Albiglutide

Name: Albiglutide

What Is Albiglutide?

Albiglutide is an injectable diabetes medicine that helps control blood sugar levels.

Albiglutide is used together with diet and exercise to treat type 2 diabetes. Albiglutide is usually given after other diabetes medications have been tried without success.

This medicine is not for treating type 1 diabetes.

Albiglutide may also be used for purposes not listed in this medication guide.

You should not use albiglutide if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer). Do not use albiglutide if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

In animal studies, albiglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

You should not use albiglutide if you are allergic to it, or if you have:

  • an endocrine system cancer called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
  • a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or
  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure albiglutide is safe for you, tell your doctor if you have:

  • pancreatitis;
  • stomach disorder such as slowed digestion;
  • an intestinal disorder;
  • liver or kidney disease;
  • if you also use insulin or oral diabetes medicine; or
  • if you have been sick with vomiting or diarrhea.

In animal studies, albiglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

Using albiglutide during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant. If you plan to get pregnant, you should stop using this medicine for at least 1 month before conception. Do not stop using albiglutide without asking your doctor about using a different medicine to treat your diabetes.

It is not known whether albiglutide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to anyone under 18 years old without medical advice.

Albiglutide Brand Names

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

  • Tanzeum

Inform MD

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 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.

 

Albiglutide Overdose

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.

Albiglutide FDA Warning

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).

Albiglutide dosing information

Usual Adult Dose for Diabetes Type 2:

Initial dose: 30 mg subcutaneously once a week
-May increase to 50 mg subcutaneously once a week based on individual glycemic response
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.
-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.

Interactions for Albiglutide

Low potential for pharmacokinetic interactions related to CYP metabolism.1

Orally Administered Drugs

Possible altered rate and extent of absorption of concomitantly administered oral drugs; use caution with concomitantly administered oral drugs.1

Specific Drugs

Drug

Interaction

Comments

Digoxin

No change in peak plasma concentration or overall AUC1 20

No dosage adjustment necessary1

Hormonal contraceptives, oral

No change in peak plasma concentration or overall AUC of ethinyl estradiol and levonorgestrel1

No dosage adjustment necessary1 10

Simvastatin

Decreased AUC and increased peak plasma concentration of simvastatin; increased AUC and peak plasma concentration of simvastatin acid (active metabolite)1

Clinical relevance not known; no dosage adjustment necessary1

Warfarin

No change in peak plasma concentration or overall AUC of R- or S-warfarin; no change in INR1

No dosage adjustment necessary1

Albiglutide Pharmacokinetics

Absorption

Bioavailability

Peak plasma albiglutide concentration achieved in 3–5 days.1 17

Distribution

Plasma Protein Binding

Not studied; albiglutide is an albumin fusion molecule.1

Elimination

Metabolism

Metabolized principally in a manner similar to that of endogenous albumin (in vascular endothelium).1 Resistant to degradation by dipeptidyl peptidase-4 (DPP-4).1 10

Half-life

5 days after sub-Q administration.1

Advice to Patients

  • Importance of patients reading the medication guide prior to initiating therapy and each time the prescription is refilled. 1 11

  • Importance of informing patients that albiglutide causes benign and malignant thyroid C-cell tumors in mice and rats and that relevance of this finding to humans is unknown.1 Patients should report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, dyspnea) to their clinician.1 11

  • Importance of informing patients of the possibility of acute pancreatitis, which may be severe or fatal, with albiglutide therapy.1 Importance of patients informing clinicians if they have a history of pancreatitis.1 Importance of informing patients about signs and symptoms of pancreatitis, including persistent severe abdominal pain sometimes radiating to the back that may or may not be accompanied by vomiting; importance of patient discontinuing albiglutide and promptly notifying clinician if such signs or symptoms occur.1 11

  • Importance of informing patients of risk of hypoglycemia, particularly if concomitant therapy with an insulin secretagogue (e.g., a sulfonylurea) or insulin is used.1 11 Importance of reviewing signs, symptoms, and management of hypoglycemia.1 11

  • Importance of informing patients of possibility of hypersensitivity reactions.1 11 Patients should be instructed to discontinue albiglutide and promptly seek medical advice if symptoms of hypersensitivity occur.1 11

  • Importance of patients reading the manufacturer's instructions for use before starting albiglutide therapy.1 Importance of instructing patient regarding proper use, storage, and disposal of injection pen.1 After dispensing, pens should be stored in the refrigerator, or may be stored at room temperature for up to 4 weeks; injection pens should not be frozen.1 12

  • Importance of informing patients not to take an extra dose of albiglutide to make up for a missed dose.1 If a dose is missed, patients should take the dose as soon as possible within 3 days after the missed dose; the next dose can be taken at the usual weekly time.1 11 If it has been more than 3 days since the missed dose, the dose should be skipped and the next dose taken at the usual weekly time.1 11

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 11

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., gallstones, pancreatitis, history of alcoholism, high triglyceride concentrations).1 11

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Dizziness or passing out.
  • Low blood sugar can happen. The chance of low blood sugar may be raised when albiglutide is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.

Pronunciation

(al bi GLOO tide)

Use Labeled Indications

Diabetes mellitus, type 2: Adjunct to diet and exercise to improve glycemic control in the treatment of type 2 diabetes mellitus (noninsulin dependent, NIDDM)

Contraindications

Severe hypersensitivity to albiglutide or any component of the formulation; history of or family history of medullary thyroid carcinoma (MTC); patients with multiple endocrine neoplasia syndrome type 2 (MEN2)

Drug Interactions

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Insulin: GLP-1 Agonists may enhance the hypoglycemic effect of Insulin. Management: Consider insulin dose reductions when used in combination with glucagon-like peptide-1 agonists. Avoid the use of lixisenatide in patients receiving both basal insulin and a sulfonylurea. Consider therapy modification

MAO Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Quinolone Antibiotics: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Sulfonylureas: GLP-1 Agonists may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose reductions when used in combination with glucagon-like peptide-1 agonists. Avoid the use of lixisenatide in patients receiving both basal insulin and a sulfonylurea. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

For the Consumer

Applies to albiglutide: subcutaneous powder for solution

Along with its needed effects, albiglutide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking albiglutide:

Rare
  • Bloating
  • chills or fever
  • darkened urine
  • fast heartbeat
  • loss of appetite
  • nausea, vomiting, or indigestion
  • pains in the stomach, side, or abdomen, possibly radiating to the back
Incidence not known
  • Anxiety, irritability, or mood changes
  • blurred vision
  • cold sweats
  • confusion
  • difficulty with breathing or swallowing
  • dizziness
  • headache
  • increased hunger
  • shakiness
  • skin itching, rash, or redness
  • slurred speech
  • swelling of the face, throat, or tongue
  • unusual tiredness or weakness

Some side effects of albiglutide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Body aches or pain
  • cough
  • diarrhea
  • ear congestion
  • loss of voice
  • muscle pain or stiffness
  • pain in the joints
  • pain or tenderness around the eyes and cheekbones
  • skin reactions, warmth, or redness at the injection site
  • sneezing
  • stuffy or runny nose

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