urs during waking hours [see Dosage and Administration (2.3)].
Skin, mucous or nail disorders: Advise patients to contact their healthcare provider if they experienceprogressive or intolerable skin, mucous or nail disorders [see Adverse Reactions (6.1)].
Hyperphosphatemia: Advise patients that their healthcare provider will assess their serum phosphatelevel between 14 and 21 days of initiating treatment and will adjust the dose if needed [see Warningsand Precautions (5.2)].
During this initial phosphate-assessment period, advise patients to avoidconcomitant use with agents that can alter serum phosphate levels. Advise patients that, after the initialphosphate assessment period, monthly phosphate level monitoring for hyperphosphatemia should beperformed during treatment with BALVERSA [see Drug Interactions (7.1)].
Drug Interactions: Advise patients to inform their healthcare providers of all concomitant medications,
including prescription medicines, over-the-counter drugs, and herbal products [see Drug Interactions
(7.1, 7.2)].
Dosing Instructions: Instruct patients to swallow the tablets whole once daily with or without food.
Ifvomiting occurs any time after taking BALVERSA, advise patients to take the next dose the next day.
[see Dosage and Administration (2.1)].
Missed dose: If a dose is missed, advise patients to take the missed as soon as possible. Resume theregular daily dose schedule for BALVERSA the next day. Extra tablets should not be taken to make upfor the missed dose [see Dosage and Administration (2.3)].
Embryo-Fetal Toxicity: Advise pregnant women and females of reproductive potential of the potentialrisk to the fetus. Advise females to inform their healthcare providers of a known or suspected pregnancy[see Warning and Precautions (5.3) and Use in Specific Population (8.1)].
Advise female patients of reproductive potential to use effective contraception during treatment and forone month after the last dose of BALVERSA. Advise male patients with female partners of reproductivepotential to use effective contraception during treatment and for one month after the last dose of
BALVERSA [see Use in Specific Populations (8.3)].
Lactation: Advise females not to breastfeed during treatment with BALVERSA and for one month afterthe last dose [see Use in Specific Populations (8.2)].
Product of Switzerland
Manufactured for:
Janssen Products, LP
Horsham, PA 19044
Under license from Astex Therapeutics Limited.
©2019 Janssen Pharmaceutical Companies
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