TM Owner Merck & Co.
Pifeltro 100mg FC Tablet
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Indications & Clinical Uses
- Pifeltro 100 mg film-coated tablets contain doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) used together with other antiretroviral medicines to treat HIV-1 infection in adults and children who weigh at least 35 kg (about 77 lb).
- It is approved both for patients starting treatment for the first time and for those switching from a stable, virologically suppressed regimen, always as part of a combination antiretroviral regimen — Pifeltro is never used alone.
- Doravirine is also available combined with lamivudine and tenofovir disoproxil fumarate in a single tablet called Delstrigo, which is a separate product.
- Pifeltro is a prescription-only, specialist-initiated medicine, typically started and monitored by an HIV specialist, and taken once daily by mouth with or without food.
- The approved age and weight limits are consistent between the US and EU labels.
Side Effects
- The most common side effects of Pifeltro reported in clinical trials include nausea, dizziness, headache, tiredness, diarrhea, stomach pain, and unusual or vivid dreams; most reactions were mild.
- Serious but uncommon reactions include severe skin reactions such as Stevens-Johnson syndrome and DRESS (drug reaction with eosinophilia and systemic symptoms), which need urgent medical attention if a severe rash, blistering, fever, or swelling develops — treatment should be stopped immediately if this occurs.
- There is no boxed warning on the current Pifeltro label.
- As with other antiretrovirals, starting treatment can trigger immune reconstitution inflammatory syndrome, causing inflammation from a previously hidden infection; report any new symptoms to your healthcare provider.
- Take Pifeltro at the same time every day, and never stop or change your HIV regimen without medical advice, since resistance can develop.
Precautions & Warnings
- Pifeltro must always be used as part of a complete antiretroviral regimen and must not be taken with strong CYP3A inducers such as rifampin, rifapentine, carbamazepine, phenobarbital, phenytoin, oxcarbazepine, enzalutamide, mitotane, or St. John's wort, because these significantly lower doravirine levels and risk treatment failure and resistance.
- HIV testing, hepatitis B status, and routine monitoring for immune reconstitution symptoms are recommended before and during treatment; patients coinfected with hepatitis B need close monitoring if a Pifeltro-containing regimen is stopped, since hepatitis can flare.
- There are no specific renal-impairment restrictions on the current label, though caution is advised in significant hepatic impairment.
- Pifeltro may be used in pregnancy when clinically needed, based on available data; discuss contraception and pregnancy planning with your healthcare provider.
- There is no specific driving restriction, though dizziness or tiredness should be taken into account.
Avoid Interactions
- Pifeltro must not be combined with strong CYP3A4 inducers, including rifampin, rifapentine, carbamazepine, phenobarbital, phenytoin, oxcarbazepine, enzalutamide, mitotane, and St. John's wort, since these lower doravirine blood levels enough to risk loss of viral control and drug resistance.
- If rifabutin is required, the Pifeltro dose must be increased to twice daily, spaced about 12 hours apart, to compensate for reduced exposure.
- Strong CYP3A4 inhibitors can raise doravirine levels, though clinically significant interactions are limited.
- Pifeltro has not shown clinically important interactions with dolutegravir, tenofovir disoproxil fumarate, lamivudine, or ritonavir-boosted regimens in studies.
- Because HIV medicines interact with many other drugs, tell your healthcare provider and pharmacist about every prescription medicine, over-the-counter product, herbal remedy, and supplement — including St. John's wort — before starting or during Pifeltro treatment.
References
Frequently Asked Questions
Pifeltro (doravirine) 100 mg tablets treat HIV-1 infection in adults and children weighing at least 35 kg (77 lb). It is always used together with other HIV medicines as part of a combination regimen, either for people starting treatment or switching from a stable, virologically suppressed regimen.
Take one Pifeltro 100 mg tablet by mouth once daily, with or without food, at about the same time each day. Swallow it whole with liquid, together with your other prescribed HIV medicines, and never skip doses, to avoid the virus becoming resistant.
The most common Pifeltro side effects are nausea, dizziness, headache, tiredness, diarrhea, stomach pain, and vivid dreams. Get urgent medical help for a severe rash, blistering, fever, or swelling, which could signal a serious skin reaction such as Stevens-Johnson syndrome.
Avoid rifampin, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, enzalutamide, mitotane, and St. John's wort with Pifeltro (doravirine), since these strongly reduce its levels and can stop it working properly. Tell your healthcare provider about every prescription medicine, over-the-counter product, and supplement before starting or during treatment.
If you miss a Pifeltro dose, take it as soon as you remember that same day, then resume your normal daily schedule; do not double up. Missing doses regularly raises the risk of the virus becoming resistant, so keep a daily reminder and every follow-up blood test appointment.
Yes, Pifeltro is approved for children who weigh at least 35 kg (about 77 lb), at the same 100 mg once-daily dose as adults, always combined with other HIV medicines. It has not been studied in children below this weight, so it is not used in lighter children.
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