DOSAGE ADMINISTRATION:
Recommended Dosage
Rheumatoid Arthritis
- TOFAJAK 5 mg twice daily.
- Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is TOFAJAK 5 mg once daily.
Psoriatic Arthritis (in combination with nonbiologic DMARDs)
- TOFAJAK 5 mg twice daily.
- Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is TOFAJAK 5 mg once daily.
Ulcerative Colitis
- Induction: 2 tablets of TOFAJAK 5 mg twice daily for 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed, continue 2 tablets of TOFAJAK 5 mg twice daily for a maximum of 16 weeks. Discontinue after 16 weeks if adequate therapeutic response is not achieved.
- Maintenance: TOFAJAK 5 mg twice daily. For patients with loss of response during maintenance treatment, 2 tablets of TOFAJAK 5 mg twice daily may be considered and limited to the shortest duration, with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dose needed to maintain response.
- Dosage adjustment is needed in patients with moderate and severe renal impairment or moderate hepatic impairment.
WARNINGS AND PRECAUTIONS
SERIOUS INFECTIONS
Patients treated with TOFAJAK are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt TOFAJAK until the infection is controlled.
Reported infections include:
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before TOFAJAK use and during therapy. Treatment for latent infection should be initiated prior to TOFAJAK use.
- Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized,disease.
- Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
MORTALITY
Rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with TOFACITINIB 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with TOFACITINIB 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study. MALIGNANCIES Lymphoma and other malignancies have been observed in patients treated with TOFACITINIB. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with TOFACITINIB and concomitant immunosuppressive medications.
THROMBOSIS
Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis have occurred in patients treated with TOFAJAK and other Janus kinase inhibitors used to treat inflammatory conditions. Rheumatoid arthritis patients who were 50 years of age and older with at least one CV risk factor treated with TOFACITINIB 10 mg twice daily compared to TOFACITINIB 5 mg twice daily or TNF blockers in a large, ongoing postmarketing safety study had an observed increase in incidence of these events. Many of these events were serious and some resulted in death. Avoid TOFACITINIB in patients at risk. Discontinue TOFACITINIB and promptly evaluate patients with symptoms of thrombosis. For patients with ulcerative colitis, use TOFACITINIB at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.
ADVERSE REACTIONS
Most common adverse reactions are:
- Rheumatoid and Psoriatic Arthritis: Reported during the first 3 months in rheumatoid arthritis 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.
- Ulcerative Colitis: Reported in ≥5% of patients treated with either 5 mg or 10 mg twice daily of TOFACITINIB and ≥1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.
- Polyarticular Course Juvenile Idiopathic Arthritis:
Consistent with common adverse reactions reported in
adult rheumatoid arthritis patients.