Version July 2025
HIV-1 infection, treatment:
Treatment-naive patients: Oral: 25 mg once daily.
Note: Do not use rilpivirine-based regimens in patients with CD4 count <200 cells/mm3 and/or HIV RNA >100,000 copies/mL (Ref).
Pregnancy: 25 mg once daily in patients on stable regimen prior to pregnancy and who are virologically suppressed.
Combination treatment with cabotegravir, treatment-experienced patients ≥35 kg: Oral:
Oral lead-in: 25 mg once daily, in combination with oral cabotegravir, for ~1 month (≥28 days) prior to initiation of cabotegravir and rilpivirine injections, to assess tolerability to rilpivirine. Note: Final oral dose should be taken on the same day as initiation of injections.
Oral bridging therapy: 25 mg once daily, in combination with oral cabotegravir, in patients who plan to miss a scheduled cabotegravir and rilpivirine injection visit by >7 days. Note: First oral dose should be initiated at approximately the same time as the planned missed injection dose and continued until the day injection dosing is restarted. Oral therapy may be used for up to 2 months to replace missed injection(s).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Mild or moderate renal impairment: No dosage adjustment necessary.
Severe or end-stage renal impairment (ESRD): Use with caution; no dosage adjustment necessary (Ref).
Hemodialysis/peritoneal dialysis: Due to extensive protein binding, significant removal by hemodialysis or peritoneal dialysis is unlikely.
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). The Canadian labeling recommends avoiding use due to lack of data.
(For additional information see "Rilpivirine: Pediatric drug information")
Dosage guidance:
Dosage form information: Rilpivirine film-coated tablets (Edurant) and tablets for oral suspension (Edurant Ped) are NOT substitutable on a mg-per-mg basis due to differing bioavailability and pharmacokinetic profiles.
HIV-1 infection, treatment; treatment-naive patients: Note: Use in combination with other antiretroviral (ARV) agents; evaluate gene mutation and ARV resistance patterns (refer to https://www.iasusa.org/ and https://hivdb.stanford.edu/ for more information). Do not use in patients with HIV RNA >100,000 copies/mL.
Children ≥2 years and Adolescents, weighing ≥14 kg:
14 to <20 kg: Tablet for oral suspension (Edurant Ped): Oral: 12.5 mg once daily.
20 to <25 kg: Tablet for oral suspension (Edurant Ped): Oral: 15 mg once daily.
≥25 kg: Tablet (Edurant): Oral: 25 mg once daily.
HIV-1 infection, treatment; treatment-experienced patients:
Combination treatment with oral cabotegravir:
Children ≥12 years and Adolescents, weighing ≥35 kg:
Oral lead-in: Tablet (Edurant): Oral: 25 mg once daily for ~1 month (≥28 days) prior to initiation of cabotegravir and rilpivirine injections, to assess tolerability to rilpivirine. Note: Initiate injection therapy on the same day as the final oral dose.
Oral bridging therapy: Patients who plan to miss a scheduled rilpivirine and cabotegravir injection visit by >7 days: Tablet (Edurant): Oral: 25 mg once daily for up to 2 months. First oral dose should be taken approximately the same day as the planned missed injection dose and continued until the day injection dosing is restarted.
Combination treatment with other antiretroviral (ARV) agents (non-cabotegravir): Note: For use in virologically suppressed (HIV RNA <50 copies/mL) patients with no history of virologic failure or resistance to rilpivirine or other ARVs in regimen (refer to https://www.iasusa.org/ for more information) (Ref).
Children ≥12 years and Adolescents, weighing ≥35 kg: Tablet (Edurant): Oral: 25 mg once daily (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥2 years and Adolescents:
Mild to moderate renal impairment: No dosage adjustment necessary.
Severe or end-stage renal impairment: Use with caution; guidelines suggest no dosage adjustment necessary; monitor closely as exposure may be increased (Ref).
Hemodialysis/peritoneal dialysis: Due to extensive protein binding, significant removal by hemodialysis or peritoneal dialysis is unlikely; monitor closely for adverse events.
