tofacitinib 22 mg/1
tofacitinib · TABLET, FILM COATED, EXTENDED RELEASE · Zydus Pharmaceuticals USA Inc.
tofacitinib is a tablet, film coated, extended release containing tofacitinib at 22 mg/1, taken oral. Manufactured by Zydus Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- tofacitinib
- Generic Name
- tofacitinib
- NDC Code (Product)
70710-1727- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Strength
- 22 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214264
- Marketing Start
- 05/20/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tofacitinib is a Janus kinase (JAK) inhibitor indicated for: Rheumatoid Arthritis: Tofacitinib extended-release tablets are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of tofacitinib extended-release tablets in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.1 ) Psoriatic Arthritis: Tofacitinib extended-release tablets are indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of tofacitinib extended-release tablets in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.2 ) Ankylosing Spondylitis: Tofacitinib extended-release tablets are indicated for the treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of tofacit…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administration Instructions Tofacitinib extended-release tablets are not interchangeable or substitutable with tofacitinib oral solution. ( 2.1 ) Changes between tofacitinib tablets and tofacitinib extended-release tablets should be made by the healthcare provider. ( 2.1 ) Do not initiate tofacitinib extended-release tablets if absolute lymphocyte count <500 cells/mm 3 , an absolute neutrophil count (ANC) < 1,000 cells/mm 3 or hemoglobin < 9 g/dL. ( 2.1 ) Recommended Dosage Rheumatoid Arthritis Tofacitinib extended-release tablets 11 mg once daily. ( 2.2 ) Psoriatic Arthritis (in combination with nonbiologic DMARDs) Tofacitinib extended-release tablets 11 mg once daily. ( 2.2 ) Ankylosing Spondylitis Tofacitinib extended-release tablets 11 mg once daily. ( 2.2 ) Dosage Adjustment See the full prescribing information for dosage adjustments by indication for patients receiving CYP2C19 and/or CYP3A4 inhibitors; in patients with moderate or severe renal impairment or moderate hepatic impairment; and patients with lymphopenia, neutropenia, or anemia. ( 2.2 , 8.7 , 8.8 ) Use of tofacitinib extended-release tablets in patients with severe hepatic impairment is …
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 6 includes drugs with clinically important drug interactions when administered concomitantly with tofacitinib and instructions for preventing or managing them. Table 6: Clinically Relevant Interactions Affecting Tofacitinib When Coadministered with Other Drugs Strong CP3A4 Inhibitors (e.g., ketoconazole) Clinical Impact Increased exposure to tofacitinib Intervention Dosage adjustment of tofacitinib is recommended [see Dosage and Administration ( 2 ), Clinical Pharmacology, Figure 3 ( 12.3 )] Moderate CYP3A4 Inhibitors Coadministered with Strong CYP2C19 Inhibitors (e.g., fluconazole) Clinical Impact Increased exposure to tofacitinib Intervention Dosage adjustment of tofacitinib is recommended [see Dosage and Administration ( 2 ), Clinical Pharmacology, Figure 3 ( 12.3 )] Strong CYP3A4 Inducers (e.g., rifampin) Clinical Impact Decreased exposure to tofacitinib and may result in loss of or reduced clinical response Intervention Coadministration with tofacitinib is not recommended [see Clinical Pharmacology, Figure 3 ( 12.3 )] Immunosuppressive Drugs (e.g., azathioprine, tacrolimus, cyclosporine) Clinical Impact Risk of added immunosuppression; coadministratio…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Mortality [see Warnings and Precautions ( 5.2 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Major Adverse Cardiovascular Events [see Warnings and Precautions ( 5.4 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Gastrointestinal Perforations [see Warnings and Precautions ( 5.6 )] Hypersensitivity [see Warnings and Precautions ( 5.7 )] Laboratory Abnormalities [see Warnings and Precautions ( 5.8 )] Most common adverse reactions are: Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis : Reported during the first 3 months in rheumatoid arthritis placebo-controlled clinical trials and occurring in ≥2% of patients treated with tofacitinib monotherapy or in combination with DMARDs: upper respiratory tract infection, nasopharyngitis, diarrhea, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies …
Frequently Asked Questions
What is tofacitinib used for?
tofacitinib contains tofacitinib. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is tofacitinib a controlled substance?
tofacitinib is not classified as a controlled substance by the DEA.
What is the generic name for tofacitinib?
The generic name for tofacitinib is tofacitinib. There are 6 other brand versions of tofacitinib.
What is the NDC code for tofacitinib 22 mg/1?
The NDC (National Drug Code) for tofacitinib 22 mg/1 is 70710-1727, listed by Zydus Pharmaceuticals USA Inc..