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Mavenclad (Cladribine) is an oral immunosuppressive treatment indicated for adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive disease. It is typically prescribed for patients who have had an inadequate response to, or are unable to tolerate, other disease-modifying therapies. Cladribine is a purine nucleoside analog that targets lymphocytes, reducing the number of T and B cells implicated in the pathogenesis of MS. Mavenclad is administered in treatment courses over two years and does not require continuous dosing, offering a unique treatment regimen in MS management.
| Fact Table | |
|---|---|
| Formula | C10H12ClN5O3 |
| License | FDA approved |
| Bioavailability | ~40% |
| Legal status | Prescription drug (Rx-only) |
| Chemical Name | 2-chlorodeoxyadenosine |
| Elimination half-life | 6–20 hours (triphosphate form: =15 hours in lymphocytes) |
| Dosage (Strength) | 10 mg tablets |
| Pregnancy | Contraindicated (Category X) |
| Brands | Mavenclad |
| Protein binding | ~20% |
| PubChem CID | 2019 |
| MedlinePlus | a608034 |
| ChEBI | 3698 |
| ATC code | L01BB04 |
| DrugBank | DB00242 |
| KEGG | D00259 |
| Routes of administration | By mouth (oral), Intravenous (IV – less common use) |
Mavenclad is taken orally in treatment cycles over two years, with no treatment required in years three and four. Each yearly treatment consists of two treatment weeks, one at the beginning of the first month and one at the beginning of the second month. The tablets should be taken for 4 or 5 consecutive days during each treatment week, depending on body weight. The tablets must be swallowed whole with water and can be taken with or without food. Patients should wash their hands before and after handling the tablets and avoid direct contact with skin.
Each Mavenclad tablet contains 10 mg of cladribine as the active substance. Inactive ingredients include hydroxypropylbetadex, sorbitol, magnesium stearate, and colloidal anhydrous silica. The film coating contains hypromellose, macrogol, and titanium dioxide.
Prior to initiating treatment, a complete blood count including lymphocyte count should be performed. Liver and kidney function must be assessed, and screening for latent infections including hepatitis B, C, and tuberculosis is recommended. Live or attenuated vaccines must not be administered during treatment and for several months after the last dose. Women and men of reproductive potential must use effective contraception during treatment and for at least 6 months after the last dose. Renal impairment may affect drug clearance, and use in such patients requires caution. Regular monitoring of lymphocyte levels is essential due to the risk of prolonged lymphopenia.
Adverse drug interaction risks are possible with patients with current malignancy, HIV infection, active chronic infections such as tuberculosis or hepatitis, and in those who are immunocompromised. It must not be used during pregnancy or in women of childbearing potential who are not using effective contraception. It is also contraindicated in breastfeeding women and individuals with hypersensitivity to cladribine or any of the excipients.
Common side effects associated with Mavenclad include:
Serious adverse events may include infections such as herpes zoster and, rarely, malignancies. Patients should be monitored closely for any signs of infection during and after treatment.
What is Mavenclad used for?
Mavenclad is used to treat adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS and active secondary progressive MS. It is generally prescribed when other treatments haven't been effective or aren't well tolerated, due to its potent effects and specific safety considerations.
How is Mavenclad taken?
Mavenclad is taken by mouth and follows a unique dosing schedule over two years. Each treatment year includes two short courses: one during the first month and another during the second month. Depending on your body weight, you will take 1 or 2 tablets daily for 4 or 5 consecutive days during each treatment week. No further treatment is required in the third and fourth years.
What are the common side effects?
Common side effects include upper respiratory infections, headache, and a drop in white blood cell counts (lymphopenia). Some people may also face serious risks like liver problems, shingles, and a potentially higher risk of cancer. Regular blood tests and monitoring are essential to manage these risks safely.
Can I take Mavenclad if I’m pregnant or planning to become pregnant?
Mavenclad must not be used during pregnancy because it can cause serious harm to the unborn baby. Women of childbearing age must use effective contraception during treatment and for at least six months afterward. Men must also use reliable contraception during this time because the drug may affect sperm and could pose a risk to a future pregnancy.
What tests are required before starting Mavenclad?
Before starting Mavenclad, your healthcare provider will order blood tests to assess your white blood cell count and liver function, and screen you for infections like hepatitis, HIV, and tuberculosis. An MRI may be done to evaluate disease activity. Women of childbearing potential will also need a pregnancy test. If you're not immune to chickenpox, your doctor may recommend vaccination before starting treatment.
Are there any medications or conditions that make Mavenclad unsafe to use?
Mavenclad should not be used if you currently have cancer, have active infections such as hepatitis, tuberculosis, or HIV, are pregnant or planning to become pregnant, or have severe liver or kidney issues. It’s also not recommended if you are taking other immunosuppressive drugs, as this could increase the risk of serious infections.
What support resources are available for Mavenclad patients?
Patients taking Mavenclad can access support through the MS LifeLines program, which offers tools like educational resources, financial assistance, and personalized support to help navigate treatment and manage multiple sclerosis more effectively.