Children ≥2 years and Adolescents:
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions are grades ≥2 reported in adults unless otherwise specified.
>10%:
Endocrine & metabolic: Hypercholesterolemia (grades 1 to 3: ≤17%), increased LDL cholesterol (grades 1 to 3: 1% to 14%)
Hepatic: Increased serum alanine aminotransferase (grades 1 to 4: 1% to 18%), increased serum aspartate aminotransferase (grades 1 to 4: 1% to 16%)
1% to 10%:
Dermatologic: Skin rash (3%)
Endocrine & metabolic: Decreased plasma cortisol (any grade: 7%), increased serum triglycerides (grades 2 to 3: 1% to 2%)
Gastrointestinal: Abdominal distress (<2%), abdominal pain (2%), cholecystitis (<2%), cholelithiasis (<2%), decreased appetite (<2%), diarrhea (<2%), nausea (1%), vomiting (1%)
Hepatic: Increased serum bilirubin (grades 1 to 3: 1% to 5%)
Nervous system: Abnormal dreams (2%), anxiety (<2%), depression (1% to 9%; including suicidal ideation, suicidal tendencies), dizziness (1%), drowsiness (<2%), fatigue (2%), headache (3%), insomnia (3%), sleep disturbance (<2%)
Renal: Increased serum creatinine (grades 1 to 3: ≤6%), membranous glomerulonephritis (<2%), nephrolithiasis (<2%), proliferative glomerulonephritis (mesangioproliferative: <2%)
Frequency not defined (any grade): Nervous system: Psychiatric disturbance
Postmarketing (any grade):
Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms, hypersensitivity reaction
Renal: Nephrotic syndrome
Coadministration with antiseizure medications (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), antimycobacterials (rifampin, rifapentine), proton pump inhibitors (esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), systemic dexamethasone (more than a single dose), or St John's wort.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to rilpivirine or any component of the formulation
Concerns related to adverse effects:
• Depressive disorders: May cause depression, depressed mood, dysphoria, major depression, mood changes, negative thoughts, suicide attempts, or suicidal ideation; if changes are noted, seek professional intervention immediately; reevaluate risk versus benefit of continued rilpivirine therapy.
• Hepatotoxicity: Has been reported during use. Patients with significant transaminase elevations or hepatitis B or C prior to treatment may be at greater risk for hepatic adverse events. Hepatotoxicity has occurred in a few adult patients with no prior hepatic disease or risk factors. Baseline and periodic laboratory LFT evaluation during therapy is recommended for patients with pre-existing risk factors; also consider LFT monitoring in patients without identifiable hepatic disease risk.
• Hypersensitivity: Hypersensitivity and severe skin reactions have been reported, including severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis or eosinophilia, or drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by constitutional symptoms (eg, fever); other skin reactions were associated with organ dysfunction (eg, hepatic serum biochemistry elevations). In clinical trials, treatment-related rashes ≥ grade 2 were reported in 3% of patients. Most rashes were grade 1 or 2 and occurred within the first 4 to 6 weeks of therapy. No grade 4 rashes were reported. Monitor laboratory parameters and clinical status; discontinue if any hypersensitivity or skin rash develop.
• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves’ disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.
Dosage form specific issues:
• Product interchangeability: Do not substitute tablets for oral use with tablets used for oral suspension on a milligram per milligram basis; underdosing or loss of therapeutic effect leading to possible resistance or severe adverse effects may occur due to the differences in pharmacokinetic profiles. Tablets for oral suspension are only indicated for pediatric patients weighing 14 kg to <25 kg.
