Aptivus (Tipranavir) Drug Information: Overdosage and Contraindications

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May 24, 2012

Aptivus

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The only drug in this class is T-20, which is administered as a twice daily subcutaneous injection. The most common side effect is redness and pain at the site of injection. Rarely, infection can occur at the injection site. There also are reports of generalized allergic reactions.

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Although there were some early concerns of liver inflammation for drugs in this class, MVC appeared to be well tolerated in clinical trials without any specific toxicities attributable to the drug. However, it is a new drug in a new class and the first to actually target the cell. For these reasons, longer follow-up from clinical trials and those followed in the clinic will be very important for assessing the overall safety of the...

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OVERDOSE

There is no known antidote for APTIVUS overdose. Treatment of overdose should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. If indicated, elimination of unabsorbed tipranavir should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug. Since tipranavir is highly protein bound, dialysis is unlikely to provide significant removal of the drug.

APTIVUS®
(tipranavir)

CONTRAINDICATIONS

Hepatic Impairment

APTIVUS is contraindicated in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [see WARNINGS AND PRECAUTIONS].

Drug Interactions

Co-administration of APTIVUS/ritonavir with drugs that are highly dependent on CYP 3A for clearance or are potent CYP 3A inducers are contraindicated (see Table 1). These recommendations are based on either drug interaction studies or they are predicted interactions due to the expected magnitude of interaction and potential for serious events or loss of efficacy. For information regarding clinical recommendations [see DRUG INTERACTIONS].

Table 1 : Drugs that are Contraindicated with APTIVUS Co-Administered with Ritonavir

Drug Class	Drugs within Class that are Contraindicated with APTIVUS Co-administered with Ritonavir	Clinical Comments:
Alpha 1-adrenoreceptor antagonist	Alfuzosin	Potentially increased alfuzosin concentrations can result in hypotension.
Antiarrhythmics	Amiodarone, bepridil, flecainide, propafenone, quinidine	Potential for serious and/or life-threatening reactions such as cardiac arrhythmias secondary to increases in plasma concentrations of antiarrhythmics.
Antimycobacterials	Rifampin	May lead to loss of virologic response and possible resistance to APTIVUS or to the class of protease inhibitors or other coadministered antiretroviral agents.
Ergot derivatives	Dihydroergotamine, ergonovine, ergotamine, methylergonovine	Potential for acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
GI motility agent	Cisapride	Potential for cardiac arrhythmias.
Herbal products	St. John's wort (hypericum perforatum)	May lead to loss of virologic response and possible resistance to APTIVUS or to the class of protease inhibitors.
HMG CoA reductase inhibitors	Lovastatin, simvastatin	Potential for myopathy including rhabdomyolysis.
Neuroleptic	Pimozide	Potential for cardiac arrhythmias.
PDE-5 inhibitors	Sildenafil (Revatio) [for treatment of pulmonary arterial hypertension]	A safe and effective dose has not been established when used with APTIVUS/ritonavir. There is increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).
Sedatives/hypnotics	Oral midazolam, triazolam	Prolonged or increased sedation or respiratory depression.

Due to the need for co-administration of APTIVUS with ritonavir, please refer to the ritonavir prescribing information for a description of ritonavir contraindications.

Last reviewed on RxList: 3/1/2012
This monograph has been modified to include the generic and brand name in many instances.