"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
- Patient Information:
Details with Side Effects
Human experience of acute overdose with REYATAZ is limited. Single doses up to 1200 mg have been taken by healthy volunteers without symptomatic untoward effects. A single self-administered overdose of 29.2 g of REYATAZ in an HIV-infected patient (73 times the 400-mg recommended dose) was associated with asymptomatic bifascicular block and PR interval prolongation. These events resolved spontaneously. At high doses that lead to high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinemia (without associated liver function test changes) or PR interval prolongation may be observed. [See WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]
Treatment of overdosage with REYATAZ should consist of general supportive measures, including monitoring of vital signs and ECG, and observations of the patient's clinical status. If indicated, elimination of unabsorbed atazanavir should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid removal of unabsorbed drug. There is no specific antidote for overdose with REYATAZ. Since atazanavir is extensively metabolized by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicine.
REYATAZ (atazanavir sulfate) is contraindicated:
- in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product.
- when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These and other contraindicated drugs are listed in Table 3.
Table 3: Drugs That Are
Contraindicated with REYATAZ (atazanavir) (Information in the table applies to
REYATAZ with or without ritonavir, unless otherwise indicated)
|Drug Class||Drugs within class that are contraindicated with REYATAZ||Clinical Comment|
|Alpha 1-Adrenoreceptor Antagonist||Alfuzosin||Potential for increased alfuzosin concentrations, which can result in hypotension.|
|Antimycobacterials||Rifampin||Rifampin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect and development of resistance.|
|Antineoplastics||Irinotecan||Atazanavir inhibits UGT1A1 and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities.|
|Benzodiazepines||Triazolam, orally administered midazolama||Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with REYATAZ may cause large increases in the concentration of these benzodiazepines. Potential for serious and/or life-threatening events such as prolonged or increased sedation or respiratory depression.|
|Ergot Derivatives||Dihydroergotamine, ergotamine, ergonovine, methylergonovine||Potential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.|
|GI Motility Agent||Cisapride||Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|Herbal Products||St. John's wort (Hypericum perforatum)||Patients taking REYATAZ should not use products containing St. John's wort because coadministration may be expected to reduce plasma concentrations of atazanavir. This may result in loss of therapeutic effect and development of resistance.|
|HMG-CoA Reductase Inhibitors||Lovastatin, simvastatin||Potential for serious reactions such as myopathy including rhabdomyolysis.|
|Neuroleptic||Pimozide||Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|PDE5 Inhibitor||Sildenafilb when dosed as REVATIO® for the treatment of pulmonary arterial hypertension||A safe and effective dose in combination with REYATAZ has not been established for sildenafil (REVATIO®) when used for the treatment of pulmonary hypertension. There is increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, priapism, and syncope).|
|Protease Inhibitors||Indinavir||Both REYATAZ and indinavir are associated with indirect (unconjugated) hyperbilirubinemia.|
|aSee DRUG INTERACTIONS, Table 13 for
parenterally administered midazolam.
b See DRUG INTERACTIONS, Table 13 for sildenafil when dosed as VIAGRA® for erectile dysfunction.
Last reviewed on RxList: 8/26/2013
This monograph has been modified to include the generic and brand name in many instances.
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