Pegvisomant is an active pharmaceutical ingredient in the Other Anterior Pituitary Lobe Hormones and Analogues group (H01AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised March 20, 2026[1]
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.
How to take
GB
CACanada· Health Canada
5 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
SOMAVERT (pegvisomant for injection) is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery, and/or radiation therapy or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels and to improve clinical signs and symptoms.
1 Pediatrics Pediatrics (< 18 years of age): The safety and effectiveness of Somavert in pediatric patients have not been established. 2 Geriatrics There is limited information in patients over 65 years of age (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).
How to take
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised February 27, 2025[3]
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.
How to take
EU
Drug interactions
Known interactions involving Pegvisomant. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
[1]MHRA (UK) · PLGB000571636 · revised March 20, 2026
[2]Health Canada (DPD) · 02272199 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/000409 · revised February 27, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
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 Pegvisomant should be administered by subcutaneous injection. The site of injection should be rotated daily to help prevent lipohypertrophy.
6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 20, 2026[1]
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. lipohypertro phy)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, generalized skin reactions (rash, erythema, pruritus, urticaria) have been reported in post marketing use.
Some patients required hospitalization. Upon re-administration, symptoms did not re-occur in all patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised March 20, 2026[1]
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.
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. Greater than 3 times ULN • Do not treat with SOMAVERT until a comprehensive workup establishes the cause of the patient’s liver dysfunction.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised March 20, 2026[1]
1.
This is not medical advice. Consult a qualified healthcare professional.
CAOfficial regulatory label· revised March 22, 2025[2]
1 Dosing Considerations Acromegalic patients with diabetes mellitus being treated with insulin and/or oral hypoglycemic agents may require dose reductions of these therapeutic agents after the initiation of therapy with Somavert (pegvisomant for injection) (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Glucose Metabolism and see 9 DRUG INTERACTIONS, Drug-Drug Interactions).
Some patients concomitantly receiving opioids may require higher serum concentrations of pegvisomant to achieve appropriate IGF-I suppression (see 7 WARNINGS AND PRECAUTIONS, General and see 9 DRUG INTERACTIONS, Drug-Drug Interactions).
2 Recommended Dose and Dosage Adjustment The recommended loading dose of pegvisomant is 40 mg given subcutaneously (SC), under the supervision of a healthcare provider. Proper training in SC injection technique should be provided to patients or their caregivers so that patients can receive once-daily SC injections.
On the next day following the loading dose, patients or their caregivers should be instructed to begin daily injections of pegvisomant 10 mg SC. The pegvisomant dose should be titrated to normalize serum IGF-I concentrations, and serum IGF-I concentrations should be measured every 4-6 weeks.
The dose should not be based on GH concentrations. It is unknown whether patients who remain symptomatic while achieving normalized IGF-I concentrations would benefit from increased pegvisomant dosage. SOMAVERT (pegvisomant for injection) Product Monograph Page 5 of 34 • The dose should be increased by 5 mg increments every 4-6 weeks if IGF-I concentrations are elevated.
• The dose should be decreased by 5 mg decrements every 4-6 weeks if IGF-I concentrations are below the normal range. • IGF-I levels should also be monitored when a pegvisomant dose given in multiple injections is converted to a single daily injection.
The recommended dose range is between 10 to 30 mg SC once daily, and the maximum daily dose is 30 mg SC once daily. 3 Reconstitution Parenteral Products: Table 1 – Reconstitution Parenteral Products: Vial Size Volume of Diluent to be Added to Vial Approximate Available Volume of diluent Nominal Concentration per mL 8 mL 1 mL of Sterile Water for Injection, Ph.
4 Administration Somavert is supplied as a lyophilized powder in a vial. Each vial of Somavert should be reconstituted with 1 mL of the diluent (Sterile Water for Injection, Ph. Eur) provided in a pre-filled syringe that is included in the package.
Detailed instructions regarding reconstitution and administration are included in the package of Somavert and should be closely followed.
Diluent Pre-filled syringe presentation:
To prepare the solution, inject the diluent (Sterile Water for Injection, Ph. ) from the pre-filled syringe into the vial of Somavert, aiming the stream of liquid against the glass wall. Hold the vial between the palms of both hands and gently roll it to dissolve the powder.
DO NOT SHAKE THE VIAL, as this may cause denaturation of pegvisomant. After reconstitution, each vial of Somavert contains 10, 15, 20, 25 or 30 mg of pegvisomant protein in 1 mL of solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
The solution should be clear after reconstitution. If the solution is cloudy, do not inject it. Only one dose should be administered from each vial. Somavert should be administered within three hours after reconstitution. The site of injection should be rotated daily to help prevent lipohypertrophy.
SOMAVERT (pegvisomant for injection) Product Monograph Page 6 of 34
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
, Immune system disorders). Cross-Reactivity with GH Assays Somavert has significant structural similarity to growth hormone (GH) which causes it to cross-react in commercially available GH assays. Since serum concentrations of therapeutically effective doses of Somavert are generally 100 to 1000 times higher than the actual serum GH concentrations seen in patients with acromegaly, measurements of serum GH concentrations will appear falsely elevated.
Monitoring and Laboratory Tests Liver Tests Recommendations for monitoring liver function are stated above (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Liver Tests [LTs]). IGF-I Levels Treatment with Somavert should be evaluated by monitoring serum IGF-I concentrations four to six weeks after therapy is initiated or any dose adjustments are made, and at least every six months after IGF-I levels have normalized.
