Cladribine (Mavenclad®) 

SELF ADMINISTRATION- ORAL

Indications for Prior Authorization: 
  • Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults
    • Because of its safety profile, use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. 
    • Mavenclad is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.
The following criteria must be met for coverage:
  • Patient is 18 years of age or older, AND
  • Patient weighs at least 40 kg, AND
  • Medication is prescribed by or in consultation with a neurologist, AND
  • Patient has a diagnosis of relapsing forms of multiple sclerosis as confirmed by chart note documentation, AND
  • Patient has tried and failed (inadequate response to or unable to tolerate) at least two other alternative drugs indicated for the treatment of MS, AND
  • This drug may not be used in combination with any other disease modifying therapy for MS either oral or injectable (e.g. Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Glatopa, Rebif, Tecfidera, Tysabri, or mitoxantrone), AND
  • Member has been assessed prior to starting each Mavenclad treatment course (assessments to include: cancer screening, pregnancy, CBC, infections (e.g. HIV, TB, HBV, HCV, acute infections, immunization status (immunize 4-6 weeks prior to starting Mavenclad), baseline MRI-due to risk of PML (progressive multifocal leukoencephalopathy)), liver injury
     
    • Contraindicated in patient with:
      • Current malignancy
      • Pregnant woman and women/men of reproductive potential who do not plan to use effective contraceptive during Mavenclad dosing and for 6 months after the last dose in each treatment course.
      • HIV infection
      • Active chronic infection
      • History of hypersensitivity to cladribine.
      • Women intending to breastfeed on a Mavenclad treatment day and for 10 days after the last dose.
  • Not recommended in patients with moderate to severe renal impairment (CrCL <60mL/min)
  • Not recommended in patients with moderate to severe hepatic impairment (Child-Pugh Score >6)
Dosing:
  • Recommended cumulative dose is 3.5 mg/kg divided into 2 yearly treatment courses (1.75 mg/kg per treatment course). Each treatment course is divided into 2 treatment cycles:
     
    • First Treatment Course:
      • First course/first cycle: start any time
      • First course/second cycle: administer 23 to 27 days after the last dose of First course/first cycle.
    • Second Treatment Course: 
      • Second course/first cycle: administer at least 43 weeks after the last dose of First course/second cycle.
      • Second course/second cycle: administer 23 to 27 days after the last dose of Second course/first cycle. 

Weight Range (Kg)

Dose in mg (number of 10 mg Tablets) per Cycle

First Cycle 

Second Cycle

40* to less than 50

40 mg (4 tablets)

40 mg (4 tablets)

50 to less than 60

50 mg (5 tablets)

50 mg (5 tablets)

60 to less than 70

60 mg (6 tablets)

60 mg (6 tablets)

70 to less than 80

70 mg (7 tablets) 

70 mg (7 tablets)

80 to less than 90

80 mg (8 tablets)

80 mg (8 tablets)

90 to less than 100

90 mg (9 tablets)

90 mg (9 tablets)

100 to less than 110

100 mg (10 tablets)

100 mg (10 tablets)

110 and above 

100 mg (10 tablets)

100 mg (10 tablets)

*The use of Mavenclad in patients weighing less than 40kg has not been investigated.

  • Administer the cycle dosage as 1 or 2 tablets once daily over the 4 or 5 consecutive days. Do not administer more than 2 tablets daily.
  • Following the administration of 2 treatment courses, do not administer additional Mavenclad treatment during the next 2 years. Treatment during these 2 years may further increase the risk of malignancy. The safety and efficacy of reinitiating Mavenclad more than 2 years after completing 2 treatment courses has not been studied. 
Approval: 
  • One treatment course at a time (Maximum of 2 treatment courses per lifetime)
    • For a second treatment: detailed documentation of response to the first treatment is required. 

Last review date: September 12, 2019

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