Cladribine (Page 5 of 5)

Chemical Stability of Vials

When stored in refrigerated conditions between 2° to 8° C (36° to 46° F) protected from light, unopened vials of cladribine are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of cladribine is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing cladribine should be administered promptly or stored in the refrigerator (2° to 8° C) for no more than 8 hours prior to administration.

Handling and Disposal

The potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering cladribine. The use of disposable gloves and protective garments is recommended. If cladribine contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2-8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your institution’s guidelines and all applicable state/local regulations for disposal of cytotoxic waste.

HOW SUPPLIED

Cladribine Injection, USP is supplied as a sterile, preservative-free, isotonic solution containing 10 mg (1 mg/mL) of cladribine as 10 mL filled into a single-use clear flint glass 20 mL vial, individually boxed.

NDC 0143-9871-01.

Store refrigerated 2° to 8°C (36° to 46°F). Protect from light during storage.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

REFERENCES

  1. Santana VM, Mirro J, Harwood FC, et al: A phase I clinical trial of 2-Chloro-deoxyadenosine in pediatric patients with acute leukemia. J. Clin. Onc., 9: 416 (1991).

  2. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U. S. Government Printing Office, Washington, D. C. 20402.

  3. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics, JAMA , March 15 (1985).

  4. National Study Commission on Cytotoxic Exposure–Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.

  5. Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents, Med. J. Australia 1:425 (1983).

  6. Jones RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. Ca–A Cancer Journal for Clinicians, Sept/Oct. 258-263 (1983).

  7. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic Drugs in Hospitals. Am. J. Hosp. Pharm ., 42:131 (1985).

  8. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (antineoplastic) Drugs. Am. J. Hosp. Pharm. , 43:1193 (1986).

    †Viaflex® containers, manufactured by Baxter Healthcare Corporation — Code No. 2B8013 (tested in 1991)

    ‡MEDICATION CASSETTE™ Reservoir, manufactured by SIMS Deltec, Inc. — Reorder No. 602100A (tested in 1991)

Manufactured by

THYMOORGAN PHARMAZIE GmbH,

Schiffgraben 23, 38690 Goslar, Germany

Distributed by

Hikma Pharmaceuticals USA Inc.

Eatontown, NJ 07724

Revised August 2019

127.207.019/01

Vial label

Cladribine Injection, USP 10 mg per 10 mL Container Label
(click image for full-size original)

Cladribine Injection, USP 10 mg per 10 mL Container Label

NDC 0143-9871-01

Rx only

Cladribine Injection

10 mg per 10 mL

(1 mg/mL)

MUST BE DILUTED PRIOR TO INTRAVENOUS INFUSION

Serialization Image

Representative Serialization Image

Representative Serialization Image

CLADRIBINE cladribine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9871
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADRIBINE (CLADRIBINE) CLADRIBINE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC
PHOSPHORIC ACID
SODIUM CHLORIDE 9 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9871-01 1 VIAL in 1 BOX, UNIT-DOSE contains a VIAL
1 10 mL in 1 VIAL This package is contained within the BOX, UNIT-DOSE (0143-9871-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075405 02/28/2000
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 10/2019 Hikma Pharmaceuticals USA Inc.

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