Black Box Warning
WARNING: MALIGNANCIES AND RISK OF TERATOGENICITY Malignancies Treatment with cladribine tablets may increase the risk of malignancy. Cladribine tablets are contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of cladribine tablets on an individual patient basis. Follow standard cancer screening guidelines in patients treated with cladribine tablets [see Contraindications (4) and Warnings and Precautions ( 5.1 )] . Risk of Teratogenicity Cladribine tablets are contraindicated for use in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with cladribine tablets in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during cladribine tablets dosing and for 6 months after the last dose in each treatment course for females, and 14 weeks for males. Stop cladribine tablets if the patient becomes pregnant [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.1, 8.3)] . WARNING: MALIGNANCIES and RISK OF TERATOGENICITY See full prescribing information for complete boxed warning. Malignancies Cladribine tablets may increase the risk of malignancy. Cladribine tablets are contraindicated in patients with current malignancy; evaluate the benefits and risks on an individual basis for patients with prior or increased risk of malignancy. ( 5.1 ) Risk of Teratogenicity Cladribine tablets are contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the risk of fetal harm. ( 5.2 )
What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Mavenclad.