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Somavert is a brand name for Pegvisomant. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-I concentrations or was not tolerated.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated under the supervision of a physician experienced in the treatment of acromegaly. Posology A loading dose of 80 mg pegvisomant should be administered subcutaneously under medical supervision. Following this, SOMAVERT 10 mg reconstituted in 1 ml of solvent should be administered once daily as a subcutaneous injection.
Dose adjustments should be based on serum IGF-I levels. Serum IGF-I concentrations should be measured every four to six weeks and appropriate dose adjustments made in increments of 5 mg/day in order to maintain the serum IGF-I concentration within the age-adjusted normal range and to maintain an optimal therapeutic response.
Assessment of baseline levels of liver enzymes prior to initiation of SOMAVERT Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests (LTs) [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP)].
4). The maximum dose should not exceed 30 mg/day.
For the different dose regimens, the following strengths are available:
SOMAVERT 10 mg, SOMAVERT 15 mg, SOMAVERT 20 mg, SOMAVERT 25 mg and SOMAVERT 30 mg. Paediatric population The safety and efficacy of SOMAVERT in children aged 0 to 17 years have not been established. No data are available. Elderly No dose adjustment is required.
Hepatic or renal impairment The safety and efficacy of SOMAVERT in patients with renal or hepatic insufficiency has not been established. Method of administration 4 Pegvisomant should be administered by subcutaneous injection. The site of injection should be rotated daily to help prevent lipohypertrophy.
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Summary of the safety profile The list below contains adverse reactions seen in clinical trials with SOMAVERT. In clinical studies, for patients treated with pegvisomant (n = 550), the majority of adverse reactions to pegvisomant were of mild to moderate intensity, of limited duration and did not require discontinuation of treatment.
The most commonly reported adverse reactions occurring in 10% of patients with acromegaly treated with pegvisomant during the clinical trials were headache 25%, arthralgia 16% and diarrhoea 13%. Tabulated list of adverse reactions The list below contains adverse reactions seen in clinical trials or that were spontaneously reported, classified by system organ class and frequency.
g. g. lipohypertr ophy)a, influenza-like illness, fatigue, asthenia, pyrexia feeling abnormal, impaired healing, hunger a see Description of selected adverse reactions below b ADR related to hypersensitivity reaction Description of selected adverse reactions Most injection site reactions characterised as localised erythemas and soreness, spontaneously resolved with local symptomatic treatment, while pegvisomant therapy continued.
Occurrence of injection site hypertrophy has been observed, including lipohypertrophy. 9% of patients treated with pegvisomant. The clinical significance of these antibodies is unknown. Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalised skin reactions (rash, erythema, pruritus, urticaria) have been reported in post marketing use.
Some patients required hospitalisation. Upon re-administration, symptoms did not re-occur in all patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. g. visual field defects), it is essential that all patients be carefully monitored.
If evidence of tumour expansion appears, alternative procedures may be advisable. Serum IGF-1 monitoring Pegvisomant is a potent antagonist of growth hormone action. A growth hormone deficient state may result from administration of this medicinal product, despite the presence of elevated serum growth hormone levels.
Serum IGF-I concentrations should be monitored and maintained within the age-adjusted normal range by adjustment of the pegvisomant dose. ALT or AST elevations Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP)].
Evidence of obstructive biliary tract disease should be ruled out in patients with elevations of ALT and AST or in patients with a prior history of treatment with any somatostatin analogue. Administration of pegvisomant should be discontinued if signs of liver disease persist.
For recommendations regarding initiation of SOMAVERT, based on baseline liver tests (LTs) and recommendations for monitoring of liver tests while on SOMAVERT, refer to Table A. 5 Table A: Recommendations for initiation of SOMAVERT treatment based on baseline LTs and for periodic monitoring of LTs during SOMAVERT treatment Baseline LT Levels Recommendations Normal May treat with SOMAVERT.
Serum concentrations of ALT and AST should be monitored at 4- to 6-week intervals for the first 6 months of treatment with SOMAVERT, or at any time in patients exhibiting symptoms suggestive of hepatitis. Elevated, but less than or equal to 3 times ULN May treat with SOMAVERT; however, monitor LTs monthly for at least 1 year after initiation of therapy and then bi-annually for the next year.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Greater than 3 times ULN Do not treat with SOMAVERT until a comprehensive workup establishes the cause of the patient’s liver dysfunction. Determine if cholelithiasis or choledocholithiasis is present, particularly in patients with a history of prior therapy with somatostatin analogues.
Based on the workup, consider initiation of therapy with SOMAVERT. If the decision is to treat, LTs and clinical symptoms should be monitored very closely.
Abbreviations:
ALT = alanine aminotransferase; AST = aspartate transaminase; LT = liver test; ULN = upper limit of normal. If a patient develops LT elevations, or any other signs or symptoms of liver dysfunction while receiving SOMAVERT, the following patient management is recommended (Table B).
Table B. Clinical recommendations based on abnormal liver test results while on SOMAVERT LT Levels and Clinical Signs/Symptoms Recommendations Elevated, but less than or equal to 3 times ULN May continue therapy with SOMAVERT. However, monitor LTs monthly to determine if further increases occur.
Greater than 3 but less than 5 times ULN (without signs/symptoms of hepatitis or other liver injury, or increase in serum TBIL) May continue therapy with SOMAVERT. However, monitor LTs weekly to determine if further increases occur (see below).
Perform a comprehensive hepatic workup to discern if an alternative cause of liver dysfunction is present. At least 5 times ULN, or transaminase elevations at least 3 times ULN associated with any increase in serum TBIL (with or without signs/symptoms of hepatitis or other liver injury) Discontinue SOMAVERT immediately.
Perform a comprehensive hepatic workup, including serial LTs, to determine if and when serum levels return to normal. If LTs normalise (regardless of whether an alternative cause of the liver dysfunction is discovered), consider cautious reinitiation of therapy with SOMAVERT, with frequent LT monitoring.
g. jaundice, bilirubinuria, fatigue, nausea, vomiting, right upper quadrant pain, ascites, unexplained oedema, easy bruisability) Immediately perform a comprehensive hepatic workup. If liver injury is confirmed, the drug should be discontinued.
Hypoglycaemia The study conducted with pegvisomant in diabetic patients treated either by insulin or by oral 6 hypoglycaemic medicinal products revealed the risk of hypoglycaemia in this population. 5). 6). Pregnancy Acromegaly control may improve during pregnancy.
6). 2) based on IGF-I values. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose. Patients on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’.