Tecfidera

Dimethyl fumarate

Adult & paed patient ≥13 yr w/ relapsing remitting multiple sclerosis (RRMS).

Adult & paed patient ≥13 yr Initially 120 mg bd. Increase to maintenance dose of 240 mg bd after 7 days. May temporarily reduce dose to 120 mg bd to reduce occurrence of flushing & GI AR, resume to maintenance dose of 240 mg bd w/in 1 mth.

Should be taken with food.

Hypersensitivity. Suspected or confirmed progressive multifocal leukoencephalopathy (PML).

Discontinue use & immediately seek medical care if patients experience signs or symptoms of anaphylaxis; treatment should not be restarted. Assess renal function (eg, creatinine, BUN & urinalysis) prior to initiation, after 3 & 6 mth of treatment, every 6-12 mth thereafter. Assess serum aminotransferases (eg, ALT, AST) & total bilirubin levels prior to initiation & during treatment. May develop lymphopenia; perform CBC including lymphocytes prior to initiation & every 3 mth after starting therapy. Enhance vigilance due to increased risk for PML. Discontinue use in patients w/ prolonged severe lymphopenia (lymphocyte count <0.5 x 10⁹/L) persisting for >6 mth. Re-assess treatment in patients w/ sustained moderate reductions of absolute lymphocyte count ≥0.5 x 10⁹/L to <0.8 x 10⁹/L for >6 mth. Regularly monitor absolute lymphocyte count in patients w/ lymphocyte count below LLN. Immediately perform MRI for diagnostic purposes in case of clinical suspicion of PML. Increased risk of PML w/ prolonged moderate to severe lymphopenia. Permanently discontinue use if patient develops PML. Prior treatment w/ immunosuppressive or immunomodulating therapies. Patients w/ severe active GI disease. Alert patients in the event of severe flushing reactions. Consider suspending treatment if patient develops a serious infection; reassess benefits & risks prior to re-initiation of therapy. Monitor patients for signs & symptoms of herpes zoster especially w/ concurrent lymphocytopenia. Gradually start treatment to reduce occurrence of flushing & GI AR. Possible Fanconi syndrome. Severe renal & hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using appropriate contraception. Lactation. Childn 10-12 yr; <10 yr. Long-term use in paed patients. Elderly ≥55 yr.

Flushing; diarrhoea, nausea, upper abdominal pain, abdominal pain; ketones measured in urine. Gastroenteritis; lymphopenia, leucopenia; burning sensation; hot flush; vomiting, dyspepsia, gastritis, GI disorder; increased AST & ALT; pruritus, rash, erythema, alopecia; proteinuria; hot feeling; presence of albumin in urine, decreased WBC count.

In combination w/ antineoplastic or immunosuppressive therapies. May increase risk of clinical infection w/ live vaccines. Avoid simultaneous use of other fumaric acid derivatives (topical or systemic). Consider potential risks associated w/ ASA therapy prior to co-administration w/ Tecfidera in patients w/ RRMS. May increase potential of renal AR (eg, proteinuria) w/ nephrotoxic medicinal products (eg, aminoglycosides, diuretics, NSAIDs or lithium). May increase frequency of GI AR w/ large quantities of strong alcoholic drinks.

Immunosuppressants

L04AX07 - dimethyl fumarate ; Belongs to the class of other immunosuppressants.

POM