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Rilpivirine

Published: July 26, 2026Updated: July 26, 2026

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used as part of combination antiretroviral therapy for the treatment of HIV-1 infection in adults and adolescents. It is typically prescribed for treatment-naive patients with baseline viral loads below 100,000 copies/mL and is also available as a long-acting injectable formulation co-administered with cabotegravir.

Quick summary

Rilpivirine is an HIV antiviral that works by blocking reverse transcriptase, used alone or with cabotegravir for long-acting HIV treatment.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
J05AG05
RxNorm
1102270
Generic
Rilpivirine
Class
atc-j05
Brands
Edurant, Complera, Odefsey, Juluca
Availability
rx
Lactation
unknown
Routes
oral
Forms
injection, tablet
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
25mg once daily
Maximum
consult physician
Frequency
once daily with a meal
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
25mg once daily
Maximum
consult physician
Frequency
once daily with a meal (for patients ≥12 years, ≥35kg)
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
25mg once daily
Maximum
consult physician
Frequency
once daily with a meal (use with caution)
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose approximately 6 times the recommended daily dose may cause increased risk of adverse effects
Chronic overdose: prolonged use above recommended dose may lead to increased CNS and psychiatric adverse effects
Immediate actions
monitor vital signs, provide supportive care, gastric lavage may be considered if ingestion is recent
Antidote
no specific antidote available(supportive care is primary treatment; no specific antidote exists)
Poison Control: 1-800-222-1222

Special Populations

10 groups
⚠

pregnancy

first trimester
caution
FDA Category
B
Dose Adjustment

no adjustment needed

Key Recommendations

use only if benefits outweigh potential risks; limited placental transfer data

Monitor

regular prenatal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

second third trimester
caution
FDA Category
B
Dose Adjustment

no adjustment needed

Key Recommendations

continue therapy if HIV suppressed; monitor viral load

Monitor

routine prenatal care and viral load monitoring

Use with caution and monitor for adverse effects.

✗

lactation

breastfeeding
unsafe
FDA Category
N
Dose Adjustment

not applicable

Key Recommendations

HIV-positive mothers should not breastfeed regardless of antiretroviral therapy to prevent vertical transmission

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

✓

pediatric_age

adolescents 12 17 years
safe
FDA Category
B
Dose Adjustment

no adjustment needed

Key Recommendations

approved for patients 12 years and older weighing at least 35 kg; adult dosing applies

Monitor

regular monitoring of growth and development

⚠

pediatric_age

children under 12 years
caution
FDA Category
B
Dose Adjustment

not recommended

Key Recommendations

not approved for children under 12 years; insufficient safety and efficacy data

Monitor

not applicable

Use with caution and monitor for adverse effects.

⚠

geriatric

elderly 65 years and older
caution
FDA Category
B
Dose Adjustment

no adjustment needed

Key Recommendations

use with caution due to limited clinical experience; monitor for adverse effects

Monitor

increased vigilance for side effects and drug interactions

Use with caution and monitor for adverse effects.

✓

renal_impairment

mild moderate
safe
FDA Category
B
Dose Adjustment

no adjustment needed

Key Recommendations

no dose adjustment required; monitor renal function as part of routine care

Monitor

routine renal function monitoring

⚠

renal_impairment

severe esrd
caution
FDA Category
B
Dose Adjustment

no adjustment needed

Key Recommendations

can be used in patients on dialysis; administer after dialysis session

Monitor

routine monitoring; no dialysis-related dose adjustment required

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild moderate
caution
FDA Category
B
Dose Adjustment

no adjustment needed

Key Recommendations

use with caution; no dose adjustment required for mild to moderate impairment

Monitor

monitor liver function tests

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

severe
caution
FDA Category
B
Dose Adjustment

not recommended

Key Recommendations

use not recommended in severe hepatic impairment due to limited data

Monitor

close monitoring if used

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2011

Rilpivirine FDA approval date

drug_classWHO
2023

Drug class

Value:Non-nucleoside reverse transcriptase inhibitor (NNRTI)

Antiretroviral drug classification

usageFDA
2023

Common uses

Value:HIV-1 infection treatment in treatment-naive adults

Therapeutic indication

brand_namesFDA
2023

Brand names

Value:Edurant, Complera, Odefsey, Juluca

Commercial product names

Treatment of HIV-1 infection in combination with other antiretroviral agents in adults and adolescents (12 years and older) who are treatment-naive or virologically suppressed. Available as oral tablets and as a long-acting injectable combination with cabotegravir for monthly or every-other-month dosing.

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by binding directly to reverse transcriptase, the enzyme HIV uses to replicate its genetic material, thereby blocking viral RNA conversion to DNA and inhibiting viral replication.

Should be taken with a meal for optimal absorption. Common side effects include depression, headache, rash, and insomnia. Resistance may develop if used without other antiretrovirals. Not effective against HIV-2. May have drug interactions with acid-reducing agents, certain antibiotics, and CYP3A4 inducers or inhibitors.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy