ister APTIVUS with ritonavir will result in plasma levels of tipranavir that will be insufficient to achieve the desired antiviral effect and will alter some drug interactions.
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APTIVUS co-administered with ritonavir capsules or solution can be taken with or without meals
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APTIVUS co-administered with ritonavir tablets must only be taken with meals
[see Clinical Pharmacology (12.3)]
APTIVUS may be administered as either capsules or oral solution to either pediatric or adult patients.
Due to the need for co-administration of APTIVUS with ritonavir, please refer to the ritonavir prescribing information.
2.1 Adults
The recommended adult dose of APTIVUS is 500 mg (two 250 mg capsules or 5 mL oral solution) co-administered with 200 mg of ritonavir, twice daily.
2.2 Pediatric Patients (age 2 to 18 years)
Healthcare professionals should pay special attention to accurate calculation of the dose of APTIVUS, transcription of the medication order, dispensing information and dosing instruction to minimize risk for medication errors, overdose, and underdose.
Prescribers should calculate the appropriate dose of APTIVUS for each individual child based on body weight (kg) or body surface area (BSA, m2) and should not exceed the recommended adult dose.
Before prescribing APTIVUS 250 mg capsules, children should be assessed for the ability to swallow capsules. If a child is unable to reliably swallow an APTIVUS capsule, the APTIVUS oral solution formulation should be prescribed.
The recommended pediatric dose of APTIVUS is 14 mg/kg with 6 mg/kg ritonavir (or 375 mg/m2 co-administered with ritonavir 150 mg/m2) taken twice daily not to exceed a maximum dose of APTIVUS 500 mg co-administered with ritonavir 200 mg twice daily. For children who develop intolerance or toxicity and cannot continue with APTIVUS 14 mg/kg with 6 mg/kg ritonavir, physicians may consider decreasing the dose to APTIVUS 12 mg/kg with 5 mg/kg ritonavir (or APTIVUS 290 mg/m2 co-administered with 115 mg/m2 ritonavir) taken twice daily provided their virus is not resistant to multiple protease inhibitors [see Adverse Reactions (6.2), Use in Specific Populations (8.4), and Clinical Studies (14.2)].
Body surface area can be calculated as follows:
3 DOSAGE FORMS AND STRENGTHS
Capsules: 250 mg, pink, oblong capsules imprinted with TPV 250
Oral solution: 100 mg/mL, yellow, viscous clear liquid with a buttermint-butter toffee flavor
4 CONTRAINDICATIONS
4.1 Hepatic Impairment
APTIVUS is contraindicated in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [see Warnings and Precautions (5.1)].
4.2 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 (7.2)].
Table 1 Drugs that are Contraindicated with APTIVUS Co-Administered with Ritonavir
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Drug Class |
Drugs wi
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