Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS • Severe or life-threatening skin reactions have been reported with the use of fosamprenavir [see Warnings and Precautions (5.2) ] .
• The most common moderate to severe adverse reactions in clinical trials of fosamprenavir were diarrhea, rash, nausea, vomiting, and headache.
• Treatment discontinuation due to adverse events occurred in 6.4% of subjects receiving fosamprenavir and in 5.9% of subjects receiving comparator treatments.
The most common adverse reactions leading to discontinuation of fosamprenavir (incidence less than or equal to 1% of subjects) included diarrhea, nausea, vomiting, AST increased, ALT increased, and rash.
• In adults the most common adverse reactions (incidence greater than or equal to 4%) are diarrhea, rash, nausea, vomiting, and headache.
( 6.1 ) • Vomiting and neutropenia were more frequent in pediatrics than in adults.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adult Trials The data for the 3 active-controlled clinical trials described below reflect exposure of 700 HIV-1– infected subjects to fosamprenavir calcium tablets, including 599 subjects exposed to fosamprenavir for greater than 24 weeks, and 409 subjects exposed for greater than 48 weeks.
The population age ranged from 17 to 72 years.
5 WARNINGS AND PRECAUTIONS • The concomitant use of fosamprenavir with ritonavir and certain other drugs may result in known or potentially significant drug interactions.
Consult the full prescribing information prior to and during treatment for potential drug interactions.
( 5.1 , 7.3 ) • Fosamprenavir should be discontinued for severe skin reactions, including Stevens-Johnson syndrome.
( 5.2 ) • Fosamprenavir should be used with caution in patients with a known sulfonamide allergy.
( 5.3 ) • Use of higher-than-approved doses may lead to transaminase elevations.
Like all medications, Fosamprenavir Calcium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: