Rx Item-Aptivus 250mg tipranavir oral Cap 120 by Boehringer Ingelheim

Clinical Information
Gen. Code and Des.
59306 tipranavir ORAL CAPSULE 250 MG
GCN and Des.
24906 tipranavir ORAL CAPSULE 250 MG
Strength
250MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
8180808 HIV PROTEASE INHIBITOR ANTIRETROVIRALS
Active Ingredients
10844 tipranavir 174484414

These highlights do not include all the information needed to use APTIVUS safely and effectively. See full prescribing information for APTIVUS.

APTIVUS® (tipranavir) capsules, for oral use
APTIVUS® (tipranavir) oral solution
Initial U.S. Approval: 2005
WARNING: HEPATOTOXICITY and INTRACRANIAL HEMORRHAGE
See full prescribing information for complete boxed warning.

Clinical hepatitis and hepatic decompensation including some fatalities. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection. (5.1)
Fatal and non-fatal intracranial hemorrhage (5.2)

INDICATIONS AND USAGE

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-naïve patients (1)

DOSAGE AND ADMINISTRATION

Adults: 500 mg APTIVUS, co-administered with 200 mg ritonavir, twice daily (2.1)
Pediatric patients (age 2 to 18 years): Dosing is based on body weight or body surface area not to exceed adult dose (2.2)
APTIVUS taken with ritonavir capsules or solution can be taken with or without meals (2)
APTIVUS taken with ritonavir tablets must be taken with meals (2)
APTIVUS capsules must be swallowed whole and must not be opened or chewed (2)
Store unopened bottles of APTIVUS capsules in the refrigerator (16)
Do not freeze or refrigerate APTIVUS oral solution (16)

DOSAGE FORMS AND STRENGTHS

Capsules: 250 mg (3)
Oral solution: 100 mg/mL (3)

CONTRAINDICATIONS

Patients with moderate or severe (Child-Pugh Class B or C) hepatic impairment (4, 5.1)
Use with drugs highly dependent on CYP 3A for clearance or are potent CYP 3A inducers (4, 5.3, 7)

WARNINGS AND PRECAUTIONS

Hepatic Impairment: Discontinue for signs and symptoms of clinical hepatitis or asymptomatic increases in ALT/AST >10 times ULN or asymptomatic increases in ALT/AST 5-10 times ULN with concomitant increases in total bilirubin. Monitor liver function tests prior to therapy and frequently thereafter. (5.1)
Intracranial Hemorrhage/Platelet Aggregation and Coagulation: Use with caution in patients at risk for increased bleeding or who are receiving medications that increase the risk of bleeding. (5.2, 5.4)
The concomitant use of APTIVUS/ritonavir and certain other drugs may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions. (5.3, 7.2)
Rash: Discontinue and initiate appropriate treatment if severe skin reaction occurs or is suspected. (5.6) Use with caution in patients with a known sulfonamide allergy. (5.7)
Patients may develop new onset or exacerbations of diabetes mellitus, hyperglycemia (5.8), immune reconstitution syndrome (5.9), redistribution/accumulation of body fat (5.10), and elevated lipids. (5.11) Monitor cholesterol and triglycerides prior to therapy and periodically thereafter.
Hemophilia: Spontaneous bleeding may occur, and additional factor VIII may be required. (5.12)

ADVERSE REACTIONS

In adults the most frequent adverse reactions (incidence >4%) were diarrhea, nausea, pyrexia, vomiting, fatigue, headache, and abdominal pain. (6.1)
In pediatric patients (age 2 to 18 years) the most frequent adverse reactions were generally similar to those seen in adults. However, rash was more frequent in pediatric patients than in adults. (6.2)


To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Co-administration of APTIVUS can alter the concentrations of other drugs and other drugs may alter the concentration of tipranavir. The potential for drug-drug interactions must be considered prior to and during therapy. (4, 5.3, 7)
USE IN SPECIFIC POPULATIONS

Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. (8.2)
The risk-benefit has not been established in pediatric patients <2 years of age (8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2020

Aptivus 250mg Cap
RX464913 464913 NDC No.00597-0003-02 00597-003-02 00597000302 0597000302 UPC/GTIN No.3-05970-00302-1 305970-003021 305970003021 MPN 302 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospita

Aptivus 250mg Cap
RX464913 464913 NDC No.00597-0003-02 00597-003-02 00597000302 0597000302 UPC/GTIN No.3-05970-00302-1 305970-003021 305970003021 MPN 302 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospita

TIPRANAVIR ORAL CAPSULE 2
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Aptivus 250mg Cap 120 by Boehringer Inge
RX464913 464913 NDC No.00597-0003-02 00597-003-02 00597000302 0597000302 UPC/GTIN No.3-05970-00302-1 305970-003021 305970003021 MPN 302 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospita

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