17.4 Use of Vitamin E
17.5 Rash
17.6 Sulfa Allergy
17.7 Contraceptives
17.8 Fat Redistribution
17.9 Administration
FULL PRESCRIBING INFORMATION
WARNING: HEPATOTOXICITY and INTRACRANIAL HEMORRHAGE
Hepatotoxicity:
Clinical hepatitis and hepatic decompensation, including some fatalities, have been reported. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity [see Warnings and Precautions (5.1)].
Intracranial Hemorrhage:
Both fatal and non-fatal intracranial hemorrhage have been reported [see Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
APTIVUS, co-administered with ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infected patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor (PI).
This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of APTIVUS/ritonavir of 48 weeks duration in treatment-experienced adults and one open-label 48-week study in pediatric patients age 2 to 18 years. The adult studies were conducted in clinically advanced, 3-class antiretroviral (NRTI, NNRTI, PI) treatment-experienced adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with APTIVUS/ritonavir:
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The use of APTIVUS/ritonavir in treatment-naïve patients is not recommended [see Warnings and Precautions (5.1)].
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The use of other active agents with APTIVUS/ritonavir is associated with a greater likelihood of treatment response [see Clinical Pharmacology (12.4) and Clinical Studies (14)].
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Genotypic or phenotypic testing and/or treatment history should guide the use of APTIVUS/ritonavir [see Clinical Pharmacology (12.4)]. The number of baseline primary protease inhibitor mutations affects the virologic response to APTIVUS/ritonavir [see Clinical Pharmacology (12.4)].
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Use caution when prescribing APTIVUS/ritonavir to patients with elevated transaminases, hepatitis B or C co-infection or patients with mild hepatic impairment [see Warnings and Precautions (5.1)].
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Liver function tests should be performed at initiation of therapy with APTIVUS/ritonavir and monitored frequently throughout the duration of treatment [see Warnings and Precautions (5.1)].
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The drug-drug interaction potential of APTIVUS/ritonavir when co-administered with other drugs must be considered prior to and during APTIVUS/ritonavir use [see Contraindications (4.2) and Drug Interactions (7)].
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Use caution when prescribing APTIVUS/ritonavir in patients who may be at risk for increased bleeding or who are receiving medications known to increase the risk of bleeding [see Warnings and Precautions (5.4)].
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The risk-benefit of APTIVUS/ritonavir has not been established in pediatric patients <2 years of age.
There are no study results demonstrating the effect of APTIVUS/ritonavir on clinical progression of HIV-1.
2 DOSAGE AND ADMINISTRATION
APTIVUS must be co-administered with ritonavir to exert its therapeutic effect. Failure to correctly co-admin
