Treatment-Nave Patients With HIV Infection

• PO (Adults and Children ≥12 yr and ≥35 kg): 25 mg once daily; Pregnant patients on stable rilpivirine regimen prior to pregnancy and virologically suppressed (HIV RNA <50 copies/mL): 25 mg once daily; Concurrent rifabutin therapy: 50 mg once daily (↓ dose to 25 mg once daily when rifabutin discontinued).

Combination Therapy With Cabotegravir for HIV Infection

• PO (Adults and Children ≥12 yr and ≥35 kg): Oral lead-in therapy to assess tolerability of rilpivirine: 25 mg once daily (with oral cabotegravir 30 mg once daily) for ≥28 days, then switch to cabotegravir/rilpivirine extended-release injection. To replace planned missed cabotegravir/rilpivirine extended-release injections for patients on monthly dosing schedule (if patient plans to miss scheduled monthly injection by >7 days): 25 mg once daily (with oral cabotegravir 30 mg once daily) initiated at the same time as missed injection of cabotegravir/rilpivirine and then continued until day the cabotegravir/rilpivirine extended-release injection is restarted (oral replacement therapy can be continued for up to 2 mo). To replace planned missed cabotegravir/rilpivirine extended-release injections for patients on every 2-mo dosing schedule (if patient plans to miss scheduled every 2-mo injection by >7 days): 25 mg once daily (with oral cabotegravir 30 mg once daily) initiated the same time as missed injection of cabotegravir/rilpivirine and then continued until day the cabotegravir/rilpivirine extended-release injection is restarted (oral replacement therapy can be continued for up to 2 mo).

Edurant

• Inhibits HIV-replication by non-competitively inhibiting HIV reverse transcriptase.

• Slowed progression of HIV infection and decreased occurrence of sequelae. Increases CD4 cell counts and decreases viral load.

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: non nucleoside reverse transcriptase inhibitors

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: 99.7%.

Metabolism/Excretion: Mostly metabolized by the liver by the CYP3A isoenzyme; 25% excreted in feces unchanged, <1% excreted unchanged in urine.

Half-life: 50 hr.

(plasma concentrations)

• Emphasize the importance of taking rilpivirine as directed, at the same time each day. It must always be used in combination with other antiretroviral drugs. Do not take more than prescribed amount and do not stop taking without consulting health care professional. Take missed doses with a meal if remembered <12 hr of the time it is usually taken, then return to regular schedule. If more than 12 hr from time dose is usually taken, omit dose and resume dosing schedule; do not double doses. Advise patient to read Patient Information prior to starting therapy and with each Rx refill in case of changes.
• Advise patient to take antacids 2 hr before or 4 hr after and H₂ antagonists 12 hr before or 4 hr after rilpivirine.
• Instruct patient that rilpivirine should not be shared with others.
• Inform patient that rilpivirine does not cure AIDS or prevent associated or opportunistic infections. Rilpivirine may reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and to avoid sharing needles or donating blood to prevent spreading the AIDS virus to others. Advise patient that the long-term effects of rilpivirine are unknown at this time.
• Inform patients and families of risk of suicidal thoughts and behavior and advise that behavioral changes, emergency or worsening signs and symptoms of depression, unusual changes in mood, or emergence of suicidal thoughts, behavior, or thoughts of self-harm should be reported to health care professional immediately.
• Immune reconstitution syndrome may trigger opportunistic infections or autoimmune disorders. Notify health care professional if symptoms or rash occur.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's wort.
• Rep: Advise patient taking oral contraceptives to use a nonhormonal method of birth control during rilpivirine therapy. If pregnancy is suspected notify health care professional promptly. Encourage health care professionals to enroll pregnant women in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263. Advise female patient to avoid breastfeeding.
• Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.

RIL-pi-vir-een

NDC Code^*

• 59676- Janssen Products, LP
  • 59676-278- EDURANT
    • 59676-278-01- 30 TABLET, FILM COATED in 1 BOTTLE (59676-278-01)