Cladribine
Drug Details
- Generic Name
- Cladribine
- Brand Names
- Cladribine, Mavenclad
- Application Number
- ANDA210856
- Sponsor
- Cilag AG
- NDC Codes
- 15
- Dosage Forms
- POWDER, INJECTION, SOLUTION, INJECTION, TABLET
- Routes
- INTRAVENOUS, ORAL
- Active Ingredients
- CLADRIBINE
Indications and Usage
1 INDICATIONS AND USAGE Cladribine tablets are indicated for the treatment of relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease in adults. Because of its safety profile, use of cladribine tablets is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [ see Warnings and Precautions (5) ]. Limitations of Use Cladribine tablets are not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [ see Warnings and Precautions (5) ]. Cladribine tablets are purine antimetabolite indicated for the treatment of relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease in adults. Because of its safety profile, use of cladribine tablets are generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. ( 1 , 5 ) Limitations of Use Cladribine tablets are not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile. ( 1 , 5 )