Albiglutide

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.

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 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 is part of the drug class:

• Other blood glucose lowering drugs, excl. insulins

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.

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.

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.

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

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

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.)

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.

• 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.

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 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.

• 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.

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

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

eGFR <15 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling.

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, changes in hepatic function are not likely to have an effect on elimination.

Reactions reported from monotherapy and combination therapy.

>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 [2%], hypersensitivity reaction at injection site [1%], rash at injection site [1%], 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%)

<1% (Limited to important or life-threatening): Appendicitis, atrial flutter, hypersensitivity, increased serum ALT, increased serum bilirubin, pancreatitis

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:
-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.

Decreased body weight has been observed in the offspring of mice whose moms were treated with this drug during gestation and lactation. There are no data of use during lactation in humans.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comment: Since this drug is an albumin-based protein therapeutic, it is likely to be present in human milk.