The goals of treatment should be to maintain a patient’s serum IGF-I concentration within the age-adjusted normal range and to control the signs and symptoms of acromegaly. GH Levels Pegvisomant interferes with the measurement of serum GH concentrations by commercially available GH assays (see
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
, Special Populations, Geriatrics). 2 CONTRAINDICATIONS • Somavert is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations Acromegalic patients with diabetes mellitus being treated with insulin and/or oral hypoglycemic agents may require dose reductions of these therapeutic agents after the initiation of therapy with Somavert (pegvisomant for injection) (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Glucose Metabolism and see 9 DRUG INTERACTIONS, Drug-Drug Interactions).
Some patients concomitantly receiving opioids may require higher serum concentrations of pegvisomant to achieve appropriate IGF-I suppression (see 7 WARNINGS AND PRECAUTIONS, General and see 9 DRUG INTERACTIONS, Drug-Drug Interactions).
2 Recommended Dose and Dosage Adjustment The recommended loading dose of pegvisomant is 40 mg given subcutaneously (SC), under the supervision of a healthcare provider. Proper training in SC injection technique should be provided to patients or their caregivers so that patients can receive once-daily SC injections.
On the next day following the loading dose, patients or their caregivers should be instructed to begin daily injections of pegvisomant 10 mg SC. The pegvisomant dose should be titrated to normalize serum IGF-I concentrations, and serum IGF-I concentrations should be measured every 4-6 weeks.
The dose should not be based on GH concentrations. It is unknown whether patients who remain symptomatic while achieving normalized IGF-I concentrations would benefit from increased pegvisomant dosage. SOMAVERT (pegvisomant for injection) Product Monograph Page 5 of 34 • The dose should be increased by 5 mg increments every 4-6 weeks if IGF-I concentrations are elevated.
• The dose should be decreased by 5 mg decrements every 4-6 weeks if IGF-I concentrations are below the normal range. • IGF-I levels should also be monitored when a pegvisomant dose given in multiple injections is converted to a single daily injection.
The recommended dose range is between 10 to 30 mg SC once daily, and the maximum daily dose is 30 mg SC once daily. 3 Reconstitution Parenteral Products: Table 1 – Reconstitution Parenteral Products: Vial Size Volume of Diluent to be Added to Vial Approximate Available Volume of diluent Nominal Concentration per mL 8 mL 1 mL of Sterile Water for Injection, Ph.
4 Administration Somavert is supplied as a lyophilized powder in a vial. Each vial of Somavert should be reconstituted with 1 mL of the diluent (Sterile Water for Injection, Ph. Eur) provided in a pre-filled syringe that is included in the package.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
• Somavert is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
This is not medical advice. Consult a qualified healthcare professional.
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.
6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised February 27, 2025[3]
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.
EUOfficial regulatory label· Warnings and precautions· revised February 27, 2025[3]
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.
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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised February 27, 2025[3]
1.
This is not medical advice. Consult a qualified healthcare professional.
• Determine if cholelithiasis or choledocholithiasis is present, particularly in patients with a history of prior therapy with somatostatin analogs. • 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.
, 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 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’.
Detailed instructions regarding reconstitution and administration are included in the package of Somavert and should be closely followed.
Diluent Pre-filled syringe presentation:
To prepare the solution, inject the diluent (Sterile Water for Injection, Ph. ) from the pre-filled syringe into the vial of Somavert, aiming the stream of liquid against the glass wall. Hold the vial between the palms of both hands and gently roll it to dissolve the powder.
DO NOT SHAKE THE VIAL, as this may cause denaturation of pegvisomant. After reconstitution, each vial of Somavert contains 10, 15, 20, 25 or 30 mg of pegvisomant protein in 1 mL of solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
The solution should be clear after reconstitution. If the solution is cloudy, do not inject it. Only one dose should be administered from each vial. Somavert should be administered within three hours after reconstitution. The site of injection should be rotated daily to help prevent lipohypertrophy.
SOMAVERT (pegvisomant for injection) Product Monograph Page 6 of 34 5 OVERDOSAGE There was one reported incident of acute overdosage with Somavert (pegvisomant for injection) during pre-marketing clinical studies in which a patient self-administered 80 mg/day for seven days.
The patient experienced a slight increase in fatigue, had no other complaints, and demonstrated no significant clinical laboratory abnormalities. In cases of overdose, administration of Somavert should be discontinued and not resumed until IGF-I levels return to within or above the normal range.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous injection Lyophilized powder, 10, 15, 20, 25 and 30 mg per vial in package that also includes diluent (Sterile Water for Injection, Ph.
) in a pre-filled syringe Glycine, mannitol, sodium phosphate dibasic anhydrous, sodium dihydrogen phosphate monohydrate Description Somavert is supplied as a sterile, white lyophilized powder intended for subcutaneous injection after reconstitution with 1 mL of Sterile Water for Injection, Ph.
Eur. It is available in single-dose vials containing 10, 15, 20, 25 and 30 mg of pegvisomant protein. The diluent (Sterile Water for Injection, Ph. Eur) is provided in a pre-filled syringe that is included in the same package as the Somavert vial.
36 mg of sodium dihydrogen phosphate monohydrate. 45 mg of sodium dihydrogen phosphate monohydrate. 56 […]
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’.