Teriflunomide is a pyrimidine synthesis inhibitor sold in the U.S. under 2 brand and generic names, for relapsing-remitting multiple sclerosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Teriflunomide (application ANDA209700). Other teriflunomide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 tablet 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 tablet treatment and periodically thereafter [see Warnings and Precautions ( 5.9 )] . 7 mg or 14 mg orally once daily, with or without food. ( 2 )
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 AvKARE at 1-855-361-3993 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 rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 2047 patients receiving teriflunomide (7 mg or 14…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 46/100 | Prescription | Tablet | Generic | $17 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| L;598 | 14 mg | blue | pentagon (5 sided) | — |
| 1114 | 7 mg | white | round | — |
| 1115 | 14 mg | blue | round | — |
| N;7 | 7 mg | green | round | — |
| N;14 | 14 mg | blue | round | — |
| G;43 | 7 mg | yellow |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Teriflunomide is 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 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 )
Effect of Teriflunomide on CYP2C8 Substrates Teriflunomide is an inhibitor of CYP2C8 in vivo . In patients taking teriflunomide, 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 on Warfarin Coadministration of teriflunomide with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide may decrease peak INR by approximately 25%. Effect of Teriflunomide on Oral Contraceptives 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 [see Clinical Pharmacology ( 12.3 )] . Effect of Teriflunomide on CYP1A2 Substrates Teriflunomide may be a weak inducer of CYP1A2 in vivo . In patients taking teriflunomide, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required [see Clinical Pharmacology ( 12.3 )] . Effect of Teriflunomide on Organic Anion Transporter 3 (OAT3) Substrates Teriflunomide inhibits the activity of…
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| Prescription |
| Tablet |
| Generic |
| $17 |
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| round |
| — |
| G;42 | 14 mg | white | round | — |
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| 7 | 7 mg | blue | hexagon (6 sided) | — |
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| 14 | 14 mg | blue | pentagon (5 sided) | — |
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| L;597 | 7 mg | blue | hexagon (6 sided) | — |
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