Mavenclad is a purine antimetabolite that interferes with enzymes that are necessary for DNA synthesis.

Mavenclad is used to treat relapsing multiple sclerosis (MS) in adults. This medicine will not cure MS, it will only decrease the frequency of relapse symptoms.

Mavenclad is usually given after other treatments have failed.

Do not take Mavenclad if you are pregnant. Both men and women should use effective birth control to prevent pregnancy while taking Mavenclad, and for 6 months after the last dose.

If you use birth control pills or other hormonal forms (implants, skin patches, vaginal rings), also use a barrier form of birth control (condom, diaphragm, cervical cap, contraceptive sponge) to prevent pregnancy while taking Mavenclad and for at least 4 weeks after your treatment course ends.

Taking cladribine may increase your risk of developing certain cancers.

Before taking this medicine

You should not take Mavenclad if you are allergic to cladribine, or if you have:

• cancer;

• an active infection such as tuberculosis or hepatitis B or C;

• HIV or AIDS; or

• if you are pregnant or breastfeeding.

To make sure Mavenclad is safe for you, tell your doctor if you have ever had:

• an active or chronic infection;

• heart problems;

• weak immune system (caused by disease or by using certain medicine);

• liver or kidney disease;

• cancer; or

• if you receive blood transfusions.

Tell your doctor if you have recently received a vaccine (within 4 to 6 weeks before you take Mavenclad).

Taking cladribine may increase your risk of developing certain cancers. Ask your doctor about this risk.

Do not take Mavenclad if you are pregnant. Cladribine could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

• Cladribine can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman taking Mavenclad, you may need to have a negative pregnancy test before starting this medicine. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man taking Mavenclad, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking this medicine.

Mavenclad can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while taking this medicine, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using the second form of birth control for at least 4 weeks after your Mavenclad treatment course ends.

Do not breastfeed while taking cladribine, and for at least 10 days after your last dose.

Take Mavenclad exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will perform medical tests to make sure you do not have conditions that would prevent you from safely using Mavenclad.

Mavenclad is taken in 2 treatment courses separated by about a year. There are 2 treatment cycles in each course. During each cycle, you will take the medicine for 4 or 5 days in a row. The 2 cycles are separated by about a month. Follow your doctor's dosing instructions very carefully.

Your doctor will determine how many treatment courses you should receive.

Take this medicine with a full glass of water. You may take Mavenclad with or without food.

Use dry hands to remove a tablet from the foil blister pack when you are ready to take the medicine.

Swallow the tablet whole and do not crush, chew, or break it.

Wash your hands after handling the tablet.

Do not use a broken tablet. The medicine from a broken pill can be dangerous if it gets in your eyes or nose, or on your skin. If this happens, rinse thoroughly with water. Ask your pharmacist how to safely dispose of a broken pill.

You may be given other medications to help prevent infections. Keep using these medicines for as long as your doctor has prescribed.

You will need frequent medical tests, and your next dose may be delayed based on the results.

Store at room temperature away from moisture and heat.

Cladribine can have long lasting effects on your body. Your doctor will need to check your progress on a regular basis and for another 2 years after your last dose.

You should not take Mavenclad if you are allergic to cladribine, or if you have:

• cancer;

• an active infection such as tuberculosis or hepatitis B or C;

• HIV or AIDS; or

• if you are pregnant or breastfeeding.

To make sure Mavenclad is safe for you, tell your doctor if you have ever had:

• an active or chronic infection;

• heart problems;

• weak immune system (caused by disease or by using certain medicine);

• liver or kidney disease;

• cancer; or

• if you receive blood transfusions.

Tell your doctor if you have recently received a vaccine (within 4 to 6 weeks before you take Mavenclad).

Taking cladribine may increase your risk of developing certain cancers. Ask your doctor about this risk.

Do not take Mavenclad if you are pregnant. Cladribine could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

• Cladribine can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman taking Mavenclad, you may need to have a negative pregnancy test before starting this medicine. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man taking Mavenclad, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking this medicine.

Mavenclad can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while taking this medicine, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using the second form of birth control for at least 4 weeks after your Mavenclad treatment course ends.

Do not breastfeed while taking cladribine, and for at least 10 days after your last dose.

Take the missed dose on the same day you remember it. If the day is almost over before you remember your dose, wait until the next day to take it.

Do not take 2 doses in one day. Take your next dose at the regular time and stay on your once-daily schedule, even if it adds an extra day to your treatment cycle for the week.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Mavenclad. You could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. Your doctor will determine when it is safe for you to receive a vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Cladribine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

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

Mavenclad may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have:

• heart problems - swelling, rapid weight gain, feeling short of breath;

• low blood cell counts - fever, swollen glands, stomach pain, cough, runny nose, joint pain, mouth sores, skin sores or rash, easy bruising, unusual bleeding;

• liver problems - nausea, vomiting, stomach pain, tiredness, loss of appetite, yellowing of your skin or eyes, dark urine;

• signs of shingles - flu-like symptoms, tingly or painful blistering rash on one side of your body; or

• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common Mavenclad side effects may include:

• headache;

• low white blood cell counts; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

If you take any other medicines by mouth, take your Mavenclad dose 3 hours before or 3 hours after you take the other medicine.

Other drugs may interact with cladribine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.