Safety was assessed in 36 pediatric patients 12 to <18 years of age in a phase 2 trial; the reported incidence of adverse reactions was higher in pediatric subjects than previously reported in adults; 52.8% overall; most were grade 1 or 2. Reported adverse reactions for pediatric patients (in at least 2 subjects, ages 12 to <18 years) include: Headache (19.4% vs 3% in adults), depression (19.4% vs 9% in adults), somnolence (13.9%), nausea (11.1% vs 1% in adults), dizziness (8.3% vs 1% in adults), abdominal pain (8.3% vs 2% in adults), vomiting (5.6% vs 1% in adults), and rash (5.6% vs 3% in adults). For depressive disorders, the incidence of grade 3 and 4 depressive disorders (regardless of causality) was 5.6% (vs 1% in adult studies). None of these pediatric patients discontinued therapy due to their depressive symptoms.
Edurant Ped 2.5 mg tablets for oral suspension: FDA approved March 2024; anticipated availability currently unknown.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Edurant: 25 mg
No
Tablets (Edurant Oral)
25 mg (per each): $59.33
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Edurant: 25 mg
Oral: Administer with a normal- to high-calorie meal (≥390 kcal) (HHS [ARV adult] 2023). Taking with a protein supplement drink alone does not increase absorption.
Oral: Administer with a meal; administration with a protein supplement drink or yogurt alone is not adequate.
Tablet, film-coated (Edurant): Swallow tablet whole with water.
Tablet for oral suspension (Edurant Ped): Do not chew or swallow whole. Must be dispersed in water for administration. Each dose should be prepared just prior to administration. Place the appropriate number of tablets in a cup; add 5 mL (1 teaspoon) of room temperature drinking water; do NOT crush tablets. Swirl cup for 1 to 2 minutes to disperse the tablets; preparation should start to look cloudy. If desired, may further dilute in 5 mL (1 teaspoon) of drinking water, milk, orange juice, or applesauce; swirl to mix or use a spoon if needed. Administer immediately, ensuring that nothing remains in the cup. If needed, add another 5 mL (1 teaspoon) of drinking water (or alternative beverage or soft food), swirl, and administer immediately.
Missed dose: If within 12 hours of scheduled dose time, administer the dose with a meal and resume the original schedule. If >12 hours, skip dose and resume at regular schedule.
HIV-1 infection, treatment:
Treatment-naive patients: Treatment of HIV-1 infections in antiretroviral treatment-naive patients ≥2 years of age and weighing ≥14 kg, with HIV-1 RNA ≤100,000 copies/mL at the start of therapy in combination with other antiretroviral agents.
Combination treatment with cabotegravir, treatment-experienced patients: Short-term treatment of HIV-1 infection, in combination with cabotegravir, in patients ≥12 years of age and weighing ≥35 kg who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either rilpivirine or cabotegravir, as oral lead-in to assess tolerability of rilpivirine prior to initiating rilpivirine and cabotegravir injections or an oral bridging therapy for missed rilpivirine and cabotegravir injections.
Substrate of CYP3A4 (Major with inducers), CYP3A4 (Minor with inhibitors); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Antacids: May decrease serum concentration of Rilpivirine. Management: Administer antacids at least 2 hours before or 4 hours after oral rilpivirine when used with most rilpivirine products. However, administer antacids at least 6 hours before or 4 hours after the rilpivirine/dolutegravir combination product. Risk D: Consider Therapy Modification
Antihepaciviral Combination Products: May increase serum concentration of Rilpivirine. Risk X: Avoid
Atidarsagene Autotemcel: Antiretroviral Agents may decrease therapeutic effects of Atidarsagene Autotemcel. Risk X: Avoid
Betibeglogene Autotemcel: Antiretroviral Agents may decrease therapeutic effects of Betibeglogene Autotemcel. Risk X: Avoid
CarBAMazepine: May decrease serum concentration of Rilpivirine. Risk X: Avoid
CYP3A4 Inducers (Moderate): May decrease serum concentration of Rilpivirine. Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Rilpivirine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for reduced rilpivirine efficacy (eg, loss of virologic response or resistance). Risk X: Avoid
CYP3A4 Inhibitors (Strong): May increase serum concentration of Rilpivirine. Risk C: Monitor
DexAMETHasone (Systemic): May decrease serum concentration of Rilpivirine. Risk X: Avoid
Didanosine: Rilpivirine may decrease absorption of Didanosine. Didanosine may decrease absorption of Rilpivirine. More specifically, simultaneous coadministration of these drugs creates a conflict between recommendations to administer with (rilpivirine) and without (didanosine) food. Management: Administer didanosine on an empty stomach at least 2 hours before or 4 hours after rilpivirine, due to the requirement that rilpivirine be administered with food. Risk D: Consider Therapy Modification
Elivaldogene Autotemcel: Antiretroviral Agents may decrease therapeutic effects of Elivaldogene Autotemcel. Management: Avoid use of antiretroviral medications for at least one month, or for the amount of time required for elimination of the retroviral medication, prior to stem cell mobilization and until the all apheresis cycles are finished Risk X: Avoid
Ergonovine: Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase serum concentration of Ergonovine. Specifically, this would be most likely with delavrdine, while other Non-Nucleoside Reverse Transcriptase Inhibitors may be more likely to decrease the concentration of Ergonovine. Risk X: Avoid
Fosphenytoin: May decrease serum concentration of Rilpivirine. Risk X: Avoid
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Histamine H2 Receptor Antagonists: May decrease serum concentration of Rilpivirine. Management: Administer histamine H2 receptor antagonists (H2RAs) at least 12 hours before or 4 hours after oral rilpivirine. Risk D: Consider Therapy Modification
Inhibitors of the Proton Pump (PPIs and PCABs): May decrease serum concentration of Rilpivirine. Risk X: Avoid
Ketoconazole (Systemic): May increase serum concentration of Rilpivirine. Rilpivirine may decrease serum concentration of Ketoconazole (Systemic). Risk C: Monitor
Levomethadone: Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease serum concentration of Levomethadone. Management: Levomethadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. Risk C: Monitor
Lovotibeglogene Autotemcel: Antiretroviral Agents may decrease therapeutic effects of Lovotibeglogene Autotemcel. Risk X: Avoid
Macrolide Antibiotics: May increase serum concentration of Rilpivirine. Management: Consider the use of azithromycin or another non-macrolide alternative when appropriate to avoid this potential interaction. Risk D: Consider Therapy Modification
Methadone: Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase metabolism of Methadone. Management: Methadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. Risk C: Monitor
Orlistat: May decrease serum concentration of Antiretroviral Agents. Risk C: Monitor
OXcarbazepine: May decrease serum concentration of Rilpivirine. Risk X: Avoid
PHENobarbital: May decrease serum concentration of Rilpivirine. Risk X: Avoid
Phenytoin: May decrease serum concentration of Rilpivirine. Risk X: Avoid
Primidone: May decrease serum concentration of Rilpivirine. Risk X: Avoid
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Reverse Transcriptase Inhibitors (Non-Nucleoside): May increase adverse/toxic effects of Reverse Transcriptase Inhibitors (Non-Nucleoside). Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease serum concentration of Reverse Transcriptase Inhibitors (Non-Nucleoside). Specifically, efavirenz and nevirapine may decrease the serum concentrations of other non-nucleoside reverse transcriptase inhibitors. Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase serum concentration of Reverse Transcriptase Inhibitors (Non-Nucleoside). Specifically, delavirdine may increase the serum concentration of etravirine. Risk X: Avoid
Rifabutin: May decrease serum concentration of Rilpivirine. Management: Increase rilpivirine dose to 50 mg/day during rifabutin treatment. Use of rifabutin with emtricitabine/rilpivirine/tenofovir alafenamide product is not recommended. Use with IV cabotegravir/rilpivirine is contraindicated. Risk D: Consider Therapy Modification
RifAMPin: May decrease serum concentration of Rilpivirine. Risk X: Avoid
Rifapentine: May decrease serum concentration of Rilpivirine. Risk X: Avoid
Saquinavir: Rilpivirine may increase arrhythmogenic effects of Saquinavir. Saquinavir may increase serum concentration of Rilpivirine. Risk X: Avoid
St John's Wort: May decrease serum concentration of Rilpivirine. Risk X: Avoid
Absorption increased when taken with a normal- to high-calorie meal (Tablet [Edurant]: ~40%; Tablet for oral solution [Edurant Ped]: 28% to 31%). Management: Administer with a normal- to high-calorie meal. Administration with a protein supplement drink alone does not increase absorption.
Grapefruit products: Grapefruit products may inhibit CYP3A4-mediated metabolism of rilpivirine and increase its exposure.
Contraception is not required to initiate or continue antiretroviral therapy (ART).
Oral rilpivirine is an alternative component of ART for patients with HIV who are not yet pregnant but are trying to conceive.
Maximum viral suppression sustained below the limits of detection prior to conception is recommended for all persons with HIV who are planning a pregnancy. Prior to pregnancy, select or make changes to a specific antiretroviral regimen as part of a shared decision-making process. In most cases, recommendations based on data obtained from cisgender women can be applied to transgender and gender diverse people assigned female sex at birth.
Health care providers caring for couples planning a pregnancy when one or both partners are diagnosed with HIV may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2024).
Rilpivirine has moderate to high placental transfer.
No increased risk of overall teratogenic effects has been observed following first trimester exposure according to data collected by the antiretroviral pregnancy registry. Maternal antiretroviral therapy (ART) may be associated with adverse pregnancy outcomes, including preterm birth, low birth weight, and small for GA infants. High viral loads are also associated with adverse outcomes, including preterm birth and pregnancy loss. Treatment improves the health of the pregnant patient and reduces the risk of perinatal transmission. Do not withhold appropriate maternal ART due to concerns for adverse neonatal outcomes. Closely monitor for pregnancy complications. Document in utero ART exposure in the long-term medical record of a child born without HIV; evaluate for potential metabolic dysfunction if significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) develop.
Oral rilpivirine is an alternative ART for pregnant patients with HIV who are antiretroviral naive, who have had ART therapy in the past but are restarting, or who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). Patients who become pregnant while taking rilpivirine may continue if viral suppression is effective and the regimen is well tolerated.
Oral rilpivirine is recommended as a component in alternative regimens for initial use in antiretroviral-naive pregnant patients with a pretreatment HIV RNA ≤100,000 copies/mL and CD4 cell count ≥200 cells/mm3.
The pharmacokinetics of oral rilpivirine in pregnancy are highly variable. Concentrations of rilpivirine may decrease in the second and third trimesters; however, use of higher doses has not been studied. Monitor viral loads more frequently in pregnant patients taking standard doses of rilpivirine or consider changing to another regimen that is recommended during pregnancy.
ART is recommended for all pregnant people with HIV to maximize their health, maintain the viral load below the limit of an ultrasensitive assay detection, and reduce the risk of perinatal transmission. Start ART prior to conception or as soon as possible during pregnancy. During pregnancy, select or make changes to a specific antiretroviral regimen as part of a shared decision-making process. Patients on fully suppressive regimens prior to pregnancy generally may continue the same regimen considering known pregnancy outcomes and pharmacokinetic data. Monitor pregnant patients more frequently than nonpregnant patients. ART initiated during pregnancy can be modified after delivery. In most cases, recommendations based on data obtained from cisgender women can be applied to transgender and gender diverse people assigned female sex at birth.
Data collection to monitor pregnancy and infant outcomes following exposure to ART is ongoing. Enroll all patients exposed to antiretroviral medications as early in pregnancy as possible in the Antiretroviral Pregnancy Registry (1-800-258-4263).
Health care providers caring for pregnant patients with HIV infection and their infants may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2024).
Rilpivirine is present in breast milk.
