Mavenclad

Treatment with Mavenclad (Cladribine) consists of two treatment courses over 2 years. The dose of Mavenclad (Cladribine) is 10 mg or 20 mg taken by mouth once daily, for 4 or 5 days at the beginning of the first and second months of year 1. This is then repeated at the beginning of the first and second months of year 2. The dose of Mavenclad (Cladribine), when used to treat MS is based on weight. Your doctor will calculate the total dose and the correct number of tablets you are to take. .

Mavenclad (Cladribine) may be taken with food or on an empty stomach. Other medications that you take by mouth should be separated from Mavenclad (Cladribine) by at least 3 hours on the days that you take Mavenclad (Cladribine).

Because these tablets do not have a coating, it is important that your hands are dry before you remove the medication from the packaging. The tablets must be taken immediately with a glass of water. Do not crush or chew the tablets. Wash your hands immediately after taking Mavenclad (Cladribine), to remove any residue that may be left after handling the medication.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, and you remember on the same day you were supposed to take it, take it as soon as possible and continue with your regular schedule. If you miss a dose and do not remember until the following day, do not take a double dose to make up for the missed one. You will need to extend the number of treatment days by one extra day. You must take the total number of doses in each treatment cycle for Mavenclad (Cladribine) to have the best effect for you. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Mavenclad (Cladribine) at room temperature in its original packaging until you are ready to take a dose. This will protect it from light and moisture. Keep this and all medications out of the sight and reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each round, white, biconvex tablet, engraved with 'C' on one side and '10' on the other side contains 10 mg of Mavenclad (Cladribine). Nonmedicinal ingredients: hydroxypropyl betadex, sorbitol and magnesium stearate.

Do not take Mavenclad (Cladribine) if you:

• are allergic to Mavenclad (Cladribine) or any ingredients of the medication
• are at an increased risk of developing infections
  • have a disease that reduces the effectiveness of the immune system
  • taking other medications that suppress the immune system
• are breast-feeding
• are pregnant
• have a history of progressive multifocal leukoencephalopathy (PML)
• have active cancer
• have moderate to severely decreased kidney function
• have severe active or long-term infections caused by bacteria, viruses or fungi (e.g., hepatitis, Tuberculosis)

There may be an interaction between Mavenclad (Cladribine) and any of the following:

• Azathioprine
• BCG (bacillus Calmette-Guérin)
• cancer medications (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Pimecrolimus, Vincristine)
• Clozapine
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• Deferiprone
• echinacea
• Hydroxyurea
• Imiquimod
• Leflunomide
• monoclonal antibodies (e.g., Belimumab, eculizumab, Infliximab, Natalizumab, Ocrelizumab, Rituximab)
• mycophenolate
• Roflumilast
• Tacrolimus
• Tofacitinib
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Mavenclad (Cladribine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Mavenclad (Cladribine).

Birth Control: Mavenclad (Cladribine) should not be used during pregnancy. Women of childbearing age who are taking Mavenclad (Cladribine) and female partners or men who are taking Mavenclad (Cladribine) should use an effective method of birth control during treatment and for at least 6 months after the last dose of the medication. It is not known if Mavenclad (Cladribine) will make birth control pills less effective. If you are using birth control pills, a barrier method of contraception (e.g., condoms) should be added during treatment and for at least 4 weeks after the last dose in each treatment year. If you become pregnant while taking Mavenclad (Cladribine), contact your doctor immediately.

Cancer: As with other medications that reduce the effectiveness of the immune system, Mavenclad (Cladribine) may increase the risk of developing certain types of cancer. Discuss any concerns you may have with your doctor. Report any unusual infections, swelling or persistent pain, or unintentional weight loss to your doctor as soon as possible.

Fructose intolerance: Mavenclad (Cladribine) contains sorbitol. If you have hereditary problems of fructose intolerance, you should not take Mavenclad (Cladribine).

Kidney function: Kidney Disease or reduced kidney function may cause Mavenclad (Cladribine) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Mavenclad (Cladribine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mavenclad (Cladribine), and whether any special monitoring is needed.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using Mavenclad (Cladribine). PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.

Serious infections: Mavenclad (Cladribine) affects the way your body's natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking Mavenclad (Cladribine) with other medications that reduce the body's ability to fight infection. For some people, these infections have been fatal. If you have a history of chronic or frequent infections, discuss with your doctor how Mavenclad (Cladribine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Contact your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency or burning while passing urine, redness or swelling of skin or joint, cold sores, tooth pain, or new or worsening pain in any part of the body.

Vaccinations: It is not known how effective vaccines may be after treatment with Mavenclad (Cladribine). Certain immunizations may be dangerous if given while receiving or shortly after receiving a treatment course of Mavenclad (Cladribine). Before starting treatment with this medication, check with your doctor to ensure your immunizations are up to date. Vaccinations, including vaccinatation against chicken pox or shingles, should be completed at least 6 weeks before starting to take Mavenclad (Cladribine).

Pregnancy: There is very little information about the effects of Mavenclad (Cladribine) on the mother or developing baby if Mavenclad (Cladribine) is taken during pregnancy. It must not be used if you are pregnant. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if Mavenclad (Cladribine) passes into breast milk. If you are a breast-feeding mother and are taking Mavenclad (Cladribine), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Mavenclad (Cladribine) have not been established for children.

Seniors: People 65 years of age and over were not included in studies for Mavenclad (Cladribine). Because seniors are more likely to have decreased kidney or liver function, they may be more likely to experience side effects of Mavenclad (Cladribine).