Albiglutide

Name: Albiglutide

Albiglutide Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • symptoms of pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • signs of a thyroid tumor--swelling or a lump in your neck, trouble swallowing, a hoarse voice, or if you feel short of breath;
  • low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or
  • signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

  • nausea, diarrhea;
  • cough, cold or flu symptoms;
  • back pain; or
  • pain, swelling, or irritation where medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Albiglutide Precautions

Serious side effects have been reported with albiglutide including the following:

Acute pancreatitis. Tell your healthcare provider right away if you have some or all of the following symptoms of acute pancreatitis:

  • severe pain in your stomach area (abdomen) that will not go away
  • vomiting
  • pain that may go from your abdomen to your back

Hypoglycemia. Tell your healthcare provider right away if you have some or all of the following symptoms:

  • dizziness or light-headedness
  • sweating
  • confusion
  • headache
  • blurred vision
  • slurred speech
  • shakiness
  • fast heart beat
  • anxiety, irritability, or mood changes
  • hunger
  • feeling jittery

Talk with your healthcare provider about how to treat low blood sugar.

Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Allergic reactions. Stop using albiglutide and get medical help right away if you have any symptoms of an allergic reaction. Do not use albiglutide if you have had an allergic reaction to albiglutide or any of the other ingredients in it. 

Symptoms of a severe allergic reaction with albiglutide may include:

  • swelling of your face, lips, tongue, or throat
  • problems breathing or swallowing
  • severe rash or itching
  • fainting or feeling dizzy
  • very rapid heartbeat

Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may result in loss of fluids (dehydration) which may worsen kidney problems.

Do not take albiglutide if you:

  • are allergic to albiglutide or to any of its ingredients
  • or your family has a history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Albiglutide Food Interactions

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 albiglutide, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

Before taking albiglutide, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to albiglutide or to any of its ingredients
  • severe stomach or intestinal problems
  • previously had pancreatitis
  • you or your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC)
  • you have an endocrine system cancer called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • have or have had problems with your pancreas, kidneys, or liver 
  • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or
    problems with digesting food
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

 

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe nausea and vomiting.

Cautions for Albiglutide

Contraindications

  • Personal or family history of MTC.1

  • MEN 2.1

  • Prior serious hypersensitivity to albiglutide or any component in the formulation.1

Warnings/Precautions

Warnings

Risk of Thyroid C-Cell Tumors

Dose-dependent and treatment-duration-dependent thyroid C-cell tumors found in rats and mice receiving GLP-1 receptor agonists at clinically relevant exposures.1 11 13 Unknown whether albiglutide causes thyroid C-cell tumors, including MTC, in humans; relevance to humans could not be ruled out by clinical or nonclinical studies.1 13

Uncertain value of routine monitoring of serum calcitonin (biological marker of MTC); if serum calcitonin is elevated, refer patient to endocrinologist for further evaluation.1 Unknown whether monitoring serum calcitonin concentrations or thyroid ultrasound examinations mitigates risk of thyroid C-cell tumors.1

Sensitivity Reactions

Hypersensitivity Reactions

Serious hypersensitivity reactions (dyspnea, pruritus, rash) reported.1 Discontinue albiglutide if hypersensitivity reaction occurs and treat patient promptly according to standard of care until manifestations resolve.1

Other Warnings and Precautions

Pancreatitis and Pancreatic Precancerous Changes

Acute pancreatitis reported during clinical trials.1 FDA has been evaluating unpublished findings suggesting an increased risk of pancreatitis and precancerous pancreatic cell changes in patients with type 2 diabetes mellitus receiving incretin mimetics (exenatide, liraglutide, sitagliptin, saxagliptin, alogliptin, linagliptin).14 15 16 FDA will notify healthcare professionals of its conclusions and recommendations when the review is complete or when the agency has additional information to report.14 15

FDA has recommended that clinicians continue to follow the recommendations in the prescribing information for incretin mimetics.14 15 Manufacturer states that if pancreatitis is suspected, promptly discontinue albiglutide and initiate appropriate management.1 If pancreatitis is confirmed, do not restart albiglutide.1

