Zuellig Pharma
Concise Prescribing Info
Relapsing-remitting & active secondary progressive multiple sclerosis (MS) in adults who had inadequate response to or are intolerant to an alternate drug.
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 2nd mth of the respective yr. Each treatment wk consists of 4 or 5 days on which patient receives 10 or 20 mg as single daily dose, depending on body wt. Patient ≥110 kg Treatment wk 1 & 2: 100 mg. 100 to <110 kg Treatment wk 1: 100 mg. Treatment wk 2: 90 mg. 90 to <100 kg Treatment wk 1: 90 mg. Treatment wk 2: 80 mg. 80 to <90 kg Treatment wk 1: 80 mg. Treatment wk 2: 70 mg. 70 to <80 kg Treatment wk 1 & 2: 70 mg. 60 to <70 kg Treatment wk 1 & 2: 60 mg. 50 to <60 kg Treatment wk 1 & 2: 50 mg. 40 to <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 for a long period. If left on a surface or a broken 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 & lactation.
Special Precautions
Not recommended in patients w/ clinically isolated syndrome. Patients w/ prior malignancy. Monitor lymphocyte counts prior to initiation in yr 1 & 2; 2 & 6 mth after start of treatment in each treatment yr. Screen for latent infections eg, TB, hepatitis B & C prior to initiation in yr 1 & 2; delay initiation in patients w/ acute infection until fully controlled. Vaccination prior to initiation in patients w/ no history of varicella zoster virus exposure; postpone treatment for 4-6 wk to allow full effect of vaccination to occur. Monitor patients w/ lymphocyte counts <500 cells/mm3 for infections eg, herpes zoster. Perform baseline MRI prior to initiation (usually w/in 3 mth) & when switching from another MS drug. Irradiation of cellular blood components in patients requiring blood transfusion. Concomitant use w/ immunomodulatory or immunosuppressive drugs. Not to be used in moderate or severe renal impairment. Not recommended in moderate or severe hepatic impairment. May affect male fertility. Women & men of childbearing potential should use effective contraception during & at least 6 mth after last dose. Not to be used during pregnancy & lactation. Paed <18 yr. Elderly >65 yr.
Adverse Reactions
Lymphopenia. Oral herpes, dermatomal herpes zoster; decreased neutrophil count; rash, alopecia.
Drug Interactions
Increased bioavailability w/ other agents (especially drugs w/ low solubility). Risk of additive effects on immune system w/ immunosuppressive or myelosuppressive therapy eg, MTX, cyclophosphamide, cyclosporine, 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 drugs 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, reserpine. Decreased exposure w/ potent BCRP (eg, corticosteroids) or P-gp (eg, rifampicin, St. John's wort) transporter inducers. Reduced 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
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