Drug Interactions between Farbital and Farydak

MONITOR CLOSELY: Coadministration of panobinostat and drugs that interfere with platelet function or coagulation may potentiate the risk of bleeding complications. Treatment with panobinostat has been associated with severe thrombocytopenia and hemorrhage (including gastrointestinal and pulmonary hemorrhage) with fatal outcomes. The risk may be increased in patients with coagulation disorders or those on chronic anticoagulation therapy. In a phase III clinical trial in patients with relapsed multiple myeloma, treatment-emergent grade 3 to 4 (CTCAE) thrombocytopenia and hemorrhage was reported in 67% and 4.2% of panobinostat-treated patients, respectively. In the same phase III clinical trial, there were 5 patients treated with panobinostat who died due to a hemorrhagic event, compared to 1 in the control arm. The patients with fatal bleeding events reported in the clinical trial had at least grade 3 (CTCAE) thrombocytopenia at the time of the event.

MANAGEMENT: Concomitant use of other medications that interfere with platelet function or coagulation should be considered cautiously in patients treated with panobinostat. Close clinical and laboratory observation for bleeding complications is recommended during therapy. A complete blood cell count should be performed prior to and at least weekly during treatment according to treatment protocols, including monitoring for thrombocytopenia. Dose modifications may be required based on individual patient tolerability. Patients should be advised to promptly report any signs of bleeding to their doctor, including pain, swelling, headache, dizziness, weakness, prolonged bleeding from cuts, increased menstrual flow, vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or brown urine, or red or black stools. Since panobinostat is indicated in combination with bortezomib and dexamethasone, the manufacturer labeling for these products should also be consulted for additional information.

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MONITOR: Coadministration with inducers of CYP450 3A4 may decrease the plasma concentrations of panobinostat, which is partially metabolized by the isoenzyme. The interaction has not been evaluated clinically, but simulations using physiologically-based pharmacokinetic (PBPK) models suggest an approximately 70% decrease in panobinostat systemic exposure in the presence of potent CYP450 3A4 inducers.

MANAGEMENT: Caution is advised during concomitant use of panobinostat with CYP450 3A4 inducers. The potential for decreased efficacy of panobinostat should be considered.

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One study has reported that coadministration of caffeine and aspirin lead to a 25% increase in the rate of appearance and 17% increase in maximum concentration of salicylate in the plasma. A significantly higher area under the plasma concentration time curve of salicylate was also reported when both drugs were administered together. The exact mechanism of this interaction has not been specified. Physicians and patients should be aware that coadministration of aspirin and caffeine may lead to higher salicylate levels faster.

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