Label Changes for:
Reyataz (atazanavir sulfate), 100 mg, 150 mg, 200 mg and 300 mg capsules
Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.6 Nephrolithiasis and Cholelithiasis
- Cases of nephrolithiasis and/or cholelithiasis have been reported during postmarketing surveillance in HIV-infected patients receiving REYATAZ therapy. Some patients required hospitalization .....
6 ADVERSE REACTIONS
6.4 Postmarketing Experience
- add interstitial nephritis
7 DRUG INTERACTIONS
7.3 Established and Other Potentially Significant Drug Interactions
- Table 13 ... information regarding coadministration with boceprevir, carbamazepine, phenytoin, phenobarbital, lamotrigine, and voriconazole
17 PATIENT COUNSELING INFORMATION
17.7 Nephrolitiasis and Cholelithiasis
- Patients should be informed that kidney stones and/or gallstones have been reported with REYATAZ use. Some patients with kidney stones and/or gallstones required hospitalization
PATIENT PACKAGE INSERT
The following medicines may require a change in the dose or dose schedule of either REYATAZ or the other medicine:
- add boceprevir, phenobarbital, phenytoin and carbamazepine
WARNINGS AND PRECAUTIONS
- Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions, including drug rash, eosinophilia and systemic symptoms (DRESS) syndrome, that have been reported in patients receiving Reyataz.
Table 3: Drugs That Are Contraindicated with Reyataz (atazanavir) (Information in the table applies to Reyataz with or without ritonavir, unless otherwise indicated)
- Alpha 1-adrenoreceptor antagonist- alfuzosin: Potential for increased alfuzosin concentrations, which can result in hypotension.
- PDE5 Inhibitors: Sildenafil 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).
PRECAUTIONS- DRUG INTERACTIONS
Table 13: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interactions (Information in the table applies to REYATAZ with or without ritonavir, unless otherwise indicated)
- Inhaled beta agonist-salmeterol: Coadministration of salmeterol with Reyataz is not recommended. Concomitant use of salmeterol and Reyataz may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.
- Endothelin receptor antagonists-Bosentan: Plasma concentrations of atazanavir may be decreased when bosentan is administered with Reyataz without ritonavir. Coadministration of bosentan and Reyataz without ritonavir is not recommended.
- PDE5 inhibitors: Use of PDE5 inhibitors for pulmonary arterial hypertension (PAH): Use of Revatio, (sildenafil) for the treatment of pulmonary hypertension (PAH) is contraindicated with Reyataz. The following dose adjustments are recommended for the use of Adcirca (tadalafil) with Reyataz: Coadministration of Adcirca in patients on Reyataz (with or without ritonavir): For patients receiving Reyataz (with or without ritonavir) for at least one week, start Adcirca at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability. Coadministration of Reyataz (with or without ritonavir) in patients on Adcirca: Avoid the use of Adcirca when starting Reyataz (with or without ritonavir). Stop Adcirca at least 24 hours before starting Reyataz (with or without ritonavir). At least one week after starting Reyataz (with or without ritonavir), resume Adcirca at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability.
- Colchicine (Antigout): Reyataz should not be coadministered with colchicine to patients with renal or hepatic impairment. Recommended dosage of colchicine when administered with Reyataz: Treatment of gout flares: 0.6 mg (1 tablet) for 1 dose, followed by 0.3 mg (half tablet) 1 hour later. Not to be repeated before 3 days. Prophylaxis of gout flares: If the original regimen was 0.6 mg twice a day, the regimen should be adjusted to 0.3 mg once a day. If the original regimen was 0.6 mg once a day, the regimen should be adjusted to 0.3 mg once every other day. Treatment of familial Mediterranean fever (FMF): Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day).