Cladribine (Oral)

Cladribine is used to treat the relapsing types of multiple sclerosis (MS), which includes relapsing-remitting disease and active secondary progressive disease, in patients who have already tried other medicines that did not work well. Cladribine will not cure MS, but it may help slow down some of the disabling effects and reduce the number of relapses of the disease.

This medicine is available only with your doctor's prescription.

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

Your doctor will perform a pregnancy test before each treatment course with this medicine. Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not be as effective when used with this medicine. Use another form of birth control (for example, 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 you become pregnant while using the medicine, inform your doctor immediately.

Using this medicine may increase your risk of developing cancer. Discuss any concerns about this risk with your doctor.

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

• If possible, avoid people with infections. Contact your doctor immediately if you think you are getting an infection or if you experience fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising, black or tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Consult 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 using sharp objects such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could happen.

You will need to have a skin test for tuberculosis (TB) before starting this medicine. Inform 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. Contact your doctor if you experience 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, and after stopping treatment, do not receive 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 could get the infection that the immunization is meant to prevent. Additionally, others in your household should not take the oral polio vaccine, as they could pass the polio virus on to you. Also, avoid people who have taken the oral polio vaccine within the last several months. Stay away from them and do not spend long periods in the same room with them. If you cannot take these precautions, consider wearing a protective face mask that covers your nose and mouth.

Contact your doctor immediately if you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of your eyes or skin. These could be signs of a serious liver problem.

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

Contact your doctor immediately 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, difficulty breathing, or weight gain. These may indicate a heart condition called heart failure.

This medicine may cause problems related to blood transfusions (for example, transfusion-associated graft-versus-host disease). Talk to your doctor if you have concerns about this.

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

In deciding to use a medicine, you and your doctor must weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done on how cladribine affects children. It is not recommended for use in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of cladribine. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution when using this medicine.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together but might require dose adjustments or other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but not necessarily a complete list.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Cancer or
• Chronic, active hepatitis infection or
• Human immunodeficiency virus (HIV) infection or
• Chronic, active tuberculosis infection—Should not be used in patients with these conditions.

• History of cancer or
• Heart disease—Use with caution. May increase the risk of side effects.

• Hepatitis B or C or
• Latent tuberculosis—Use with caution. May reactivate these infections.

• Acute infection—Must be treated first before using this medicine.

• Moderate to severe kidney disease or
• Moderate to severe liver disease—Use is not recommended in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Contact your doctor right away if you experience any of the following side effects:

More common

• 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

• 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

• 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

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your healthcare professional may provide ways to prevent or lessen some of these side effects. Contact your healthcare professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

More common

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

Less common

• Thinning or loss of hair

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

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

In the U.S.

• Mavenclad

Available Dosage Forms:

• Tablet

Therapeutic Class: Musculoskeletal Agent

Pharmacologic Class: Antimetabolite

Chemical Class: Purine Nucleoside Analog

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

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.

If you are taking any other oral medicines, take them at least 3 hours before or after using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For relapsing forms of multiple sclerosis: Adults—Dose is based on body weight and must be determined by your doctor. The dose is 3.5 milligrams (mg) per kilograms (kg) of body weight divided into 2 yearly treatment courses (1.75 mg per kg per treatment course). Each treatment course is divided into 2 treatment cycles and will be determined by your doctor. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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