Teriflunomide

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film coated tablets7,14 mg

Teriflunomide is an immunomodulatory agent with anti-inflammatory properties.

INDICATIONS

Teriflunomide is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active .secondary progressive disease, in adults.

It is not known if Teriflunomide is safe and effective in children.

DOSAGE AND ADMINISTRATION

The recommended dose of Teriflunomide is 7 mg or 14 mg orally once daily. Teriflunomide can be taken with or without food.

WARNINGS AND PRECAUTIONS

• decreases in your white blood cell count.

• allergic reactions.

• serious skin reactions.

• other types of allergic reactions or serious problems that may affect different parts of the body such as your liver, kidneys, heart, or blood cells.

• numbness or tingling in your hands or feet that is different from you MS symptoms.

• new or worsening breathing problems.

• high blood pressure.

• liver problems

DRUG INTERACTIONS

Coadministration of Teriflunomide with warfarin requires close monitoring of the international normalized ratio (INR).
Teriflunomide may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with Teriflunomide.
In patients taking Teriflunomide, exposure of paclitaxel, pioglitazone, repaglinide, rosiglitazone, cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) as required.
In patients taking Teriflunomide, exposure of alosetron, duloxetine, theophylline and tizanidine may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) as required.
For a patient taking Teriflunomide, the dose of rosuvastatin should not exceed 10 mg once daily. For mitoxantrone, methotrexate, rifampin, atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin, consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking Teriflunomide.

Rifampicin, carbamazepine, phenobarbital, phenytoin and St John’s Wort should be used with caution during the treatment with Teriflunomide.

Brouchure

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