albiglutide

General

**REMS Drug**

**Off Market Drug**
This medication is no longer available in the United States. Information provided here is for reference purposes only.

Pronunciation:
al-bi-gloo-tide


Trade Name(s)

  • Tanzeum

Ther. Class.

antidiabetics

Pharm. Class.

glucagon like peptide 1 glp 1 receptor agonists

Indications

Adjunct to diet and exercise in the treatment of type 2 diabetes mellitus (not recommended as first-line therapy).

Action

Acts as an agonist at the glucagon-like peptide-1 (GLP-1) receptor resulting in augmented glucose-dependent insulin secretion. Bound to a molecule of human albumin which results in prolonged duration of action.

Therapeutic Effect(s):

Improved glycemic control.

Pharmacokinetics

Absorption: Bioavailability following subcutaneous injection unknown.

Distribution: Unknown.

Metabolism and Excretion: Degraded by proteolytic enzymes; albumin portion is broken down by vascular endothelium.

Half-life: 5 days.

TIME/ACTION PROFILE (effect on HbA1c)

ROUTEONSETPEAKDURATION
SUBQwithin 4 wk12 wk†throughout treatment
† Steady-state levels achieved in 4–5 wk.

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity;
  • History of pancreatitis;
  • Personal or family history of medullary thyroid carcinoma
  • Multiple Endocrine Neoplasia syndrome type 2
  • History of severe gastrointestinal disease;
  • Lactation: Discontinue albiglutide or discontinue breast feeding.

Use Cautiously in:

  • Renal impairment (monitor renal function during initiation and dose escalation);
  • Geri:  May be more sensitive to drug effects;
  • OB:  Avoid use during pregnancy (taper and discontinue at least 1 mo prior to planned pregnancy;
  • Pedi:  Safety and effectiveness not established.

Adverse Reactions/Side Effects

GI: PANCREATITIS, diarrhea, nausea, delayed gastric emptying, dyspepsia, reflux

GU: renal impairment (in association with nausea, vomiting, dehydration)

Endo: THYROID C-CELL TUMORS, hypoglycemia (↑ with insulin/sulfonylureas), ↑ risk of thyroid C-cell tumors

Local: injection site reactions

Misc: hypersensitivity reactions

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  • ↑ risk of hypoglycemia with other  antidiabetic agents, especially  insulin  and  sulfonylureas  (dose reduction of insulin or sulfonylureas may be warranted).
  • May alter the absorption of concurrently administered  oral medications.

Route/Dosage

SUBQ (Adults): 30 mg once weekly, may ↑ to 50 mg once weekly if needed.

Availability

Lypohilized powder for subcutaneous injection (requires reconstitution): 30 mg/single-use Pen, 50 mg/single-use Pen

Assessment

  • Observe patient taking concurrent insulin for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety).
  • If thyroid nodules or elevated serum calcitonin are noted, patient should be referred to an endocrinologist.
  • Monitor for signs and symptoms of hypersensitivity reactions (pruritus, rash, dyspnea). If signs and symptoms occur, discontinue therapy and treat symptomatically.
  • Monitor for pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, discontinue albiglutide; if confirmed, do not restart albiglutide.

Lab Test Considerations:

Monitor serum HbA1c periodically during therapy to evaluate effectiveness.

Potential Diagnoses

Implementation

  • Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
  • Albiglutide is not indicated to patients with diabetes type I or for diabetic ketoacidosis.
  • SUBQ Administer once weekly at any time of the day, without regard to food. Day of the wk may be changed as long as last dose was administered 4 or more days before. Inject into abdomen, thigh, or upper arm. Solution should be clear and colorless; do not administer solutions that are discolored or contain particulate matter.
    • Consider decreasing dose of concurrently administered insulin secretagogues (e.g. sulfonylureas) or insulin to reduce risk of hypoglycemia.
    • Follow manufacturer's instructions carefully regarding use of pen for administration. Use within 8 hrs of reconstitution.

Patient/Family Teaching

  • Instruct patient on use of  Tanzeum  pen and to take albiglutide as directed. Pen should never be shared between patients, even if needle is changed. Store pen in refrigerator; do not freeze. After initial use, pen may be stored at room temperature or refrigerated up to 30 days. Keep pen cap on when not in use. Protect from excessive heat and sunlight. Remove and safely discard needle after each injection and store pen without needle attached. Advise patient to read the  Patient Medication Guide  before starting albiglutide and with each Rx refill.
  • If a dose is missed take as soon as possible within 3 days of missed dose. If longer than 3 days are missed, instruct patient to wait and take next dose at usual weekly time.
  • Inform patient that nausea is the most common side effect, but usually decreases over time.
  • Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long-term.
  • Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water and notify health care professional.
  • Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
  • Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness, and health care professional should be notified if significant changes occur.
  • Advise patient to tell health care professional what medications they are taking and to avoid taking new Rx, OTC, vitamins, or herbal products without consulting health care professional.
  • Advise patient to discontinue albiglutide and notify health care professional immediately if signs of pancreatitis (nausea, vomiting, abdominal pain) occur.
  • Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
  • Advise patient to inform health care professional of medication regimen before treatment or surgery.
  • Inform patient of risk of benign and malignant thyroid C-cell tumors. Advise patient to notify health care professional if symptoms of thyroid tumors (lump in neck, hoarseness, trouble swallowing, shortness of breath) or if signs of allergic reaction (swelling of face, lips, tongue, or throat; fainting or feeling dizzy; very rapid heartbeat; problems breathing or swallowing; severe rash or itching) occur.
  • If pregnancy is planned, consider stopping albiglutide at least 1 mo before a planned pregnancy. Insulin is the preferred method of controlling blood glucose during pregnancy. Counsel female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.
  • Emphasize the importance of routine follow-up exams.

Evaluation/Desired Outcomes

Improved glycemic control.