Teriflunomide

Teriflunomide tablets are 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. Teriflunomide tablets are a pyrimidine synthesis inhibitor 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. ( 1 )

• The recommended dose of teriflunomide tablets is 7 mg or 14 mg orally once daily
• Teriflunomide tablets can be taken with or without food
• Monitoring to Assess Safety: • Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy
• Monitor ALT levels at least monthly for six months after starting teriflunomide tablets [see Warnings and Precautions ] . • Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with teriflunomide tablets
• Further monitoring should be based on signs and symptoms of infection [see Warnings and Precautions ] . • Prior to initiating teriflunomide tablets, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection [see Warnings and Precautions ] . • Exclude pregnancy prior to initiation of treatment with teriflunomide tablets in females of reproductive potential [see Warnings and Precautions ] . • Check blood pressure before start of teriflunomide tablets treatment and periodically thereafter [see Warnings and Precautions ] . 7 mg or 14 mg orally once daily, with or without food

Teriflunomide Tablets are available containing 7 mg or 14 mg of teriflunomide. • The 7 mg tablets are light blue, film-coated, round, unscored tablets debossed with A on one side and 7 on the other side. • The 14 mg tablets are light yellow, film-coated, round, unscored tablets debossed with A on one side and 14 on the other side. 7 mg and 14 mg film-coated tablets ( 3 )

• Safety and effectiveness
• In pediatric patients have not been established
• Effectiveness of teriflunomide tablets
• For the treatment of relapsing form of multiple sclerosis
• In pediatric patients (10 to 17 years of age) was not established in an adequate and well-controlled clinical study in 166 patients (109 patients received once daily doses of teriflunomide tablets and 57 patients received placebo) for up to 96 weeks
• Pancreatitis has been reported
• In adults in the postmarketing setting, but appears to occur at higher frequency in the pediatric population. …

Clinical studies of teriflunomide tablets did not include patients over 65 years old.

• Advise the patient to read the FDA-approved patient labeling ( Medication Guide )
• A Medication Guide is required for distribution with teriflunomide tablets
• Hepatotoxicity: Inform patients that teriflunomide tablets may cause liver injury, which can be life-threatening, and that their liver enzymes will be checked before starting teriflunomide tablets and at least monthly for 6 months after starting teriflunomide tablets [see Dosage and Administration and Warnings and Precautions ]
• Advise patients that they should contact their physician if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. …

• Teriflunomide tablets are contraindicated in/with: • Patients with severe hepatic impairment [see Warnings and Precautions ] . • Pregnant women and females of reproductive potential not using effective contraception
• Teriflunomide tablets may cause fetal harm [see Warnings and Precautions and Use in Specific Populations ] . …

Effect of Teriflunomide Tablets on CYP2C8 Substrates Teriflunomide is an inhibitor of CYP2C8 in vivo . In patients taking teriflunomide tablets, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required [see Clinical Pharmacology (12.3) ] . Effect of Teriflunomide Tablets on Warfarin Coadministration of teriflunomide tablets with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide tablets may decrease peak INR by approximately 25%. …

• Elimination of teriflunomide tablets can be accelerated by administration of cholestyramine or activated charcoal for 11 days. ( 5.3 ) • Teriflunomide tablets may decrease WBC. A recent CBC should be available before starting teriflunomide tablets. Monitor for signs and symptoms of infection. Consider suspending treatment with teriflunomide tablets in case of serious infection. Do not start teriflunomide tablets in patients with active infections. ( 5.4 ) • Stop teriflunomide tablets if patient has anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms; initiate rapid elimination. …

The following serious adverse reactions are described elsewhere in the prescribing information: • Hepatotoxicity [see Contraindications (4) and Warnings and Precautions (5.1) ] • Bone Marrow Effects/Immunosuppression Potential/Infections [see Warnings and Precautions (5.4) ] • Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.5) ] • Serious Skin Reactions [see Warnings and Precautions (5.6) ] • Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.7) ] • Peripheral Neuropathy [see Warnings and Precautions (5.8) ] • Increased Blood Pressure [see Warnings and Precautions (5.9) ] • Respiratory Effects [see Warnings and Precaut …

8.1 Pregnancy Risk Summary Teriflunomide tablets are contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data [see Contraindications (4) and Warnings and Precautions (5.2) ] . …

There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg daily up to 14 days was well tolerated by healthy subjects. In the event of clinically significant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination [see Warnings and Precautions (5.3) ] .

Tómala en cuanto te acuerdes, salvo que falte poco para la siguiente. En ese caso, sáltate la olvidada. Nunca tomes dos dosis a la vez para compensar. Revisa tu prospecto, porque algunos medicamentos son distintos.