Leustatin

DRUG DESCRIPTION

LEUSTATIN (cladribine) Injection (also commonly known as 2-chloro-2 -deoxy- ? -D-adenosine) is a synthetic antineoplastic agent for continuous intravenous infusion. It is a clear, colorless, sterile, preservative-free, isotonic solution. LEUSTATIN (cladribine) Injection is available in single-use vials containing 10 mg (1 mg/mL) of cladribine, a chlorinated purine nucleoside analog. Each milliliter of LEUSTATIN (cladribine) Injection contains 1 mg of the active ingredient and 9 mg (0.15 mEq) of sodium chloride as an inactive ingredient. The solution has a pH range of 5.5 to 8.0. Phosphoric acid and/or dibasic sodium phosphate may have been added to adjust the pH to 6.3?±0.3.

The chemical name for cladribine is 2-chloro-6-amino-9-(2-deoxy-?-D-erythropento-furanosyl) purine and the structure is represented below:

LEUSTATIN® (cladribine) Injection Structural Formula Illustration

cladribine...............MW 285.7

What are the possible side effects of cladribine (Cladribine Novaplus, Leustatin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • numbness, tingling, weakness, or burning pain in your fingers or toes;
  • feeling like you might pass out;
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth;
  • ...

Read All Potential Side Effects and See Pictures of Leustatin »

What are the precautions when taking cladribine (Leustatin)?

Before using cladribine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, nerve/muscle disorder, blood/bone marrow disorder, recent/current infections.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well...

Read All Potential Precautions of Leustatin »


Leustatin Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, headache, cough, weakness, or pain/swelling/redness at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: pain/swelling/redness of arms or legs, mental/mood changes, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Cladribine can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using cladribine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, nerve/muscle disorder, blood/bone marrow disorder, recent/current infections.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Leustatin Patient Information Including Side Effects

Brand Names: Cladribine Novaplus, Leustatin

Generic Name: cladribine (Pronunciation: KLAD ri been)

  • What is cladribine (Leustatin)?
  • What are the possible side effects of cladribine (Leustatin)?
  • What is the most important information I should know about cladribine (Leustatin)?
  • What should I discuss with my healthcare provider before receiving cladribine (Leustatin)?
  • How is cladribine given (Leustatin)?
  • What happens if I miss a dose (Leustatin)?
  • What happens if I overdose (Leustatin)?
  • What should I avoid while receiving cladribine (Leustatin)?
  • What other drugs will affect cladribine (Leustatin)?
  • Where can I get more information?

What is cladribine (Leustatin)?

Cladribine is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Cladribine is used to treat hairy cell leukemia (a type of blood cancer).

Cladribine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of cladribine (Leustatin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • numbness, tingling, weakness, or burning pain in your fingers or toes;
  • feeling like you might pass out;
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • fast or slow heart rate, weak pulse, feeling short of breath, confusion, fainting;
  • pale or yellowed skin, dark colored urine, fever, confusion; or
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), purple or red pinpoint spots under your skin, loss of appetite, mouth sores, unusual weakness.

Less serious side effects may include:

  • headache, tired feeling;
  • nausea, diarrhea, constipation;
  • mild itching or skin rash;
  • cough; or
  • pain, swelling, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cladribine (Leustatin)?

Do not use cladribine without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are receiving cladribine

If you have liver or kidney disease or a bone marrow problem, you may need a dose adjustment or special tests to safely receive cladribine.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Do not miss any follow-up visits to your doctor.

Cladribine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Tell your caregivers at once if you have a serious side effect such as numbness or tingling, weakness or burning pain in your fingers or toes, lower back pain, blood in your urine, urinating less than usual, pale or yellowed skin, dark colored urine, or feeling like you might pass out.

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