CinnoTec®


(Dimethyl Fumarate)


CinnoTec (dimethyl fumarate)

Hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate

What is CinnoTec?

CinnoTec is a drug used for immunomodulation

What is CinnoTec used for?

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

CinnoTec may also be used for purposes not listed in this medication guide.

What should I know BEFORE taking CinnoTec?

Before taking and while you take CinnoTec, tell your doctor if you have or have had a low white blood cell counts or an infection.

CinnoTec may cause a serious viral infection of the brain that can lead to disability or death. 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. These symptoms may start gradually and get worse quickly.

You should not use CinnoTec if you are allergic to dimethyl fumarate.

To make sure CinnoTec is safe for you, tell your doctor if you have an active infection.

Your doctor may perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

FDA pregnancy category C. It is not known whether CinnoTec will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether dimethyl fumarate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take CinnoTec?

Take CinnoTec exactly as your doctor has prescribed Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take CinnoTec with or without food.

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

CinnoTec is usually given in two different strengths, one for a starter dose and the other for a maintenance dose. The starter dose is usually taken for only 7 days. Follow your doctor's dosing instructions very carefully.

Store at room temperature away from moisture, heat, and light. Throw away any unused capsules 90 days after you first opened the bottle.

Other drugs may interact with CinnoTec , including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What should I know, while taking CinnoTec?

Get emergency medical help if you have any of these signs of an allergic reaction to CinnoTec: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

CinnoTec may cause a serious viral infection of the brain that can lead to disability or death. Symptoms may start gradually and get worse quickly.Call your doctor right away if you have:

  • any change in your mental state;
  • decreased vision;
  •  weakness on one side of your body;
  •  problems with speech or walking.
  • fever, pain when swallowing, cold or flu symptoms;
  •  severe stomach pain; or
  • severe feeling of warmth or tingling, or a burning sensation.

Common CinnoTec side effects may include:

  •  nausea, diarrhea, stomach pain; or
  • flushing (warmth, redness, or tingly feeling).

Administration of CinnoTec with food may reduce the incidence of flushing. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to CinnoTec dosing may reduce the incidence or severity of flushing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Pregnancy and Lactation

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses. CinnoTec should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CinnoTec is administered to a nursing woman.

How should I store CinnoTec?

CinnoTec is available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate.

Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container. Once opened, discard bottles of CinnoTec after 90 days.

FAQs

A

Multiple sclerosis (MS) is a demyelinating disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged.[1] This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and sometimes psychiatric problems.[2][3][4] Specific symptoms can include double vision, blindness in one eye, muscle weakness, trouble with sensation, or trouble with coordination.[1] MS takes several forms, with new symptoms either occurring in isolated attacks (relapsing forms) or building up over time (progressive forms).[5] Between attacks, symptoms may disappear completely; however, permanent neurological problems often remain, especially as the disease advances.[5]

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