status (e.g., infections). Hold MAVENCLAD therapy if the
lymphocyte count is below 200 cells per microliter
• periodically thereafter and when clinically indicated [see Warnings and Precautions
(5.5)]
2.6 Recommended Concomitant Medication
Herpes Prophylaxis
Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells permicroliter [see Warnings and Precautions (5.4)].
3 DOSAGE FORMS AND STRENGTHSMAVENCLAD is available as 10 mg tablets. The tablets are uncoated, white, round, biconvex,and engraved with a “C” on one side and “10” on the other side.
4 CONTRAINDICATIONS
MAVENCLAD is contraindicated:
• in patients with current malignancy [see Warnings and Precautions (5.1)].
• in pregnant women and in women and men of reproductive potential who do not plan touse effective contraception during MAVENCLAD dosing and for 6 months after the lastdose in each treatment course. May cause fetal harm [see Warnings and Precautions(5.2) and Use in Specific Populations (8.1, 8.3)].
• in patients infected with the human immunodeficiency virus (HIV) [see Warnings andPrecautions (5.4)].
• in patients with active chronic infections (e.g., hepatitis or tuberculosis) [see Warningsand Precautions (5.4)].
• in patients with a history of hypersensitivity to cladribine [see Warnings and Precautions(5.8)].
• in women intending to breastfeed on a MAVENCLAD treatment day and for 10 daysafter the last dose [see Use in Specific Populations (8.2)].
5 WARNINGS AND PRECAUTIONS
5.1 Malignancies
Treatment with MAVENCLAD may increase the risk of malignancy. In controlled and extensionclinical studies worldwide, malignancies occurred more frequently in MAVENCLAD-treatedpatients [10 events in 3,754 patient-years (0.27 events per 100 patient-years)], compared toplacebo patients [3 events in 2,275 patient-years (0.13 events per 100 patient-years)].
Malignancy cases in MAVENCLAD patients included metastatic pancreatic carcinoma,malignant melanoma (2 cases), ovarian cancer, compared to malignancy cases in placebo
patients, all of which were curable by surgical resection [basal cell carcinoma, cervicalcarcinoma in situ (2 cases)]. The incidence of malignancies in United States MAVENCLADclinical study patients was higher than the rest of the world [4 events in 189 patient-years(2.21 events per 100 patient-years) compared to 0 events in United States placebo patients];however, the United States results were based on a limited amount of patient data.
After the completion of 2 treatment courses, do not administer additional MAVENCLADtreatment during the next 2 years [see Dosage and Administration (2.2)]. In clinical studies,patients who received additional MAVENCLAD treatment within 2 years after the first2 treatment courses had an increased incidence of malignancy [7 events in 790 patient-years(0.91 events per 100 patient-years) calculated from the start of cladribine treatment in Year 3].
The risk of malignancy with reinitiating MAVENCLAD more than 2 years after the completionof 2 treatment courses has not been studied.
MAVENCLAD is contraindicated in patients with current malignancy. In patients with priormalignancy or with increased risk of malignancy, eva luate the benefits and risks of the use ofMAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines inpatients treated with MAVENCLAD.
5.2 Risk |
