Cladribine Injection - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||Hairy Cell Leukemia|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||Cladribine, Sodium chloride, Phosphoric acid, Sodium phosphate, Dibasic|
About This Medication
What the Medication is Used For
Cladribine Injection is used in the treatment of patients with Hairy Cell Leukemia, which is defined by very low blood counts, associated with abnormally shaped white blood cells.
What it Does
Cladribine passively crosses the cell membrane, accumulates within cells and is believed to reduce cellular metabolism and interrupt cell division of lymphocytes and monocytes.
When it Should not be Used
Do not use Cladribine Injection if you are allergic (hypersensitive) to cladribine or any of the other ingredients in Cladribine Injection. If you have any concerns, discuss them with your doctor.
What the Medicinal Ingredient Is
What the Important Nonmedicinal Ingredients Are
Dibasic Sodium Phosphate, Phosphoric Acid, Sodium Chloride, and Water for Injection.
What Dosage Forms it Comes In
Cladribine Injection is supplied as a sterile, preservative–free, isotonic solution containing 10 mg (1 mg/mL) of cladribine in a single–use clear flint glass 20 mL vial.
Cladribine is available in packages of 25 individually boxed vials.
Warning and Precautions
Serious Warnings and Precautions
Cladribine Injection should be given under the supervision of a qualified doctor experienced in the use of cancer therapy.
- An initial suppression of bone marrow function should be expected while taking Cladribine Injection. These effects are usually reversible and appear to be related to the amount of drug given;
- A significant, sometimes severe, and possible extended drop in the amount of white blood cells has been observed;
- At 4 to 9 times the typical drug levels given to Hairy Cell Leukemia patients, severe neurotoxicity (severe weakness in the limbs) has been reported and also observed rarely during usual dosing practices;
- At 4 to 9 times the typical drug levels given to Hairy Cell Leukemia patients, sudden abnormal kidney function has been observed, especially when taken together with other kidney–damaging drugs/therapies.
Before you take Cladribine Injection, talk to your doctor or pharmacist if:
- you have known or suspected abnormal kidney or liver function;
- there is intent to conceive children (being pregnant);
- you are a nursing mother.
Interactions With This Medication
Interactions with other drugs, foods, herbs, and laboratory tests have not been established. Tell your doctor about all medications, natural health products, vitamins, herbal medicines and/or therapies you have taken or currently participate in.
Proper Use of This Medication
Cladribine Injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.The following is the usual dose for Cladribine Injection: 0.09 mg/kg/day to be given by continuous injection (intravenous infusion) for 7 days in a row.
|If you suspect an overdose of Cladribine Injection has occurred, contact your doctor/health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Side Effects and What to do About Them
Like all medicines, Cladribine Injection can have side effects. If you experience any of the following side effects mentioned below, contact your doctor or nurse as soon as possible. Some of these effects may be serious. However, there might be ways to reduce discomfort of these effects.
The following are side effects observed in patients at the beginning of clinical trials:
- severe drop in white blood cells (70%);
- fever (69%);
- infection (28%);
- fatigue (45%);
- nausea (28%);
- rash (27%);
- headache (22%);
- injection site reactions (19%).
Most of the non–blood adverse experiences were mild to moderate in severity.
The following are side effects reported by ≥ 5% of patients during the first 2 weeks following treatment initiation, regardless of relationship to the drug:
Body as a Whole: Fever, chills, fatigue (malaise), loss of strength (asthenia), trunk pain, profuse sweating (diaphoresis).
Gastrointestinal System: Nausea, decreased appetite, constipation, vomiting, diarrhea, abdominal pain.
Blood/Lymphatic System: Purplish bruising (purpura), very small reddish/purplish spotting (petechiae), nose bleed (epistaxis).
Nervous System: Headache, dizziness, inability to obtain adequate sleep (insomnia).
Respiratory System: Cough.
Skin/Subcutaneous Tissue: Rash, injection site reactions, itching (pruritus), pain, redness of skin (erythema).
Musculoskeletal System: Muscle pain (myalgia), joint pain (arthralgia).
Serious Side Effects, how Often They Happen and What to do About Them
|Symptom / effect||Talk with your doctor immediately|
|Cardiovascular System||swelling (edema), rapid beating of the heart (tachycardia)||✓|
|Respiratory System||abnormal breath sounds,abnormal chest sounds, shortness of breath||✓|
This is not a complete list of side effects. For any unexpected effects while taking Cladribine Injection, contact your doctor or pharmacist.
How to Store It
When vials and infusion solutions are stored between 2 °C and 8 °C (36 °F to 46 °F) protected from light, unopened vials of Cladribine Injection 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 Injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing Cladribine Injection should be administered promptly or stored in the refrigerator (2 °C to 8 °C) for no more than 8 hours prior to administration.
Cladribine Injection should be refrigerated 2 °C to 8 °C (36 °F to 46 °F).
Protect from light during storage.
Keep out of reach of children.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1–866–234–2345 (toll–free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1–866–678–6789 (toll–free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator
Postage paid labels and the Consumer Side Effect Reporting Form are available at MadEffet (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd. at: