biopharmaceuticals Zistdaru Danesh 

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TECZIFUMA

General description

Read all Teczifoma leaflet carefully before you start using this medicine because it contains important information for you. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or Medical Support Team of Zistdaru Danesh Co. This medicine has been prescribed for you only. Do not pass it on to others, even if their signs of illness are the same as yours. This medicine could be prescribed by doctor for medical condition not mentioned in this leaflet. If you get any side effects, talk to your doctor, pharmacist or nurse.

Important Things To Know

On this page you read

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

However, the starting dose is 120 mg twice a day in the first week and 240 mg twice a day after that. Take Teczifuma with food or immediately after 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.  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 enteric coated 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 the medicines containing dimethylfumerate, 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

Hypersensitivity 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 difficult 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 should 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

– Flushing 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, Rash, Redness

– Gastrointestinal: Vomiting, Indigestion

– Urinary: Proteinuria

 – Hematologic: Lymphocytopenia

– Liver: Rise in AST enzyme

Rare (Less than 1%):

 – Transient eosinophilia


7- Use in Specific Populations

 Pregnancy 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.

 Nursing 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.

Pediatrics Safety and efficacy of this drug in children have not been established. Geriatrics 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- Active Ingredients of Teczifuma

Dimethyl Fumarate (white powder)


10- Teczifuma Storage and Handling

– Store below 30˚C and in original packaging.

– Protect from light.

 – Keep out of sight and reach of children.

– Prescribed only medicine


11- D.Nurse-Patient Helpline Team 

You can contact Drugs Expert Consultation Center at 0935 220 3041-4 to get answers to your inquiries and also get to know nursing support centers in your city.Expert Consultation Center is always ready to answer the questions of our valued customers.