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HomeCoverage and SupportCoverage and SupportCoverage and Patient SupportCo-Pay Savings ProgramEnroll patients in XELSOURCEResources   ResourcesEventsMaterialsVideosDosing & Monitoring     Coverage and SupportCoverage and Patient SupportCo-Pay Savings ProgramEnroll patients in XELSOURCEEfficacy & Safety    Coverage and SupportCoverage and Patient SupportCo-Pay Savings ProgramEnroll patients in XELSOURCEMarket Experience Coverage and SupportCoverage and Patient SupportCo-Pay Savings ProgramEnroll patients in XELSOURCE
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Coverage and Patient SupportCo-Pay Savings ProgramEnroll Patients in ​XELSOURCERequest a Representative
ResourcesResources

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Dosing & MonitoringDosing and Monitoring

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Efficacy & SafetyEfficacy & Safety

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RA Efficacy and SafetyPsA Efficacy and SafetyAS Efficacy and SafetypcJIA Efficacy and SafetySafety: ORAL Surveillance and Pooled Safety Analysis (RA)
Market Experience 
Prescribing InformationIndicationsLoadingMedication GuidePatient Site
Enroll eligible patients in XELSOURCE
XELSOURCE can help eligible prescribed patients get started with their treatment and support them along the way.
Forms & ResourcesLoadingHelp with Benefit Investigation 
  • Investigate and assess your patient’s insurance benefits and coverage determinations 
  • Send an explanation of benefits to the patient with a summary of benefits  
Prior Authorization Assistance* Appeals Assistance*
  • Provide the necessary forms, phone numbers, and contact information to assist patients who would like to appeal a PA denial​​​​​​​
Available for all patients. PA and appeals assistance may be discontinued if requested information is not received in a timely manner.Choose the way that works best for you to enroll patients into XELSOURCEAppeals Assistance*e-Platform

Electronically via the XELSOURCE Healthcare Provider e-Platform at XELSOURCEportal.com

Appeals Assistance*e-Prescribe

e-Prescribe directly to Sonexus Health Pharmacy Services*

Send to: Sonexus Health Pharmacy Services, 2730 S. Edmonds Lane #400, Lewisville, TX 75067 (NCPDP: 5910206; NPI: 1447680210)

Appeals Assistance*Fax

Fax a completed

Prescription & Enrollment Form to XELSOURCE at 1-866-297-3471

If you choose to e-Prescribe directly to Sonexus Health Pharmacy Services, you are certifying you have received patient consent for Sonexus Health Pharmacy Services and XELSOURCE to contact your patient or caregiver and provide them services.

Field Reimbursement Manager (FRM)

At any point in the medication access journey for prescribed patients, you can get in touch with a Field Reimbursement Manager, a designated Pfizer field colleague. They are familiar with insurance and reimbursement requirements for XELSOURCE.

FRMs can:

  • Provide information to HCPs and office staff about coverage, reimbursement, and relevant payer policies
  • Address questions about the prescription status of patients enrolled in XELSOURCE
  • Coordinate with XELSOURCE as needed to understand payer requirements for individual patients
  • Demonstrate how to use the HCP e-Platform if requested
FRMs cannot:
  • Answer clinical questions
  • Complete reimbursement forms for your office
  • Offer personal or medical advice to patients
  • Promote Pfizer products
  • Give out any Pfizer Patient Assistance Program-related patient status updates
FRMs are available to speak with you in person or over the phone. Contact your Pfizer Representative to be put in touch with your FRM.

Patient Access Coordinator (PAC)

When prescribed patients choose to opt in for Patient Access Coordinator support, they can rely on a knowledgeable and dedicated Pfizer professional who collaborates with XELSOURCE and can help them understand how their insurance works for their prescribed medication.

PACs can:

  • Serve as subject matter expert in reimbursement, access, and coverage issues for patients/caregivers who opted in for support
  • Provide, in some cases, an estimated out-of-pocket cost for the patient’s prescribed Pfizer medication
  • Be a point of contact for patients/caregivers regarding the status of their request for reimbursement support
  • Answer patients’ questions about XELSOURCE and the process to obtain medication from a specialty pharmacy
PACs cannot:
  • Provide treatment recommendations or medical advice to patients/caregivers
  • Make any referrals for alternative health insurance coverage
  • Assist beyond helping to address acute access challenges for opted-in patients/caregivers who have been prescribed Pfizer medication
Patients can opt into the PAC by:
  • Checking the box for “PAC Opt-in” in Section 7 of the XELSOURCE Patient Support Enrollment Form when they are completing it with you and your office staff
See how the XELSOURCE HCP Portal streamlines the enrollment processFind out more about XELSOURCEForms and resources to help eligible patients access their prescribed medicationXELSOURCE Patient Support Form

Complete, print, and fax to enroll patients in XELSOURCE.

