Information on how to access XELJANZ®▼ (tofacitinib citrate) prescribing information and adverse event reporting can be found at the bottom of the page.
Practical Considerations for Use1
Laboratory Monitoring
Lab monitoring recommendations for patients taking XELJANZ |
|||
|---|---|---|---|
At initiation |
After 4 to 8 weeks |
Every 3 months thereafter |
|
Lymphocytes |
|
||
Neutrophils |
|||
Haemoglobin |
|||
Lipids |
After 8 weeks following initiation of therapy |
||
Liver enzymes |
Routine monitoring of liver test and prompt investigation of the cause of liver enzyme elevation are also recommended |
||
Avoid initiating treatment in patients with: |
Absolute lymphocyte count <0.75 x109 cells/L |
Absolute neutrophil count <1.0 x109 cells/L |
Haemoglobin levels |
Lab monitoring recommendations for patients taking XELJANZ 1 |
|
|---|---|
Lymphocytes |
|
At initiation |
|
After 4 to 8 weeks |
|
Every 3 months thereafter |
|
Neutrophils |
|
At initiation |
|
After 4 to 8 weeks |
|
Every 3 months thereafter |
|
Haemoglobin |
|
At initiation |
|
After 4 to 8 weeks |
|
Every 3 months thereafter |
|
Lipids |
|
At initiation |
|
After 4 to 8 weeks |
After 8 weeks following initiation of therapy |
Every 3 months thereafter |
|
Liver enzymes |
|
At initiation |
Routine monitoring of liver test and prompt investigation of the cause of liver enzyme elevation are also recommended |
After 4 to 8 weeks |
|
Every 3 months thereafter |
|
Avoid initiating treatment in patients with: |
|
At initiation |
Absolute lymphocyte count <0.75 cells x109/L |
After 4 to 8 weeks |
Absolute neutrophil count <1.0 x109 cells/L |
Every 3 months thereafter |
Haemoglobin levels |
Please refer to the full PI for recommended dose modifications based on changes in lab tests.
Vaccination
- Prior to initiating XELJANZ it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
- It is recommended that live vaccines not be given concurrently with XELJANZ. The decision to use live vaccines prior to XELJANZ treatment should take into account the pre-existing immunosuppression in a given patient.
- Prophylactic zoster vaccination should be considered in accordance with vaccination guidelines. Particular consideration should be given to patients with long-standing rheumatoid arthritis who have received two or more prior biological DMARDs. If live zoster vaccine is administered, it should only be administered to patients with a known history of chickenpox or those that are seropositive for varicella zoster virus (VZV). If the history of chickenpox is considered doubtful or unreliable it is recommended to test for antibodies against VZV.
- Vaccination with live vaccines should occur at least 2 weeks, but preferably 4 weeks prior to initiation of XELJANZ, or in accordance with current vaccination guidelines regarding immunomodulatory medicinal products.
Combination with other therapies
- XELJANZ has not been studied and its use should be avoided in patients in combination with biologics such as TNF antagonists, IL-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL‑17 antagonists, IL‑12/IL‑23 antagonists, anti-integrins, and 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 is a higher incidence of adverse events for the combination of XELJANZ plus MTX versus XELJANZ as monotherapy in RA clinical trials.
Serious infections
- Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving XELJANZ. The risk of opportunistic infections is higher in Asian geographic regions (see section 4.8 of the XELJANZ Summary of Product Characteristics). Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection.
- XELJANZ should not be initiated in patients with active infections, including localised infections. The risks and benefits of treatment should be considered prior to initiating XELJANZ 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,
- who are over 65 years of age.
- Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ. Treatment must be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with XELJANZ 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 infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients over 65 years of age XELJANZ should only be considered if no suitable alternative treatment is available.
- Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection. Discontinuation and monitoring criteria for lymphopenia are discussed in section 4.2 of the XELJANZ Summary of Product Characteristics.
Tuberculosis
- The risks and benefits of treatment should be considered prior to initiating XELJANZ in patients:
- who have been exposed to TB
- who have resided or travelled in areas of endemic TB or endemic mycoses
- Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during administration of XELJANZ.
Please refer to SmPC for full guidance on managing patients with TB and use of anti-TB treatments.
Viral reactivation
- Viral reactivation and cases of herpes virus reactivation (e.g. herpes zoster) were observed in clinical studies with XELJANZ. In patients treated with XELJANZ, the risk of herpes zoster appears to be increased in:
- Japanese and Korean patients
- Patients with an absolute lymphocyte count (ALC) less than 1.0 x 109 cells/L
- Patients with long standing RA who have previously received two or more biologic DMARDs
- Patients treated with 10 mg twice daily*
Malignancies and lymphoproliferative disorder [excluding non-melanoma skin cancer (NMSC)]
- XELJANZ should only be used in patients with other malignancy risk factors if no suitable treatment alternatives are available.
