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SOMAVERT is a brand name for Pegvisomant, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's HC label. Tap a section to expand.
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.
, 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
, 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.
• 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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
• 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 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 […]