July 27, 2016
Recommended Topic Related To:

Sovaldi

"The US Food and Drug Administration (FDA) has okayed expanded use of the combination antiviral drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) in patients with genotype 4, 5, and 6 chronic hepatitis C virus (HCV) infection and in p"...

A A A

Sovaldi

Overdosage
Contraindications

OVERDOSE

The highest documented dosage of sofosbuvir was a single dose of sofosbuvir 1200 mg (three times the recommended dosage) administered to 59 healthy subjects. In that trial, there were no untoward effects observed at this dosage level, and adverse events were similar in frequency and severity to those reported in the placebo and sofosbuvir 400 mg treatment groups. The effects of higher dosages are not known.

No specific antidote is available for overdose with SOVALDI. If overdose occurs, the patient must be monitored for evidence of toxicity. Treatment of overdose with SOVALDI consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. A 4-hour hemodialysis session removed 18% of the administered dose.

CONTRAINDICATIONS

When SOVALDI is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/31/2016

Overdosage
Contraindications

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.


Women's Health

Find out what women really need.