Mavenclad: 7 things you should know

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 26, 2023.

1. How it works

• Mavenclad is a brand (trade) name for cladribine which may be used to treat multiple sclerosis (MS).
• Experts are not sure exactly how Mavenclad works but suggest it involves cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, which decreases their numbers. B and T cells are immune system cells that can attack nerves and lead to inflammation in MS. The number of B and T cells will begin to recover after each yearly Mavenclad administration, but this may take several months and levels may not go back to pretreatment values.
• Mavenclad belongs to the class of medicines known as purine antimetabolites.

2. Upsides

• May be used for the treatment of relapsing forms of MS in adults who have had an inadequate response to, or who are unable to tolerate other medications for MS that have a more favorable safety profile. Mavenclad is approved to treat relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). It is not recommended for MS patients with clinically isolated syndrome or as a first-line agent due to its side effects.
• Approved to treat adults aged 18 years and older.
• Given orally (by mouth) for two treatment courses (each course has two cycles) every two years. The first treatment course cycle can be started at any time with the next cycle given 23 to 27 days after the last dose. The second treatment course is administered at least 43 weeks after the first treatment course. The second cycle of the second treatment course is administered 23 to 27 days after the first cycle of the second treatment course.
• The cycle dosage is usually given once daily over 4 to 5 consecutive days.
• Available in one strength: 10mg. Dosage varies depending on weight.
• Weight gain has not been reported as a side effect with Mavenclad.
• May be taken with or without food.

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Upper respiratory tract infections, a headache, and decreased white blood cell counts are the most common side effects reported. 11% of patients reported hypersensitivity reactions.
• Causes a dose-dependent decrease in lymphocyte counts with trials reporting 87% of Mavenclad-treated patients affected. The lowest counts occurred 2 to 3 months after the start of each treatment course. Monitor patients with lymphocyte counts below 500 cells per microliter for signs and symptoms of infections, such as herpes infections. Decreases in other blood cells, such as neutrophils, and hematological parameters have also been reported.
• Obtain a CBC before initiating the first and second treatment courses of Mavenclad, 2 and 6 months after the start of each treatment course unless the lymphocyte count at month 2 is below 200 cells per microliter, then monitor monthly until month 6. Hold Mavenclad treatment if the lymphocyte count is below 200 cells per microliter. Perform periodically thereafter and when clinically indicated.
• Can reduce the body's immune defense and increase the risk of infections such as herpes zoster, pyelonephritis, and fungal infections. Consider delaying the initiation of Mavenclad until an infection is fully controlled or in those currently receiving immunosuppressive or myelosuppressive treatments.
• Transfusion-associated graft versus host disease has been observed rarely.
• Boxed safety warnings for Mavenclad include the increased risk of developing cancer with treatment and the possibility of birth defects in an unborn baby. A boxed safety warning is the most stringent drug safety warning from the FDA.
• Perform tuberculosis (TB) screening and hepatitis B and C screening before the initiation of the first and second treatment course of Mavenclad. Latent TB infections may be activated with Mavenclad treatment.
• Treatment with Mavenclad may increase the risk of malignancies (cancer). Do not use Mavenclad in people with active cancer and those with prior malignancy or at increased risk for malignancy, weigh up the benefits of using Mavenclad against the potential risks.
• Liver injury is uncommon but serum aminotransferase, alkaline phosphatase, and total bilirubin levels should be obtained before the first and second treatment course.
• Vaccinate people who are antibody-negative for varicella-zoster virus before the initiation of Mavenclad. Administer live-attenuated or live vaccines at least 4 to 6 weeks before starting Mavenclad.
• May increase a person's risk of developing progressive multifocal leukoencephalopathy (PML), a serious viral infection. Symptoms include progressive weakness on one side of the body, limb clumsiness, vision disturbance, and changes in thinking, memory, and orientation leading to confusion, and personality changes. Obtain a baseline MRI within 3 months before the first treatment course.
• Hair loss is an infrequent side effect, occurring in approximately 3% of people treated with Mavanclad.
• Not recommended for MS patients with clinically isolated syndrome or as a first-line agent due to its side effects.
• Screen patients for cancer before starting Mavenclad. Not suitable for those with HIV infection, TB, hepatitis B or C, or acute infection.
• Dosing is based on weight and ranges from 40mg (4 tablets) each day of the cycle for those weighing 40-50kg to 100mg (10 tablets) each day of the cycle for those weighing 110kg and above.
• Do not use it in pregnant women or in women or men of childbearing potential who refuse to use effective contraception because Mavenclad may cause fetal harm. Effective contraception should be continued for at least 6 months after the last dose of Mavenclad.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

4. Bottom Line

Mavenclad may be given to people with relapsing forms of MS who have had an inadequate response to, or who are unable to tolerate other medications for MS that have a more favorable safety profile. Mavenclad reduces the number of relapses and progression of disability of MS. People should be screened for cancer, HIV, hepatitis B and C, and TB; and pregnancy should be excluded and adequate contraception started before treatment begins.

