Mavenclad

Mavenclad is a prescription medication used to treat relapsing multiple sclerosis (MS).

Mavenclad belongs to a group of drugs called antimetabolites. It is thought to work by preventing B- and T-cells from replicating in the body, thus reducing the number of these types of cells in circulation.

This medication comes in tablet form and is given as two yearly treatment courses. Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart. Mavenclad tablets are taken with water, and swallowed whole without chewing.

Common side effects of Mavenclad include upper respiratory tract infection, headache, and lymphopenia (low blood cell count).

Mavenclad is a prescription medication used to treat relapsing multiple sclerosis (MS). Because of its safety profile, use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. Mavenclad is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mavenclad. See the "Mavenclad Precations" section.

Common side effects of Mavenclad incluse the following:

• upper respiratory infection
• headache
• low blood counts

This is not a complete list of Mavenclad side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

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

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• drugs that suppress your immune system such as tacrolimus, prednisone and cyclosporine
• drugs that decrease or destroy red blood cells (RBCs) such as chlorambucil, methotrexate and hydroxyurea
• antiviral and antiretroviral drugs such as acyclovir, Tamiflu and efavirenz
• drugs that assist in the uptake of other anticancer drugs such as dasatinib, imatinib and ponatinib

This is not a complete list of Mavenclad drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mavenclad including the following:

• Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
• Mavenclad may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with Mavenclad or become pregnant during Mavenclad dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with Mavenclad and contact your healthcare provider right away if you become pregnant during treatment with Mavenclad.
  • For females who are able to become pregnant:
    • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of Mavenclad to make sure that you are not pregnant.
    • Use effective birth control (contraception) on the days on which you take Mavenclad and for at least 6 months after the last dose of each yearly treatment course.
    • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
    • You should use a second method of birth control on the days on which you take Mavenclad and for at least 4 weeks after your last dose of each yearly treatment course.
  • For males with female partners who are able to become pregnant:
    • Use effective birth control (contraception) during the days on which you take Mavenclad and for at least 6 months after the last dose of each yearly treatment course.
• low blood cell counts. Low blood cell counts have happened and can increase your risk of infections during your treatment with Mavenclad. Your healthcare provider will do blood tests before you start treatment with Mavenclad, during your treatment with Mavenclad, and afterward, as needed.
• serious infections such as:
  • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including:
    • fever
    • aching painful muscles
    • headache
    • feeling of being generally unwell
    • loss of appetite
    • burning, tingling, numbness or itchiness of the skin in the affected area
    • skin blotches, blistered rash and severe pain

• progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking Mavenclad, it may happen in people with weakened immune systems. Symptoms of PML get worse over days to weeks. Call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms of PML, that have lasted several days, including:
  • weakness on 1 side of your body
  • loss of coordination in your arms and legs
  • decreased strength
  • problems with balance
  • changes in your vision
  • changes in your thinking or memory
  • confusion
  • changes in your personality

• liver problems. Mavenclad may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking Mavenclad. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
  • nausea
  • vomiting
  • stomach pain
  • tiredness
  • loss of appetite
  • your skin or the whites or your eyes turn yellow
  • dark urine

• allergic reactions (hypersensitivities). Mavenclad can cause serious allergic reactions. Stop your treatment with Mavenclad and go to the closest emergency room for medical help right away if you have any signs or symptoms of allergic reactions. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
• heart failure. Mavenclad may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

Do not take Mavenclad if you:

• have cancer (malignancy).
• are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
• are human immunodeficiency virus (HIV) positive.
• have active infections, including tuberculosis (TB), hepatitis B or C.
• are allergic to cladribine.
• are breastfeeding.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Mavenclad, there are no specific foods that you must exclude from you diet when receiving this medication.

Before taking Mavenclad, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Mavenclad or any of its ingredients
• have or think you have an infection
• have heart failure
• have liver or kidney problems
• have taken, take or plan to take medicines that affect your immune system or your blood cells, or other treatments for MS
• have had a recent vaccination or are scheduled to receive any vaccinations
• have had or have cancer
• are breatfeeding or plan to breastfeed
• are pregnant or may become pregnant (woman), or are a man who plans to start a family

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

Pregnant women, and women and men of reproductive potential who do not plan to use effective contraception during Mavenclad treatment and for 6 months after the last dose should not recieve this medication due to the risk of fetal harm. 

Please refer to the warning on the label of the Mavenclad package for more information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Mavenclad is contraindicated in breastfeeding women because of the potential for serious adverse reactions in breastfed infants [see package insert for more information]. Women are advised not to breastfeed during treatment and for 10 days after the last dose.

Take Mavenclad exactly as prescribed.

• Mavenclad is given as two yearly treatment courses.
• Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart. Your healthcare provider will tell you when you have to start your treatment weeks and how many tablets per week you need, depending on your weight. Each treatment week is 4 or 5 days.
• Your pharmacist will dispense a carton of Mavenclad for each treatment week. The prescribed number of tablets per day are provided in child resistant day packs.
• Take Mavenclad exactly as your healthcare provider tells you. Do not change your dose or stop taking Mavenclad unless your healthcare provider tells you to.
• Take Mavenclad with water and swallow whole without chewing. Mavenclad can be taken with or without food.
• Swallow Mavenclad right away after opening the blister pack.
• Your hands must be dry when handling Mavenclad and washed well with water afterwards.
• Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get Mavenclad on your skin or on any surface, wash it right away with water.
• Take Mavenclad at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day Mavenclad treatment week.
• If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take Mavenclad. It is not known if Mavenclad is safe and effective in people who restart Mavenclad treatment more than 2 years after completing 2 yearly treatment courses.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The total dose of Mavenclad is about 3.5 mg per kg of body weight taken by mouth and divided into 2 yearly treatment courses (1.75 mg per kg per treatment course). 

Each treatment course is divided into 2 treatment cycles:

Administration of First Treatment Course

• First Course/First Cycle: start any time.
• First Course/Second Cycle: administer 23 to 27 days after the last dose of First Course/First Cycle.

Administration of Second Treatment Course

• Second Course/First Cycle: administer at least 43 weeks after the last dose of First Course/Second Cycle.
• Second Course/Second Cycle: administer 23 to 27 days after the last dose of Second Course/First Cycle.

If you take too much Mavenclad, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Keep this and all medications out of reach of children
• Mavenclad is a cytotoxic drug. Follow special handling and disposal procedures.
• Keep in blister pack until ready to use. Uncoated tablet must be swallowed immediately once removed from the blister.
• If 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.
• Hands must be dry when handling the tablets and washed thoroughly afterwards. Avoid prolonged contact with skin.
• Store at room temperature.

WARNING: MALIGNANCIES AND RISK OF TERATOGENICITY 

 Malignancies Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD 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 MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with MAVENCLAD.

 Risk of Teratogenicity MAVENCLAD 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 MAVENCLAD in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course. Stop MAVENCLAD if the patient becomes pregnant.