Tanzeum Side Effects

Generic name: albiglutide

Medically reviewed by Drugs.com. Last updated on Oct 19, 2024.

Note: This document provides detailed information about Tanzeum Side Effects associated with albiglutide. Some dosage forms listed on this page may not apply specifically to the brand name Tanzeum.

Applies to albiglutide: subcutaneous powder for solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are using albiglutide (the active ingredient contained in Tanzeum) unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Check with your doctor right away if you have the following symptoms while using this medicine: a mass in the neck, difficulty with swallowing, hoarseness, or troubled breathing. These may be symptoms of a serious thyroid problem.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use albiglutide with other medicines that can lower blood sugar, such as insulin, metformin, or a sulfonylurea. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.

• Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
• If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

• Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst.
• If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Common side effects of Tanzeum

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:

Serious side effects of Tanzeum

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:

For healthcare professionals

Applies to albiglutide: subcutaneous powder for injection.

General adverse events

The most commonly reported adverse reactions have included diarrhea, nausea, and injection site reactions which have included rash, erythema, or itching at the injection site.

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 than 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]

Hypersensitivity

• Frequency not reported: Pruritus, rash, dyspnea
• Postmarketing reports: Angioedema^[Ref]

Oncologic

• Very rare (less than 0.01%): Medullary thyroid cancer^[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. MTC has been reported in patients treated with liraglutide, another GLP-1 receptor agonist. The data is insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor use in humans.^[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)
• Frequency not reported: Decreased appetite^[Ref]

Renal

• Frequency not reported: Acute renal failure
• Postmarketing reports: Acute renal failure, worsening of chronic renal failure, sometimes requiring hemodialysis^[Ref]

Acute renal failure has been reported and may have been the result of dehydration. Postmarketing reports of acute renal failure and worsening chronic renal failure, sometimes requiring hemodialysis, have been reported. Some of these reports have been in patients without known kidney disease. A majority of patients had experienced nausea, vomiting, diarrhea, or dehydration.^[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
• Frequency not reported: Increased heart rate^[Ref]

Hepatic

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

Immunologic

• Very common (10% or more): Positive test for anti-albiglutide (the active ingredient contained in Tanzeum) antibodies^[Ref]

In a pooled trials, 116 (5.5%) of 2,098 patients exposed to this drug tested positive for anti-albiglutide antibodies at any time during the trials. None of these antibodies were shown to neutralize the activity of albiglutide in an in vitro bioassay.^[Ref]

See also:

Further information

Tanzeum side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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