biopharmaceuticals Zistdaru Danesh 

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TEBAZIO

General Description

Read all Tebazio 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 Tebazio? 

Tebazio is indicated for the treatment of patients with relapsing-remitting form of multiple sclerosis (RRMS).


2- Dosage and Administration

The recommended dose of Tebazio is one 14 mg tablet per day.     

    Drug Overdose:

In case of accidental drug overdose, contact your doctor or healthcare providers.Studies indicate that taking more than 70 mg teriflunomide per day for more than 2 (two) weeks in healthy individuals is well tolerated.

In case of overdose with clinical significance or onset of intoxication, cholestyramine or activated charcoal is administered by the doctor for accelerated elimination of the medicine.

Missed Dose:

In case you forget taking one dose, never take two tablets for the next dose and take your next dose as scheduled.


3- Dosage Form and Strength

Tebazio is available as film-coated (FC) tablets containing 14 mg of teriflunomide colored matt or pale blue. Tebazio is a pentagonal tablet with dose strength 14 imprinted on one side and engraved with the English letter Z on other side.


4- Tips before taking Tebazio

Who should not take Tebazio?

Avoid taking Tebazio if you have:

– Severe hepatic impairment; taking this drug in patients with severe hepatic impairment is contraindicated.

– Pregnancy; taking this drug in pregnant women or females of reproductive potential not using effective contraception is contraindicated because it may cause fetal harm.

– Coadministration with leflunomide; concurrent use of this medicine with leflunomide is contraindicated.


5- Warnings and Precautions

  • Blood tests before initiating treatment:

 Before you start taking Tebazio, your doctor should check white blood cell counts and liver function in your last (within last 6 months) blood test report.

  • Liver problems

Taking this drug in patients with a history of liver problems can be problematic. Patients with pre-existing acute or chronic liver disease before initiating treatment, should not normally be treated with this drug. Taking this drug in patients with severe hepatic impairment is contraindicated.

Before initiating treatment with Tebazio and for at least six (6) months after starting it, your doctor should monthly monitor your liver function through blood tests.

The doctor should check liver function in patients with symptoms suggestive of hepatic dysfunction like unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine.

In case of liver damage due to Tebazio, your doctor may decide to discontinue the drug and liver tests continue until they reach normal levels. Should your doctor diagnosis be that the liver problem is not due to Tebazio, taking the drug is resumed.

  • Bone Marrow Effects

-Decreases in white blood cell counts (WBC)

Before starting treatment with Tebazio, your doctor should obtain a complete blood cell count (CBC) to test your blood. Further examination by the physician is based on clinical signs and blood test results.

-Infection

Tell your doctor if after starting treatment with Tebazio you get and not recover from influenza, ear and throat infection, sinusitis, urinary infection, digestive tract infection, etc. Before taking or continuing therapy, pros and cons are reconsidered by your doctor. Infection symptoms include fever, fatigue, body pain, cold and nausea. Taking this drug in patients with immune deficiency and severe uncontrolled infections is not recommended

-Vaccination

Administration of live vaccines while in therapy and for six (6) months after stopping the drug is not recommended.

  • Peripheral Neuropathy

Report any tingling and numbness in feet and legs (besides those normally experienced in MS patients) to your doctor if you are over sixty (60) and/or are diabetic and concurrently use this drug with neurotoxic medications.

  • Renal Toxicity

Patients under therapy with Tebazio should inform their doctor of prior history of kidney disease.

  • Skin Reactions

In case of prior skin reactions due to taking this or other drugs, inform your doctor.

  • Increased Blood Pressure

Periodically measure and control your blood pressure before initiating and during treatment with Tebazio. Contact your doctor about any elevations during treatment with Tebazio.

  • Respiratory Effects

Respiratory problems like initiation or worsening symptoms of lung diseases(prior to treatment) such as cough, respiratory problems with or without fever should be monitored, and decision to continue Tebazio be made by the doctor.

