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Xeljanz is a brand name for Tofacitinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 4.1 Therapeutic indication Rheumatoid arthritis Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated. Posology Rheumatoid arthritis and psoriatic arthritis The recommended dose is 5 mg film-coated tablets administered twice daily, which should not be exceeded.
No dose adjustment is required when used in combination with MTX. For information on switching between tofacitinib film-coated tablets and tofacitinib prolonged-release tablets see Table 1.
Table 1:
Switching between tofacitinib film-coated tablets and tofacitinib prolonged-release tablets Switching between tofacitinib 5 mg film-coated tablets and tofacitinib 11 mg prolonged-release tableta Treatment with tofacitinib 5 mg film-coated tablets twice daily and tofacitinib 11 mg prolonged-release tablet once daily may be switched between each other on the day following the last dose of either tablet.
2 for comparison of pharmacokinetics of prolonged-release and film-coated formulations. Ankylosing spondylitis The recommended dose of tofacitinib is 5 mg administered twice daily. Ulcerative colitis Induction treatment The recommended dose is 10 mg given orally twice daily for induction for 8 weeks.
4 For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance. Tofacitinib induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.
Maintenance treatment The recommended dose for maintenance treatment is tofacitinib 5 mg given orally twice daily. 8). 4), tofacitinib 10 mg orally twice daily may be considered if the patient experiences a decrease in response on tofacitinib 5 mg twice daily and failed to respond to alternative treatment options for ulcerative colitis such as tumour necrosis factor inhibitor (TNF inhibitor) treatment.
Tofacitinib 10 mg twice daily for maintenance treatment should be used for the shortest duration possible. The lowest effective dose needed to maintain response should be used. In patients who have responded to treatment with tofacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
4). 2%). Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus infection, BK virus infections and listeriosis were reported with tofacitinib.
Some patients have presented with disseminated rather than localised disease. , coccidioidomycosis). 2%). 8% for patients taking tofacitinib. 15%). Psoriatic arthritis Overall, the safety profile observed in patients with active PsA treated with tofacitinib was consistent with the safety profile observed in patients with RA treated with tofacitinib.
Ankylosing spondylitis Overall, the safety profile observed in patients with active AS treated with tofacitinib was consistent with the safety profile observed in patients with RA treated with tofacitinib. Ulcerative colitis The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily in the induction studies were headache, nasopharyngitis, nausea, and arthralgia.
In the induction and maintenance studies, across tofacitinib and placebo treatment groups, the most common categories of serious adverse reactions were gastrointestinal disorders and infections, and the most common serious adverse reaction was worsening of UC.
16 Overall, the safety profile observed in patients with UC treated with tofacitinib was consistent with the safety profile of tofacitinib in the RA indication. Tabulated list of adverse reactions The adverse reactions listed in the table below are from clinical studies in patients with RA, PsA, AS, and UC and are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
g. 1). Combination with other therapies Tofacitinib has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporin and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies. The use of tofacitinib in combination with phosphodiesterase 4 inhibitors has not been studied in tofacitinib clinical studies.
8). 1). In a post hoc exploratory analysis within this study, in patients with known VTE risk factors, occurrences of subsequent VTEs were observed more frequently in tofacitinib-treated patients that, at 12 months treatment, had D-dimer level ≥2× ULN versus those with D-dimer level <2× ULN; this was not evident in TNF inhibitor-treated patients.
Interpretation is limited by the low number of VTE events and restricted D-dimer test availability (only assessed at Baseline, Month 12, and at the end of the study). In patients who did not have a VTE during the study, mean D-dimer levels were significantly reduced at Month 12 relative to Baseline across all treatment arms.
However, D-dimer levels ≥2× ULN at Month 12 were observed in approximately 30% of patients without subsequent VTE events, indicating limited specificity of D-Dimer testing in this study. 2). 4 “Major adverse cardiovascular events (including myocardial infarction)” and “Malignancies and lymphoproliferative disorders”) tofacitinib should only be used if no suitable treatment alternatives are available.
9 In patients with VTE risk factors other than MACE or malignancy risk factors, tofacitinib should be used with caution. VTE risk factors other than MACE or malignancy risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, inherited coagulation disorder.
1. 4). 2). 6). 8
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Retreatment in UC If therapy is interrupted, restarting treatment with tofacitinib can be considered. If there has been a loss of response, reinduction with tofacitinib 10 mg twice daily may be considered. The treatment interruption period in clinical studies extended up to 1 year.
1). Polyarticular JIA and juvenile PsA (children between 2 and 18 years of age) Tofacitinib may be used as monotherapy or in combination with MTX. 2 mL of oral solution) twice daily 20 - < 40 4 mg (4 mL of oral solution) twice daily ≥ 40 5 mg (5 mL of oral solution or 5 mg film-coated tablet) twice daily Patients 40 kg treated with tofacitinib 5 mL oral solution twice daily may be switched to tofacitinib 5 mg film-coated tablets twice daily.
Patients < 40 kg cannot be switched from tofacitinib oral solution. Dose interruption and discontinuation in adults and paediatric patients Tofacitinib treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia. 4). 5 It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 750 cells/mm3.
4) Laboratory value (cells/mm3) Recommendation ALC greater than or equal to 750 Dose should be maintained. ALC 500-750 For persistent (2 sequential values in this range on routine testing) decrease in this range, dosing should be reduced or interrupted.
For patients receiving tofacitinib 10 mg twice daily, dosing should be reduced to tofacitinib 5 mg twice daily. For patients receiving tofacitinib 5 mg twice daily, dosing should be interrupted. When ALC is greater than 750, treatment should be resumed as clinically appropriate.
ALC less than 500 If laboratory value confirmed by repeat testing within 7 days, dosing should be discontinued. It is recommended not to initiate dosing in adult patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3.
It is recommended not to initiate dosing in paediatric patients with an absolute neutrophil count (ANC) less than 1,200 cells/mm3. 4) Laboratory Value (cells/mm3) Recommendation ANC greater than 1,000 Dose should be maintained. ANC 500-1,000 For persistent (2 sequential values in this range on routine testing) decreases in this range, dosing should be reduced or interrupted.
For patients receiving tofacitinib 10 mg twice daily, dosing should be reduced to tofacitinib 5 mg twice daily. For […]
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 1). The majority […]
Patients should be re-evaluated periodically during tofacitinib treatment to assess for changes in VTE risk. For patients with RA with known risk factors for VTE, consider testing D-dimer levels after approximately 12 months of treatment.
If D-dimer test result is ≥ 2× ULN, confirm that clinical benefits outweigh risks prior to a decision on treatment continuation with tofacitinib. Promptly evaluate patients with signs and symptoms of VTE and discontinue tofacitinib in patients with suspected VTE, regardless of dose or indication.
8). The patients should be advised to promptly seek medical care in case they experience symptoms suggestive of RVT. 8). 8). Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection. Tofacitinib should not be initiated in patients with active infections, including localised infections.
The risks and benefits of treatment should be considered prior to initiating tofacitinib in patients: • with recurrent infections, • with a history of a serious or an opportunistic infection, • who have resided or travelled in areas of endemic mycoses, • who have underlying conditions that may predispose them to infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with tofacitinib. Treatment should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis.
A patient who develops a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
As there is a higher incidence of […]