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Edurant
rilpivirine
Adult Dosing .
Dosage forms: TAB: 25 mg
Special Note
- [equivalency or interchangeability info]
- Info: not interchangeable w/ rilpivirine dispersable tabs; do not substitute on a mg to mg basis
HIV infection
- [tx-naive]
- Dose: 25 mg PO qd; Info: for pts w/ HIV-1 RNA <100,000 and CD4 >200; give w/ meals
- [pregnant pts]
- Dose: 25 mg PO qd; Info: for pts w/ HIV-1 RNA <50 on stable rilpivirine-containing regimen prior to pregnancy; give w/ meals
- [lead-in dosing w/ PO cabotegravir]
- Dose: 25 mg PO qd for at least 28 days; Start: 1mo before cabotegravir and rilpivirine injections; Info: for short-term tx in pts w/ HIV-1 RNA <50 and no known tx failure or resistance to cabotegravir or rilpivirine; give w/ meals
- [replacement dosing for missed cabotegravir and rilpivirine injections]
- Dose: 25 mg PO qd until next cabotegravir and rilpivirine injections for up to 2mo; Start: 1-2mo after last cabotegravir and rilpivirine injections; Info: for short-term tx if planned missed cabotegravir and rilpivirine injections by >7 days; give w/ PO cabotegravir; give w/ meals
HIV post-exposure prophylaxis, occupational (off-label)
- [25 mg PO qd]
- Info: part of multi-drug regimen; refer to HIV Post-Exposure Prophylaxis, Occupational table; give w/ meals
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 25 mg
Special Note
- [equivalency or interchangeability info]
- Info: not interchangeable w/ rilpivirine dispersable tabs; do not substitute on a mg to mg basis
HIV infection
- [2 yo and older, >25 kg, tx-naive]
- Dose: 25 mg PO qd; Info: for pts w/ HIV-1 RNA <100,000; give w/ meals
- [2 yo and older, >25 kg, pregnant pts]
- Dose: 25 mg PO qd; Info: for pts w/ HIV-1 RNA <50 on stable rilpivirine-containing regimen prior to pregnancy; give w/ meals
- [lead-in dosing w/ PO cabotegravir]
- Dose: 25 mg PO qd for at least 28 days; Start: 1mo before cabotegravir and rilpivirine injections; Info: for short-term tx in pts 12 yo and older, >35 kg, w/ HIV-1 RNA <50, and no known tx failure or resistance to cabotegravir or rilpivirine; give w/ meals
- [replacement dosing for missed cabotegravir and rilpivirine injections]
- Dose: 25 mg PO qd until next cabotegravir and rilpivirine injections for up to 2mo; Start: 1-2mo after last cabotegravir and rilpivirine injections; Info: for short-term tx in pts 12 yo and older and >35 kg if planned missed cabotegravir and rilpivirine injections by >7 days; give w/ PO cabotegravir; give w/ meals
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined, caution advised
- HD/PD: not defined, caution advised
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 (pts w/ cracked nipple or bleeding nipple)
- avoid: breastfeeding (pts w/ mastitis)
- avoid: breastfeeding (HIV infection use in pts w/ non-virological suppression throughout 3rd trimester)
- avoid: breastfeeding (HIV infection use in pts w/ non-virological suppression postpartum)
- avoid: breastfeeding (HIV post-exposure prophylaxis use)
- caution: renal impairment, severe
- caution: depressive disorder
- caution: HIV infection and HBV infection, concurrent
- caution: HIV infection and HCV infection, concurrent
- caution: liver transaminases elevated
- caution: electrolyte abnormalities
- caution: long QT syndrome, congenital
- caution: QT prolongation
- caution: QT prolongation family hx
- caution: torsades de pointes hx
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
Drug Interactions .
