Indications:
Psoriatic Arthritis: Tofacent is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
Ulcerative Colitis: Tofacent is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
Doges:
Administration Instructions
Do not initiate Tofacitinib / Tofacitinib XR if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 g/dL.
Recommended Dosage:
• Rheumatoid Arthritis & Ankylosing Spondylitis: Tofacitinib 5 mg twice daily or Tofacitinib XR 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.
• Psoriatic Arthritis (in combination with nonbiologic DMARDs): Tofacitinib 5 mg twice daily or Tofacitinib XR 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.
• Ulcerative Colitis: • Induction: Tofacitinib 10 mg twice daily or Tofacitinib XR 22 mg once daily for 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed, continue Tofacitinib 10 mg twice daily or Tofacitinib XR 22 mg once daily for a maximum of 16 weeks. Discontinue Tofacitinib 10 mg twice daily or Tofacitinib XR 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved. • Maintenance: Tofacitinib 5 mg twice daily or Tofacitinib XR 11 mg once daily. For patients with loss of response during maintenance treatment, Tofacitinib 10 mg twice daily or Tofacitinib XR 22 mg once 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.
• Polyarticular Course Juvenile Idiopathic Arthritis: Tofacitinib / Tofacitinib Oral Solution 5 mg twice daily
or weight-based equivalent twice daily. Dosage adjustment is needed in patients with moderate and
severe renal impairment or moderate hepatic impairment.
Side Effect:
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.
• With high dose chance of blood clot and death.
Precautions & Warnings:
- Serious Infections: Avoid use of Tofacent during an active serious infection, including localized infections.
- Gastrointestinal Perforations: Use with caution in patients that may be at increased risk.
- Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids.
- Immunizations: Live vaccines: Avoid use with Tofacent.
- Do not initiate Tofacent if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 gm/dL.
Use in Special Populations:
Geriatric Use: The frequency of serious infection among Tofacent-treated subjects 65 years of age and older was higher than among those under the age of 65. As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.
Moderate and severe renal impairment or moderate hepatic impairment: half the total daily dosage recommended for patients with normal renal and hepatic function.
Reviews
There are no reviews yet.