- The risks and benefits of XELJANZ treatment should be considered prior to initiating therapy in patients with current, or a history of, malignancy other than successfully treated non-melanoma skin cancer (NMSC), or when considering continuing XELJANZ in patients who develop a malignancy. The possibility exists for XELJANZ to affect host defences against malignancies.
- Lymphomas have been observed in patients treated with XELJANZ. Patients with RA, particularly those with highly active disease may be at a higher risk (up to several-fold) than the general population for the development of lymphoma. The role of XELJANZ in the development of lymphoma is uncertain.
- Other malignancies were observed in clinical studies and the post-marketing setting, including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer and pancreatic cancer.
- The effect of XELJANZ on the development and course of malignancies is not known.
Non-melanoma skin cancer
- Non-melanoma skin cancers (NMSCs) have been reported in patients treated with XELJANZ. The risk of NMSC may be higher in patients treated with XELJANZ 10 mg twice daily than in patients treated with 5 mg twice daily*. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Interstitial lung disease
- Caution is recommended in patients with a history of chronic lung disease as they may be more prone to infections.
- Events of interstitial lung disease (some of which had a fatal outcome) have been reported in patients treated with XELJANZ in RA clinical trials and in the post-marketing setting although the role of Janus kinase (JAK) inhibition in these events is not known. Asian RA patients are known to be at higher risk of interstitial lung disease, thus caution should be exercised in treating these patients.
Venous thromboembolism (VTE)
- Serious VTE events including pulmonary embolism (PE), some of which were fatal, and deep vein thrombosis (DVT), have been observed in patients taking XELJANZ. A dose-dependent increased risk for VTE was observed in a clinical study with XELJANZ compared to TNF inhibitors.
- XELJANZ should be used with caution in patients with known risk factors for VTE, regardless of indication and dosage.
- VTE risk factors include previous VTE, patients undergoing major surgery, immobilisation, myocardial infarction (within previous 3 months), heart failure, use of combined hormonal contraceptives or hormone replacement therapy, inherited coagulation disorder, malignancy. Additional VTE risk factors such as age, obesity (BMI ≥30), diabetes, hypertension, smoking status should also be considered. Patients should be re-evaluated periodically during XELJANZ treatment to assess for changes in VTE risk.
- Promptly evaluate patients with signs and symptoms of VTE and discontinue XELJANZ in patients with suspected VTE, regardless of dose or indication.
- XELJANZ should only be used in patients with other cardiovascular risk factors if no suitable treatment alternatives are available
Liver enzyme elevations
- Treatment with XELJANZ was associated with an increased incidence of liver enzyme elevation in some patients.
- Caution should be exercised when considering initiation of XELJANZ treatment in patients with elevated ALT or AST, particularly when initiated in combination with potentially hepatotoxic medicinal products such as MTX.
- Following initiation, routine monitoring of liver tests and prompt investigation of the causes of any observed liver enzyme elevations are recommended to identify potential cases of drug-induced liver injury. If drug-induced liver injury is suspected, the administration of XELJANZ should be interrupted until this diagnosis has been excluded.
Please refer to the full XELJANZ SmPC for further information on liver enzyme elevations.
Lymphocytes, Neutrophils & Haemoglobin
- Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia and anaemia.
- Recommendations for temporary dose interruption or permanent discontinuation of treatment are made according to the severity of laboratory abnormalities.
Please refer to the XELJANZ SmPC for dose modifications.
Lipids
- Treatment with XELJANZ was associated with increases in lipid parameters such as total cholesterol, LDL and HDL, maximum effects were generally observed within 6 weeks.
- Assessment of lipid parameters should be performed 8 weeks after initiation of XELJANZ and managed according to hyperlipidaemia guidelines.
Explore more
Support & Resources
Explore the resources avaliable for patients who have been prescribed XELJANZ for PsA
Visit page
Xeljanz (tofacitinib citrate) Prescribing Information (Great Britain) - 5mg film-coated tablets
Xeljanz (tofacitinib citrate) Prescribing Information (Northern Ireland) - 5mg and 10mg film-coated tablets
References:
- XELJANZ (tofacitinib citrate) Summary of Product Characteristics
Announcement Title
*XELJANZ 5 mg BID is the only approved dosage for the treatment of PsA, which should not be exceeded. 10 mg is not licensed for PsA.
Announcement Title
XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.
Dosing in PsA
- Dosing
- Practical Considerations for Use
For UK Healthcare Professionals*
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-PFE-GBR-2688. December 2020
No