TIPRANAVIR (Aptivus) Nursing Considerations

What is the generic name?

TIPRANAVIR

What is the Trade Name for TIPRANAVIR?

Aptivus

What are the Indications for TIPRANAVIR?

• 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: The use of APTIVUS/ritonavir in treatment-na√Øve patients is not recommended [ see Warnings and Precautions (5.1) ]. The use of other active agents with APTIVUS/ritonavir is associated with a greater likelihood of treatment response [ see Microbiology (12.4) and Clinical Studies (14) ]. Genotypic or phenotypic testing and/or treatment history should guide the use of APTIVUS/ritonavir [ see Microbiology (12.4) ]. The number of baseline primary protease inhibitor mutations affects the virologic response to APTIVUS/ritonavir [ see Microbiology (12.4) ]. 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) ]. 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) ]. 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) and Drug Interactions (7) ]. 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) ]. 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. APTIVUS, a protease inhibitor, 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 ( 1 ) Do not use APTIVUS/ritonavir in treatment-na√Øve patients ( 1 )

References: https://open.fda.gov/