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FDA Approves EDURANT™ (rilpivirine) for Use in Treatment-Naive Adults With HIV-1

Saturday, May 21, 2011 General News J E 4
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Third medication for Tibotec Therapeutics HIV treatment portfolio

Important Safety Information

Drug Interactions

  • Coadministration of EDURANT™ with the following drugs is contraindicated because  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 and cross-resistance: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, proton pump inhibitors such as esomeprazole, lansoprozole, omeprazole, pantoprozole, and rabeprozole, systemic dexamethasone, and products containing St. John's wort (Hypericum perforatum). EDURANT should be used with caution when co administered with drugs that may reduce the exposure of rilpivirine
  • EDURANT™ should be used with caution when coadministered with drugs that may reduce the exposure of rilpivirine a drug with a known risk of Torsade de Pointes
  • EDURANT™ should not be used in combination with NNRTIs

This is not a complete list of potential drug interactions.

Please see full Prescribing Information for more details.

Warnings and Precautions

  • Depressive Disorders: Severe depressive disorders, defined as depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation, have been reported with EDURANT™. Immediate medical evaluation is recommended for severe depressive symptoms
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
  • Immune Reconstitution Syndrome has been reported in patients treated with combination ARV therapy, including EDURANT™

Use in Specific Populations

  • Hepatic Impairment: EDURANT™ should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT™ have not been evaluated in these patients
  • Pregnancy Category B: EDURANT™ should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women

Adverse Reactions

  • The most common adverse drug reactions reported (incidence >2%) of at least moderate intensity (= Grade 2) in patients taking EDURANT™ through 48 weeks were depressive disorders (4%), insomnia (3%), headache (3%), and rash (3%)
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