or placebo.

Injection Site Reactions: In the pool of placebo-controlled trials, injection site reactions occurred more frequently on TANZEUM (18%) than on placebo (8%). In addition to the term “injection site reaction” (see Table 1), the following other types of injection site reactions also occurred more frequently on TANZEUM: injection site hematoma (1.9% versus 2.1% for placebo versus TANZEUM ), injection site erythema (0.4% versus 1.7% for placebo versus TANZEUM), injection site rash (0% versus 1.4% for placebo versus TANZEUM), injection site hypersensitivity (0% versus 0.8% for placebo versus TANZEUM), and injection site hemorrhage (0.6% versus 0.7% for placebo versus TANZEUM). Injection site pruritus also contributed to the frequently reported reactions. The majority of injection site reactions were judged as “mild” by investigators in both groups (73% for TANZEUM versus 94% for placebo). More patients on TANZEUM than on placebo: discontinued due to an injection site reaction (2% versus 0.2%), experienced more than 2 reactions (38% versus 20%), had a reaction judged by investigators to be “moderate” or “severe” (27% versus 6%), and required local or systemic treatment for the reactions (36% versus 11%).

Pool of Placebo- and Active-Controlled Trials

The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 7 placebo- and active-controlled trials. These trials evaluated the use of TANZEUM as monotherapy, as add-on therapy to oral antidiabetic agents, and as add-on therapy to basal insulin . In this pool, a total of 2,116 patients with type 2 diabetes were treated with TANZEUM for a mean duration of 75 weeks. The mean age of patients treated with TANZEUM was 55 years, 1.5% of the population in these studies was 75 years or older and 51% of participants were male. Forty-eight percent of patients were white, 15% African/African American, 9% Asian, and 26% were Hispanic/Latino. At baseline, the population had diabetes for an average of 8 years and had a mean HbA1c of 8.2%. At baseline, 21% of the population reported peripheral neuropathy and 5% reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR >60 mL/min/1.73 m2) in 92% of the population and moderately impaired (eGFR 30 to 60 mL/min/1.73 m2) in 8% of the population.

In the pool of placebo- and active-controlled trials, the types and frequencies of common adverse reactions excluding hypoglycemia were similar to those listed in Table 1.

Other Adverse Reactions

Hypoglycemia: The proportion of patients experiencing at least one documented symptomatic hypoglycemic episode on TANZEUM and the proportion of patients experiencing at least one severe hypoglycemic episode on TANZEUM in clinical trials is shown in Table 2. Hypoglycemia was more frequent when TANZEUM was added to sulfonylurea or insulin .

Table 2. Incidence (%) of Hypoglycemia in Clinical Trials of TANZEUMa

  OAD = Oral antidiabetic agents.   a Data presented are to the primary endpoint and include only events occurring on-therapy with randomized medications and excludes events occurring after use of glycemic rescue medications (i.e., primarily metformin or insulin).   b In this trial, no documented symptomatic or severe hypoglycemia was reported for TANZEUM 50 mg and these data are omitted from the table.   c Plasma glucose concentration ≤70 mg/dL and presence of hypoglycemic symptoms.   d Event requiring another person to administer a resuscitative action.   e Rate of documented symptomatic hypoglycemia for active controls 18% (glimepiride) and 2% (sitagliptin).

Pneumonia: In the pool of 7 placebo- and active-controlled trials, the adverse reaction of pneumonia was reported more frequently in patients receiving TANZEUM (1.8%) than in patients in the all-comparators group (0.8%). More cases of pneumonia in the group receiving TANZEUM were serious (0.4% for TANZEUM versus 0.1% for all comparators).

Atrial Fibrillation/Flutter: In the pool of 7 placebo- and active-controlled trials, adverse reactions of atrial fibrillation (1.0%) and atrial flutter (0.2%) were reported more frequently for TANZEUM than for all comparators (0.5% and 0%, respectively). In both groups, patients with events were generally male, older, and had underlying renal impairment or cardiac disease (e.g., history of arrhythmia, palpitations, congestive heart failure, cardiomyopathy, etc.).