  • Lactose intolerance

Tell your doctor if you are suffering from lactose intolerance, since Tebazio contains lactose monohydrate.


6- Adverse Effects

– Very common (more than 10 percent of patient population):

*CNS: headache

*Skin: hair thinning or hair loss

*Endocrines and metabolism: decreased phosphate levels in blood

*Digestive: diarrhea, nausea

*Liver: increased liver enzymes in blood test

*Blood: decreased neutrophils (type of white blood cells), decreased white blood cell counts

*Other: influenza

– Common (1 to 10 percent of patient population):

 *Cardiovascular: increased blood pressure, palpitations

*CNS: anxiety

*Skin: itch, acne, burning sensation

*Endocrine and metabolism: increased levels of potassium in blood test

*Digestive: abdominal pain, toothache, viral digestive problems, weight loss, bloating

*Genitourinary: cystitis

*Blood: decreased levels of blood platelet counts, anemia

*Liver: increased levels of some liver enzymes in blood test

*Neuro-muscular and skeletal: sensory impairment, musculoskeletal pains, sciatica nerve pain, peripheral nerve system damage

*Eye: blurred vision, conjunctivitis

*Kidney: renal failure (transient)

*Respiratory: upper respiratory tract infection, bronchitis, sinusitis

*Other: Herpes simplex virus infection, seasonal allergy

– Rare (less than 1 percent of patient population):

*remission of viral hepatitis, jaundice, heart infarction (MI)


7- Use in specific populations

*Pregnancy:

This drug is in category X. Administration of this drug in pregnant women or women with reproduction potentials not using effective contraception is contraindicated because it may cause fetal harm. Contact your doctor if you become pregnant while taking Tebazio and two (2) years after stopping it. In case you are test positive for pregnancy, your doctor should devise a special drug regimen to accelerate elimination of Tebazio from your body to decrease fetal harm. Consult your doctor in case you wish to become pregnant after stopping Tebazio. Before pregnancy, the drug should be fully eliminated from your body. Complete elimination of Tebazio from your body may take up to two (2) years, but may be reduced to a few weeks if given a special drug regimen by your doctor.

*Nursing:

Since it is not clear whether this drug is excreted in mother milk, your doctor should decide to stop the drug or stop nursing and continue using the drug given the importance of therapy in nursing mother.

*Children/Pediatrics:

Safety and efficacy of this drug in children has not been established.

*Elderly/Geriatrics:

There is not enough information available about safety and efficacy of this drug in the elderly.


8- Drug Interactions

Tell your doctor in case you use other drugs, even herbal drugs and supplements. Tebazio interactions can include:

*Coadministration of Tebazio and leflunomide is contraindicated.

*Coadministration of Tebazio and drugs like repaglinide, paclitaxel, pioglitazone or rosiglitazone should be under your doctor supervision.

*Coadministration of Tebazio and warfarin; accurate follow up and monitoring levels of international normalized ratio (INR) by your doctor is recommended.

*Live Vaccines: Administration of live vaccines while in therapy and six (6) months after stopping Tebazio is not recommended.

*Patients under coadministration of Tebazio and drugs like duloxetin, alosetron, theophylline and tizanidine, given the possibility of decreasing their efficacy, should be supervised by the doctor.

*Coadministration of Tebazio and other drugs affecting immune system (used in treatment of rheumatoid arthritis, irritable bowel syndrome, cancers and MS) is not recommended.


9- Tebazio Composition

Active Ingredient (AI):

Teriflunomide

Inactive Ingredients:

Microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, Hydroxypropyl Cellulose, Magnesium stearate, Corn starch, Film coating (RT.Film® NOR Blue 0720) In case you have a history of allergies or adverse reactions to Tebazio ingredients, consult your doctor or pharmacist before taking it.


10- Tebazio Storage

Store below 30˚C. Keep out of sight and reach of children.


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.