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(pegvisomant) for Injection
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.
Amino Acid Sequence of
Stippled residues indicate PEG attachment sites (Phe1, Lys38, Lys41, Lys70, Lys115, Lys120, Lys140, Lys145, Lys158)
SOMAVERT is supplied as a sterile, white lyophilized powder intended for subcutaneous injection after reconstitution with 1 mL of Sterile Water for Injection, USP. SOMAVERT is available in single-dose sterile vials containing 10, 15, or 20 mg of pegvisomant protein (approximately 10, 15, and 20 U activity, respectively). Vials containing 10, 15, and 20 mg of pegvisomant protein correspond to approximately 21, 32, and 43 mg pegvisomant, respectively. Each vial 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.
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 singledose containers to be used as a diluent.
What are the possible side effects of pegvisomant (Somavert)?
If you experience any of the following uncommon but serious side effects, stop taking pegvisomant and seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
- liver problems (may be detected by blood tests or symptoms such as yellowing of the skin or eyes, vomiting, abdominal pain, unusual fatigue, loss of appetite, itching, clay-colored stools, or dark urine).
Other, less serious side effects may be more likely to occur. Continue...
What are the precautions when taking pegvisomant (Somavert)?
Before using this medication, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the product packaging), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.
If you have diabetes, pegvisomant may help improve symptoms of diabetes, such as lowering high blood sugar levels. Check your blood sugar regularly. Your doctor may need to adjust your diabetes medications.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription...
Last reviewed on RxList: 3/29/2013
This monograph has been modified to include the generic and brand name in many instances.
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