Cladribine 1 mg/mL
Cladribine · INJECTION, SOLUTION · Hisun Pharmaceuticals USA, Inc.
Cladribine is a injection, solution containing cladribine at 1 mg/mL, taken intravenous. Manufactured by Hisun Pharmaceuticals USA, Inc..
Key Facts
- Brand Name
- Cladribine
- Generic Name
- Cladribine
- NDC Code (Product)
42658-010- Manufacturer
- Hisun Pharmaceuticals USA, Inc.
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA210856
- Drug Class
- Purine Antimetabolite [EPC]
- Marketing Start
- 05/18/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Cladribine tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive 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 ,…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Assessments are required prior to starting each cladribine treatment course. (2.1) Cumulative dosage of 3.5 mg/kg administered orally and divided into 2 treatment courses (1.75 mg/kg per treatment course). Each treatment course is divided into 2 treatment cycles. (2.2) Cladribine tablets are a cytotoxic drug. (2.4) Separate administration from any other oral drug by at least 3 hours. (2.4) 2.1 Assessments Prior to Starting Each Cladribine Treatment Course Cancer Screening Follow standard cancer screening guidelines because of the risk of malignancies [ see Boxed Warning and Warnings and Precautions (5.1) ]. Pregnancy Exclude pregnancy prior to treatment with cladribine tablets in females of reproductive potential [ see Contraindications (4) , Warnings and Precautions (5.2) , and Use in Specific Populations (8.1, 8.3) ]. Complete Blood Count (CBC) Obtain a CBC with differential including lymphocyte count [ see Dosage and Administration (2.5) and Warnings and Precautions (5.3) ]. Lymphocytes must be: within normal limits before initiating the first treatment course at least 800 cells per microliter before initiating the second treatment course If necessary…
Contraindications
4 CONTRAINDICATIONS Cladribine tablets are contraindicated: in patients with current malignancy [ see Warnings and Precautions (5.1) ] . in pregnant women and in females and males of reproductive potential who do not plan 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. 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 and Precautions (5.4) ]. in patients with active chronic infections (e.g., hepatitis or tuberculosis) [ see Warnings and Precautions (5.4) ]. in patients with a history of hypersensitivity to cladribine [ see Warnings and Precautions (5.8) ]. in females intending to breastfeed on a cladribine treatment day and for 10 days after the last dose [ see Use in Specific Populations (8.2) ]. Patients with current malignancy. (4) Pregnant women, and females and males of reproductive potential who do not plan to use effective contraception during cladribine tablets dosing and for 6 months after the last dose in each treatment course …
Drug Interactions
7 DRUG INTERACTIONS Table 3 Drug Interactions with cladribine tablets 7.1 Immunomodulatory, Immunosuppressive, or Myelosuppressive Drugs Clinical Impact Concomitant use of cladribine with immunomodulatory, immunosuppressive, or myelosuppressive drugs may increase the risk of adverse reactions because of the additive effects on the immune system [see Warnings and Precautions ( 5.4 )]. Prevention or Management Concomitant use with myelosuppressive or other immunosuppressive drugs is not recommended. Acute short-term therapy with corticosteroids can be administered. In patients who have previously been treated with immunomodulatory or immunosuppressive drugs, consider potential additive effect, the mode of action, and duration of effect of the other drugs prior to initiation of cladribine. 7.2 Interferon-Beta Clinical Impact Concomitant use of cladribine with interferon-beta did not change the exposure of cladribine to a clinically significant effect; however, lymphopenia risk may be increased [ see Warnings and Precautions (5.3) ]. Prevention or Management Concomitant use is not recommended. 7.3 Hematotoxic Drugs Clinical Impact Concomitant use of cladribine with hematotoxic drugs ma…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions and potential risks are discussed, or discussed in greater detail, in other sections of the labeling: Malignancies [ see Warnings and Precautions (5.1) ] Risk of Teratogenicity [ see Warnings and Precautions (5.2) ] Lymphopenia [ see Warnings and Precautions (5.3)] Infections [ see Warnings and Precautions (5.4) ] Hematologic Toxicity [ see Warnings and Precautions (5.5) ] Graft-Versus-Host Disease With Blood Transfusion [ see Warnings and Precautions (5.6) ] Liver Injury [ see Warnings and Precautions (5.7) ] Hypersensitivity [ see Warnings and Precautions (5.8) ] Cardiac Failure [ see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence > 20%) are upper respiratory tract infection, headache, and lymphopenia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect t…
Frequently Asked Questions
What is Cladribine used for?
Cladribine contains Cladribine. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Cladribine a controlled substance?
Cladribine is not classified as a controlled substance by the DEA.
What is the generic name for Cladribine?
The generic name for Cladribine is Cladribine. There are 1 other brand versions of Cladribine.
What is the NDC code for Cladribine 1 mg/mL?
The NDC (National Drug Code) for Cladribine 1 mg/mL is 42658-010, listed by Hisun Pharmaceuticals USA, Inc..