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Does Mavenclad have a Black Box Warning?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Aug 2, 2023.

Official answer


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


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