Statements in which the resource exists as a subject.
PredicateObject
rdf:type
rdfs:label
Somavert (Kit)
dailymed-instance:dosage
A loading dose of 40 mg of SOMAVERT should be administered subcutaneously under physician supervision. The patient should then be instructed to begin daily subcutaneous injections of 10 mg of SOMAVERT. Serum IGF-I concentrations should be measured every four to six weeks, at which time the dosage of SOMAVERT should be adjusted in 5-mg increments if IGF-I levels are still elevated (or 5-mg decrements if IGF-I levels have decreased below the normal range).While the goals of therapy are to achieve (and then maintain) serum IGF-I concentrations within the age-adjusted normal range and to alleviate the signs and symptoms of acromegaly, titration of dosing should be based on IGF-I levels. It is unknown whether patients who remain symptomatic while achieving normalized IGF-I levels would benefit from increased dosing with SOMAVERT. The maximum daily maintenance dose should not exceed 30 mg. SOMAVERT is supplied as a lyophilized powder. Each vial of SOMAVERT should be reconstituted with 1 mL of the diluent provided in the package (Sterile Water for Injection, USP). Instructions regarding reconstitution and administration are included in the package of SOMAVERT and should be closely followed. To prepare the solution, withdraw 1 mL of Sterile Water for Injection, USP and inject it 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. Discard the diluent vial containing the remaining water for injection. After reconstitution, each vial of SOMAVERT contains 10, 15, or 20 mg of pegvisomant protein in one 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 six hours after reconstitution. Pegvisomant may be given in the thigh, buttocks, upper arm, or abdomen; the site of SC injections should be rotated daily to help prevent lipohypertrophy.
dailymed-instance:descripti...
SOMAVERT contains pegvisomant for injection, 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. Stippled residues indicate PEG attachment sites (Phe, Lys, Lys, Lys, Lys, Lys, Lys, Lys, Lys) 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 correspondto 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 plastic 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.
dailymed-instance:clinicalP...
Mechanism of Action: Pegvisomant selectively binds to growth hormone (GH) receptors on cell surfaces, where it blocks the binding of endogenous GH, and thus interferes with GH signal transduction. Inhibition of GH action results in decreased serum concentrations of insulin-like growth factor-I (IGF-I), as well as other GH-responsive serum proteins, including IGF binding protein-3 (IGFBP-3), and the acid-labile subunit (ALS).<br/>Pharmacokinetics:<br/>Absorption: Following subcutaneous administration, peak serum pegvisomant concentrations are not generally attained until 33 to 77 hours after administration. The mean extent of absorption of a 20-mg subcutaneous dose was 57%, relative to a 10-mg intravenous dose.<br/>Distribution: The mean apparent volume of distribution of pegvisomant is 7 L (12% coefficient of variation), suggesting that pegvisomant does not distribute extensively into tissues. After a single subcutaneous administration, exposure (C, AUC) to pegvisomant increases disproportionately with increasing dose. Mean��SEM serum pegvisomant concentrations after 12 weeks of therapy with daily doses of 10, 15, and 20 mg were 6600��1330; 16,000��2200; and 27,000��3100 ng/mL, respectively.<br/>Metabolism and Elimination: The pegvisomant molecule contains covalently bound polyethylene glycol polymers in order to reduce the clearance rate. Clearance of pegvisomant following multiple doses is lower than seen following a single dose. The mean total body systemic clearance of pegvisomant following multiple doses is estimated to range between 36 to 28 mL/h for subcutaneous doses ranging from 10 to 20 mg/day, respectively. Clearance of pegvisomant was found to increase with body weight. Pegvisomantis eliminated from serum with a mean half-life of approximately 6 days following either single or multiple doses. Less than 1% of administered drug is recovered in the urine over 96 hours. The elimination route of pegvisomant has not been studied in humans.<br/>Drug-Drug Interactions: In clinical studies, patients on opioids often needed higher serum pegvisomant concentrations to achieve appropriate IGF-I suppression compared with patients not receiving opioids. The mechanism of this interaction is not known .<br/>Special Populations:<br/>Renal: No pharmacokinetic studies have been conducted in patients with renal insufficiency.<br/>Hepatic: No pharmacokinetic studies have been conducted in patients with hepatic insufficiency.<br/>Geriatric: No pharmacokinetic studies have been conducted in elderly subjects.<br/>Pediatric: No pharmacokinetic studies have been conducted in pediatric subjects.<br/>Gender: No gender effect on the pharmacokinetics of pegvisomant was found in a population pharmacokinetic analysis.<br/>Race: The effect of race on the pharmacokinetics of pegvisomant has not been studied.
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dailymed-instance:contraind...
SOMAVERT is contraindicated in patients with a history of hypersensitivity to any of its components. The stopper on the vial of SOMAVERT contains latex.
dailymed-instance:supply
SOMAVERT is available in single-dose, sterile glass vials in the following strengths: 10 mg (as protein) vial NDC 0009-5176-0115 mg (as protein) vial NDC 0009-5178-0120 mg (as protein) vial NDC 0009-5180-01 Each package of SOMAVERT also includes a single-dose LifeShield plastic fliptop vial containing 10 mL of Sterile Water for Injection, USP. The stopper on the vial of SOMAVERT contains latex.<br/>Storage: Prior to reconstitution, SOMAVERT should be stored in a refrigerator at 2 to 8��C (36 to 46��F). Protect from freezing. After reconstitution, SOMAVERT should be administered within six hours. Only one dose should be administered from each vial.
dailymed-instance:genericDr...
dailymed-instance:activeMoi...
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dailymed-instance:overdosag...
In one reported incident of acute overdose with SOMAVERT during pre-marketing clinical studies, 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.<br/>Drug Abuse and Dependence: Available data do not demonstrate drug-abuse potential or psychological dependence with SOMAVERT. Radiolabeled pegvisomant does not cross the blood-brain barrier in rats.
dailymed-instance:genericMe...
pegvisomant
dailymed-instance:fullName
Somavert (Kit)
dailymed-instance:adverseRe...
Laboratory Changes: Elevations of serum concentrations of ALT and AST greater than ten times the ULN were reported in two subjects (0.8%) exposed to SOMAVERT in pre-approval clinical studies .<br/>General: Nine acromegalic patients (9.6%) withdrew from pre-marketing clinical studies because of adverse events, including two patients with marked transaminase elevations , one patient with lipohypertrophy at the injection sites, and one patient with substantial weight gain. The majority of reported adverse events were of mild to moderate intensity and limited duration. Most adverse events did not appear to be dose dependent. Table 5 shows the incidence of treatment-emergent adverse events that were reported in at least two patients treated with SOMAVERT and at frequencies greater than placebo during the 12-week, placebo-controlled study.<br/>Immunogenicity: In pre-marketing clinical studies, approximately 17% of the patients developed low titer, non-neutralizing anti-GH antibodies. Although the presence of these antibodies did not appear to impact the efficacy of SOMAVERT, the long-term clinical significance of these antibodies is not known. No assay for anti-pegvisomant antibodies is commercially available for patients receiving SOMAVERT.<br/>Post-Marketing Experience: Lipohypertrophy has been reported in<5% of patients following pegvisomant administration. Asymptomatic, transient elevations in transaminases up to 15 times ULN have been observed in<2% of patients in the post-marketing experience. These reports were not associated with an increase in bilirubin, and there were no clinical consequences for these patients. Transaminase elevations normalized with time, most often after suspending treatment (SOMAVERT should be used in accordance with the information presented in Table 4 with respect to liver test abnormalities).
dailymed-instance:indicatio...
SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum IGF-I levels.
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dailymed-instance:routeOfAd...
dailymed-instance:name
Somavert