Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (1)
- macimorelin
pegvisomant, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that may blunt the growth hormone (GH) response to macrimorelin may impact the accuracy of the diagnostic test. Discontinue GH products at least 1 week before administering macimorelin. .
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.
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)
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
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.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
Images
Patient Handout
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 and Instructions for Use 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. The dosage is based on your medical condition, lab tests, and response to treatment.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 last or get worse, 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 you have any very serious side effects, including: signs of liver problems (such as nausea/vomiting that doesn't stop, 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. 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 2023. Copyright(c) 2023 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.
Formulary
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