5. Tips

• Take Mavenclad with a glass of water. Swallow whole without chewing. You can take it with or without food.
• Mavenclad is usually given as oral tablets in two treatment courses.
• Separate the administration of Mavenclad and any other oral medications by at least 3 hours during the 4 to 5-day treatment cycle.
• If you miss a dose, do not double up on the next dose. Take the missed dose on the following day and extend the number of days in the treatment cycle.
• Even if it feels like your MS is under control, you still need to complete the yearly treatment schedules for both year one and year two. After the second treatment in year two, you will not take another course of Mavenclad for at least 2 years due to an increased risk for cancer.
• How much you take depends on your weight and your doctor will calculate this for you.
• Talk to your doctor if you have any worrying side effects, such as signs of an infection, a rash, aching muscles, headache, vision changes, weakness on 1 side of your body, nausea, vomiting, or difficulty breathing.
• Mavenclad is a cytotoxic drug. Your hands must be dry when handling the tablets and washed thoroughly afterward. You should avoid prolonged contact of the tablet with your skin and once the tablet is removed from the blister you should swallow it immediately. If the tablet is left on a surface or a broken or fragmented tablet is released from the blister, the area must be thoroughly washed with water.
• If you have had cancer previously or are currently experiencing cancer, tell your doctor because Mavenclad may not be suitable for you. Mavenclad is also not suitable for people who are HIV positive; have active infections, including tuberculosis (TB), hepatitis B or C; are allergic to Mavenclad; or who are breastfeeding.
• Tell your doctor if you have missed any childhood vaccinations because you will need to be fully vaccinated before starting Mavenclad.
• May increase a person's risk of developing progressive multifocal leukoencephalopathy (PML) a serious viral infection. Symptoms include progressive weakness on one side of the body, limb clumsiness, vision disturbance, and changes in thinking, memory, and orientation leading to confusion, and personality changes. See your doctor immediately if any of these symptoms happen to you.
• Tell your doctor if you are pregnant or intend to become pregnant because Mavenclad is not suitable during pregnancy. You should have a pregnancy test before you begin your first and second yearly treatment course of Mavenclad to make sure that you are not pregnant. Your doctor will order this test for you at the right time.
• 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. If you use hormonal contraceptives, such as the "pill" (oral contraceptives) for birth control you should use barrier methods of birth control (such as condoms) on the days on which you take Mavenclad and for at least 4 weeks after your last dose of that cycle. Do not breastfeed during a Mavenclad cycle and for 10 days after the last dose.
• Males who take Mavenclad: if your female partner can become pregnant, you should use effective birth control (contraception) during the days that Mavenclad is taken and for at least 6 months after the last dose of each yearly treatment course.

6. Response and effectiveness

• Causes a dose-dependent reduction in lymphocyte count, with the lowest absolute lymphocyte numbers occurring approximately 2 to 3 months after the start of each treatment cycle. The average time to recovery of lymphocytes was 28 weeks.
• The effectiveness of Mavenclad was demonstrated in a clinical trial with 1,326 patients. Mavenclad significantly decreased the number of relapses and the progression of disability in these patients compared to a placebo.
• Studies evaluating the use of Mavenclad (generic name: cladribine) for multiple sclerosis (MS) found a reduction in MS relapses (flare-ups) over about two years. A relapse is a period when MS symptoms get worse. Over 96 weeks, 81% of patients who took Mavenclad were relapse-free compared to 63% of those who took a placebo.
• Mavenclad decreased the 3-month progression of disability (worsening) due to MS when compared to a placebo. It also significantly reduced the median number of MRI lesions when compared to a placebo at 96 weeks.
• The average time patients stayed on Mavenclad (including follow-up) was almost 5 years, and roughly one-quarter of patients who received treatment had 8 years in the study, including follow-up.
• Mavenclad works for a long period, but for most patients, the active ingredient in Mavenclad does not remain in the body beyond one week after administration. However, long-term safety concerns exist with Mavenclad.
• Mavenclad contains hydroxypropyl betadex that may form complexes with other medications and supplements. Separate administration of these by 3 hours.

7. Interactions

Medicines that interact with Mavenclad may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Mavenclad. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Mavenclad interacts with over 390 medications; the majority of these interactions are considered major or moderate. Common medications that may interact with Mavenclad include:

• anticonvulsants, such as carbamazepine
• antineoplastics, such as capecitabine, or cyclophosphamide
• antivirals that require intracellular phosphorylation to become active, such as lamivudine, ribavirin, or zidovudine
• biologics, such as adalimumab, etanercept, golimumab, or infliximab
• busulfan
• colchicine
• corticosteroids (such as budesonide, prednisone, or dexamethasone)
• etanercept
• fingolimod
• herbals, such as brewer's yeast or St. John's Wort
• hormones, such as ethinylestradiol or medroxyprogesterone
• hydroxyurea
• immunosuppressants such as azathioprine, cyclosporine, or tacrolimus
• interferon
• live vaccines and some other vaccines, such as BCG, cholera, sars-cov-2 (covid-19) vaccines, measles, hepatitis b vaccines, yellow fever, or live influenza vaccines
• methotrexate
• probiotics, such as lactobacillus

Mavenclad can bind to other medications, vitamins, and herbs. Take Mavenclad three hours away from other medications.

Avoid coadministration with potent ENT1, CNT3, or BCRP transporter inhibitors such as ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine during the 4 to 5-day treatment cycles of Mavenclad. potent BCRP or P-gp transporter inducers, such as rifampicin or St. John's Wort may also decrease Mavenclad efficacy

It is unknown if Mavenclad reduces the effectiveness of systemically acting hormonal contraceptives. Women should use a barrier method of contraception during Mavenclad cycles and for at least 4 weeks after the last dose in the treatment cycle.

Mavenclad may have additive immune-suppressing effects when given with any other medications such as anticancer drugs, immune-modulating, or immunosuppressive therapies, which may increase a person's risk for infection. Do not use in combination with other immunosuppressants such as 6-mercaptopurine, azathioprine, cyclosporine, methotrexate, or inhibitors of TNF-α.

Avoid the use of Mavenclad with other hemotoxic drugs.

Note that this list is not all-inclusive and includes only common medications that may interact with Mavenclad. You should refer to the prescribing information for Mavenclad for a complete list of interactions.

References

• Mavenclad (cladribine) Updated 10/2022. EMD Serono, Inc. https://www.drugs.com/pro/mavenclad.html

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Mavenclad only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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