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Pifeltro Generic Name & Formulations
Legal Class
Rx
General Description
Doravirine 100mg; tabs.
Pharmacological Class
Non-nucleoside reverse transcriptase inhibitor.
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Pifeltro Indications
Indications
In combination with other antiretroviral agents for HIV-1 infection in antiretroviral treatment-naïve patients, or to replace the current antiretroviral regimen in virologically suppressed (HIV-1 RNA <50copies/mL) patients on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.
Pifeltro Dosage and Administration
Adult
≥18yrs: 100mg once daily. Concomitant rifabutin: 100mg twice daily (approx. 12hrs apart).
Children
<18yrs: not established.
Pifeltro Contraindications
Contraindications
Concomitant strong CYP3A inducers (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John's wort): discontinue for ≥4wks prior to starting Pifeltro.
Pifeltro Boxed Warnings
Not Applicable
Pifeltro Warnings/Precautions
Warnings/Precautions
ESRD or dialysis: not studied. Severe hepatic impairment (Child-Pugh C): not studied. Elderly. Pregnancy. Nursing mothers: not recommended.
Pifeltro Pharmacokinetics
See Literature
Pifeltro Interactions
Interactions
Concomitant efavirenz, etravirine, nevirapine: not recommended. May be antagonized by CYP3A inducers (see Contraindications). May be potentiated by CYP3A inhibitors.
Pifeltro Adverse Reactions
Adverse Reactions
Nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, abnormal dreams; immune reconstitution syndrome.
Pifeltro Clinical Trials
See Literature
Pifeltro Note
Notes
To register pregnant patients to the Antiretroviral Pregnancy Registry, call (800) 258–4263.
Pifeltro Patient Counseling
See Literature
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