Somavert
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FDA Labeling Changes
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Uses
SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery 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.
History
There is currently no drug history available for this drug.
Other Information
SOMAVERT contains pegvisomant, an analog of human growth hormone (GH) that has been structurally altered to act as a GH receptor antagonist.
Pegvisomant is a protein of recombinant DNA origin containing 191 amino acid residues to which several polyethylene glycol (PEG) polymers are covalently bound (predominantly 4 to 6 PEG/protein molecule). The molecular weight of the protein of pegvisomant is 21,998 Daltons. The molecular weight of the PEG portion of pegvisomant is approximately 5000 Daltons. The predominant molecular weights of pegvisomant are thus approximately 42,000, 47,000, and 52,000 Daltons. The schematic shows the amino acid sequence of the pegvisomant protein (PEG polymers are shown attached to the 5 most probable attachment sites). Pegvisomant is synthesized by a specific strain of Escherichia coli bacteria that has been genetically modified by the addition of a plasmid that carries a gene for GH receptor antagonist. Biological potency is determined using a cell proliferation bioassay. Binding of Somavert to the GH receptor results in disruption of the proper binding of the second GH receptor with inhibition of functional receptor dimerization and subsequent intracellular signaling.
Stippled residues indicate PEG attachment sites (Phe1, Lys38, Lys41, Lys70, Lys115, Lys120, Lys140, Lys145, Lys158)
Shown below are the amino acid substitutions in pegvisomant, relative to human GH.
| hGH | Pegvisomant |
|---|---|
| His18 | Asp18 |
| Ala21 | Asn21 |
| Gly120 | Lys120 |
| Arg167 | Asn167 |
| Lys168 | Ala168 |
| Asp171 | Ser171 |
| Lys172 | Arg172 |
| Glu174 | Ser174 |
| Ile179 | Thr179 |
SOMAVERT for injection is supplied as a sterile, white lyophilized powder intended for subcutaneous injection after reconstitution with 1 mL of Sterile Water for Injection. SOMAVERT is available in single-dose sterile vials containing 10, 15, 20, 25 or 30 mg of pegvisomant protein (approximately 10, 15, 20, 25 and 30 U activity, respectively). Each vial 10, 15 and 20 also contains 1.36 mg of glycine, 36.0 mg of mannitol, 1.04 mg of sodium phosphate dibasic anhydrous, and 0.36 mg of sodium phosphate monobasic monohydrate. Each 25 mg vial also contains 1.7 mg of glycine, 46.1 mg of mannitol, 1.3 mg of sodium phosphate dibasic anhydrous, and 0.5 mg of sodium phosphate monobasic monohydrate. Each 30 mg vial also contains 2.1 mg of glycine, 56.5 mg of mannitol, 1.6 mg of sodium phosphate dibasic anhydrous, and 0.6 mg of sodium phosphate monobasic monohydrate.
SOMAVERT is supplied in packages that include a vial containing diluent. Sterile Water for Injection, USP, is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent, or added buffer, and is supplied in single-dose containers to be used as a diluent.
Sources
Somavert Manufacturers
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Pharmacia And Upjohn Company
![Somavert (Pegvisomant) Kit [Pharmacia And Upjohn Company]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Somavert | Pharmacia And Upjohn Company
2.1 Dosage InformationThe recommended loading dose of SOMAVERT is 40 mg given subcutaneously, under healthcare provider supervision. Provide proper training in subcutaneous injection technique to patients or their caregivers so they can receive once daily subcutaneous injections. On the next day following the loading dose, instruct patients or their caregivers to begin daily subcutaneous injections of 10 mg of SOMAVERT.
Titrate the dosage to normalize serum IGF-I concentrations (serum IGF-I concentrations should be measured every four to six weeks). The dosage should not be based on growth hormone (GH) concentrations or signs and symptoms of acromegaly. It is unknown whether patients who remain symptomatic while achieving normalized IGF-I concentrations would benefit from increased SOMAVERT dosage.
