Leustatin 1mg/mL: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

LEUSTATIN^® 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:

LEUSTATIN^® 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 LEUSTATIN^® if you are allergic (hypersensitive) to cladribine or any of the other ingredients in LEUSTATIN^®. If you have any concerns, discuss with your doctor.

What the medicinal ingredient is:

Cladribine

What the nonmedicinal ingredients are:

Sodium chloride

The reconstituted solution may also contain benzyl alcohol.

What dosage forms it comes in:

LEUSTATIN^® 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. LEUSTATIN^® for Injection is available in individually boxed vials.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

LEUSTATIN^® should be given under the supervision of a qualified doctor experienced in the use of cancer therapy.

• Suppression of bone marrow function: This is usually reversible and appears to be related to the amount of drug given;
• Significant and prolonged drop in white blood cell count (lymphopenia);

• Severe neurotoxicity (severe weakness in the limbs)

  has been reported in patients receiving 4 to 9 times the dose recommended for Hairy Cell Leukemia, and rarely at the recommended dose;

• Sudden abnormal kidney function has been seen at high doses, especially when given together with other kidney-damaging drugs/treatments.

BEFORE you use LEUSTATIN^®, talk to your doctor or pharmacist if:

• you have or suspect abnormal kidney or liver function;

• you are pregnant or planning to get pregnant;

  LEUSTATIN should not be given during pregnancy;

• you are a nursing mother; It is advised that you do not breast-feed while you are receiving LEUSTATIN;
• you are a male patient and planning to father a child.

The safety and efficacy of LEUSTATIN^® have not been established in patients under 21 years of age.

Before receiving any vaccine, check with your doctor.

Contraception and Pregnancy:

Both men and women must use effective contraception while receiving LEUSTATIN^®, and for 6 months after their treatment. Pregnancy should be avoided during treatment, however, if it happens you should contact your doctor immediately.

INTERACTIONS WITH THIS MEDICATION

Interactions with other drugs, food, 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.

Since your immune system while receiving LEUSTATIN^® is suppressed, it is not recommended that you receive live attenuated vaccines while being treated.

PROPER USE OF THIS MEDICATION

Usual dose:

A dose of 0.09 mg/kg/day is given by intravenous infusion for 7 days in a row as a single course of treatment.

Overdose:

In case of drug overdose, contact a health care practitioner, 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, LEUSTATIN^® 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:

Very common (≥ 10%) side effects

• very low white blood cell count;
• fever;
• infection;
• fatigue;
• nausea;
• rash;
• headache;

• reaction at the injection site: redness, swelling,

  pain.

The following are side effects reported during the first 2 weeks following treatment initiation, regardless of relationship to drug:

Common (≥5%) side effects

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)

This is not a complete list of side effects. For any unexpected effects while taking LEUSTATIN^®, contact your doctor, or pharmacist.

HOW TO STORE IT

When vials and infusion solutions are stored between 2°C to 8°C protected from light, unopened vials of LEUSTATIN^® 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 LEUSTATIN^® is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing LEUSTATIN^® should be administered promptly or stored in the refrigerator (2°C to 8°C) for no more than 8 hours prior to administration.

Store refrigerated between 2°C to 8°C.

Protect from light during storage.

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701D

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals can be found at:

http://www.janssen.com

or by contacting the sponsor, Janssen Inc., at: 1-800-567-3331

Janssen Inc.

Toronto, Ontario M3C 1L9

Last revised: November 2, 2010

© 2010 JANSSEN Inc.