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Mavenclad
Cladribine
$3800.00
10mg · 1 tablets
BrandBranded medicine· By Merck Serono
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10mg
FDA boxed warningMalignancies 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 females and males 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 for females, and 14 weeks for males. Stop MAVENCLAD if the patient becomes pregnant
Malignancies MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy; evaluate the benefits and risks on an individual basis for patients with prior or increased risk of malignancy.
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 risk of fetal harm.
About Mavenclad
Overview
Mavenclad is a tablet medicine containing cladribine for adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS and active secondary progressive MS. Because of its safety profile, it is generally recommended when another MS medicine has not worked well enough or cannot be tolerated. It is not recommended for clinically isolated syndrome (CIS). How it works is not fully understood, but it is thought to reduce certain immune cells called B and T lymphocytes by interfering with their ability to make DNA.
What it treats
- Relapsing forms of multiple sclerosis (MS) in adults, including relapsing-remitting MS and active secondary progressive MS. Because of its safety profile, Mavenclad is generally recommended when another MS medicine has not worked well enough or cannot be tolerated. It is not recommended for clinically isolated syndrome (CIS).
Safety information
Side effects
The most common side effects of Mavenclad are upper respiratory tract infections, headache and low lymphocyte counts (a reduction in a type of white blood cell). Each occurred in more than 20% of patients. Serious risks include cancer, birth defects, serious infections, blood cell problems, liver injury, allergic reactions and heart failure. Infections can be life-threatening or fatal. Contact your doctor promptly if you develop an infection or suspect a serious side effect. A serious reaction called graft-versus-host disease can occur with blood transfusions. The label recommends irradiated blood components to reduce this risk. Blood counts, including lymphocyte counts, need monitoring before, during and after treatment. Liver tests are required before treatment; Mavenclad must be stopped if clinically significant liver injury is suspected.
FDA boxed 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 females and males 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 for females, and 14 weeks for males. Stop MAVENCLAD if the patient becomes pregnant
Malignancies MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy; evaluate the benefits and risks on an individual basis for patients with prior or increased risk of malignancy.
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 risk of fetal harm.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take Mavenclad if you: • Have cancer, HIV infection, or an active chronic infection such as hepatitis or tuberculosis. • Are pregnant. Mavenclad may harm an unborn baby. • Could become pregnant or father a child and do not plan to use effective contraception during treatment and after the last dose of each treatment course: for 6 months for females and 14 weeks for males. • Have previously had an allergic reaction to cladribine. • Intend to breastfeed on a treatment day or within 10 days after the last dose. Mavenclad can lower lymphocyte counts and affect other blood cells. Blood counts must be monitored before, during and after treatment. Serious, life-threatening and fatal infections have occurred. Screening for active and latent infections is needed, and treatment should be delayed until an infection is fully resolved or controlled. Depending on your varicella-zoster virus status, vaccination against chickenpox before treatment or a recombinant shingles vaccine before or during treatment is recommended. Preventive anti-herpes treatment is needed if lymphocyte counts fall below 200 cells per microliter. Clinically significant liver injury has occurred. Liver tests are needed before treatment, and Mavenclad must be stopped if significant liver injury is suspected. If you need a blood transfusion, tell the treating team that you take Mavenclad; irradiated cellular blood components are recommended to reduce the risk of graft-versus-host disease.
Interactions
Mavenclad can interact with medicines and supplements, including: • Medicines that affect or suppress the immune system or reduce blood cell production: combined effects may increase side effects. Use with other immune-suppressing or bone marrow-suppressing medicines is not recommended. Previous treatments may also have lasting, overlapping effects. Short-term corticosteroid treatment may be used. • Interferon-beta: use together is not recommended because it may increase the risk of low lymphocyte counts, a type of white blood cell. • Medicines that can harm blood cells: combined use may increase blood-related side effects and requires blood count monitoring. • Certain antiviral and HIV medicines, including lamivudine, zalcitabine, ribavirin, stavudine and zidovudine: these may interfere with cladribine becoming active inside cells. Use together should be avoided. • Medicines and supplements that block certain transport proteins: these may change how cladribine is absorbed, distributed within cells or removed by the kidneys. Examples include ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole and reserpine. These should be avoided during Mavenclad treatment cycles. If this is not possible, the prescriber may consider alternatives, adjust the other treatment or its timing, and monitor closely. • Rifampicin, St. John’s wort and corticosteroids: these may increase the activity of certain transport proteins and could reduce cladribine exposure and effectiveness. Discuss any of these medicines or supplements with your doctor, including immune-system treatments you have used previously.
Using Mavenclad
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label MAVENCLAD (CLADRIBINE) TABLET [EMD SERONO, INC.] (DailyMed, retrieved 19 September 2026).
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