Appendicitis: In the pool of placebo- and active-controlled trials, serious events of appendicitis occurred in 0.3% of patients treated with TANZEUM compared with 0% among all comparators.

Consistent with the high homology of albiglutide with human GLP-1, the majority of patients (approximately 79%) with anti-albiglutide antibodies also tested positive for anti-GLP-1 antibodies; none were neutralizing. A minority of patients (approximately 17%) who tested positive for anti-albiglutide antibodies also transiently tested positive for antibodies to human albumin.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to albiglutide cannot be directly compared with the incidence of antibodies of other products.

Liver Enzyme Abnormalities: In the pool of placebo- and active-controlled trials, a similar proportion of patients experienced at least one event of alanine aminotransferase (ALT) increase of 3-fold or greater above the upper limit of normal (0.9% and 0.9% for all comparators versus TANZEUM). Three subjects on TANZEUM and one subject in the all-comparator group experienced at least one event of ALT increase of 10-fold or greater above the upper limit of normal. In one of the 3 cases an alternate etiology was identified to explain the rise in liver enzyme (acute viral hepatitis). In one case, insufficient information was obtained to establish or refute a drug-related causality. In the third case, elevation in ALT (10 times the upper limit of normal) was accompanied by an increase in total bilirubin (4 times the upper limit of normal) and occurred 8 days after the first dose of TANZEUM. The etiology of hepatocellular injury was possibly related to TANZEUM but direct attribution to TANZEUM was confounded by the presence of gallstone disease diagnosed on ultrasound 3 weeks after the event.

Gamma Glutamyltransferase (GGT) Increase: In the pool of placebo-controlled trials, the adverse event of increased GGT occurred more frequently in the group treated with TANZEUM (0.9% and 1.5% for placebo versus TANZEUM).

Heart Rate Increase: In the pool of placebo-controlled trials, mean heart rate in patients treated with TANZEUM was higher by an average of 1 to 2 bpm compared with mean heart rate in patients treated with placebo across study visits. The long-term clinical effects of the increase in heart rate have not been established .

6.2 Immunogenicity

Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with TANZEUM may develop anti-albiglutide antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to albiglutide in the studies described below cannot be directly compared with the incidence of antibodies in other studies or to other products.

In the pool of 7 placebo- and active-controlled trials, 116 (5.5%) of 2,098 patients exposed to TANZEUM tested positive for anti-albiglutide antibodies at any time during the trials. None of these antibodies were shown to neutralize the activity of albiglutide in an in vitro bioassay.

6.3 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of TANZEUM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Angioedema.

Close 7 DRUG INTERACTIONS

TANZEUM did not affect the absorption of orally administered medications tested in clinical pharmacology studies to any clinically relevant degree . However, TANZEUM causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with TANZEUM.

Close 8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of TANZEUM in pregnant women. Nonclinical studies have shown reproductive toxicity, but not teratogenicity, in mice treated with albiglutide at up to 39 times human exposure resulting from the maximum recommended dose of 50 mg/week, based on AUC . TANZEUM should not be used during pregnancy unless the expected benefit outweighs the potential risks.

Due to the long washout period for TANZEUM, consider stopping TANZEUM at least 1 month before a planned pregnancy.

There are no data on the effects of TANZEUM on human fertility. Studies in mice showed no effects on fertility . The potential risk to human fertility is unknown.

8.3 Nursing Mothers

There are no adequate data to support the use of TANZEUM during lactation in humans.

It is not known if TANZEUM is excreted into human milk during lactation. Given that TANZEUM is an albumin-based protein therapeutic, it is likely to be present in human milk. Decreased body weight in offspring was observed in mice treated with TANZEUM during gestation and lactation . A decision should be made whether to discontinue nursing or to discontinue TANZEUM, taking into account the importance of the drug to the mother and the potential risks to the infant.

8.4 Pediatric Use

Safety and effectiveness of TANZEUM have not been established in pediatric patients (younger than 18 years).

8.5 Geriatric Use

Of the total number of patients (N = 2,365) in 8 Phase III clinical trials who received TANZEUM, 19% (n = 444) were 65 years and older, and
dailymed.nlm.nih.gov

Leave a Reply

Your email address will not be published. Required fields are marked *