Cladribine (KLAD-ri-been)

Treats relapsing forms of multiple sclerosis (MS).

Brand Name(s):

Mavenclad

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole with water. Do not crush, break, or chew it. Remove the tablet from the blister once you are ready to use it.
• Your hands must be dry when handling the tablet. Wash your hands with soap and water afterwards. Limit direct skin contact with the tablets and wash the exposed areas thoroughly.
• If a tablet is left on a surface or if a broken or fragmented tablet is released from the blister, the area must be thoroughly washed with water.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. This will extend the number of days in that treatment cycle. If you miss 2 doses in a row, extend the treatment cycle by 2 days.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines may affect how cladribine works. Tell your doctor if you are using any of the following:
  • Cilostazol, curcumin, cyclosporine, dilazep, dipyridamole, eltrombopag, interferon beta, nifedipine, nimodipine, reserpine, rifampicin, ritonavir, St John's wort, sulindac
  • Birth control pills
  • Medicine that can destroy red blood cells
  • Medicine that can weaken the immune system (including cancer medicine, steroids)
  • Medicine to treat HIV infection (including lamivudine, ribavirin, stavudine, zalcitabine, zidovudine)
  • Steroid medicine
• If you are taking any other oral medicines, take them at least 3 hours before or after using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should receive live or live-attenuated vaccines at least 4 to 6 weeks before starting this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (including condoms or spermicide) along with your pills during treatment and for at least 6 months after the last dose in each treatment course. Male patients with female partners should use an effective form of birth control during treatment and for at least 6 months after the last dose in each treatment course.
• Do not breastfeed during treatment with this medicine and for 10 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, or any type of infection.
• This medicine may cause the following problems:
  • Increased risk of cancer
  • Increased risk of serious or life-threatening infections, including bacterial, viral, parasitic, and fungal
  • Blood transfusion problems
  • Liver problems
  • Heart failure
• This medicine may make you bleed, bruise, or get infections more easily. You will be at risk for infections including herpes, pyelonephritis, tuberculosis (TB), hepatitis B or C, progressive multifocal leukoencephalopathy, or fungal infections. Take precautions to prevent illness and injury. Wash your hands often.
• You will need to have a TB skin test 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.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blurred vision, loss of coordination, clumsiness, memory loss, confusion, personality changes, weakness on one side of the body
• Cold sores or blisters on the lips, nose, eyes, or genitals
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Swelling in your hands, ankles, or feet
• Trouble breathing, cold sweat, bluish-colored skin
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Back, joint, or muscle pain
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

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