Somavert (Pegvisomant) - Side Effects and Adverse Reactions

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Somavert Rx

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ADVERSE REACTIONS

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 (see PRECAUTIONS, Liver Tests [LTs]).

GENERAL

Nine acromegalic patients (9.6%) withdrew from pre-marketing clinical studies because of adverse events, including two patients with marked transaminase elevations (see PRECAUTIONS, Liver Tests [LTs]), 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.

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.

Table 5. Number of Patients (%) with Acromegaly Reporting Adverse Events in a 12-week Placebo-controlled Study with SOMAVERT *
Event	SOMAVERT			Placebo n=32
Event	10 mg/day n=26	15 mg/day n=26	20 mg/day n=28	Placebo n=32
Body as a whole
Infection ^*/	6 (23%)	0	0	2 (6%)
Pain	2 (8%)	1 (4%)	4 (14%)	2 (6%)
Injection site reaction	2 (8%)	1 (4%)	3 (11%)	0
Accidental injury	2 (8%)	1 (4%)	0	1 (3%)
Back pain	2 (8%)	0	1 (4%)	1 (3%)
Flu syndrome	1 (4%)	3 (12%)	2 (7%)	0
Chest pain	1 (4%)	2 (8%)	0	0
Digestive
Abnormal liver function tests	3 (12%)	1 (4%)	1 (4%)	1 (3%)
Diarrhea	1 (4%)	0	4 (14%)	1 (3%)
Nausea	0	2 (8%)	4 (14%)	1 (3%)
Nervous
Dizziness	2 (8%)	1 (4%)	1 (4%)	2 (6%)
Paresthesia	0	0	2 (7%)	2 (6%)
Metabolic and nutritional disorders
Peripheral edema	2 (8%)	0	1 (4%)	0
Cardiovascular
Hypertension	0	2 (8%)	0	0
Respiratory
Sinusitis	2 (8%)	0	1 (4%)	1 (3%)
* Table includes only those events that were reported in at least 2 patients and at a higher incidence in patients treated with SOMAVERT than in patients treated with placebo.
^*/The 6 events coded as "infection" in the group treated with SOMAVERT 10 mg were reported as cold symptoms (3), upper respiratory infection (1), blister (1), and ear infection (1). The 2 events in the placebo group were reported as cold symptoms (1) and chest infection (1).

REPORTS OF SUSPECTED SOMAVERT SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Somavert. The information is not vetted and should not be considered as verified clinical evidence.

Possible Somavert side effects / adverse reactions in 36 year old male

Reported by a physician from France on 2011-10-26

Patient: 36 year old male weighing 85.0 kg (187.0 pounds)

Reactions: Cytolytic Hepatitis

Suspect drug(s):
Somavert

Other drugs received by patient: Minoxidil

Possible Somavert side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from Ireland on 2011-11-07

Patient: 60 year old female

Reactions: Dyspnoea

Suspect drug(s):
Somavert

Possible Somavert side effects / adverse reactions in 40 year old male

Reported by a physician from Japan on 2011-11-11

Patient: 40 year old male

Reactions: Abdominal Pain, Renal Impairment, Oxygen Consumption Decreased, General Physical Health Deterioration, Gallbladder Necrosis, Cholecystitis, Inflammation

Adverse event resulted in: hospitalization

Suspect drug(s):
Somavert
    Dosage: 10 mg, twice weekly
    Indication: Acromegaly
    Start date: 2011-03-01

Sandostatin LAR
    Dosage: 40 mg, qmo
    Indication: Acromegaly
    Start date: 2010-01-01
    End date: 2011-10-13

See index of all Somavert side effect reports >>

Drug label data at the top of this Page last updated: 2006-09-01

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