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FARYDAK- panobinostat capsule


Patient Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Dosing and Administration

Instruct patients to take FARYDAK exactly as prescribed and not to change their dose or to stop taking FARYDAK unless they are told to do so by their healthcare provider. If a patient misses a dose, advise them to take their dose as soon possible and up to 12 hours after the specified dose time. If vomiting occurs advise the patient not to repeat the dose, but to take the next usual prescribed dose on schedule.

Cardiac Toxicity/Electrocardiographic Changes

Inform patients to report chest pain or discomfort, changes in heart beat (fast or slow), palpitations, lightheadedness, fainting, dizziness, blue discoloration of lips, shortness of breath, and swelling of lower limbs or skin as these may be warning signs of a heart problem.

Bleeding Risk

Inform patients that FARYDAK is associated with thrombocytopenia. Advise patients to contact their healthcare provider right away if they experience any signs of bleeding and inform patients that it might take longer than usual for them to stop bleeding. Advise patients of the need to monitor blood chemistry and hematology prior to the start of FARYDAK therapy and periodically thereafter.

Infections

Inform patients of the risk of neutropenia and severe and life-threatening infections. Instruct patients to contact their physician immediately if they develop a fever and/or any exhibit any signs of infection.

Gastrointestinal Toxicities

Inform patients that FARYDAK can cause severe nausea, vomiting and diarrhea which may require medication for treatment. Advise patients to contact their physician at the start of diarrhea, for persistent vomiting, or signs of dehydration. Inform patients to consult with their physicians prior to using medications with laxative properties.

Pregnancy

Inform patients that FARYDAK can cause fetal harm. Advise women of reproductive potential to avoid pregnancy while taking FARYDAK. Advise women of reproductive potential to use effective contraception while taking FARYDAK and for at least 3 months after the last dose of the drug.

Advise sexually active men to use condoms while receiving FARYDAK and for at least 6 months following the last dose of the drug.

Lactation

Advise women not to breastfeed while taking FARYDAK.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

Novartis

T2016-49
June 2016



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