Leustatin Side Effects

Generic name: cladribine

Medically reviewed by Drugs.com. Last updated on Dec 23, 2024.

Note: This document provides detailed information about Leustatin Side Effects associated with cladribine. Some dosage forms listed on this page may not apply specifically to the brand name Leustatin.

Applies to cladribine: oral tablet.

Other dosage forms:

• intravenous solution

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Malignancy. Treatment with cladribine may increase the risk of malignancy.

Cladribine is contraindicated in patients with current malignancy.

In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of cladribine on an individual patient basis.

Follow standard cancer screening guidelines in patients treated with cladribine.Risk of Teratogenicity. Cladribine is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm.

Malformations and embryolethality occurred in animals.

Exclude pregnancy before the start of treatment with cladribine in females of reproductive potential.

Advise females and males of reproductive potential to use effective contraception during cladribine dosing and for 6 months after the last dose in each treatment course.

Stop cladribine if the patient becomes pregnant.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Your doctor will give you a pregnancy test before the start of each treatment course of this medicine. Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills during treatment and for at least 4 weeks after the last dose in each treatment course. Men should use an effective form of birth control during treatment and for at least 6 months after the last dose in each treatment course to prevent pregnancy in a sexual partner. If a pregnancy occurs while using the medicine, tell your doctor right away.

Using this medicine may increase your risk of getting cancer. Talk to your doctor if you have concerns about this risk.

Cladribine can temporarily lower the number of white blood cells in your blood, which will increase the risk of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, these are precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Check with your doctor if you have weakness on one side of the body, clumsiness, blurred vision, changes in thinking, memory problems, confusion, or personality changes.

While you are being treated with cladribine (the active ingredient contained in Leustatin) and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. You may receive live or live-attenuated vaccines at least 4 weeks to 6 weeks before starting this medicine. Cladribine may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Check with your doctor right away if you have more than one of these symptoms: chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, shortness of breath, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, or weight gain. These may be signs of a heart condition called heart failure.

This medicine may cause blood transfusion problems (eg, transfusion-associated graft-versus-host disease). Talk with your doctor if you have concerns about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Leustatin

Along with its needed effects, cladribine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cladribine:

More common side effects

• body aches or pain
• chills
• cough
• ear congestion
• fast heartbeat
• fever
• headache
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• loss of voice
• lower back or side pain
• painful or difficult urination
• redness of the skin
• runny or stuffy nose
• sneezing
• sore throat
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing
• unusual tiredness or weakness

Less common side effects

• blurred vision
• cough producing mucus
• discouragement
• dizziness
• feeling sad or empty
• lack of appetite
• loss of interest or pleasure
• nervousness
• pounding in the ears
• slow heartbeat
• trouble concentrating
• trouble sleeping

Rare side effects

• burning or stinging of the skin
• confusion
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• seizures
• stiff neck
• vomiting

Incidence not known

• blistering, peeling, loosening of the skin
• chest pain
• diarrhea
• muscle pain
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• unusual bleeding or bruising

Other side effects of Leustatin

Some side effects of cladribine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• back pain
• difficulty in moving
• muscle stiffness
• trouble sleeping

Less common side effects

• thinning or loss of hair

For healthcare professionals

Applies to cladribine: intravenous solution, oral tablet.

Hematologic adverse events

• Very common (10% or more): Neutropenia, thrombocytopenia, anemia, purpura
• Common (1% to 10%): Febrile neutropenia
• Uncommon (0.1% to 1%): Bone marrow suppression with prolonged pancytopenia, aplastic anemia, hypereosinophilia, myelodysplastic syndrome
• Postmarketing reports: Hemolytic anemia, febrile neutropenia^[Ref]

Renal

• Common (1% to 10%): Renal impairment, renal failure

Gastrointestinal

• Very common (10% or more): Nausea (28%), anorexia (17%), vomiting (13%), diarrhea (10%)
• Common (1% to 10%): Constipation, abdominal pain, flatulence
• Uncommon (0.1% to 1%): Mucositis^[Ref]

Dermatologic

• Very common (10% or more): Rash (28%), diaphoresis, pruritus
• Common (1% to 10%): Hyperhidrosis, petechiae, ecchymosis, urticaria
• Uncommon (0.1% to 1%): Stevens-Johnson syndrome, toxic skin eruption, toxic epidermal necrolysis
• Rare (less than 0.1%): Alopecia^[Ref]

Nervous system

• Very common (10% or more): Headache
• Common (1% to 10%): Dizziness, somnolence
• Uncommon (0.1% to 1%): Depressed level of consciousness, neurological toxicity (including peripheral sensory neuropathy, motor neuropathy (paralysis), polyneuropathy, paraparesis)^[Ref]

Local

• Very common (10% or more): Administration site reaction^[Ref]

Metabolic

• Common (1% to 10%): Weight loss
• Uncommon (0.1% to 1%): Tumor lysis syndrome, metabolic acidosis^[Ref]

Cardiovascular

• Common (1% to 10%): Edema, tachycardia, myocardial ischemia, peripheral edema
• Rare (less than 0.1%): Heart failure, arrhythmia, heart murmur, hypotension, thrombosis^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, myalgia
• Uncommon (0.1% to 1%): Muscular weakness, paraparesis^[Ref]

Respiratory

• Very common (10% or more): Cough
• Common (1% to 10%): Pulmonary interstitial infiltrates (including lung infiltration, interstitial lung disease, pneumonitis and pulmonary fibrosis), abnormal breath sounds, abnormal chest sounds, dyspnea, rales^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increases in bilirubin, increases in transaminases, jaundice^[Ref]

Immunologic

• Very common (10% or more): Infection (unspecified) (up to 28%)
• Common (1% to 10%): Bacteremia, cellulitis, localized infection, pneumonia, septic shock, serious infection, opportunistic infection^[Ref]

Ocular

• Postmarketing reports: Conjunctivitis^[Ref]

Other

• Very common (10% or more): Fatigue, pyrexia, pain
• Common (1% to 10%): Asthenia, chills, malaise, localized edema, chills^[Ref]

Oncologic

• Postmarketing reports: Secondary malignancies^[Ref]

Psychiatric

• Common (1% to 10%): Confusion, anxiety, insomnia^[Ref]

See also:

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Further information

Leustatin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer