Bone Marrow Suppression; Neurotoxicity; Nephrotoxicity
- Cladribine injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.
Bone Marrow Suppression
- Suppression of bone marrow function should be anticipated. This is usually reversible and appears to be dose dependent. Serious neurological toxicity (including irreversible paraparesis and quadraparesis) has been reported in patients who received cladribine injection by continuous infusion at high doses (four to nine times the recommended dose for Hairy Cell Leukemia). Neurologic toxicity appears to demonstrate a dose relationship; however, severe neurological toxicity has been reported rarely following treatment with standard cladribine dosing regimens.
- Acute nephrotoxicity has been observed with high doses of cladribine injection (four to nine times the recommended dose for Hairy Cell Leukemia), especially when given concomitantly with other nephrotoxic agents/therapies.
- Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is 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 MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with Mavenclad
Risk of Teratogenicity
- MAVENCLAD is 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 potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with MAVENCLAD in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course. Stop MAVENCLAD if the patient becomes pregnant
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Serious neurological toxicity (including irreversible paraparesis and quadraparesis) have been reported with continuous infusion at high doses (4 to 9 times the recommended dose for hairy cell leukemia). Severe neurological toxicity rarely reported with standard dosing regimens.
- Perform hematological testing on regular basis during therapy.
- Perform periodic assessment of renal/hepatic function as clinically needed.
Patient Counseling Information