 Download Now Loading
e-Platform Enrollment Form

Complete, print, and fax to register for XELSOURCEportal.com.

 Download Now Loading
XELSOURCE Prescription and Enrollment Form

Complete, print, and fax to enroll patients in XELSOURCE.

 Download now Loading
Pfizer Patient Access Coordinator (PAC) Opt-In Form

Complete, print, and mail or fax to help patients receive support from a PAC.

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Sample Letter of Medical Necessity

An example for when requesting coverage from patients’ insurance providers.

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Coverage and Support A XELSOURCE REPRESENTATIVE IS AVAILABLE MONDAY-FRIDAY, 8:00 AM-8:00 PM ET 1-844-935-5269
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To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

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XELJANZ (tofacitinib) SUMMARY OF INDICATIONS, INCLUDING LIMITATIONS OF USEXELJANZ® (tofacitinib) is indicated for patients who have had an inadequate response or intolerance to one or more TNF blockers in adults with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), or moderately to severely active ulcerative colitis (UC), and patients 2 years of age and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Limitations of Use: XELJANZ in combination with biological therapies or with potent immunosuppressants is not recommended. See full INDICATIONS for additional information.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
Rheumatoid Arthritis 
  • XELJANZ®/XELJANZ® XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers.
  • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Psoriatic Arthritis
  • XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers.
  • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
     
Ankylosing Spondylitis 
  • XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers.
  • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Ulcerative Colitis 
  • XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers.
  • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Polyarticular Course Juvenile Idiopathic Arthritis 
  • XELJANZ/XELJANZ Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.
  • Limitations of Use: Use of XELJANZ/XELJANZ Oral Solution in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
Indications

SERIOUS INFECTIONS

Patients treated with XELJANZ* (tofacitinib) 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 XELJANZ 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 XELJANZ use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ 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. 

The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. Avoid use of XELJANZ in patients with an active, serious infection, including localized infections.

In the UC population, XELJANZ 10 mg twice daily was associated with greater risk of serious infections compared to 5 mg twice daily. Opportunistic herpes zoster infections (including meningoencephalitis, ophthalmologic, and disseminated cutaneous) were seen in patients who were treated with XELJANZ 10 mg twice daily.

The risks and benefits of treatment with XELJANZ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection, or those who have lived or traveled in areas of endemic TB or mycoses. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy.


Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Caution is also recommended in patients with a history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infection.

MORTALITY

In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular (CV) risk factor comparing XELJANZ 5 mg twice a day or XELJANZ 10 mg twice a day to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden CV death, was observed with XELJANZ 5 mg twice a day or XELJANZ 10 mg twice a day. A XELJANZ 10 mg twice daily (or a XELJANZ XR 22 mg once daily) dosage is not recommended for the treatment of RA or PsA. For UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.

MALIGNANCIES

Malignancies, including lymphomas and solid tumors, have occurred in patients treated with XELJANZ and other Janus kinase inhibitors used to treat inflammatory conditions. In RA patients, a higher rate of malignancies (excluding NMSC) was observed in patients treated with XELJANZ 5 mg twice a day or XELJANZ 10 mg twice a day compared with TNF blockers.

Lymphoma and lung cancers were observed at a higher rate in patients treated with XELJANZ 5 mg twice a day or XELJANZ 10 mg twice a day in RA patients compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications.


Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with XELJANZ, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy while on treatment, and patients who are current or past smokers. A XELJANZ 10 mg twice daily (or a XELJANZ XR 22 mg once daily) dosage is not recommended for the treatment of RA or PsA. 

Other malignancies were observed in clinical studies and the postmarketing setting including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer. NMSCs have been reported in patients treated with XELJANZ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. In the UC population, treatment with XELJANZ 10 mg twice daily was associated with greater risk of NMSC.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

RA patients 50 years of age and older with at least one CV risk factor, treated with XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, had a higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke), compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue XELJANZ in patients that have experienced a myocardial infarction or stroke.
 

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with XELJANZ, particularly in patients who are current or past smokers and patients with other CV risk factors. Inform patients about the symptoms of serious CV events. A XELJANZ 10 mg twice a day (or a XELJANZ XR 22 mg once daily) dosage is not recommended for the treatment of RA or PsA.

THROMBOSIS

Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, have occurred in patients treated with XELJANZ and other Janus kinase inhibitors used to treat inflammatory conditions. Many of these events were serious and some resulted in death. RA patients 50 years of age and older with at least one CV risk factor treated with XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily compared to TNF blockers had an observed increase in incidence of these events. Avoid XELJANZ in patients at risk. Discontinue XELJANZ and promptly evaluate patients with symptoms of thrombosis.
 

