dache, and lymphopenia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact EMD Seronoat 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
• Immunosuppressive drugs: Consider overlapping effects on immunesystem, when used sequentially. Concomitant use not recommended. (7.1)
• Hematotoxic drugs: Monitor patients for additive effects on thehematological profile. (7.3)
• Antiviral and antiretroviral drugs: Avoid concomitant use. (7.4)
• BCRP or ENT/CNT inhibitors: May alter bioavailability of cladribine.
Avoid concomitant use. (7.5)
See 17 for PATIENT COUNSELING INFORMATION and MedicationGuide.
Revised: 3/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Assessments Prior to Starting Each MAVENCLAD Treatment
Course
2.2 Recommended Dosage
2.3 Missed Dose
2.4 Administration
2.5 Laboratory Testing and Monitoring to Assess Safety
2.6 Recommended Concomitant Medication
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Malignancies
5.2 Risk of Teratogenicity
5.3 Lymphopenia
5.4 Infections
5.5 Hematologic Toxicity
5.6 Risk of Graft-Versus-Host Disease With Blood Transfusions
5.7 Liver Injury
5.8 Hypersensitivity
5.9 Cardiac Failure
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Immunomodulatory, Immunosuppressive, or MyelosuppressiveDrugs
7.2 Interferon-Beta
7.3 Hematotoxic Drugs
7.4 Antiviral and Antiretroviral Drugs
7.5 Potent ENT, CNT, and BCRP Transporter Inhibitors
7.6 Potent BCRP and P-gp Transporter Inducers
7.7 Hormonal Contraceptives
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Patients with Renal Impairment
8.7 Patients with Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.6 Hydroxypropyl Betadex-Related Complex Formation
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.
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FULL PRESCRIBING INFORMATION
WARNING: MALIGNANCIES AND RISK OF TERATOGENICITY
• Malignancies
Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD iscontraindicated in patients with current malignancy. In patients with prior malignancy 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
in patients treated with MAVENCLAD [see Contraindications (4) and Warnings andPrecautions (5.1)].
• Risk of Teratogenicity
MAVENCLAD is contraindicated for use in pregnant women and in women and men ofreproductive potential who do not plan to use effective contraception because of the
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