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Concise Prescribing Info
Relapsing-remitting multiple sclerosis (RRMS) to reduce clinical relapses frequency & to delay physical disability progression.
Dosage/Direction for Use
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. 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. Max: 2 treatment courses over 2 consecutive yr. ≥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.
Hypersensitivity. Not to be initiated in patients w/ HIV; active chronic infections (TB or hepatitis). Immunocompromised patients including those receiving immunosuppressive or myelosuppressive therapy w/ agents eg, cyclosporin, methotrexate, mitoxantrone, azathioprine, natalizumab, or chronic corticosteroids use. Active malignancy. Moderate or severe renal impairment (CrCl <60 mL/min). Pregnancy & lactation.
Special Precautions
Long term treatment. 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. Exclude HIV infection, active TB & active hepatitis before initiation of therapy. 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. Carefully monitor patients w/ lymphocyte counts <500 cells/mm3 for signs & symptoms suggestive of infections, in particular herpes zoster. Consider baseline MRI before initiating therapy (usually w/in 3 mth) particularly if patients are switched from other multiple sclerosis (MS) agents that have a risk of progressive multifocal leukoencephalopathy. Irradiation of cellular blood components is recommended prior to administration in patients requiring blood transfusion. MS patients w/ prior or current malignancies (w/ exception of in situ basal or squamous cell skin cancer surgically removed w/o recurrence for at least 5 yr). 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. Consider mode of action & duration of effect of other products prior to initiation of therapy in patients previously treated w/ immunomodulating or immunosuppressive therapies. Not recommended in patients w/ fructose intolerance. Patients w/ renal impairment. Not recommended in patients w/ moderate or severe hepatic impairment (Child-Pugh score >6). Exclude pregnancy before initiation of therapy in yr 1 & 2. Women of childbearing potential must use reliable contraception during treatment & for at least 6 mth after the last dose. Women using systemically acting hormonal contraceptives should add a barrier method during treatment & for 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. Not recommended in childn <18 yr. Elderly.
Adverse Reactions
Lymphopenia (grade 3 or 4). Oral herpes, dermatomal herpes zoster; decreased neutrophil count; rash (eg, pustular, papular, macular, pruritic, erythematous rash), alopecia.
Drug Interactions
May lead to complex formation w/ other agents (especially medicines w/ low solubility). Risk of additive effects on immune status w/ immunosuppressive or myelosuppressive therapy (eg, cyclosporin, methotrexate, mitoxantrone, azathioprine, natalizumab, or chronic use of corticosteroids). Not recommended in combination w/ other disease-modifying treatments for MS. Possible additive haematological adverse effects w/ other agents that affect the haematological profile (eg, carbamazepine, NSAIDs). More pronounced effect in lymphocyte count reduction when combined w/ β-interferon. Risk of active vaccine infection w/ live or attenuated live vaccines. May alter bioavailability, intracellular distribution & renal elimination by potent ENT1, CNT3 & ABCG2 transporter inhibitors (eg, dipyridamole, dilazep, nifedipine, nimodipine, cilostazol, sulindac, reserpine or eltrombopag). Possible decrease in exposure w/ potent ABCG2 (eg, corticosteroids) or P-gp (eg, rifampicin, St. John's wort) transporter inducers. May reduce effectiveness of systemically acting hormonal contraceptives.
MIMS Class
ATC Classification
L04AA40 - cladribine ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Mavenclad tab 10 mg
1 × 4's;1 × 6's;1's
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