Overview
rilpivirine
NNRTI
- CYP3A4 substrate
- affected by altered fat absorption
- gastric pH sensitive
- interferes w/ gene therapy
- prolongs QT interval (conditional)
Contraindicated
- carbamazepine
- dexamethasone
- dexlansoprazole
- esomeprazole
- fosphenytoin
- lansoprazole
- omeprazole
- oxcarbazepine
- pantoprazole
- phenobarbital
- phenytoin
- pimozide
- rabeprazole
- rifabutin
- rifampin
- rifapentine
- St. John's wort
- thioridazine
- vonoprazan
Avoid/Use Alternative
- adagrasib
- amiodarone
- anagrelide
- apalutamide
- apomorphine
- arsenic trioxide
- artemether/lumefantrine
- asenapine
- atidarsagene autotemcel
- azithromycin
- bedaquiline
- betibeglogene autotemcel
- bosentan
- butalbital
- cabozantinib
- cenobamate
- ceritinib
- chloroquine
- cisapride
- citalopram
- clarithromycin
- clofazimine
- cobicistat
- crizotinib
- dabrafenib
- degarelix
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- disopyramide
- dofetilide
- domperidone
- donepezil
- dronedarone
- droperidol
- efavirenz
- elivaldogene autotemcel
- encorafenib
- enzalutamide
- ephedra
- epirubicin
- eribulin
- erythromycin
- etravirine
- fexinidazole
- flecainide
- fluorouracil
- gilteritinib
- glasdegib
- goserelin
- haloperidol
- histrelin
- hydroxychloroquine
- hydroxyzine
- ibutilide
- inotuzumab ozogamicin
- isoflurane
- ivosidenib
- lefamulin
- leuprolide
- levofloxacin
- levoketoconazole
- lofexidine
- lonafarnib
- lorlatinib
- lovotibeglogene autotemcel
- lumacaftor/ivacaftor
- macimorelin
- mavacamten
- methadone
- mitapivat
- mitotane
- mobocertinib
- modafinil
- moxifloxacin
- nafcillin
- nevirapine
- nilotinib
- oliceridine
- ondansetron
- osimertinib
- pacritinib
- paliperidone
- palonosetron
- panobinostat
- pasireotide
- pentamidine
- pentobarbital
- pexidartinib
- primidone
- procainamide
- propafenone
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- repotrectinib
- revumenib
- ribociclib
- rilpivirine
- romidepsin
- rucaparib
- selpercatinib
- sevoflurane
- sotalol
- sotorasib
- tecovirimat
- telavancin
- tetrabenazine
- toremifene
- tramadol
- triclabendazole
- trifluridine
- triptorelin
- vandetanib
- vemurafenib
- ziprasidone
Monitor/Modify Tx
- aluminum hydroxide
- atazanavir
- calcium carbonate
- chloramphenicol
- cimetidine
- darunavir
- famotidine
- fluconazole
- idelalisib
- itraconazole
- ketoconazole
- lopinavir/ritonavir
- magnesium carbonate
- magnesium hydroxide
- magnesium oxide
- mifepristone
- nefazodone
- nelfinavir
- nizatidine
- orlistat
- posaconazole
- ritonavir
- sodium bicarbonate
- sodium citrate
- sodium zirconium cyclosilicate
- tipranavir
- tucatinib
- voriconazole
Caution Advised
- armodafinil
- belzutifan
- bexarotene
- brigatinib
- clobazam
- danshen
- darolutamide
- dicloxacillin
- echinacea
- elafibranor
- elagolix
- enasidenib
- eslicarbazepine acetate
- felbamate
- garlic
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- meropenem
- odevixibat
- olutasidenib
- omaveloxolone
- perampanel
- pioglitazone
- prednisone
- rufinamide
- sarilumab
- somatropin
- stiripentol
- sunvozertinib
- suzetrigine
- tazemetostat
- telotristat ethyl
- tocilizumab
- topiramate
- tovorafenib
- vaborbactam
- vamorolone
- vinblastine
- vorasidenib
- zanubrutinib
Adverse Reactions .
Serious Reactions
- depression
- suicidality
- hepatotoxicity
- immune reconstitution syndrome
- autoimmune disorder
- skin rxn, severe
- drug rxn w/ eosinophilia and systemic sx
Common Reactions
- ALT or AST elevated
- hypercholesterolemia
- somnolence (peds pts)
- nausea (peds pts)
- dizziness (peds pts)
- vomiting (peds pts)
- Cr elevated
- hyperbilirubinemia
- depression
- rash
- insomnia
- headache
- abdominal pain
- fatigue
- abnormal dreams
- hypertriglyceridemia
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, 2-8wk after tx start or change, then q6mo
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; no known risk of fetal harm based on limited human data and animal data at 15x and 70x recommended human dose; possible risk of lower exposure during pregnancy, though not clinically relevant if virologically suppressed
Pregnancy Registry
enroll pts in Antiretroviral Pregnancy Registry at 1-800-258-4263; additional info at www.apregistry.com
Lactation
Clinical Summary
HIV Infection Use: 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 w/ 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 human data; inadequate human data available, though possible risk of fetal harm based on drug excretion into milk; no human data available to assess effects on milk production
HIV Post-Exposure Prophylaxis Use: avoid breastfeeding; risk of postnatal HIV transmission if non-virologically suppressed based on human data; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 3A substrate
Excretion: feces 85% (25% unchanged), urine 6.1% (<1% unchanged); Half-life: 50h
Subclass: HIV: Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Mechanism of Action
inhibits reverse transcriptase and incorporates into viral DNA, resulting in DNA chain termination
Formulary .
No Formulary Selected
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