Cladribine (Mavenclad): Uses, How It Works, and Side Effects

Cladribine (brand name: Mavenclad) is an oral prescription medication used to treat adults with relapsing forms of multiple sclerosis (MS). Unlike many MS medications that require continuous treatment, Mavenclad is taken in two yearly treatment courses designed to provide long-lasting disease control. Because of its potential risks, Mavenclad is generally prescribed when another MS treatment has not worked well or cannot be tolerated. Read on to learn how Mavenclad works, its uses, recommended dosage, possible side effects, and cost. 

Note: This article is about cladribine tablets, sold under the brand name Mavenclad. Cladribine injection, sold under the brand name Leustatin, is used to treat cancer of the blood and bone marrow. 

Cladribine (Mavenclad) Introduction and Uses

Mavenclad is a brand-name prescription medication. The active ingredient is cladribine, a purine antimetabolite that works by reducing certain immune cells involved in multiple sclerosis. 

The FDA approved cladribine tablets in 2019 to treat adults with relapsing forms of multiple sclerosis. Because Mavenclad carries serious risks, including an increased risk of cancer and fetal harm, it is generally reserved for people who have had an inadequate response to or cannot tolerate another MS treatment. 

Mavenclad is available as 10 mg oral tablets. The tablets are round and white to off-white in color. 

Mavenclad is not recommended for use in people with symptoms similar to multiple sclerosis but don’t meet the criteria for a multiple sclerosis diagnosis. 

Cladribine (Mavenclad) Mechanism of Action

The exact mechanism of action of cladribine in multiple sclerosis is not fully understood. According to the manufacturer, it works by reducing the number of immune cells, particularly B and T lymphocytes, that contribute to inflammation and damage to the protective covering of nerves (myelin). By reducing the number of these immune cells, Mavenclad helps reduce disease activity and relapses. After treatment, the immune system gradually rebuilds over time. 

How Effective Is Cladribine (Mavenclad)?

Clinical studies have shown that Mavenclad can significantly reduce disease activity in people with relapsing forms of multiple sclerosis. In the phase 3 CLARITY clinical trial, people treated with Mavenclad experienced fewer relapses, fewer new MRI brain lesions, and slower disability progression than those who received a placebo. Because treatment is given over two yearly courses rather than continuously, many patients experience lasting benefits without taking the medication every day. Your response to treatment will depend on factors such as your disease severity, previous therapies, and overall health.

Important Cladribine (Mavenclad) Warnings

This medication may increase the risk of cancer and harm an unborn baby (fetus). 

Risk of cancer

Taking cladribine tablets may make you more likely to develop cancer. Discuss the risk with your healthcare provider. Ask your healthcare provider if you need cancer screening. 

Risk of harm to the fetus

If you are a female who is able to get pregnant, your healthcare provider will order a pregnancy test before each treatment course. 

Taking cladribine tablets during pregnancy may cause birth defects or the loss of pregnancy. Don’t take this medication if you are pregnant or plan to get pregnant. If you become pregnant during treatment with cladribine, stop the treatment and call your healthcare provider right away. 

Hormonal contraceptives, including birth control pills, may not completely prevent pregnancy when used with cladribine tablets. Thus, use another birth control method along with the hormonal contraceptives during treatment and for at least 6 months after the final dose of each treatment course. 

If you are a male with a female partner who can get pregnant, use an effective method of birth control during treatment and for at least 14 weeks after the final dose of each treatment course. 

Before Taking Cladribine (Mavenclad) Tablets

Don’t take this medication if you:

• Have cancer 
• Have HIV, tuberculosis (TB), hepatitis, or any other active infection
• Are allergic to cladribine or any other product component
• Are breastfeeding or pregnant

Before you receive your first dose of cladribine, inform your provider if you:

• Suspect you have an infection
• Have heart, liver, or kidney problems
• Have cancer or had it in the past
• Have used, currently use, or plan to use medications that affect the immune system or blood cells
• Have used, currently use, or plan to use other medications for multiple sclerosis
• Have recently been vaccinated or are scheduled to get vaccinated (vaccination with live or live-attenuated vaccines within 4 to 6 weeks before, during, or after treatment with cladribine is not usually recommended)
• Are pregnant or plan to get pregnant
• Are breastfeeding or plan to breastfeed (Avoid breastfeeding during and for 10 days after the final dose of the treatment cycle)

Cladribine (Mavenclad) Dosing 

Your healthcare provider will determine the dose based on your body weight. Mavenclad is given as two yearly treatment courses. The recommended total dose is 1.75 mg/kg per treatment course. Each course is divided into 2 treatment cycles. 

