Teriflunomide 14 mg/1
Teriflunomide · TABLET, FILM COATED · Biocon Pharma Inc.
Teriflunomide is a tablet, film coated containing teriflunomide at 14 mg/1, taken oral. Manufactured by Biocon Pharma Inc..
Key Facts
- Brand Name
- Teriflunomide
- Generic Name
- Teriflunomide
- NDC Code (Product)
70377-018- Manufacturer
- Biocon Pharma Inc.
- Strength
- 14 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209639
- Drug Class
- Pyrimidine Synthesis Inhibitor [EPC]
- Marketing Start
- 03/13/2023
Recall History
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 (5.1) ] . • 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 (5.4) ] . • 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 (5.4) ] . • Exclude pregnancy prior to initiation of treatment with teriflunomide tablets in females of reproductive potential [see Warnings and Precautions (5.2) ] . • Check blood pressure before start of teriflunomide tablets treatment and periodically thereafter [see Warnings and Precautions (5.9) ] . 7 mg or 14 mg orall…
Contraindications
4 CONTRAINDICATIONS Teriflunomide tablets are contraindicated in/with: • Patients with severe hepatic impairment [see Warnings and Precautions (5.1) ] . • Pregnant women and females of reproductive potential not using effective contraception. Teriflunomide tablets may cause fetal harm [see Warnings and Precautions (5.2 , 5.3) and Use in Specific Populations (8.1) ] . • Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablets. Reactions have included anaphylaxis, angioedema, and serious skin reactions [see Warnings and Precautions (5.5) ]. • Coadministration with leflunomide [see Clinical Pharmacology (12.3) ]. • Severe hepatic impairment ( 4 , 5.1 ) • Pregnancy ( 4 , 5.2 , 8.1 ) • Hypersensitivity ( 4 , 5.5 ) • Current leflunomide treatment ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 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%. Effect of Teriflunomide Tablets on Oral Contraceptives Teriflunomide tablets 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 tablets [see Clinical Pharmacology (12.3) ] . Effect of Teriflunomide Tablets on CYP1A2 Substrates Teriflunomide may be a weak inducer of CYP1A2 in vivo . In patients taking teriflunomide tablets, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, the…
Adverse Reactions
6 ADVERSE REACTIONS 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 Precautions (5.10) ] • Pancreatitis in Pediatric Patients [see Warnings and Precautions (5.11) ] Most common adverse reactions (≥ 10% and ≥ 2% greater than placebo): headache, diarrhea, nausea, alopecia, increase in ALT. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction ra…
Frequently Asked Questions
What is Teriflunomide used for?
Teriflunomide contains Teriflunomide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Teriflunomide a controlled substance?
Teriflunomide is not classified as a controlled substance by the DEA.
What is the generic name for Teriflunomide?
The generic name for Teriflunomide is Teriflunomide. There are 4 other brand versions of Teriflunomide.
What is the NDC code for Teriflunomide 14 mg/1?
The NDC (National Drug Code) for Teriflunomide 14 mg/1 is 70377-018, listed by Biocon Pharma Inc..