EDURANT Rx

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EDURANT

Viral infections
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Generic Name and Formulations:

Rilpivirine 25mg; tabs.

Select therapeutic use:

Indications for EDURANT:

In combination with other antiretroviral agents for HIV-1 infection in antiretroviral treatment-naïve patients with HIV-1 RNA ≤100,000 copies/mL at start of therapy.

Adults and Children:

<12yrs: not recommended. Take with a meal. ≥12yrs (≥35kg): 25mg once daily. Concomitant rifabutin: 50mg once daily; decrease to 25mg once daily when rifabutin is stopped.

Contraindications:

Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than a single dose), St. John's wort.

Warnings/Precautions:

Prolongation of QTc interval with supratherapeutic doses. Promptly evaluate if depressive symptoms occur. Monitor liver enzymes prior to initiation and during therapy in patients with underlying hepatitis B or C, or marked elevations in transaminases; consider monitoring LFTs in patients without pre-existing hepatic dysfunction or other risks. Discontinue immediately if severe skin or hypersensitivity reactions develop. Severe renal impairment or ESRD: monitor. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

Concomitant NNRTIs (eg, delavirdine): not recommended. Caution when concomitant drugs with a known risk for torsades de pointes. Antagonized by CYP3A inducers (see Contraindications). May be potentiated by CYP3A inhibitors (eg, azole antifungals [monitor for breakthrough fungal infections], clarithromycin, erythromycin, telithromycin [consider azithromycin use]). Concomitant methadone; monitor. Separate didanosine, antacids (by at least 2hrs before or at least 4hrs after) and H2-receptor antagonists (by at least 12hrs before or 4hrs after rilpivirine); drugs that increase gastric pH may result in decreased plasma concentrations.

Pharmacological Class:

Non-nucleoside reverse transcriptase inhibitor.

Adverse Reactions:

Depressive disorders, insomnia, headache, rash; hepatotoxicity, fat redistribution, immune reconstitution syndrome.

Metabolism:

Hepatic (CYP3A4); 99.7% protein bound.

Elimination:

Fecal (primarily), renal.

Generic Availability:

NO

How Supplied:

Tabs—30

EDURANT 25mg tablets (Qty:30)

appx. price $995.00