Version May 2024
Acromegaly:
Note: For use in patients with persistent, significant disease despite surgical resection or radiation therapy, or in patients who are not candidates for such therapies; may be used either as monotherapy or in combination with a somatostatin analog (eg, octreotide, lanreotide) (Ref). May be preferred over somatostatin analogs in patients with diabetes mellitus due to favorable glycemic effects (Ref).
Initial: SUBQ: 40 mg as a single loading dose, followed by 10 mg once daily beginning the day after the loading dose.
Dosage adjustment: Increase or decrease dose in 5 mg increments every 4 to 6 weeks based on insulin-like growth factor 1 concentrations (recommended maintenance range: 10 to 30 mg/day; maximum maintenance dose: 30 mg/day).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
At initiation of therapy:
Normal liver function test (LFT): No dosage adjustment necessary; monitor LFT monthly for first 6 months, quarterly for next 6 months, then biannually the following year.
Baseline LFT elevated but ≤3 x ULN: No dosage adjustment necessary; monitor LFT monthly for at least 1 year then biannually the following year.
Baseline LFT >3 times ULN: Do not initiate treatment without comprehensive work-up to determine cause; determine if cholelithiasis or choledocholithiasis is present (particularly if prior history of somatostatin analog therapy). Based on work-up may consider initiating therapy; there are no specific dosage adjustments provided in the manufacturer labeling if treatment is initiated; monitor LFT and clinical symptoms very closely.
With ongoing therapy:
LFT ≥3 x but <5 x ULN without signs/symptoms of hepatitis, hepatic injury, or increase in total bilirubin: Continue treatment, but monitor LFT weekly for further increases; perform comprehensive hepatic work-up to rule out alternative cause of hepatic dysfunction
LFT ≥5 x ULN or transaminase ≥3 x ULN associated with any increase in total bilirubin (with or without signs/symptoms of hepatitis or other liver injury): Discontinue immediately and perform comprehensive hepatic work-up. If LFTs return to normal, may cautiously consider restarting therapy with frequent LFT monitoring.
Signs or symptoms of hepatitis or hepatic injury: Perform comprehensive hepatic work-up immediately; discontinue permanently if liver injury is confirmed.
Refer to adult dosing; use with caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Pain (8% to 14%)
Gastrointestinal: Diarrhea (≤14%), nausea (≤14%)
Hepatic: Abnormal hepatic function tests (4% to 12%; >10 x ULN: ≤1%; ≤15 times ULN: <2%)
Immunologic: Antibody development (17%; non-neutralizing anti-GH antibodies; relevance unknown)
Infection: Infection (≤23%)
Local: Injection site reaction (4% to 11%)
Respiratory: Flu-like symptoms (4% to 12%)
1% to 10%:
Cardiovascular: Chest pain (≤8%), hypertension (≤8%), peripheral edema (≤8%)
Central nervous system: Dizziness (≤8%), paresthesia (≤7%)
Endocrine & metabolic: Lipohypertrophy (1%)
Neuromuscular & skeletal: Back pain (≤8%)
Respiratory: Sinusitis (≤8%)
Miscellaneous: Accidental injury (≤8%)
<1%, postmarketing, and/or case reports: Anaphylactoid reaction, anaphylaxis, angioedema, erythema, hypersensitivity reaction, increased serum alkaline phosphatase, laryngospasm, pruritus, skin rash, tumor growth, urticaria, weight gain
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to pegvisomant and any component of the formulation.
Concerns related to adverse effects:
• Hepatic effects: May increase liver function tests; transient but marked elevations (≤15 × ULN) in transaminase levels, usually without accompanying hyperbilirubinemia, have been reported with use; transaminase levels often normalized following interruption of therapy. Additionally, elevated transaminase (>20 × ULN) and total bilirubin (>2 × ULN) have been reported in postmarketing studies; discontinuation of therapy resulted in improvement or resolution in most cases.
• Hypersensitivity: Systemic hypersensitivity reactions (eg, anaphylactic reactions, angioedema, laryngospasm, rash, erythema, pruritus, urticaria) have been reported; re-challenge with pegvisomant has been successful in some patients.
• Lipohypertrophy: May occur following administration; daily rotation of injection site may prevent or reduce incidence.
Disease-related concerns:
• Diabetes mellitus: May improve glucose tolerance in some patients. Dosage adjustments of antidiabetic therapy may be necessary.
Other warnings/precautions:
• Administration: The manufacturer recommends the initial dose be administered under the supervision of prescribing health care provider.
• Monitoring: Interferes with commercially available GH assays; do not make dose adjustments based on serum GH concentrations reported from assays; use insulin-like growth factor I (IGF-I) levels to adjust therapy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Subcutaneous [preservative free]:
Somavert: 10 mg (1 ea); 15 mg (1 ea); 20 mg (1 ea); 25 mg (1 ea); 30 mg (1 ea)
No
Solution (reconstituted) (Somavert Subcutaneous)
10 mg (per each): $321.40
15 mg (per each): $482.15
20 mg (per each): $642.82
25 mg (per each): $803.52
30 mg (per each): $964.22
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Subcutaneous:
Somavert: 10 mg (1 ea); 15 mg (1 ea); 20 mg (1 ea); 25 mg (1 ea); 30 mg (1 ea)
SUBQ: For SUBQ administration only; to minimize the risk for lipohypertrophy, rotate injection site daily; if 2 injections are required, select a different injection site for second injection; may administer in upper arm, upper thigh, abdomen, or buttocks; do not rub injection site. Do not use on area of skin with rash, lumps, bruising or on broken skin. The manufacturer recommends the initial dose be administered under the supervision of prescribing healthcare provider.