First treatment course (year 1)

Treatment cycle 1: Take the recommended dose once daily for 4 to 5 days in a row. 

Treatment cycle 2: Repeat the dosage 23 to 27 days later. 

Second treatment course (year 2)

Treatment cycle 1: Take the recommended dose once daily for 4 to 5 days in a row at least 43 weeks after the final dose of cycle 2 of the first course. 

Treatment cycle 2: Repeat the dosage 23 to 27 days later. 

Proper Use

• Take Mavenclad exactly as prescribed by your healthcare provider. Don’t take more than two tablets daily. 
• Swallow the entire tablet immediately after opening the pack.
• Avoid crushing, chewing, or breaking the tablets.
• You may take this medication with or without food. 
• Complete each treatment cycle exactly as prescribed, and talk to your healthcare provider before making any changes to your treatment plan. 
• Keep your hands dry while handling the tablets. Immediately after you take a tablet, wash your hands properly. 

• Minimize direct contact between the tablet and your skin. Don’t touch your nose, eyes, and other body parts. 
• If the tablet comes in contact with a surface, wash the surface immediately with water.
• Take your dose at least 3 hours apart from other oral drugs.
• If you miss a dose, take the missed dose immediately after you remember, on the same day. If the day has passed, take the missed dose the following day. Never take 2 doses at the same time. 

Monitoring During Treatment

Your healthcare provider will monitor you before and during treatment to help ensure Mavenclad is safe and effective. This may include blood tests to check your lymphocyte (white blood cell) count, liver function, and kidney function. You will also be screened for infections such as tuberculosis, hepatitis, and HIV before starting treatment. Women who can become pregnant will need a pregnancy test before each treatment course.

Cladribine (Mavenclad) Side Effects

Common Side Effects

• Upper respiratory infection
• Low white blood cell count
• Headache

Talk to your healthcare provider or pharmacist if any side effects worsen or persist. 

Severe Side Effects

Call your healthcare provider immediately or seek emergency care if you have:

• Fever, sore throat, chills, muscle pain, cough, or other signs of infection
• Cough, chest pain, coughing up blood or mucus, tiredness, weight loss, loss of appetite, chills, fever, night sweats
• Painful rash with blisters
• Burning, tingling, numbness, or itchiness of the skin
• Rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat
• Chills, fever, nausea, vomiting, pain in your back, side, or groin, frequent and painful urination
• Unusual bleeding or bruising
• Weakness on one side of your body, loss of coordination in your arms or legs, decreased strength, problems with balance, confusion, changes in your vision, thinking, memory, or personality
• Shortness of breath, fast heartbeat, headache, dizziness, pale skin, confusion, tiredness
• Nausea, vomiting, extreme tiredness, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, dark urine
• Shortness of breath, fast or irregular heartbeat, swelling in a part of your body

Cladribine (Mavenclad) Cost

Cost can vary depending on your insurance plan, location, and pharmacy. Ask your insurance provider whether your plan covers this medication or requires prior authorization. 

Many insurance plans, including Medicare Part D and commercial insurance plans, cover Mavenclad, although prior authorization is often required. Depending on your insurance coverage, you may still have copays or coinsurance. Your healthcare provider or specialty pharmacy can help verify your benefits and estimate your out-of-pocket costs before treatment begins. 

EMD Serono, Inc., a subsidiary of Merck, provides financial and treatment support to patients through its MS LifeLines support service. 

If you are eligible and have commercial insurance, you may qualify for the MS LifeLines Co-Pay Assistance Program. To learn more, contact us if you are interested in financial assistance or copay assistance for cladribine.

Conclusion

Mavenclad is an effective oral treatment option for certain adults with relapsing forms of multiple sclerosis. Although it is taken for only two yearly treatment courses, careful monitoring is necessary because of its potential risks, including infections, cancer, and fetal harm. If you’re considering Mavenclad, talk with your healthcare provider about whether its benefits outweigh the risks for your specific situation.