EDURANT

EDURANT- rilpivirine hydrochloride tablet, film coated
Janssen Products, LP

1 INDICATIONS AND USAGE

1.1 Treatment of HIV-1 in Treatment-Naïve Patients

EDURANT® , in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with plasma HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.

Limitations of Use:

  • More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies (14.1)].

1.2 Treatment of HIV-1 in Combination with Cabotegravir

EDURANT is indicated in combination with VOCABRIA (cabotegravir) for short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as [see Dosage and Administration (2.2)]:

  • oral lead-in to assess the tolerability of rilpivirine prior to administration of rilpivirine extended-release injectable suspension, a component of CABENUVA (cabotegravir, rilpivirine) extended-release injectable suspensions.
  • oral therapy for patients who will miss planned injection dosing with CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Treatment-Naïve Patients

The recommended dosage of EDURANT in patients 12 years of age and older and weighing at least 35 kg is one 25 mg tablet taken orally once daily with a meal [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].

For pregnant patients who are already on a stable EDURANT regimen prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) the recommended dosage is one 25 mg tablet once daily taken orally with a meal. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].

2.2 Recommended Dosage in Combination with Cabotegravir

Consult the prescribing information for CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions before initiating EDURANT to ensure therapy with CABENUVA is appropriate.

Oral Lead-In Dosing to Assess Tolerability of Rilpivirine

Oral lead-in should be used for approximately 1 month (at least 28 days) to assess the tolerability of rilpivirine prior to the initiation of CABENUVA. The recommended oral daily dose is one 25 mg tablet of EDURANT (rilpivirine) in combination with one 30 mg tablet of VOCABRIA (cabotegravir). EDURANT should be taken with VOCABRIA (cabotegravir) orally once daily at approximately the same time each day with a meal [see Clinical Pharmacology (12.3)].

Because EDURANT is indicated in combination with VOCABRIA (cabotegravir), the prescribing information for VOCABRIA (cabotegravir) tablets should also be consulted.

The last oral dose should be taken on the same day injections with CABENUVA are started.

Oral Dosing to Replace Planned Missed Injections of CABENUVA (Up to 2 Consecutive Monthly Injections)

If a patient plans to miss a scheduled CABENUVA injection visit by more than 7 days, take daily oral therapy to replace up to 2 consecutive monthly injection visits. The recommended oral daily dose is one 25 mg tablet of EDURANT and one 30 mg tablet of VOCABRIA (cabotegravir), taken orally once daily at approximately the same time each day with a meal. The first dose of oral therapy should be taken approximately 1 month after the last injection dose of CABENUVA and continued until the day injection dosing is restarted. See full prescribing information for CABENUVA to resume monthly injection dosing.

2.3 Recommended Dosage with Rifabutin Coadministration

If EDURANT is coadministered with rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin coadministration is stopped, the EDURANT dose should be decreased to 25 mg once daily, taken with a meal [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

Note that use of CABENUVA (cabotegravir; rilpivirine injections) with rifabutin is contraindicated.

3 DOSAGE FORMS AND STRENGTHS

25 mg white to off-white, film-coated, round, biconvex, tablet of 6.4 mm, debossed with “TMC” on one side and “25” on the other side. Each tablet contains 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of rilpivirine.

4 CONTRAINDICATIONS

EDURANT is contraindicated for coadministration with the drugs in Table 1 for which significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to EDURANT or to the class of NNRTIs [see Drug Interactions (7) and Clinical Pharmacology (12.3)]

Table 1: Drugs That are Contraindicated with EDURANT
Drug Class Contraindicated Drugs in Class Clinical Comment
Anticonvulsants CarbamazepineOxcarbazepinePhenobarbitalPhenytoin Potential for significant decreases in rilpivirine plasma concentrations due to CYP3A enzyme induction, which may result in loss of virologic response.
Antimycobacterials RifampinRifapentine
Glucocorticoid (systemic) Dexamethasone(more than a single-dose treatment)
Herbal Products St John’s wort (Hypericum perforatum)
Proton Pump Inhibitors e.g., EsomeprazoleLansoprazoleOmeprazolePantoprazole Rabeprazole Potential for significant decreases in rilpivirine plasma concentrations due to gastric pH increase, which may result in loss of virologic response.

5 WARNINGS AND PRECAUTIONS

5.1 Skin and Hypersensitivity Reactions

Severe skin and hypersensitivity reactions have been reported during the postmarketing experience, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries. During the Phase 3 clinical trials, treatment-related rashes with at least Grade 2 severity were reported in 3% of subjects receiving EDURANT. No Grade 4 rash was reported. Overall, most rashes were Grade 1 or 2 and occurred in the first four to six weeks of therapy [see Adverse Reactions (6 and 6.2)]. Discontinue EDURANT immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, including but not limited to, severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis or eosinophilia. Clinical status including laboratory parameters should be monitored and appropriate therapy should be initiated.

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