albiglutide (Rx)

Brand and Other Names:Tanzeum
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • 30mg/pen
  • 50mg/pen
  • Available as a single-use injectable pen

Diabetes Mellitus, Type 2

Glucagonlike peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

30 mg SC once weekly; may increase to 50 mg once weekly if glycemic response is inadequate

Limitations of Use

Not recommended as first-line therapy for patients inadequately controlled on diet and exercise; prescribe albiglutide only to patients for whom potential benefits are considered to outweigh potential risks

Has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies in patients with a history of pancreatitis

Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis

Not for patients with pre-existing severe gastrointestinal disease

Has not been studied in combination with prandial insulin

Dosage Modifications

Renal impairment (any severity): No dosage adjustment required

Safety and efficacy not established

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Interactions

Interaction Checker

and albiglutide

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Upper respiratory tract infection (13%)

            Diarrhea (10.5%)

            1-10%

            Nausea (9.6%)

            Injection site reaction (2.1%)

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            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; use caution when initiating or escalating doses in patients with renal impairment and/or in those reporting severe gastrointestinal symptoms; advise patients of potential risk of dehydration in relation to gastrointestinal side effects and to take precautions to avoid fluid depletion

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

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            Pregnancy & Lactation

            Pregnancy Category: C

            Because of the long washout period for albiglutide, consider discontinuing at least 1 month before a planned pregnancy

            Lactation: Unknown if distributed in human breast milk; a decision should be made whether to discontinue breastfeeding or to discontinue albiglutide, taking into account the importance of the drug to the mother and the potential risks to the infant

            Since albiglutide is an albumin-based protein, it should be assumed that it is present in human milk; decreased body weight in offspring was observed in mice treated with albiglutide during gestation and lactation

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Incretin mimetic; analogue of human glucagonlike peptide-1 (GLP-1); acts as GLP-1 receptor agonist to augment glucose-dependent insulin secretion

            Absorption

            Peak plasma time: 3-5 days

            Peak plasma concentration: 1.74 mcg/mL

            AUC: 465 mcg•h/mL

            Steady-state concentration: 4-5 weeks

            Distribution

            Vd: 11 L

            Protein bound: Not assessed

            Metabolism

            Biotransformation studies have not been performed

            Likely follows a metabolic pathway similar to native human serum albumin, which is catabolized primarily in the vascular endothelium

            Elimination

            Half-life: 5 days

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            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
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.