How quickly does Mavenclad work?
Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Aug 12, 2020.
Studies evaluating the use of Mavenclad (generic name: cladribine) for multiple sclerosis (MS) found a reduction in MS relapses (flare-ups) over about a two year period. A relapse is a period of time 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 also decreased 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.
In the clinical trial program of Mavenclad in MS, the mean time in the study (including follow-up) was almost 5 years, and roughly one-quarter of patients who received treatment had 8 years of time in the study, including follow-up.
Mavenclad works over the long-term, 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, and you should discuss these with your doctor before starting treatment.
How well does Mavenclad work in MS?
In March 2019, the FDA approved Mavenclad (cladribine), a purine antimetabolite used for the treatment of relapsing forms of multiple sclerosis (MS) in adults 18 years of age and older. Mavenclad is used in relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Mavenclad is not recommended for MS patients with clinically isolated syndrome or as a first-line agent due to its safety profile.
- Mavenclad was studied in CLARITY, a Phase 3, double-blind study and compared to a placebo (treatment with no active drug).
- The effectiveness of Mavenclad was shown in a 96 week (~2 year) clinical trial with 1,326 patients with relapsing forms of MS who had at least one relapse in the previous 12 months.
- In the study, Mavenclad significantly decreased the number of relapses (the primary endpoint of the study) when compared to a placebo (an inactive treatment). Over the 96 weeks, 81% of patients who took Mavenclad were relapse-free compared to 63% of those who took a placebo.
- Mavenclad also decreased 3-month progression of disability due to MS, measured by expanded disability status scale (EDSS), when compared to placebo. Results showed 87% of patients on Mavenclad had no confirmed EDSS progression compared to 81% of patients taking a placebo, a 33% risk reduction.
Mavenclad helps to reduce immune system cells (T and B cells) that can attack nerves and lead to inflammation in MS. The number of these cells will begin to recover after each yearly Mavenclad administration. This may take several months and your levels of immune system cells may not go back to pretreatment levels.
How is Mavenclad given?
- Mavenclad is usually given as oral tablets in two treatment courses. You take the medicine for up to 10 days in each of year one and year two. It is taken with water.
- 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.
- The medication is dosed based on your weight. The number of tablets you'll take also depend on your weight. Mavenclad can be taken with or without food.
- Mavenclad is a cytotoxic drug. Your hands must be dry when handling the tablets and washed thoroughly afterwards. You should avoid prolonged contact of the tablet with your skin.
- You should separate the time you take Mavenclad and any other oral drugs by at least 3 hours during the 4 to 5 day treatment cycles.
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. The manufacturer states that they do not know if Mavenclad can be restarted safely after the 2-year break.
Does Mavenclad have a Black Box Warning?
Yes, Mavenclad has a Boxed Warning from the FDA in its package labeling. A Boxed Warning is the most stringent safety warning from the FDA. Discuss these warnings with your doctor.
Mavenclad warnings involve concerns around the increased risk of cancer and the increased risk of birth defects in pregnancy.
- Cancer Risk
According to the warning, treatment with Mavenclad may increase your risk of developing cancer. Talk to your doctor about this risk and follow your health care provider instructions for cancer screenings.
Do not use Mavenclad if you have an active cancer. If you have a history of previous cancer, discuss the risk and benefit and Mavenclad with your doctor.
- Birth defects
Mavenclad may cause birth defects if used during pregnancy. Females MUST not be pregnant when they start treatment with Mavenclad or become pregnant during Mavenclad dosing. They also should not become pregnant within 6 months after the last dose of each yearly treatment course.
Stop your treatment and call your doctor right away if you become pregnant during treatment with Mavenclad. Talk to your doctor about the most appropriate and effective birth control options for you.
Men with female partners who are able to become pregnant should use effective birth control (contraception) during the days on which you take Mavenclad and for at least 6 months after the last dose of each yearly treatment course.
You should not take Mavenclad if you:
- have an active 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.
- are HIV positive
- have active infections, including tuberculosis (TB), hepatitis B or C
- are allergic to Mavenclad (cladribine)
- are breastfeeding.
The most common side effects with Mavenclad include upper respiratory tract infections, headache and decreased white blood cell counts.
Read More: Mavenclad Side Effects
- In 2 year studies conducted by the manufacturer, 81% of patients who took Mavenclad were relapse-free compared to 63% of those who took a placebo.
- Mavenclad also decreased 3-month progression of disability due to MS when compared to a placebo.
- Results with Mavenclad have been followed up over the long-term. About 25% of patients who received treatment had close to 8 years of time in the study, including follow-up.
This is not all the information you need to know about Mavenclad (generic name: cladribine) for safe and effective use. Review the full Mavenclad information here, and discuss this information with your doctor or other health care provider.
- Mavenclad (cladribine). Product Label. EMD Serono, Inc. Rockland, MA. April 2019. Accessed August 12, 2020 at https://www.emdserono.com/us-en/pi/mavenclad-pi.pdf
- EMD Serono. Mavenclad website. Accessed August 12, 2020 at https://www.mavenclad.com
- Dosing Guide. Mavenclad (cladribine) Tablets. EMD Serono. April 2019. Accessed August 12, 2020 at https://www.mavenclad.com/content/dam/web/healthcare/neurology/united-states/pdfs/MAVENCLAD_Dosing_Guide_4.29.pdf
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