pegvisomant (Rx)

Brand and Other Names:Somavert
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 10mg
  • 15mg
  • 20mg

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; determine if cholelithiasis or choledocholithiasis present, especially in patients with history of prior therapy with somatostatin analogs; if decision made to initiate treatment, monitor LFTs and clinical symptoms very closely

LFTs During Treatment

  • ≥3 times, but <5 times ULN (without signs/symptoms of hepatitis or other liver injury, or increase in serum total bilirubin, TBIL): Continue treatment; monitor LFTs qWk and perform comprehensive hepatic workup
  • ≥5 times ULN or transaminase elevations >3x ULN associated with increase in serum TBIL (with or without signs/symptoms of hepatitis or other liver injury): Discontinue therapy; perform hepatic workup & monitor serial LFTs; if LFTs normalize (regardless of whether alternative cause of liver dysfunction discovered), may re-initiate treatment with frequent monitoring
  • Signs or symptoms of hepatitis or other liver injury: Perform hepatic workup; if liver injury confirmed, discontinue pegvisomant

Safety and efficacy not established

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Interactions

Interaction Checker

and pegvisomant

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (31)

                • albiglutide

                  pegvisomant increases effects of albiglutide by Other (see comment). Use Caution/Monitor. Comment: Pegvisomant may increase glucose tolerance. Dosage reductions of antidiabetic agents may be needed to avoid potential hypoglycemia.

                • alfentanil

                  alfentanil decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • belladonna and opium

                  belladonna and opium decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • buprenorphine

                  buprenorphine decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • buprenorphine buccal

                  buprenorphine buccal decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • butorphanol

                  butorphanol decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • codeine

                  codeine decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • dextromoramide

                  dextromoramide decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • diamorphine

                  diamorphine decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • difenoxin hcl

                  difenoxin hcl decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • diphenoxylate hcl

                  diphenoxylate hcl decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • dipipanone

                  dipipanone decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • exenatide injectable solution

                  pegvisomant increases effects of exenatide injectable solution by pharmacodynamic synergism. Use Caution/Monitor. Pegvisomant may increase glucose tolerance. Dosage reductions of antidiabetic agents may be needed to avoid potential hypoglycemia.

                • hydrocodone

                  hydrocodone will decrease the level or effect of pegvisomant by unknown mechanism. Use Caution/Monitor. Prescribing information describes higher pegvisomant doses are required to control insulinlike growth factor levels when coadministered with opioids.

                • hydromorphone

                  hydromorphone decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • levorphanol

                  levorphanol decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • liraglutide

                  pegvisomant increases effects of liraglutide by Other (see comment). Use Caution/Monitor. Comment: Pegvisomant may increase glucose tolerance. Dosage reductions of antidiabetic agents may be needed to avoid potential hypoglycemia.

                • meperidine

                  meperidine decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • methadone

                  methadone decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • morphine

                  morphine decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • nalbuphine

                  nalbuphine decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • opium tincture

                  opium tincture decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • oxycodone

                  oxycodone decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • oxymorphone

                  oxymorphone decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • papaveretum

                  papaveretum decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • pegloticase

                  pegloticase will decrease the level or effect of pegvisomant by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknown

                • pegvaliase

                  pegvaliase, pegvisomant. Other (see comment). Use Caution/Monitor. Comment: The majority of patients treated with pegvaliase develop anti-polyethylene glycol (PEG) IgM and IgG antibodies. Risk of coadministration with different PEGylated products is unknown. There is a case report of anaphylaxis following a medroxyprogesterone acetate injectable suspension that contained PEG 3350. Carefully read all drug labels, including OTC drugs to check contents for PEG. Note: Unable to include an exhaustive product list for this interaction.

                • pentazocine

                  pentazocine decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • sufentanil

                  sufentanil decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • tapentadol

                  tapentadol decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                • tramadol

                  tramadol decreases effects of pegvisomant by unknown mechanism. Use Caution/Monitor.

                Minor (23)

                • acarbose

                  pegvisomant increases effects of acarbose by pharmacodynamic synergism. Minor/Significance Unknown.

                • chlorpropamide

                  pegvisomant increases effects of chlorpropamide by pharmacodynamic synergism. Minor/Significance Unknown.

                • glimepiride

                  pegvisomant increases effects of glimepiride by pharmacodynamic synergism. Minor/Significance Unknown.

                • glipizide

                  pegvisomant increases effects of glipizide by pharmacodynamic synergism. Minor/Significance Unknown.

                • glyburide

                  pegvisomant increases effects of glyburide by pharmacodynamic synergism. Minor/Significance Unknown.

                • insulin aspart

                  pegvisomant increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown.

                • insulin detemir

                  pegvisomant increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown.

                • insulin glargine

                  pegvisomant increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown.