Increase the dosage by 5 mg increments every 4–6 weeks if IGF-I concentrations are elevated. Decrease the dosage 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 Somavert dose given in multiple injections is converted to a single daily injection [see CLINICAL PHARMACOLOGY (12)].The recommended dosage range is between 10 to 30 mg given subcutaneously once daily and the maximum daily dosage is 30 mg given subcutaneously once daily.
2.2 Assess Liver Tests Prior to Initiation of SOMAVERTPrior 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)]. For recommendations regarding initiation of SOMAVERT based on baseline liver tests and recommendations for monitoring of liver tests while on SOMAVERT, refer to Table 1 in Warning and Precautions (5.2).
2.3 Loading Dose Injection ProcedureThe following instructions are for the healthcare provider to reconstitute and prepare the 40 mg loading dose. The healthcare provider will need to reconstitute 1 vial of lyophilized powder of SOMAVERT containing 20 mg of pegvisomant with supplied diluent (two vials of lyophilized powder and two vials of diluet will be needed for the 40 mg loading dose). The healthcare provider will also need to inject the reconstituted SOMAVERT solution twice into the patient's upper arm, upper thigh, abdomen, or buttocks (each injection in a different area).
(a) Before administering the loading dose, remove the first package (1 vial of lyophilized powder of SOMAVERT containing 20 mg of pegvisomant and 1 vial containing the diluent) from the refrigerator about 10 minutes prior to the planned injection time. (b) Withdraw 1 mL of the supplied diluent (Sterile Water for Injection) and inject slowly onto the sides of the vial containing lyophilized powder of SOMAVERT. Do not inject the diluent directly on the powder. (c) Do not invert the vial or shake the solution as this may cause denaturation of the pegvisomant protein. Slowly swirl the solution to ensure that all of the lyophilized powder has gone into solution. If foaming of the reconstituted SOMAVERT solution is seen, the solution is likely damaged and therefore inappropriate to inject. (d) Visually inspect the reconstituted SOMAVERT solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear. If the solution is cloudy, do not use it. Once reconstituted, the solution will contain 20 mg of pegvisomant in 1 mL of solution. (e) Withdraw the 1 mL reconstituted SOMAVERT solution. The solution must be administered within 6 hours of reconstitution. (f) Inject the first reconstituted SOMAVERT solution (20 mg/mL) subcutaneously into the patient's upper arm, upper thigh, abdomen, or buttocks using a 90-degree angle. (g) Repeat steps (a) to (e) to reconstitute the second Somavert dose of 20mg. (h) Finally, inject the second reconstituted SOMAVERT solution (20 mg/mL) subcutaneously into the patient's upper arm, upper thigh, abdomen, or buttocks using a 90-degree angle (different area than the first injection). 2.4 Maintenance Dose Injection ProcedureFor patient or caregiver instructions for reconstitution and administration of daily doses (10 to 30 mg), see the Patient's Instructions for Use.
a) Before administering the dose, remove one package (1 vial of lyophilized powder of SOMAVERT containing 10, 15, 20, 25 or 30 mg of pegvisomant and 1 vial containing the diluent) from the refrigerator about 10 minutes prior to the planned injection time. b) Withdraw 1 mL of the supplied 5 ml diluent (Sterile Water for Injection) and inject slowly onto the sides of the vial containing lyophilized powder of SOMAVERT. Do not inject the diluent directly on the powder. c) Do not invert the vial or shake the solution as this may cause denaturation of the pegvisomant protein. Slowly swirl the solution to ensure that all of the lyophilized powder has gone into solution. If foaming of the reconstituted SOMAVERT solution is seen, the solution is likely is damaged and therefore inappropriate to inject. d) Visually inspect the reconstituted SOMAVERT solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear. If the solution is cloudy, do not use it. Once reconstituted, the solution will contain 10, 15, 20, 25 or 30 mg of pegvisomant in 1 mL of solution. e) Withdraw the 1 mL reconstituted SOMAVERT solution. The solution must be administered within 6 hours of reconstitution. f) Inject the reconstituted SOMAVERT solution subcutaneously into the upper arm, upper thigh, abdomen, or buttocks using a 90-degree angle.
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