Somavert
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Somavert
Somavert Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Somavert (pegvisomant) is used for the treatment of acromegaly (a growth disorder caused by too much growth hormone). It is a manufactured protein similar to human growth hormone (GH). Common side effects include lumps under the skin if the same injection site is used often. To reduce the chance of this side effect, change the injection site daily. Redness/swelling at the injection site, pain, diarrhea, or nausea may also occur.
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. Somavert may interact with insulin, oral diabetes medicines, or narcotics. Tell your doctor all medications and supplements you use. During pregnancy, Somavert should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding. Our Somavert (pegvisomant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Somavert in Detail - Patient Information: Side Effects
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 to take pegvisomant and talk to your doctor if you experience
- discomfort at the injection site;
- "flu-like" symptoms
- nausea or diarrhea;
- dizziness; or
- water retention or slight weight gain.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Somavert (Pegvisomant) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Somavert Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Get medical help right away if any of these rare but serious side effects occur: signs of liver problems (such as persistent nausea, vomiting, stomach/abdominal pain, unusual tiredness, yellowing eyes/skin, dark urine).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Somavert (Pegvisomant)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Somavert FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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 patients with acromegaly (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 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.
Table 5: Number of
Patients (%) with Acromegaly Reporting Adverse Events in a 12-week Placebo-controlled
Study with SOMAVERT*
| Event | SOMAVERT | Placebo n=32 |
||
| 10 mg/day n=26 |
15 mg/day n=26 |
20 mg/day n=28 |
||
| 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). |
||||
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.
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).
Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria) have been reported in post-marketing use. Some patients required hospitalization. Symptoms did not re-occur in all patients after re-challenge (See PRECAUTIONS).
Read the entire FDA prescribing information for Somavert (Pegvisomant) »
Additional Somavert Information
Somavert - User Reviews
Somavert User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Somavert sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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