CinnoTec®


(Dimethyl Fumarate)

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Description

Dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate. CinnoTec® is the brand name of dimethyl fumarate which is an oral medicine in first line treatment of MS. Each tablet of CinnoTec® contains 120mg or 240mg dimethyl fumarate.

Indications

CinnoTec® (glatiramer acetate) is indicated for treatment of relapsing forms of multiple sclerosis.

Important safety information

  • Dermatitis/irritation: May cause rash, pruritus, or erythema.  
  • Gastrointestinal events: GI events (eg, nausea, vomiting, diarrhea, abdominal pain, dyspepsia) generally occur in the first month of use and decrease thereafter. To improve tolerability, administer with food or temporarily reduce the dosage.
  • Hepatotoxicity: Clinically significant postmarketing cases of hepatic injury have been reported, with an onset ranging from a few days to several months after treatment initiation. Signs/symptoms of hepatic injury, including transaminase elevations >5 times the upper limit of normal (ULN) and total bilirubin elevations >2 times ULN have been observed. Monitor liver function tests prior to treatment initiation and during treatment.
  • Hypersensitivity reactions: Anaphylaxis and angioedema may occur after the first dose or at any time during treatment.  
  • Lymphopenia: Decreased lymphocyte counts may occur. The risk for lymphopenia is not reduced over time. Obtain a CBC including lymphocyte count prior to initiation of therapy, then every 3 months thereafter, or as clinically indicated.
  • Progressive multifocal leukoencephalopathy: Cases of progressive multifocal leukoencephalopathy (PML) due to the John Cunningham (JC) virus, including fatality, have been reported. The most common risk factors were persistent leukocytopenia, sarcoidosis, cancer history, and prior immunosuppressant use. Severe, long-standing lymphopenia was identified as a primary risk for PML, and the majority of PML cases occurred in patients with lymphocyte counts <500/mm3.

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