                • insulin glulisine

                  pegvisomant increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown.

                • insulin lispro

                  pegvisomant increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown.

                • insulin NPH

                  pegvisomant increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown.

                • insulin regular human

                  pegvisomant increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown.

                • metformin

                  pegvisomant increases effects of metformin by pharmacodynamic synergism. Minor/Significance Unknown.

                • miglitol

                  pegvisomant increases effects of miglitol by pharmacodynamic synergism. Minor/Significance Unknown.

                • nateglinide

                  pegvisomant increases effects of nateglinide by pharmacodynamic synergism. Minor/Significance Unknown.

                • pioglitazone

                  pegvisomant increases effects of pioglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

                • repaglinide

                  pegvisomant increases effects of repaglinide by pharmacodynamic synergism. Minor/Significance Unknown.

                • rosiglitazone

                  pegvisomant increases effects of rosiglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

                • saxagliptin

                  pegvisomant increases effects of saxagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

                • sitagliptin

                  pegvisomant increases effects of sitagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

                • tolazamide

                  pegvisomant increases effects of tolazamide by pharmacodynamic synergism. Minor/Significance Unknown.

                • tolbutamide

                  pegvisomant increases effects of tolbutamide by pharmacodynamic synergism. Minor/Significance Unknown.

                • vildagliptin

                  pegvisomant increases effects of vildagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

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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; obtain baseline serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP) levels prior to initiating therapy

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                Pregnancy & Lactation

                Pregnancy

                Postmarketing reports of use in pregnant women are insufficient to establish a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes

                Published data from case reports, case series, and a small interventional study in pregnant women with acromegaly have demonstrated that acromegaly may improve or stabilize without treatment during pregnancy, particularly if acromegaly is treated before pregnancy

                In rare cases, acromegaly may worsen during pregnancy; since IGF-1 levels may change physiologically during pregnancy and interpreting IGF-1 and growth hormone levels in pregnant women with acromegaly may be unreliable, clinical monitoring is recommended

                Animal data

                • In animal reproduction studies, fetotoxicity was observed at a dose that was 6 times maximum recommended human dose based on body surface area following subcutaneous administration during organogenesis or during preimplantation period

                Reproductive potential

                • Discuss potential for unintended pregnancy with premenopausal women as therapeutic benefits of a reduction in growth hormone (GH) levels and normalization of insulin-like growth factor 1 (IGF-1) concentration in acromegalic females treated with pegvisomant may lead to improved fertility

                Lactation

                Limited information from a case report in published literature reported that the level of the drug in human milk was below the level of detection

                There is no information available on effects of the drug on breastfed infant or effects on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

                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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                Images

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                Patient Handout

                Patient Education
                pegvisomant subcutaneous

                PEGVISOMANT - INJECTION

                (peg-VIH-so-mant)

                COMMON BRAND NAME(S): Somavert

                USES: Pegvisomant is used to treat a certain condition called acromegaly. Acromegaly occurs when the body makes too much growth hormone and other natural substances such as insulin-like growth factor-I (IGF-I). Pegvisomant is usually used if you have not responded to other treatments (such as surgery, radiation, other medications). Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Pegvisomant works by blocking the action of growth hormone and by reducing the amount of IGF-I to normal levels.

                HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using pegvisomant and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Inject this medication under the skin as directed by your doctor, usually once daily into the upper arm, upper thigh, stomach area, or buttock. Dosage is based on your medical condition, lab test results, and response to treatment. Do not use more than 30 milligrams daily unless directed by your doctor.The first dose is usually given by a health care professional. If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Take your dose out of the refrigerator and let it warm to room temperature. Do not shake the vial when preparing this medication. Gently roll the vial back and forth in your palms to dissolve the powder in the mixing solution.Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site daily to lessen injury under the skin. Choose areas that are not bruised, lumpy, or irritated.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Learn how to store and discard needles and medical supplies safely.Tell your doctor if your condition does not improve or if it worsens.

                SIDE EFFECTS: Lumps may occur under the skin if the same injection site is used often. To reduce the chance of this side effect, change the injection site daily. Redness/swelling at the injection site, pain, diarrhea, or nausea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Get medical help right away if any of these rare but serious side effects occur: signs of liver problems (such as persistent nausea, vomiting, stomach/abdominal pain, unusual tiredness, yellowing eyes/skin, dark urine).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the product packaging), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.If you have diabetes, pegvisomant may help improve symptoms of diabetes, such as lowering high blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: somatostatin analogs (such as lanreotide, octreotide).

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: increased tiredness.

                NOTES: Do not share this medication with others.Lab and/or medical tests (such as liver function tests, IGF-I levels) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

                MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. Use this medication immediately after mixing or within the time period indicated in the product instructions. Discard any unused portion remaining in the vial. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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