Drug Interaction Report

GENERALLY AVOID: Coadministration with other myelosuppressive agents may potentiate the hematologic toxicities of ropeginterferon alfa-2b. Decreased peripheral blood counts have been reported in patients receiving interferon alfa products, including ropeginterferon alfa-2b. In two open label trials consisting of 178 patients receiving ropeginterferon alfa-2b monotherapy (dosed every 2 to 4 weeks) for the treatment of polycythemia vera, 80% of whom were exposed for 12 months or longer, leukopenia occurred in 20% of patients and thrombocytopenia in 19% of patients. Leukopenia, thrombocytopenia and anemia of grade 3 or higher occurred in 2%, 2% and 1% of patients, respectively. Moreover, infections occurred in 48% of patients, while serious infections occurred in 8% of patients.

MANAGEMENT: Concomitant use of ropeginterferon alfa-2b with other myelosuppressive agents should be avoided when possible. Otherwise, close clinical and laboratory monitoring are advised. Complete blood counts should be performed at baseline, during titration, and every 3 to 6 months or more frequently as clinically indicated during the maintenance phase.

GENERALLY AVOID: Taking stiripentol on an empty stomach may reduce its oral bioavailability. Stiripentol degrades rapidly when exposed to gastric acid in an empty stomach.

GENERALLY AVOID: Alcohol may potentiate the depressant effects of stiripentol on the central nervous system. Concomitant use may result in increased sedation and dizziness as well as impairment of psychomotor skills.

GENERALLY AVOID: It is not known whether stiripentol may reduce theophylline and caffeine metabolism, as data on the potential for inhibition of CYP450 1A2 are limited. Consumption of foods and nutritional products such as cola drinks (which contain significant quantities of caffeine) and chocolate (which contains caffeine and trace amounts of theophylline) may be unsafe during treatment with stiripentol, particularly in children.

MANAGEMENT: Stiripentol should be taken during a meal for optimal absorption; however, it should not be taken with milk, dairy products (e.g., yogurt, soft cream cheese), fruit juice, or carbonated beverages. Patients should be advised to avoid or limit consumption of alcohol and to avoid activities requiring mental alertness such as driving or operating hazardous machinery until they know how the medication affects them. Food and beverages that may contain caffeine or theophylline such as colas, chocolate, coffee, tea, or energy drinks should also be avoided during treatment with stiripentol.