Somavert Powder For Solution For Injection 10Mg Drug Medication Dosage Information
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Somavert: Powder for solution for injection (10mg)

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What is this Medicine?

PEGVISOMANT (peg VI soe mant) blocks growth hormone. It is used to treat acromegaly, a condition where the body makes too much growth hormone.

In-Depth Information

Somavert 10mg Powder for Injection

NDC: 000095176
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Acromegaly

Storage Information
Refrigerate (between 36 and 46 degrees F)
Reconstituted product may be stored at room temperature (77 degrees F) for use within 6 hours
Protect from freezing
Somavert 10mg Powder for Injection

Reported Side Effects for Somavert 10mg Powder for Injection

Elevated Hepatic Enzymes Incidence:
1.2-12.0%*
Severity: MODERATE
Onset: DELAYED
Injection Site Reaction Incidence:
4.0-11.0%*
Severity: MILD
Onset: RAPID
Lightheadedness Incidence:
4.0-8.0%*
Severity: MILD
Onset: EARLY
Chest Pain Incidence:
4.0-8.0%*
Severity: MODERATE
Onset: EARLY
Back Pain Incidence:
4.0-8.0%*
Severity: MILD
Onset: DELAYED
Fluid Retention Incidence:
4.0-8.0%*
Severity: MODERATE
Onset: DELAYED
Infection Incidence:
4.0-23.0%*
Severity: MILD
Onset: DELAYED
Sinus Infection Incidence:
4.0-8.0%*
Severity: MILD
Onset: DELAYED
Loose Stools Incidence:
4.0-14.0%*
Severity: MILD
Onset: EARLY
Paresthesias Incidence:
7.0%*
Severity: MILD
Onset: DELAYED
High Blood Pressure Incidence:
8.0%*
Severity: MODERATE
Onset: EARLY
Upset Stomach Incidence:
8.0-14.0%*
Severity: MILD
Onset: EARLY
Antibody Formation Incidence:
17.0%*
Severity: MODERATE
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

SECOND Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

THIRD Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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