Data related to the presence of rilpivirine in breast milk are available from 2 lactating patients taking rilpivirine 25 mg once daily during pregnancy and postpartum. Single samples of breast milk and maternal plasma were sampled ~15 hours after a dose 1 month following delivery. Median concentrations of rilpivirine were 122 ng/mL (breast milk; range 107 to 140 ng/mL) and 113 ng/mL (maternal plasma; range 120 to 126 ng/mL). Rilpivirine was also detected in the infant plasma (4 ng/mL) when sampled 16 hours after the maternal dose. Authors of the study calculated the estimated infant dose of rilpivirine via breast milk to be 0.02 mg/kg/day (Aebi-Popp 2022).
Provide patient-centered evidence-based counseling for infant feeding options as early as possible in pregnancy.
• Using properly prepared formula or pasteurized banked donor milk eliminates the risk of postnatal HIV transmission via breastfeeding.
• Counsel patients on antiretroviral therapy (ART) who achieve and maintain a consistently undetectable plasma viral load during pregnancy and postnatally about feeding options, including breastfeeding, formula feeding, or banked donor milk. Maintaining maximum viral suppression decreases but does not eliminate the risk of HIV transmission via breast milk. Temporary discontinuation of breastfeeding and use of replacement feeding may be required if maternal viral load becomes detectable or if mastitis or bleeding nipples develop. Permanent discontinuation of breastfeeding is recommended if the maternal HIV RNA is ≥200 copies/mL.
• Formula feeding or banked donor milk is recommended for persons with HIV who are not on ART and/or do not have sustained viral suppression. Provide the infant presumptive ART throughout breastfeeding and for up to 6 weeks after the last exposure to breastmilk if the breastfeeding parent does not have sustained viral suppression but breastfeeding is continued; conduct infant virologic diagnostic testing at specified intervals.
• When the HIV status at delivery is not known, breast milk may be expressed and stored until a negative test is available.
• Discontinue breastfeeding immediately if HIV infection is diagnosed after breastfeeding has been initiated.
• Evaluate and provide support for maternal conditions that would make adherence to postpartum ART difficult.
Information is available for counseling and managing patients with HIV who are considering breastfeeding (1-888-448-8765). In most cases, recommendations based on data obtained from cisgender women can be applied to transgender and gender diverse people assigned female sex at birth (HHS [perinatal] 2024).
Take with a normal- to high-calorie meal. Administration with a protein supplement drink alone does not increase absorption.
Cholesterol, triglycerides, hepatic transaminases; signs of skin rash, fever, and/or hypersensitivity reactions, signs and symptoms of infection
As a non-nucleoside reverse transcriptase inhibitor, rilpivirine has activity against HIV-1 by binding to reverse transcriptase. It consequently blocks the RNA-dependent and DNA-dependent DNA polymerase activities, including HIV-1 replication. It does not require intracellular phosphorylation for antiviral activity.
Note: Pharmacokinetic data in pediatric patients 2 to <18 years reported to be similar to that in adult patients; exposures may be similar or slightly higher compared to adults.
Absorption: Tablet (Edurant): Increased 40% with a meal (normal-to-high calorie); Tablet for oral suspension (Edurant Ped): Increased 28% to 31% with a meal (in adults).
Protein binding: 99.7% (primarily albumin).
Metabolism: Hepatic, primarily by CYP3A4.
Half-life elimination: ~50 hours.
Time to peak, plasma: 4 to 5 hours.
Excretion: Feces (85%, ~25% as unchanged drug); urine (~6%; <1% as unchanged drug).
Altered kidney function: Exposure was similar in HIV-1-infected subjects with mild renal impairment relative to HIV-1–infected subjects with healthy renal function; no dose adjustment is required. There is limited information regarding the pharmacokinetics in patients with moderate or severe renal impairment or in patients with ESRD. Concentrations may be increased because of alteration of drug absorption, distribution, and metabolism secondary to renal dysfunction. The potential impact is not expected to be of clinical relevance for subjects with moderate renal impairment; no dose adjustment is required.
Hepatic function impairment: The multiple-dose exposure was 47% higher in subjects with mild hepatic impairment and 5% higher in subjects with moderate hepatic impairment; no dose adjustment is required. Rilpivirine has not been studied in subjects with severe hepatic impairment.