Efficacy and safety not established in patients with a history of pancreatitis; consider other antidiabetic agents in such patients.1

Use with Drugs Known to Cause Hypoglycemia

Patients receiving albiglutide in combination with an insulin secretagogue (e.g., a sulfonylurea) or insulin have an increased risk of hypoglycemia.1 3 4 5 6 7 8 9 10 A lower dosage of the concomitant insulin secretagogue or insulin may be required to reduce this risk.1

Renal Effects

Acute renal failure and worsening of chronic renal failure (sometimes requiring hemodialysis) reported with GLP-1 receptor agonists during postmarketing experience.1 Some patients did not have known underlying renal disease.1 Most events occurred in patients experiencing nausea, vomiting, diarrhea, or dehydration.1 The frequency of GI effects increased as renal function declined.1 Because such adverse GI effects may worsen renal function, use caution when initiating albiglutide or escalating dosage in patients with renal impairment.1 11

Macrovascular Outcomes

Evidence of macrovascular risk reduction with albiglutide or any other antidiabetic agent has not been conclusively demonstrated in controlled clinical trials.1

Specific Populations

Pregnancy

Category C.1

Lactation

Not known whether albiglutide distributed into milk in humans.1 Discontinue nursing or the drug, taking into account the importance of the drug to the woman.1

Pediatric Use

Safety and efficacy not established in pediatric patients younger than 18 years of age.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out. 1

Hepatic Impairment

Limited experience in patients with hepatic impairment; unlikely to affect albiglutide elimination.1 12

Renal Impairment

Systemic exposure increased in patients with severe renal impairment; use caution when initiating albiglutide or escalating dosage in patients with renal impairment.1 (See Special Populations under Dosage and Administration and Renal Effects under Cautions.)

Common Adverse Effects

Upper respiratory tract infection,1 10 diarrhea,1 10 nausea,1 10 injection site reaction,1 cough,1 back pain,1 10 arthralgia,1 sinusitis,1 influenza.1 10

What are some things I need to know or do while I take Albiglutide?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Follow the diet and workout plan that your doctor told you about.
  • Wear disease medical alert ID (identification).
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
  • Talk with your doctor before you drink alcohol.
  • Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
  • Kidney problems have happened with drugs like this one. Sometimes, kidney problems have needed to be treated in the hospital. Dialysis has also been needed. Talk with your doctor.
  • Tell your doctor if you have upset stomach, throwing up, loose stools (diarrhea), or too much sweating. Losing too much fluid may raise your chance of kidney problems. Talk with the doctor.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Pen-injector, Subcutaneous [preservative free]:

Tanzeum: 30 mg (1 ea); 50 mg (1 ea) [contains polysorbate 80]

Reconstitution

Reconstitute powder with the diluent contained in the pen device. Refer to manufacturer's product labeling for full reconstitution instructions. Administer within 8 hours of reconstitution.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, nausea, injection site irritation, back pain, joint pain, cough, or rhinitis. Have patient report immediately to prescriber signs of thyroid cancer (new lump or swelling in the neck, pain in the front of the neck, persistent cough, persistent change in voice like hoarseness, or difficulty swallowing or breathing), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), severe dizziness, passing out, urinary retention, change in amount of urine passed, or signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Adverse Effects

>10%

Upper respiratory tract infection (13%)

Diarrhea (10.5%)

1-10%

Nausea (9.6%)

Injection site reaction (2.1%)

Warnings

Black Box Warnings

Risk of thyroid C-cell tumors

  • Causes thyroid C-cell tumors in rodents; human risk could not be determined
  • Contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with albiglutide

Contraindications

Hypersensitivity

Personal or family history of medullary thyroid carcinoma

Multiple endocrine neoplasia type 2 (MEN-2)

