THERAPY

Contraindicated in patients who are:

- hypersensitive to cladribine or to any ingredient in the formulation o component of the container.

- Patients with increased risk for opportunistic infections, including those who are immunocompromised due to treatment (e.g. immunosuppressive or immunomodulating therapies, antineoplastic, myelosuppressive therapies, total lymphoid irradiation or bone marrow transplantation) or disease (e.g.immunodeficiency syndrome).

-Patients with latent or active infections including active chronic bacterial, fungal or viralinfections (e.g. hepatitis, tuberculosis). Patients with a history of progressive multifocal leukoencephalopathy (PML).

- Patients with active malignancy.

-Patients with moderate or severe renal impairment (creatinine clearance < 60 mL/min)

- Patients who are pregnant or breast-feeding. Women and men of reproductive potential who do not plan to use effective contraception during dosing and for 6 months after last dose in each treatment course.

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Before Initiation of Therapy :

• CBC, creatinine, TSH, AST, ALT, LDH, alkaline phosphatase, bilirubin, HIV, VZV and measles serology, HepBsAg, HepBcAb, HepBsAb, HepC Ab,
• Pregnancy test
• Chest Xray and/or Quantiferon
• Immunization should be brought up to date and vaccination for Pneumococcus and Haemophilus Influenza type B and VZV should be done
• Brain MRI unless recently (<3 months) done
• When switching from Gilenya (fingolimod) a normalized lymphocyte count is recommended
• When switching from Aubagio, cholestyramine 8 gms Q8H PO X 11 days or until serum levels are less than 0.02mg/L is recommended
• When switching from Tysabri a less than 2 month washout period, serum JCV index and baseline brain MRI with CSF PCR for JCV is recommended
• Live vaccines are contraindicated from 6 weeks prior to the first treatment to the normalization of the immune cells following the last treatment of Mavenclad
• Patients must be warned of the risk of serious fetal harm if they conceive during and for 6 months after the last cycle of Mavenclad. Breastfeeding is discouraged during and for 6 months from the last treatment cycle.
• Patients should be screened for any increased baseline risk of malignancy or liver disorder. They should follow standard cancer screening guidelines
• Mavenclad should not be initiated unless the baseline lymphocyte count and liver enzymes are normal. The second cycle should be withheld until lymphocytes are greater than 0.8 (grade 1).
• Latent TB should be treated prior to initiation Mavenclad treatment.

Monitoring During Therapy :

• CBC,AST,ALT,total bilirubin alkaline phosphatase (month 3,9,12 post treatment or more frequently if lymphocytes fall below 0.5 or liver enzymes start to rise)
• Lymphocyte must have recovered ≥0.8 and liver enzymes remained normal before retreating
• Annual cerebral MRI
• Infections should be assessed and treated promptly.
• Blood products need to be irradiated prior to transfusion in order to prevent graft versus host disease

Discontinue Therapy :

serious opportunistic infection, onset of pregnancy, de novo cancer, recurrant serious infections, evidence of liver injury, persistent grade 3  lymphopenia or pancytopenia

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