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Pifeltro
doravirine
Adult Dosing .
Dosage forms: TAB: 100 mg
HIV infection
- [1 tab PO qd]
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 100 mg
HIV infection
- [>35 kg]
- Dose: 1 tab PO qd
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding (patients with non-virological suppression throughout 3rd trimester)
- avoid: breastfeeding (patients with non-virological suppression postpartum)
- avoid: breastfeeding (patients with cracked nipple or bleeding nipple)
- avoid: breastfeeding (patients with mastitis)
Drug Interactions .
Overview
doravirine
NNRTI
- CYP3A4 substrate
- affected by altered fat absorption
- interferes w/ gene therapy
Contraindicated
- apalutamide
- butalbital
- carbamazepine
- encorafenib
- enzalutamide
- fosphenytoin
- ivosidenib
- lumacaftor/ivacaftor
- mitotane
- oxcarbazepine
- pentobarbital
- phenobarbital
- phenytoin
- primidone
- rifampin
- rifapentine
- St. John's wort
Avoid/Use Alternative
- atidarsagene autotemcel
- betibeglogene autotemcel
- bosentan
- cenobamate
- dabrafenib
- efavirenz
- elivaldogene autotemcel
- etravirine
- fexinidazole
- lopinavir/ritonavir
- lorlatinib
- lovotibeglogene autotemcel
- marnetegragene autotemcel
- mavacamten
- mitapivat
- modafinil
- nafcillin
- nevirapine
- orlistat
- pacritinib
- pexidartinib
- repotrectinib
- sotorasib
Monitor/Modify Tx
- etuvetidigene autotemcel
- rifabutin
Caution Advised
- adagrasib
- armodafinil
- artemether/lumefantrine
- atazanavir
- belzutifan
- bexarotene
- brigatinib
- ceritinib
- chloramphenicol
- clarithromycin
- clobazam
- cobicistat
- danshen
- darolutamide
- dexamethasone
- dicloxacillin
- echinacea
- elafibranor
- elagolix
- enasidenib
- eslicarbazepine acetate
- felbamate
- fosamprenavir
- garlic
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- idelalisib
- itraconazole
- ketoconazole
- levoketoconazole
- lonafarnib
- meropenem
- mifepristone
- mobocertinib
- nefazodone
- nelfinavir
- odevixibat
- olutasidenib
- omaveloxolone
- perampanel
- pioglitazone
- posaconazole
- prednisone
- relacorilant
- ribociclib
- ritonavir
- rufinamide
- sarilumab
- stiripentol
- sunvozertinib
- suzetrigine
- tazemetostat
- tecovirimat
- telotristat ethyl
- tipranavir
- tocilizumab
- topiramate
- tovorafenib
- tucatinib
- vaborbactam
- vamorolone
- vemurafenib
- vinblastine
- vorasidenib
- voriconazole
- zanubrutinib
Adverse Reactions .
Serious Reactions
- depression
- suicidality
- immune reconstitution syndrome
- autoimmune disorder
- skin reaction, severe
- hepatitis
Common Reactions
- dizziness
- nausea
- abdominal pain
- headache
- fatigue
- diarrhea
- abnormal dreams
- sleep disorders
- LFTs elevated
- insomnia
- depression
- somnolence
- altered consciousness
- syncope
- lethargy
- Cr incr.
- CK elevated
- rash
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of fetal harm based on animal data at >8x recommended human dose
Pregnancy Registry
enroll patients in Antiretroviral Pregnancy Registry at 1-800-258-4263; additional info at www.apregistry.com
Lactation
Clinical Summary
weigh risk/benefit if virologically suppressed throughout 3rd trimester and at delivery, otherwise avoid breastfeeding; avoid breastfeeding if mastitis or nipples cracked or bleeding; give infant antiretroviral prophylaxis with zidovudine or nevirapine; risk of postnatal HIV transmission if non-virologically suppressed based on human data; risk of postnatal HIV transmission low if virologically suppressed based on limited human data; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for doravirine: liver; CYP450: 3A substrate
Excretion: for doravirine: urine 6%, feces minimally; Half-life: 15h
Subclass: HIV: Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Mechanism of Action
for doravirine: inhibits reverse transcriptase and incorporates into viral DNA, resulting in DNA chain termination
Formulary .
No Formulary Selected
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