Edurant

Rilpivirine HCl

In combination w/ other antiretroviral agents for treatment of HIV-1 infection in treatment-naïve adult & ped patients ≥12 yr (weighing ≥35 kg) w/ HIV-1 RNA ≤100,000 copies/mL at the start of therapy.

1 tab (25 mg) once daily. Patient concomitantly receiving rifabutin 2 tab (50 mg) once daily.

Should be taken with food: Take w/ meals for optimal absorption.

Hypersensitivity. Co-administration w/ drugs which induce CYP3A enzymes or increase gastric pH.

Severe skin & hypersensitivity reactions. Risk of virologic failure if baseline HIV-1 RNA >100,000 copies/mL or if CD4+ cell count <200 cells/mm³. Treatment-emergent resistance/cross-resistance to NRTI & NNRTI. Patients who are suspected to be at an increased risk of experiencing proarrhythmic conditions (eg, hypokalemia, clinically significant bradycardia, acute myocardial ischemia, CHF or congenital prolongation of QTc interval). Depressive disorders. Serum lipids & blood glucose may increase during therapy. Perform appropriate laboratory testing prior to initiating therapy & monitoring for hepatotoxicity during therapy especially in patients w/ underlying hepatic disease. Immune reconstitution inflammatory syndrome. Concomitant use w/ drugs that may reduce exposure of rilpivirine; drugs w/ known risk of Torsade de Pointes. Rare hereditary problems of galactose intolerance (severe lactase deficiency or glucose-galactose malabsorption). Caution in mild to moderate hepatic impairment or severe renal impairment or end-stage renal disease. Not recommended in severe hepatic impairment. Pregnancy. Do not breastfeed while receiving treatment. Elderly >65 yr. Not recommended in childn <12 yr.

Depression; rash; abdominal pain, nausea, vomiting; headache, dizziness; increased AST, increased pancreatic amylase. Adult: Insomnia. Childn 12 to <18 yr: Somnolence.

Decreased plasma conc or loss of virologic response w/ drugs that induce CYP3A [eg, carbamazepine, oxcarbazepine, phenobarb, phenytoin, rifampin, rifapentine, dexamethasone (systemic), St. John's wort, rifabutin] or increase gastric pH (eg, proton pump inhibitors, antacids, H₂-receptor antagonists). Increased plasma conc w/ CYP3A inhibitors (eg, darunavir/ritonavir, lopinavir/ritonavir, other boosted PIs, unboosted PIs, azole antifungals, macrolide antibiotics, grapefruit juice). Not recommended to co-administer w/ other NNRTIs. Caution when co-administered w/ drugs that prolong the QTc interval; drugs that can disrupt electrolyte levels, drugs w/ known risk of Torsade de Pointes. Didanosine should be administered on an empty stomach & at least 2 hr before or at least 4 hr after Edurant. Adjustment of methadone maintenance therapy may be needed in some patients.

Antivirals

J05AG05 - rilpivirine ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

P₁S₁S₃