Dimethyl Fumarate (DMF):120 mg and 240 mg Delayed-Release Oral Capsules

The information in this leaflet is important for you. Therefore, read it carefully before taking Teczifuma.
Please keep this leaflet since you may again need to refer to it.
In case you need further information, please contact your doctor, pharmacist or Nursing and Patient Support Unit at Zistdaru Danesh Company.
This medication is prescribed for your current condition only, so you should avoid using it in similar cases or recommending it to others.
As with all medication, Teczifuma may also cause adverse effects, though all may not be seen in one individual. In case you observe any of the side effects mentioned in this leaflet or any others, consult your doctor, pharmacist or healthcare professional.
In this leaflet you will learn:
1. What is Teczifuma?
2. Dosage and administration
3. Dosage forms and strengths
4. Tips before taking Teczifuma
5. Warnings and precautions
6. Common adverse effects
7. Use in specific populations
8. Teczifuma drug interactions
9. Teczifuma composition/description
10. Teczifuma storage and handling

1. What is Teczifuma?
Teczifuma is prescribed in patients with relapsing forms of multiple sclerosis (MS). Teczifuma is not the definite treatment of MS but is effective in reducing number of attacks and the rate of incidence of disability by slowing the progression of the disease.

Mechanism of Action:
The precise mechanism of action of dimethyl fumarate (DMF) in controlling MS is unknown. Animal and human studies indicate that dimethyl fumarate and its active metabolite, monomethyl Fumarate (MMF), activate the nuclear factor (erythroid-derived) Nrf2. Nrf2 pathway is involved in cellular response to oxidative stress. Monomethyl fumarate has also been identified as a nicotinic acid receptor agonist.

2. Dosage and Administration:
Your doctor would advise you on dosage of Teczifuma. However, the starting dose is 120 mg twice a day in the first week and 240 mg twice a day after that. Teczifuma can be taken with or without food. Taking Teczifuma after food effectively reduces the incidence of flushing. Teczifuma capsules should be swallowed whole and intact and not chewed or crushed. Avoid sprinkling the capsule contents on food. Protect the drug from light and to this effect, store it in original container.
•Drug Overdose:
There are reported cases of dimethyl fumarate overdose. In all cases, patient symptoms indicate adverse effects mentioned in this leaflet. However, since there is no antidote for this medicine, in case of overdose contact healthcare centers and/or drug and poison control center for help.
•Missed Dose:
In case you forget taking one dose, never take two capsules for the next dose. In case there is at least 4 hours left to the next dose, take your dose. Otherwise, do not take the missed dose and take your next dose as scheduled.

3. Dosage Forms and Strengths:
Teczifuma is available as gelatin capsule containing delayed-release microtablets in two strengths of 120 mg and 240 mg. The 120 mg capsules are available in white body and green cap and 240 mg capsules in green body and green cap.

4. Tips before taking Teczifuma:
•Who should not take Teczifuma?
In case of any history of hypersensitivity reactions (like angioedema, anaphylaxis, etc.) while taking Taczifuma including any of its excipients, do not use this product.
•Blood tests prior to initiation of therapy:
Before you start taking Teczifuma, your doctor should check lymphocyte count in your recent, within 6 months, blood test report.
•Before taking Teczifuma, tell your doctor or pharmacist if you have/are:
– A history of low lymphocytes
– A history of infection
– A history of liver or kidney disorders
– A history of gastrointestinal diseases
– Pregnant or plan to become pregnant
– Nursing mother
5. Warnings and Precautions:
Following the first dose or any time after taking dimethyl fumarate, there could be anaphylaxis or angioedema reactions. Signs and symptoms of such reactions are blister, rash or swelling of face, lips, mouth or difficulty breathing. In case of any hypersensitivity reactions, contact your doctor or a healthcare center.
•Progressing Multifocal Leukoencephalopathy (PML)
PML is a rare opportunistic viral infection in the brain caused by a specific virus (JC Virus) in susceptible individuals with a suppressed immune system. This infection may lead to severe disability or even death. Lymphopenia seems to affect its incidence. PML symptoms include progressive weakness on one side of the body or clumsiness in limbs, disturbances of vision, changes in thinking and memory leading to confusion and personality changes. Following the incidence of such symptoms, referral to your doctor is essential and emergency.
•Low Lymphocytes
Studies indicate that dimethyl fumarate can cause reduction in blood lymphocytes. To prevent and control such a problem, blood tests before the therapy and every 6 to 12 months after that or following clinical symptoms are recommended.

•liver problems
Liver function tests before therapy and, if necessary, after starting the therapy is to be taken. In case you notice any change in your liver function, contact your doctor. Such problems can be pointed to the following:
-Severe tiredness
-Loss of appetite
-Pain on the right side of your stomach
-Dark or brown (tea-color) urine
-Yellowing of your skin or the white part of your eyes
Dimethyl fumarate can cause flushing of the skin (in the form of warmth, redness, itching and/or burning sensation).These usually start with initial doses and improve or are resolved over time. Taking the drug with food may reduce the incidence of flushing.

6. Common Adverse Effects of Teczifuma:
• Very common (>10%)
– Cardiovascular: Flushing (40%)
– Gastrointestinal: stomach pain (18%), Diarrhea (14%), Nausea (12%)
-Infection: the medicine (60%), Placebo (58%)
• Common (1% to 10%)
-Skin: Itching (8%), Rash (8%), Redness (5%)
-Gastrointestinal: Vomiting (9%), Indigestion (5%)
-Urinary: Proteinuria (6%)
-Hematologic: Lymphocytopenia (2% to 6%)
-Liver: Rise in AST enzyme (4%)
• Rare (<1%)
– Transient eosinophilia

7. Use in Specific Populations:
This drug is in category C. At present, there are no complete or controlled studies regarding dimethyl fumarate use in pregnant women. Given the laboratory tests and effects of dimethyl fumarate on growth and development of fetus in animal studies, the medicine may be taken only if the potential benefits justify the potential risks and is at the discretion of the doctor.
The amount of dimethyl fumarate excreted in human milk is not quite clear. Since lots of medicines are excreted in breast milk, caution should be taken in prescribing dimethyl fumarate.
Your doctor decides to continue or discontinue Teczifuma while nursing.
Safety and efficacy of this drug in children have not been established.
None of the studies taken on dimethyl fumarate include a sufficient number of elderly patients aged 65 and over. To this effect, still there is not enough information regarding safety and efficacy of this drug in the elderly.
8. Teczifuma Drug Interactions:
Tell your doctor if you use other drugs or even herbal drugs or supplements.
Fumaric acid: Teczifuma should not be taken with products containing derivatives of fumaric acid. To learn about such products, consult your doctor or pharmacist.
Vaccines: Using vaccines that contain live virus while under therapy with Teczifuma is not recommended.
9. Teczifuma Composition/Description:
Active Ingredients (API): Dimethyl Fumarate (DMF) (water soluble white powder)
Inactive Ingredients: microcrystalline cellulose, sodium starch glycolate, talc, silicon dioxide, magnesium stearate, triethyl citrate, eudragit, sodium lauryl sulfate, glycerin mono stearate and polysorbate80.
10. Teczifuma Storage and Handling:
Keep Teczifuma at room temperature (between 15 to 30˚c) and protect capsules from light. Store the medicine in its original container. Keep Teczifuma out of reach of children.

*FDA-approved patient labeling, Revised 1.2017

Manufactured by:
Zistdaru Danesh Company
Tehran, Iran.
Issue date: May 2017
Website address: www.zistdaru.ir
E-mail address: Nursing@zistdaru.ir