albiglutide

albiglutide

(al-bi-gloo-tide),

Tanzeum

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: glucagon like peptide 1 glp 1 receptor agonists
Pregnancy Category: C

Indications

Adjunct to diet and exercise in the treatment of type 2 diabetes mellitus.

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 effects

Improved glycemic control.

Pharmacokinetics

Absorption: Absorption follows subcutaneous injection.
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
subcutwithin 4 wk12 wk†throughout treatment
† Steady-state levels achieved in 4–5 wk.

Contraindications/Precautions

Contraindicated in: Hypersensitivity; History of pancreatitis; Personal/family history of medullary thyroid cell cancer (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 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); Geriatric: Elderly patients may be more sensitive to drug effects; Obstetric: Avoid use during pregnancy (taper and discontinue at least 1 mo prior to planned pregnancy; Pediatric: Safe and effective use in children <18 yr has not been established.

Adverse Reactions/Side Effects

Gastrointestinal

  • pancreatitis (life-threatening)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • delayed gastric empyting
  • dyspepsia
  • reflux

Genitourinary

  • renal impairment (in association with nausea, vomiting, dehydration)

Endocrinologic

  • hypoglycemia (↑ with insulin/sulfonylureas) (most frequent)
  • ↑ risk of thyroid C-cell tumors

Local

  • injection site reactions (most frequent)

Miscellaneous

  • hypersensitivity reactions

Interactions

Drug-Drug interaction

↑ 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

Subcutaneous (Adults) 30 mg once weekly, may be ↑ 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

Nursing implications

Nursing 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 Nursing Diagnoses

Imbalanced nutrition: more than body requirements (Indications)
Noncompliance (Patient/Family Teaching)

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.
  • Subcutaneous: Administer once weekly at any time of the day, without regard to food. Day of the week 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 notify discontinue albiglutide and health care professional immediately if signs of pancreatitis (nausea, vomiting, abdominal pain) occur.
  • 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 breastfeeding.
  • Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
  • Emphasize the importance of routine follow-up exams.

Evaluation/Desired Outcomes

  • Improved glycemic control.
References in periodicals archive ?
Those approved in the United States are albiglutide (Tanzeum), dulaglutide (Trulicity), exenatide (Byetta, Bydureon), and liraglutide (Saxenda, Victoza).
There are six new drugs belonging to the endocrine /metabolic pharmacologic class: albiglutide (Tanzeum), dapagliflozin (Farxiga), dulaglutide (Trulicity), eliglustat (Cerdelga), elosulfase alfa (Vimizim), and empagliflozin (Jardiance).
Six late-stage pipeline products are expected to be launched during the forecast period, such as dulaglutide, albiglutide, trelagliptin, and tofogliflozin.
Safety data for albiglutide in these studies were also consistent with the results observed up to year one.
It was a quiet day in the North Index, with Glaxo announcing the submission of a marketing authorisation application for the diabetes drug Albiglutide to the European Medicines Agency.
GSK and Human Genome share rights to Benlysta, but GSK is in charge of developing both the new heart drug darapladib and albiglutide for diabetes.
GlaxoSmithKline will push ahead with plans to file its experimental once-weekly diabetes drug albiglutide for regulatory approval, following the read-out from a series of clinical trials.
GSK to acquire full ownership of BENLYSTA([R]), albiglutide and darapladib
There are six new drugs belonging to the endocrine/metabolic pharmacologic class: albiglutide (Tanzeum), dapagliflozin (Farxiga), dulaglutide (Trulicity), eliglustat (Cerdelga), elosulfase alfa (Vimizim), and empagliflozin (Jardiance).
Vlad Hogenhuis, Senior Vice-President and Head, Cardiovascular, Metabolic and Neurosciences Franchise, GSK, said, "While many phase III trials in type 2 diabetes are typically six months in duration, we set out to assess weekly-administered albiglutide for up to three years.
Albiglutide, a glucagon-like peptide-1 receptor agonist (GLP-1), is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen supplied with a 5mm 29-gauge thin-walled needle.
The once-weekly administered diabetes drug, Albiglutide, is to be submitted for regulatory approval.