Tanzeum

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Tanzeum slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Tanzeum

may affect the way some medicines work and some other medicines may affect the way Tanzeum works.

Especially tell your doctor if you take:

• insulin, or any other anti-diabetes medicines
• birth control pills that are taken by mouth (oral contraceptives)
• digoxin (Digox, Lanoxin)
• warfarin (Coumadin, Jantoven)
• simvastatin (Zocor)

​This is not a complete list of Tanzeum drug interactions. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tanzeum, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tanzeum falls into category C. There are no well-controlled studies that have been done in pregnant women. Tanzeum should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on how you respond to this medication.

The recommended dose of Tanzeum used to control blood glucose (sugar) in people with type 2 diabetes is 30 mg once every seven days (weekly). The dose can be administered at any time of day, with or without meals.

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• Store in a refrigerator. Do not freeze.
• Store in original container.
• This medicine may be stored at room temperature for up to 4 weeks before use.
• Do not use if it has been frozen.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Tanzeum is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].

Limitations of Use:

Carcinogenesis, Mutagenesis, Impairment of Fertility

As albiglutide is a recombinant protein, no genotoxicity studies have been conducted.

Carcinogenicity of albiglutide could not be assessed in rodents due to the rapid development of drug-clearing, anti-drug antibodies. Other GLP-1 receptor agonists have caused thyroid C-cell tumors in rodent carcinogenicity studies. Human relevance of GLP-1 receptor agonist induced rodent thyroid C-cell tumors has not been determined.

In a mouse fertility study, males were treated with SC doses of 5, 15, or 50 mg/kg/day for 7 days prior to cohabitation with females and continuing through mating. In a separate fertility study, females were treated with SC doses of 1, 5, or 50 mg/kg/day for 7 days prior to cohabitation with males and continuing through mating. Reductions in estrous cycles were observed at 50 mg/kg/day, a dose associated with maternal toxicity (body weight loss and reduced food consumption). There were no effects on mating or fertility in either sex at doses up to 50 mg/kg/day (up to 39 times clinical exposure based on AUC).

Reproductive and Developmental Toxicity

In order to minimize the impact of the drug-clearing, anti-drug antibody response, reproductive and developmental toxicity assessments in the mouse were partitioned to limit the dosing period to no more than approximately 15 days in each study.

In pregnant mice given SC doses of 1, 5, or 50 mg/kg/day from gestation Day 1 to 6, there were no adverse effects on early embryonic development through implantation at 50 mg/kg/day (39 times clinical exposure based on AUC).

In pregnant mice given SC doses of 1, 5, or 50 mg/kg/day from gestation Day 6 through 15 (organogenesis), embryo-fetal lethality (post-implantation loss) and bent (wavy) ribs were observed at 50 mg/kg/day (39 times clinical exposure based on AUC), a dose associated with maternal toxicity (body weight loss and reduced food consumption).

Pregnant mice were given SC doses of 1, 5, or 50 mg/kg/day from gestation Day 6 to 17. Offspring of pregnant mice given 50 mg/kg/day (39 times clinical exposure based on AUC), a dose associated with maternal toxicity, had reduced body weight pre-weaning, dehydration and coldness, and a delay in balanopreputial separation.

Pregnant mice were given SC doses of 1, 5, or 50 mg/kg/day from gestation Day 15 to lactation Day 10. Increased mortality and morbidity were seen at all doses (≥1 mg/kg/day) in lactating females in mouse pre- and postnatal development studies. Mortalities have not been observed in previous toxicology studies in non-lactating or non-pregnant mice, nor in pregnant mice. These findings are consistent with lactational ileus syndrome which has been previously reported in mice. Since the relative stress of lactation energy demands is lower in humans than mice and humans have large energy reserves, the mortalities observed in lactating mice are of questionable relevance to humans. The offspring had decreased pre-weaning body weight which reversed post-weaning in males but not females at ≥5 mg/kg/day (2.2 times clinical exposure based on AUC) with no other effects on development. Low levels of albiglutide were detected in plasma of offspring.

Lactating mice were given SC doses of 1, 5, or 50 mg/kg/day from lactation Day 7 to 21 (weaning) under conditions that limit the impact of lactational ileus (increased caloric intake and culling of litters). Doses ≥1 mg/kg/day (exposures below clinical AUC) caused reduced weight gain in the pups during the treatment period.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 30 mg subcutaneously once a week, on the same day each week

May be increased to 50 mg subcutaneously once a week if glycemic response is inadequate.

Comments: The day of weekly administration may be changed if necessary as long as the last dose was administered 4 or more days before.

Use: Adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Common side effects of Tanzeum include: injection site reaction, diarrhea, and nausea. Other side effects include: vomiting. See below for a comprehensive list of adverse effects.

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 (the active ingredient contained in Tanzeum) 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]

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