Mavenclad

Adults w/ relapsing-remitting multiple sclerosis (MS) as defined by clinical or imaging features.

Recommended cumulative dose: 3.5 mg/kg over 2 yr, administered as 1 treatment course of 1.75 mg/kg/yr. Each treatment course consists of 2 treatment wk, 1 at the beginning of 1st mth & 1 at the beginning of the 2nd mth of the respective yr. Treatment course in yr 2 can be delayed for up to 6 mth if medically necessary (eg, recovery of lymphocytes). Each treatment wk consists of 4 or 5 days on which patient receives 10 or 20 mg as a single daily dose, depending on body wt. ≥110 kg Treatment wk 1 & 2: 100 mg. 100-<110 kg Treatment wk 1: 100 mg. Treatment wk 2: 90 mg. 90-<100 kg Treatment wk 1: 90 mg. Treatment wk 2: 80 mg. 80-<90 kg Treatment wk 1: 80 mg. Treatment wk 2: 70 mg. 70-<80 kg Treatment wk 1 & 2: 70 mg. 60-<70 kg Treatment wk 1 & 2: 60 mg. 50-<60 kg Treatment wk 1 & 2: 50 mg. 40-<50 kg Treatment wk 1 & 2: 40 mg.

May be taken with or without food: Swallow whole w/ water, do not chew. Consume immediately once removed from blister. Do not leave exposed or handled for a long period. If left on a surface or a broken or fragmented tab is released from the blister, the area must be thoroughly washed.

Hypersensitivity. HIV infection; active chronic infection (TB or hepatitis); active malignancy. Immunocompromised patients including those receiving immunosuppressive or myelosuppressive therapy. Moderate or severe renal impairment (CrCl <60 mL/min). Pregnancy & breast-feeding.

Determine lymphocyte counts before initiation of therapy in yr 1 & 2; 2 & 6 mth after start of treatment in each treatment yr; actively monitor until values increase again if lymphocyte count is <500 cells/mm³. Screen for latent infections eg, TB, hepatitis B & C prior to initiation of therapy in yr 1 & 2. Consider delay in initiation of therapy in patients w/ acute infection until fully controlled. Vaccination is recommended prior to initiation of therapy in patients w/ no history of exposure to varicella-zoster virus; postpone treatment for 4-6 wk to allow full effect of vaccination to occur. Consider anti-herpes prophylaxis (according to local standard practice) if lymphocyte counts drop <200 cells/mm³, during grade 4 lymphopenia. Monitor patients w/ lymphocyte counts <500 cells/mm³ for signs & symptoms suggestive of infections, in particular herpes zoster. Progressive multifocal leukoencephalopathy in patients treated for hairy cell leukaemia w/ different treatment regimen. Perform baseline MRI prior to initiation (usually w/in 3 mth) & when switching from another MS drug. Perform individual benefit-risk evaluation in patients w/ prior malignancy. Patients are advised to follow standard cancer screening guidelines. Assess serum aminotransferase, alkaline phosphatase & total bilirubin levels prior to initiation of therapy in yr 1 & 2. Interrupt or discontinue use if clinical signs, unexplained liver enzyme elevations or symptoms suggestive of hepatic dysfunction (eg, unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice &/or dark urine) develops. Irradiation of cellular blood components is recommended prior to administration in patients requiring blood transfusion. Consider mode of action & duration of effect of other medicinal products prior to initiation of therapy in patients previously treated w/ immunomodulatory or immunosuppressive therapies. Concomitant use w/ sorbitol-containing products & dietary intake of sorbitol. Not recommended in patients w/ moderate or severe hepatic impairment (Child-Pugh score >6). Women of childbearing potential must use effective contraception during treatment & for at least 6 mth after the last dose. Women using systemically acting hormonal contraceptives should add barrier method during treatment & at least 4 wk after last dose in each treatment yr. Male patients must take precautions to prevent pregnancy of their partner during treatment & for at least 6 mth after last dose. Discontinue treatment during pregnancy. Paed patients <18 yr. Elderly >65 yr.

Lymphopenia. Oral herpes, dermatomal herpes zoster; decreased neutrophil count; hypersensitivity including pruritus, urticaria, rash & rare cases of angio-oedema; rash, alopecia.

Increased bioavailability w/ medicinal products w/ low solubility. Risk of additive effects on the immune system w/ immunosuppressive or myelosuppressive therapy eg, MTX, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids. Increased risk of lymphopenia w/ interferon β. Not recommended w/ other disease-modifying treatments for MS. Additive haematological AR w/ haematotoxic medicinal products eg, carbamazepine. Risk of active vaccine infection w/ live or attenuated live vaccines. Increased oral bioavailability & systemic exposure w/ BRCP inhibitors eg, eltrombopag. Altered bioavailability, intracellular distribution & renal elimination w/ potent ENT1 & CNT3 transporter inhibitors eg, dilazep, nifedipine, nimodipine, cilostazol, sulindac, or reserpine. Possible decrease in exposure w/ potent inducers of BCRP (eg, corticosteroids) or P-gp (eg, rifampicin, St. John's wort). May reduce effectiveness of systemically acting hormonal contraceptives.

Immunosuppressants

L04AA40 - cladribine ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.

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