Acromegaly: Treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate.
Pegvisomant may be confused with peginesatide
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Blood Glucose Lowering Effects: Pegvisomant may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Macimorelin: Products that Affect Growth Hormone may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination
Opioid Agonists: May diminish the therapeutic effect of Pegvisomant. Risk C: Monitor therapy
Pegloticase: May diminish the therapeutic effect of PEGylated Drug Products. Risk C: Monitor therapy
Pegvaliase: PEGylated Drug Products may enhance the adverse/toxic effect of Pegvaliase. Specifically, the risk of anaphylaxis or hypersensitivity reactions may be increased. Risk C: Monitor therapy
Somatostatin Analogs: May enhance the adverse/toxic effect of Pegvisomant. Specifically, this combination may increase the risk for significant elevations of liver enzymes. Risk C: Monitor therapy
Because normalization of insulin-like growth factor 1 and growth hormone may restore fertility in patients with acromegaly, patients who could become pregnant should use adequate contraception during treatment. The Endocrine Society suggests discontinuing pegvisomant approximately 2 months before attempts to conceive; short-acting octreotide may be used until conception if needed (ES [Katznelson 2014]). Pegvisomant should be reserved for use in patients trying to conceive who have severe symptoms that cannot be controlled by other agents (ESE [Luger 2021]).
Pregnancy outcome data concerning use of pegvisomant in pregnancy is limited (Brian 2007; Cheng 2012; ESE [Luger 2021]; Guarda 2020; Qureshi 2006; van der Lely 2015).
Use of pegvisomant during pregnancy is not recommended. If treatment for acromegaly is required during pregnancy for worsening symptoms (eg, headaches or evidence of tumor growth), alternative agents are recommended. Monitoring of insulin-like growth factor 1 (IGF-1) and/or growth hormone (GH) is not recommended during pregnancy, as an active placental GH variant present in maternal blood limits the usefulness of the results (ES [Katznelson 2014]). Pegvisomant should be reserved for use in pregnant patients with severe symptoms that cannot be controlled by other agents (ESE [Luger 2021]).
It is not known if pegvisomant is present in breast milk.
Breast milk concentrations were below the limit of detection (<50 ng/mL) in one woman using pegvisomant 25 mg/day since her third month of pregnancy (time of postpartum milk collection not stated) (Brian 2007).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
MRI to assess growth hormone (GH)–secreting tumor size (consider at 6 and 12 months after initiation of therapy then yearly based on tumor size) (ES [Katznelson 2014]); serum glucose in patients with diabetes mellitus; serum insulin-like growth factor 1 (every 4 to 6 weeks after initial dose and dosage change, every 6 months when normalized, and when multiple injections are converted to single daily injections); GH levels should not be monitored to assess efficacy of pegvisomant (ACG [Melmed 2018]; ES [Katznelson 2014]); signs/symptoms of hepatic dysfunction; hypersensitivity reactions, particularly if performing re-challenge in patients with prior hypersensitivity to pegvisomant.
Liver function tests (ALT, AST, total bilirubin, and alkaline phosphatase levels):
Baseline:
Normal: Monthly for first 6 months, quarterly for next 6 months, biannually for the next year
Elevated, but ≤3 × ULN: Monitor monthly for at least 1 year, then biannually for the next year
>3 × ULN: Withhold treatment; perform comprehensive liver function evaluation (rule out cholelithiasis or choledocholithiasis); if appropriate for treatment, closely monitor hepatic function and clinical status.
During therapy:
≥3 × but <5 × ULN without signs/symptoms of hepatitis, hepatic injury or increase in total bilirubin: Monitor weekly for further increases; perform comprehensive hepatic work-up to rule out alternative cause of dysfunction
≥5 × ULN or transaminase ≥3 × ULN associated with any increase in total bilirubin (with or without signs/symptoms of hepatitis or other liver injury): Discontinue treatment immediately; perform comprehensive hepatic work-up. If hepatic function normalizes (regardless of source of dysfunction) may consider resuming therapy with frequent monitoring of hepatic function
Age-normalized serum insulin-like growth factor 1 (IGF-1) and a random growth hormone (GH) <1 mcg/L correlate with control of acromegaly; consider targeting postoperative GH level <0.4 mcg/L if ultra-sensitive GH assay is available; use of the same IGF-1 and GH assay in the same patient throughout management is suggested. GH levels should not be monitored to assess efficacy of pegvisomant (ACG [Melmed 2018]; ES [Katznelson 2014])
An analogue of human growth hormone, pegvisomant selectively binds to growth hormone (GH) receptors, blocking the binding of endogenous GH, leading to decreased serum concentrations of insulin-like growth factor-1 (IGF-I) and other GH-responsive proteins.
Absorption: SubQ: 57%
Distribution: 7 L
Half-life elimination: ~60 to 138 hours (~2.5 to 6 days)
Time to peak, serum: 33 to 77 hours
Excretion: Urine (<1%)
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