Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- Measure serum transaminase levels and bilirubin at the initiation of VFend therapy and monitor at least weekly for the first month of treatment. Monitoring frequency can be reduced to monthly during continued use if no clinically significant changes are noted. If liver function tests become markedly elevated compared to baseline, VFend should be discontinued unless the medical judgment of the benefit-risk of the treatment for the patient justifies continued use.
Arrhythmias and QT Prolongation
Voriconazole should be administered with caution to patients with potentially proarrhythmic conditions, such as:
- Congenital or acquired QT-prolongation
- Cardiomyopathy, in particular when heart failure is present
- Sinus bradycardia
Existing symptomatic arrhythmias
- Concomitant medicinal product that is known to prolong QT interval
- Rigorous attempts to correct potassium, magnesium and calcium should be made before starting and during voriconazole therapy
- VFend has been associated with photosensitivity skin reaction. Patients, including children, should avoid exposure to direct sunlight during VFend treatment and should use measures such as protective clothing and sunscreen with high sun protection factor (SPF). If phototoxic reactions occur, the patient…
- The frequency of phototoxicity reactions is higher in the pediatric population. Because squamous cell carcinoma has been reported in patients who experience photosensitivity reactions, stringent measures for photoprotection are warranted in children. In children experiencing photoaging injuries such as lentigines or ephelides, sun avoidance and dermatologic follow-up are recommended even after treatment discontinuation.
- Coadministration of standard doses of voriconazole with efavirenz doses of 400 mg q24h or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. Voriconazole also significantly increases efavirenz plasma concentrations [see Drug Interactions (7), and Clinical Pharmacology (12.3)].
7 DRUG INTERACTIONS
- added .....Everolimus
WARNINGS AND PRECAUTIONS
Skeletal Adverse Events
- Fluorosis and periostitis have been reported during long-term voriconazole therapy. If a patient develops skeletal pain and radiologic findings compatible with fluorosis or periostitis, voriconazole should be discontinued
- The following adverse reactions have been identified during post approval use of voriconazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Skeletal: fluorosis and periostitis have been reported during long-term voriconazole therapy