Cautions

Carcinogenicity of albiglutide could not be assessed in rodents due to rapid development of drug-clearing, anti-drug antibodies; other GLP-1 receptor agonists have caused dose-related and treatment-duration-dependent thyroid C-cell tumors (adenomas or carcinomas) in rodents; human relevance of GLP-1 receptor agonist induced C-cell tumors in rodents not determined; cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, reported in postmarketing period; data in these reports are insufficient to establish or exclude causal relationship between MTC and GLP-1 receptor agonist use in humans (see Black Box Warnings and Contraindications); routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with albiglutide; significantly elevated serum calcitonin may indicate MTC; patients with MTC usually have values >50 ng/L; if serum calcitonin is measured and found to be elevated, evaluate patient further; patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated

Acute pancreatitis reported (rare); discontinue if pancreatitis suspected and do not restart if confirmed; consider other antidiabetic therapies in patients with a history of pancreatitis

Hypoglycemia may occur when used in combination with insulin secretagogues (eg, sulfonylureas) or insulin; consider lowering sulfonylurea or insulin dosage when starting albiglutide

Serious hypersensitivity reactions reported, including angioedema and generalized pruritus, rash, and dyspnea; discontinue albiglutide if such reactions occur

Anaphylaxis and angioedema reported with other GLP-1 receptor agonists; use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with therapy

Acute renal failure and worsening of chronic renal failure (some requiring hemodialysis) reported with treatment with GLP-1 receptor agonists; monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions

Clinical trials have not established conclusive evidence of macrovascular risk reduction with albiglutide or any other antidiabetic drug

Administration

SC Preparation

Reconstitution of lyophilized powder

  • To mix the diluent with the lyophilized powder, twist the clear cartridge on the pen in the direction of the arrow until the pen is felt/heard to “click” into place and the [2] is seen in the number window
  • Slowly and gently rock the pen side to side 5 times to mix the reconstituted solution
  • Advise the patient to not shake the pen hard to avoid foaming
  • Wait 15 minutes for the 30-mg pen and 30 minutes for the 50-mg pen to ensure the reconstituted solution is mixed

Preparing pen for injection

  • After the reconstituted solution rests, slowly and gently rock the pen side to side 5 additional times to mix the reconstituted solution
  • Visually inspect the reconstituted solution in the viewing window for particulates
  • The reconstituted solution is yellow
  • After reconstitution, use within 8 hr
  • Holding the pen upright, attach the needle to the pen; gently tap the clear cartridge to bring large bubbles to the top

SC Administration

Administer SC in abdomen, thigh, or upper arm

May be administered any time of day without regard to meals

Administer SC once weekly on the same day each week

The day of weekly administration may be changed as long as the last dose was administered ≥4 days before

Missed dose

  • If a dose is missed, administer as soon as possible within 3 days after the missed dose; thereafter, patients can resume dosing on their usual day of administration
  • If >3 days after the missed dose, instruct patients to wait until their next regularly scheduled weekly dose

Self-administration

  • Use immediately after the needle is attached and primed
  • The product can clog the needle if allowed to dry in the primed needle
  • After inserting the needle SC into the skin in the abdomen, thigh, or upper arm region, press the injection button and HOLD the injection button until you hear a “click” and then hold the button for 5 additional seconds to deliver the full dose

Usual Adult Dose for Diabetes Type 2

Initial dose: 30 mg subcutaneously once a week
-May increase to 50 mg subcutaneously once a week based on individual glycemic response
Maintenance dose: 30 or 50 mg subcutaneously once a week

Comments:
-This drug is not recommended as first-line therapy because of uncertain relevance of the rodent C-cell tumor findings to humans; prescribe only to patients for whom the potential benefits are considered to outweigh the potential risk.
-The dose of concomitantly administered insulin or insulin secretagogues may need to be reduced when starting therapy in order to decrease the risk of hypoglycemia.
-This drug has not been studied in combination with prandial insulin.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Albiglutide Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: C Comments: -Women of childbearing potential should be encouraged to use effective contraception. -This drug should be stopped 1 month prior to a planned pregnancy due to its long washout period.

Animal studies in mice have not shown teratogenicity; reduced estrous cycling at maternally toxic doses has been observed in mice, although no harmful effects with respect to fertility were observed. The potential risk to human fertility is unknown. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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