CinnoTec (Dimethyl Fumarate) for Multiple Sclerosis

CinnoTec (dimethyl fumarate) is a prescription medicine used to treat relapsing multiple sclerosis.

CinnoTec (Dimethyl fumarate) is used to treat patients with relapsing forms of multiple sclerosis.

You should not use CinnoTec if you are allergic to dimethyl fumarate or any of the ingredients in CinnoTec.

• are pregnant or planning to become pregnant. It is not known if CinnoTec can harm your unborn baby.

• are breastfeeding or planning to breastfeed. It is not known whether CinnoTec can pass into your breast milk.

You can take CinnoTec with or without food. Taking CinnoTec with food may help prevent flushing (warmth, itching, or burning sensations).

Do not chew, crush, break, or open a capsule. Swallow it whole.

CinnoTec is usually given in two different strengths:

• a starter dose (is usually taken for only 7 days) and
• a maintenance dose.

While using this medicine, you will need frequent blood tests.

Initial dose: 120 mg orally twice a day for 7 days.

Maintenance dose: 240 mg orally twice a day.

Common CinnoTec side effects may include:

• stomach pain, indigestion;

• nausea, vomiting, diarrhea;

• rash, itching; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor to know more about the side effects.

• Dermatitis or irritation: May cause pruritus, rash, or erythema.  

• Gastrointestinal events: GI events (eg, nausea, diarrhea, abdominal pain, vomiting, dyspepsia) generally occur in the first month of use and decrease thereafter. To improve tolerability, your doctor may administer with food or temporarily reduce the dosage.

• Hepatotoxicity: liver problems may occur with the use of CinnoTec, with an onset ranging from a few days to several months after treatment initiation. your doctor will monitor your liver function prior to treatment initiation and during treatment.

• Hypersensitivity reactions: Anaphylaxis and angioedema may occur after the first dose of CinnoTec or at any time during treatment.  

• Lymphopenia: Decreased lymphocyte counts may occur with the use of CinnoTec. Your doctor will check your lymphocyte count prior to initiation of therapy, then every 3 months thereafter, or as clinically indicated.

• PML or Progressive multifocal leukoencephalopathy: progressive multifocal leukoencephalopathy (PML) due to the John Cunningham (JC) virus (a brain infection), including fatality, has been reported. The most common risk factors were sarcoidosis, cancer history, persistent leukocytopenia, and prior immunosuppressant use.
  • Call your doctor right away if you have any change in your mental state; decreased vision; weakness on one side of your body; or problems with speech or walking.

• Call your doctor if you see other signs or symptoms like
  • fever, pain when swallowing, cold or flu symptoms;
  • severe redness or feelings of warmth, tingling, itching, or burning; or
  • liver problems – loss of appetite, upper stomach pain (right side), tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Store at room temperature away from moisture, heat, and light.