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.

Discontinue immediately if signs or symptoms of severe skin & hypersensitivity reactions develop. Risk of virologic failure if baseline HIV-1 RNA >100,000 copies/mL or if CD4+ cell count <200 cells/mm³. Risk of QT interval prolongation. Caution in 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). Reports of depressive disorders. Patients w/ severe depressive symptoms should seek immediate medical evaluation to assess possibility that the symptoms are related to Edurant. Serum lipids & blood glucose may increase during therapy. Reports of hepatic adverse events. Perform appropriate lab testing prior to initiating therapy & monitoring for hepatotoxicity during therapy especially in patients w/ underlying hepatic disease. Reports of immune reconstitution inflammatory syndrome. Treatment-emergent resistance/cross-resistance to NRTI & NNRTI. Not recommended for patients w/ rare hereditary problems of galactose intolerance (severe lactase deficiency or glucose-galactose malabsorption). Caution in patients w/ mild or moderate hepatic impairment; severe renal impairment or ESRD; elderly >65 yr. Not recommended in severe hepatic impairment (Child-Pugh C). Do not use during pregnancy unless potential benefits outweigh potential risks. Lower rilpivirine exposures observed during 2nd & 3rd trimesters of pregnancy. Do not breastfeed while receiving treatment. Not recommended in childn <12 yr.

Depression; headache, dizziness; rash; abdominal pain, nausea, vomiting; increased AST/ALT, pancreatic amylase, LDL-C; decreased WBC. Adult: Insomnia, abnormal dreams, sleep disorders; diarrhea; fatigue; decreased appetite. 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, PPIs, 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. When taken w/ only a protein-rich nutritional drink, exposures were 50% lower than when taken w/ a meal.

Antivirals

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

P₁S₁S₃