Tipranavir indications and usage: Difference between revisions
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==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-naïve patients is '''not recommended'''. | |||
*The use of other active agents with APTIVUS/ritonavir is associated with a greater likelihood of treatment response. | |||
*'''Genotypic''' or phenotypic testing and/or treatment history should guide the use of APTIVUS/ritonavir. | |||
*The number of baseline primary protease inhibitor mutations affects the virologic response to APTIVUS/ritonavir. | |||
*Use caution when prescribing APTIVUS/ritonavir to patients with elevated transaminases, hepatitis B or C co-infection or patients with mild hepatic impairment . | |||
*'''Liver function tests''' should be performed at initiation of therapy with APTIVUS/ritonavir and monitored frequently throughout the duration of treatment. | |||
*The drug-drug interaction potential of APTIVUS/ritonavir when co-administered with other drugs must be considered prior to and during APTIVUS/ritonavir use . | |||
*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 . | |||
*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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = APTIVUS (TIPRANAVIR) CAPSULE, LIQUID FILLED APTIVUS (TIPRANAVIR) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=08982e49-d2eb-4b25-b01a-1be52fd669ef | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Latest revision as of 14:36, 9 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
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-naïve patients is not recommended.
- The use of other active agents with APTIVUS/ritonavir is associated with a greater likelihood of treatment response.
- Genotypic or phenotypic testing and/or treatment history should guide the use of APTIVUS/ritonavir.
- The number of baseline primary protease inhibitor mutations affects the virologic response to APTIVUS/ritonavir.
- Use caution when prescribing APTIVUS/ritonavir to patients with elevated transaminases, hepatitis B or C co-infection or patients with mild hepatic impairment .
- Liver function tests should be performed at initiation of therapy with APTIVUS/ritonavir and monitored frequently throughout the duration of treatment.
- The drug-drug interaction potential of APTIVUS/ritonavir when co-administered with other drugs must be considered prior to and during APTIVUS/ritonavir use .
- 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 .
- 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.[1]
References
Adapted from the FDA Package Insert.