Mavenclad

What is Mavenclad?

• Mavenclad (cladribine) is a purine antimetabolite used for the treatment of adult patients with highly active forms of relapsing-remitting multiple sclerosis.

Cladribine

Cladribine2

What are the uses of this medicine?

• Mavenclad (cladribine) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, Mavenclad is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.

Limitations of Use:

• Mavenclad is not recommended for use in people with clinically isolated syndrome (CIS).

How does this medicine work?

• The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• 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.
• have active infections, including tuberculosis (TB), hepatitis B or C.
• are allergic to cladribine.
• are breastfeeding.

What drug interactions can this medicine cause?

• Concomitant use of Mavenclad with immunomodulatory, immunosuppressive, or myelosuppressive drugs may increase the risk of adverse reactions because of the additive effects on the immune system.
• Concomitant use of Mavenclad with interferon-beta is not recommended.
• Concomitant use of Mavenclad with hematotoxic drugs may increase the risk of adverse reactions because of the additive hematological effects.
• Avoid concomitant use with Antiviral and antiretroviral drugs (e.g., lamivudine, zalcitabine, ribavirin, stavudine, and zidovudine).
• Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day Mavenclad treatment cycles.
• Women using systemically acting hormonal contraceptives should add a barrier method during Mavenclad dosing and for at least 4 weeks after the last dose in each treatment course.

Is this medicine FDA approved?

• Cladribine tablets were later approved in Europe, in August 2017, for highly active relapsing-remitting multiple sclerosis, and has since been approved by the FDA for the treatment of relapsing-remitting and secondary progressive multiple sclerosis in the US.

How should this medicine be used?

• Follow standard cancer screening guidelines because of the risk of malignancies.
• Exclude pregnancy prior to treatment with Mavenclad in females of reproductive potential.
• Obtain a CBC with differential including lymphocyte count.
• Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels.

Recommended dosage:

• Cumulative dosage of 3.5 mg/kg administered orally and divided into 2 treatment courses (1.75 mg/kg per treatment course).
• Each treatment course is divided into 2 treatment cycles.

Administration:

• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 10 mg

This medicine is available in fallowing brand namesː

• Mavenclad

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory infection
• headache
• low white blood cell counts

Mavenclad can cause serious side effects, including:

• Risk of cancer (malignancies)
• cause birth defects
• TB, hepatitis B or C, and shingles (herpes zoster)
• progressive multifocal leukoencephalopathy (PML)
• liver problems
• hypersensitivities
• heart failure

What special precautions should I follow?

• Treatment with Mavenclad may increase the risk of malignancy. Mavenclad is contraindicated in patients with current malignancy. Follow standard cancer screening guidelines in patients treated with Mavenclad.
• Mavenclad may cause fetal harm when administered to pregnant women. Mavenclad is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception.
• Mavenclad causes a dose-dependent reduction in lymphocyte count. Monitor lymphocyte counts before, during and after treatment.
• Mavenclad can reduce the body's immune defense and may increase the likelihood of infections. Screen patients for latent infections; consider delaying treatment until infection is fully controlled. Vaccinate patients antibody-negative to varicella zoster virus prior to treatment. Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells per microliter. Monitor for infections.
• In addition to lymphopenia, decreases in other blood cells and hematological parameters have been reported with Mavenclad. Monitor complete blood count before, during and after treatment.
• Transfusion-associated graft-versus-host disease has been observed rarely after transfusion of nonirradiated blood in patients treated with cladribine for non-MS treatment indications. Irradiation of cellular blood components is recommended.
• Mavenclad-treated patients had liver injury. Obtain tests prior to treatment. Discontinue if clinically significant injury is suspected.
• Mavenclad-treated patients had hypersensitivity reactions. If a hypersensitivity reaction is suspected, discontinue Mavenclad therapy. Do not use Mavenclad in patients with a history of hypersensitivity to cladribine.
• Mavenclad-treated patient experienced life-threatening acute cardiac failure with myocarditis, which improved after approximately one week. Instruct patients to seek medical advice if they experience symptoms of cardiac failure (e.g., shortness of breath, rapid or irregular heartbeat, swelling).

What to do in case of emergency/overdose?

Symptoms of overdosage may:

• There is no experience with overdose of Mavenclad.
• Lymphopenia is known to be dose-dependent.

Treatment of overdosage:

• There is no known specific antidote to an overdose of Mavenclad.
• Treatment consists of careful observation and initiation of appropriate supportive measures.
• Discontinuation of Mavenclad may need to be considered. Because of the rapid and extensive intracellular and tissue distribution, hemodialysis is unlikely to eliminate cladribine to a significant extent.

Can this medicine be used in pregnancy?

• Mavenclad is contraindicated in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception.
• There are no adequate data on the developmental risk associated with use of Mavenclad in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness in pediatric patients (below 18 years of age) have not been established.
• Use of Mavenclad is not recommended in pediatric patients because of the risk of malignancies.

What are the active and inactive ingredients in this medicine?

• Active ingredient: cladribine
• Inactive ingredients: hydroxypropyl betadex, magnesium stearate, and sorbitol.

Who manufactures and distributes this medicine?

Distributed by:

• EMD Serono, Inc., Rockland, MA
• Mavenclad is a registered trademark of Merck KGaA, Darmstadt, Germany.

What should I know about storage and disposal of this medication?

• Mavenclad comes in a child resistant package.
• Store Mavenclad at room temperature between 68°F and 77°F (20°C and 25°C).
• Store Mavenclad in the original package to protect from moisture.
• Ask your healthcare provider or pharmacist about how to safely throw away any unused or expired Mavenclad tablets and packaging.

• Dailymed label info on Mavenclad
• FDA Mavenclad

Mavenclad Resources
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