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MONDAY, April 1, 2019 (Pharmacist's Briefing) -- Mavenclad (cladribine) tablets were approved to treat adult patients with relapsing-remitting and active secondary progressive multiple sclerosis (MS) who have inadequately responded to or cannot tolerate an alternate drug for MS, the U.S. Food and Drug Administration announced Friday.

The approval was based on efficacy data from a clinical trial of 1,326 patients with relapsing forms of MS who had at least one relapse in the previous year. Researchers found that patients who received Mavenclad experienced significantly fewer relapses compared with patients who received placebo. Mavenclad also reduced disability progression compared with placebo. Commonly reported adverse reactions included upper respiratory tract infections, headache, and decreased lymphocyte counts.

According to the manufacturer's prescribing information, Mavenclad is administered orally in a cumulative dosage of 3.5 mg/kg divided into two dosage courses of 1.75 mg/kg per treatment course. Mavenclad should be administered separately from any other oral drugs by at least three hours. The FDA indicates that Mavenclad, which is not indicated for patients with clinically isolated syndrome, must be dispensed with a patient medication guide describing the drug's uses and risks. The boxed warning accompanying Mavenclad warns of an increased risk for malignancy and fetal harm. The drug should not be used in patients with a current malignancy. In those patients with a previous malignancy or increased risk for a malignancy, health care professionals should evaluate the benefits and risks of using Mavenclad based on the individual patient.

Due to the potential for fetal harm, Mavenclad should not be used in pregnant women or in women and men of reproductive age who do not plan to use effective contraception during treatment and for six months after treatment. If a patient becomes pregnant, treatment should be stopped. Other warnings include risk for decreased lymphocyte counts, infections, hematologic toxicity, and bone marrow suppression. Mavenclad has also been associated with graft-versus-host disease after blood transfusions with nonirradiated blood. It may also cause liver injury, and treatment should be interrupted or discontinued if clinically significant liver injury is suspected.

Pharmacist's Editorial Note:

Mavenclad (cladribine) tablets include several counseling pearls that are important for pharmacists to consider when discussing new therapy with their patients:

  • This drug contains a black box warning concerning potential teratogenicity and malignancy; a medication guide must be provided to all patients receiving this medication.
  • If a patient misses a dose, they should not double up on the next dose(s) but rather add the missed dose to the end of the regimen and extend the total number of days of therapy for that course.
  • Before initiating therapy, all patients should ensure they are up to date on all vaccinations. If any live vaccines are required, the patient should plan to receive them at least four to six weeks prior to initiation of therapy. If the patient has not received the varicella zoster vaccine, it should be administered at least four to six weeks prior to initiation of therapy.
  • Due to the toxic nature of this medication, it is sold in unit-dose containers. The pharmacy should not remove the medication from the packaging and should advise the patient or caregiver on how to properly handle and dispose of the medication.

Approval was granted to EMD Serono Inc.

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