Mavenclad
(cladribine)MAVENCLAD 4 Tablet PackMAVENCLAD 5 Tablet Pack
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Mavenclad FAQs
Is MAVENCLAD safe for pregnant women?No, MAVENCLAD is contraindicated in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception. There are no adequate data on the developmental risk associated with use of MAVENCLAD in pregnant women. Cladribine was embryolethal when administered to pregnant mice and produced malformations in mice and rabbits. The observed developmental effects are consistent with the effects of cladribine on DNA.
Can breastfeeding women use MAVENCLAD?No, MAVENCLAD is contraindicated in breastfeeding women because of the potential for serious adverse reactions in breastfed infants. Advise women not to breastfeed during dosing with MAVENCLAD and for 10 days after the last dose.
What precautions should females and males of reproductive potential take while using MAVENCLAD?In females of reproductive potential, pregnancy should be excluded before the initiation of each treatment course of MAVENCLAD. Females of reproductive potential should prevent pregnancy by use of effective contraception during MAVENCLAD dosing and for at least 6 months after the last dose in each treatment course. Women who become pregnant during MAVENCLAD therapy should discontinue treatment. In males, adverse effects on human gametogenesis could be expected, so male patients of reproductive potential should take precautions to prevent pregnancy of their partner during MAVENCLAD dosing and for at least 6 months after the last dose in each treatment course.
Is MAVENCLAD safe for pediatric use?The safety and effectiveness in pediatric patients (below 18 years of age) have not been established. Use of MAVENCLAD is not recommended in pediatric patients because of the risk of malignancies.
Is MAVENCLAD safe for use in elderly patients?Clinical studies with MAVENCLAD did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Caution is recommended when MAVENCLAD is used in elderly patients, taking into account the potential greater frequency of decreased hepatic, renal, or cardiac function, concomitant diseases, and other drug therapy.
Is MAVENCLAD safe for use in patients with renal or hepatic impairment?MAVENCLAD is not recommended in patients with moderate to severe renal impairment (creatinine clearance below 60 mL per minute) or moderate to severe hepatic impairment.
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