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pegvisomant (Rx)Brand and Other Names:Somavert

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 10mg
  • 15mg
  • 20mg
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Acromegaly

Load: 40 mg SC under physician supervision

Maintenance: 10 mg SC qDay; titrate by 5 mg increments q4-6Weeks according to IGF-1 levels

No more than 30 mg/day maintenance

Monitor: Growth hormone (GH), IGF-1, LFTs (see cautions)

Administration

  • Reconstitiute with 1 mL supplied diluent (sterile water for injection)
  • Inject within 6 hours of reconstitution
  • Rotate injection sites daily

Hepatic Impairment

Obtain baseline LFTs

  • WNL: monitor qMonth for 6 months, then quarterly for 6 months, then bianually for 1yr
  • Elevated, but ≤ 3 times ULN: monitor qMonth for 1 yr, then bianually for 1 yr
  • >3 times ULN: Do not use pegvisomant until full workup for cause of liver dysfunction; if decision made to initiate treatment, monitor LFTs very closely

LFTs During Treatment

  • ≥3 times, but less than 5 times ULN: continue treatment; monitor LFTs qWk and perform comprehensive hepatic workup
  • ≥5 times ULN: Discontinue pegvisomant; perform hepatic workup & monitor serial LFTs; if LFTs normalize, may re-initiate treatment with frequent monitoring
  • Signs or symptoms of hepatitis or other liver injury: hepatic workup; if liver injury confirmed, discontinue pegvisomant

Safety and efficacy not established

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Interactions

Interaction Checker

pegvisomant and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Pain

            Injection site reaction

            Diarrhea

            Nausea

            Flu syndrome

            1-10%

            Injury

            Back pain

            Chest pain

            Dizziness

            Paresthesia

            Edema

            Hypertension

            Sinusitis

            Lipohypertrophy

            Postmarketing Reports

            Elevated transaminases

            Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria)

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            Warnings

            Contraindications

            Hypersensitivity to pegvisomant or latex (vial stopper contains latex)

            Cautions

            Potential for GH deficiency; observe patients for signs or symptoms of GH deficiency; monitor serum IGF-1 q4-6wk

            Lipohypertrophy may occur; rotation of injection site may reduce occurence

            May increase liver function tests

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: not known if crosses in to breast milk, use caution

            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

            Recombinant human growth hormone receptor antagonist, with several polyethylene glycol (PEG) polymers covalently bound

            Pharmacokinetics

            Half-Life: 6 days

            Onset: within 2 wk

            Peak Plasma Time: 33-77 hr

            Bioavailability: 57% (SC)

            Vd: 7 L

            Clearance: Total body: 28-36 mL/hr

            Excretion: unknown

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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