A XELJANZ 10 mg twice daily (or XELJANZ XR 22 mg once daily) dosage is not recommended for the treatment of RA or PsA. In a long-term extension study in UC, five cases of pulmonary embolism were reported in patients taking XELJANZ 10 mg twice daily, including one death in a patient with advanced cancer. For UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.

GASTROINTESTINAL PERFORATIONS
 

Gastrointestinal perforations have been reported in XELJANZ clinical trials, although the role of JAK inhibition is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). There was no discernible difference in frequency of gastrointestinal perforation between the placebo and the XELJANZ arms in clinical trials of patients with UC, and many of them were receiving background corticosteroids. XELJANZ should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs). 


HYPERSENSITIVITY
 

Angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving XELJANZ and some events were serious. If a serious hypersensitivity reaction occurs, promptly discontinue tofacitinib while evaluating the potential cause or causes of the reaction.

LABORATORY ABNORMALITIES

Lymphocyte Abnormalities: Treatment with XELJANZ was associated with initial lymphocytosis at one month of exposure followed by a gradual decrease in mean lymphocyte counts. Avoid initiation of XELJANZ treatment in patients with a count less than 500 cells/mm3. In patients who develop a confirmed absolute lymphocyte count less than 500 cells/mm3, treatment with XELJANZ is not recommended. 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. Monitor lymphocyte counts at baseline and every 3 months thereafter.

Neutropenia: Treatment with XELJANZ was associated with an increased incidence of neutropenia (less than 2000 cells/mm3) compared to placebo. Avoid initiation of XELJANZ treatment in patients with an ANC less than 1000 cells/mm3. For patients who develop a persistent ANC of 500-1000 cells/mm3, interrupt XELJANZ dosing until ANC is greater than or equal to 1000 cells/mm3. In patients who develop an ANC less than 500 cells/mm3, treatment with XELJANZ is not recommended. Monitor neutrophil counts at baseline and after 4-8 weeks of treatment and every 3 months thereafter. 

Anemia: Avoid initiation of XELJANZ treatment in patients with a hemoglobin level less than 9 g/dL. Treatment with XELJANZ should be interrupted in patients who develop hemoglobin levels less than 8 g/dL or whose hemoglobin level drops greater than 2 g/dL on treatment. Monitor hemoglobin at baseline and after 4-8 weeks of treatment and every 3 months thereafter.

Liver Enzyme Elevations: Treatment with XELJANZ was associated with an increased incidence of liver enzyme elevation compared to placebo. Most of these abnormalities occurred in studies with background DMARD (primarily methotrexate) therapy. If drug-induced liver injury is suspected, the administration of XELJANZ should be interrupted until this diagnosis has been excluded. Routine monitoring of liver tests and prompt investigation of the causes of liver enzyme elevations is recommended to identify potential cases of drug-induced liver injury.

Lipid Elevations: Treatment with XELJANZ was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Maximum effects were generally observed within 6 weeks. There were no clinically relevant changes in LDL/HDL cholesterol ratios. Manage patients with hyperlipidemia according to clinical guidelines. Assessment of lipid parameters should be performed approximately 4-8 weeks following initiation of XELJANZ therapy.

VACCINATIONS

Avoid use of live vaccines concurrently with XELJANZ. The interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ therapy.

PATIENTS WITH GASTROINTESTINAL NARROWING

Caution should be used when administering XELJANZ XR to patients with pre-existing severe gastrointestinal narrowing. There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs utilizing a non-deformable extended-release formulation.

HEPATIC and RENAL IMPAIRMENT

Use of XELJANZ in patients with severe hepatic impairment is not recommended. For patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily, reduce to XELJANZ 5 mg once daily. For UC patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 10 mg twice daily, reduce to XELJANZ 5 mg twice daily. If taking XELJANZ XR 22 mg once daily, reduce to XELJANZ XR 11 mg once daily.

ADVERSE REACTIONS

The most common serious adverse reactions were serious infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical trials in patients with RA with XELJANZ 5 mg twice daily and placebo, respectively, (occurring in greater than or equal to 2% of patients treated with XELJANZ with or without DMARDs) were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension. The safety profile observed in patients with active PsA treated with XELJANZ was consistent with the safety profile observed in RA patients.  
 

Adverse reactions reported in ≥5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and ≥1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials for UC were: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.

USE IN PREGNANCY

Available data with XELJANZ use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal studies, tofacitinib at 6.3 times the maximum recommended dose of 10 mg twice daily demonstrated adverse embryo-fetal findings. The relevance of these findings to women of childbearing potential is uncertain. Consider pregnancy planning and prevention for females of reproductive potential.

*Unless otherwise stated, “XELJANZ” in the Important Safety Information refers to XELJANZ, XELJANZ XR, and XELJANZ Oral Solution.

 

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

Important Safety Information