Tofacitinib: Brands, Price & Uses in Bangladesh

Established / FDA-Approved Uses

• Rheumatoid arthritis (RA): Moderately to severely active RA in adults who have had an inadequate response or intolerance to methotrexate. Tofacitinib may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
• Psoriatic arthritis (PsA): Active PsA in adults who have had an inadequate response or intolerance to methotrexate or other DMARDs, usually used in combination with a non-biologic DMARD such as methotrexate.
• Ulcerative colitis (UC): Moderately to severely active UC in adults who have had an inadequate response, loss of response, or intolerance to a TNF blocker.
• Polyarticular course juvenile idiopathic arthritis (pJIA): Active pJIA in children 2 years of age and older.

Important Limitation

Tofacitinib is not recommended for use in combination with biologic DMARDs (e.g. TNF blockers, IL-1 or IL-6 antagonists) or with potent immunosuppressants such as azathioprine or cyclosporine, because of the possibility of increased immunosuppression and increased risk of infection.

Given the extensive boxed warnings associated with Tofacitinib (see Precautions and Warnings), it is generally reserved for patients who have not responded adequately to other therapies, and the lowest effective dose should be used for the shortest duration consistent with treatment goals.

Rheumatoid Arthritis and Psoriatic Arthritis (Adults)

Doses of 10 mg twice daily (or 22 mg XR once daily) are not recommended for RA or PsA.

Ulcerative Colitis (Adults)

Polyarticular Juvenile Idiopathic Arthritis (Children ≥2 years, weight-based)

Dose Adjustments

• Renal impairment (moderate to severe): reduce to 5 mg once daily (adults); dose reduction also required for pJIA per weight band.
• Hepatic impairment (moderate): reduce to 5 mg once daily (adults); avoid in severe hepatic impairment.
• Concomitant strong CYP3A4 inhibitors or combined moderate CYP3A4/strong CYP2C19 inhibitors: dose reduction required — see Interactions.
• Low lymphocyte, neutrophil, or hemoglobin counts: therapy should be interrupted or discontinued per laboratory monitoring guidance — see Precautions and Warnings.

Administration

Tofacitinib immediate-release tablets and oral solution may be taken with or without food. Extended-release tablets must be swallowed whole and must not be split, crushed, or chewed. Do not abruptly stop Tofacitinib without consulting a physician, as this may lead to loss of disease control.

Common Side Effects

• Upper respiratory tract infection and nasopharyngitis (common cold-type symptoms)
• Headache
• Diarrhea
• Elevated blood pressure
• Elevated cholesterol/lipid levels
• Rash
• Herpes zoster (shingles)

Serious Side Effects

Serious infections, malignancy, major adverse cardiovascular events, and blood clots (venous and arterial thrombosis) can occur with Tofacitinib — these are subjects of the FDA boxed warnings; see Precautions and Warnings for details and warning signs to watch for. Other serious but less common effects include gastrointestinal perforation, significant elevations in liver enzymes, and low blood counts (lymphopenia, neutropenia, anemia).

Seek prompt medical attention for signs of infection (fever, chills, persistent cough), chest pain or shortness of breath, one-sided limb swelling or pain, sudden weakness or vision changes, or unusual bleeding while taking Tofacitinib.