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Albiglutide Side Effects

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

For Healthcare Professionals

Applies to albiglutide: subcutaneous powder for injection

Gastrointestinal

Very common (10% or more): Diarrhea (13.1%), nausea (11.1%),
Common (1% to 10%): Vomiting, gastroesophageal reflux disease, dyspepsia, constipation
Uncommon (0.1% to 1%): Appendicitis, acute pancreatitis, intestinal obstruction[Ref]

The incidence of pancreatitis (adjudicated as likely to be related to therapy) in clinical trials was 0.3% compared with 0% for placebo and 0.1% for comparators (e.g., liraglutide, pioglitazone, glimepiride, sitagliptin, and insulin glargine) with or without background antidiabetic therapy (e.g. metformin)

Gastrointestinal events occurred more frequently with this drug compared to comparators (38% versus 32%). Diarrhea (13% vs 9%), nausea (12% vs 11%), vomiting (5% vs 4%), and constipation (5% vs 4%) were the most commonly reported , and the majority of events occurred within the first 6 months.[Ref]

Immunologic

Very common (10% or more): Positive test for anti-albiglutide antibodies[Ref]

Local

Very common (10% or more): Injection site reaction (up to 15%)
Common (1% to 10%): Injection site hematoma, erythema, rash, and/or pruritus
Uncommon (0.1% to 1%): Injection site hypersensitivity and/or hemorrhage[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (when used in combination with insulin or sulfonylurea)
Common (1% to 10%): Hypoglycemia (when used as monotherapy in combination with metformin or pioglitazone)[Ref]

Musculoskeletal

Very common (10% or more): Back pain (6.7%), arthralgia (6.6%)[Ref]

Other

Very common (10% or more): Influenza (5.2%)[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (14.2%), cough (6.9%), sinusitis (6.2%)
Common (1% to 10%): Pneumonia[Ref]

Cardiovascular

Common (1% to 10%): Atrial fibrillation
Uncommon (0.1% to 1%): Atrial flutter[Ref]

Hepatic

Common (1% to 10%): Increased ALT, gamma glutamyltransferase[Ref]

Hypersensitivity

Frequency not reported: Pruritus, rash, dyspnea[Ref]

Oncologic

Frequency not reported: Risk of Thyroid C-cell Tumors[Ref]

Medullary thyroid cancer (MTC) was diagnosed in 1 patient receiving this drug and 1 patient receiving placebo across 8 phase 3 clinical trials. Both of these patients had markedly elevated serum calcitonin levels at baseline.[Ref]

Renal

Frequency not reported: Renal impairment[Ref]

References

1. "Product Information. Tanzeum (albiglutide)." GlaxoSmithKline, Research Triangle Park, NC.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Some side effects of albiglutide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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