“In clinical trials, XELJANZ demonstrated consistent efficacy across a broad range of clinical measures and patient types, including patients who inadequately responded to non-biologic DMARDs and anti-TNF agents, and it has a safety profile that is well-characterized to date,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer. “We are proud of the comprehensive data that support the use of XELJANZ, and we are excited to make it available to patients in the U.S. as a powerful oral option that can be taken as a second-line treatment with or without methotrexate.”Safety findings observed in the overall XELJANZ RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; decreased hemoglobin; liver enzyme elevations; and lipid elevations. The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, diarrhea and nasopharyngitis. Regarding the potential for further assessment by the FDA of the inhibition of structural damage, Pfizer plans to immediately discuss with the FDA the submission of the results of the previously disclosed ORAL Start (A3921069) study, which demonstrated significant efficacy of XELJANZ taken as monotherapy versus methotrexate, including inhibiting structural damage. The ORAL Start study was ongoing at the time of the New Drug Application submission and was not included in the original application to the FDA. In the clinical trials, XELJANZ was studied in both a 5 mg and 10 mg twice-daily dosing regimen. The FDA has approved the 5 mg twice-daily dose in the second-line setting and has indicated that further data are required to assess the benefit: risk profile of the 10 mg twice-daily dose. Pfizer will continue to generate additional clinical data on the 10 mg twice-daily dose and work with the FDA to understand the additional data needed for further assessment of the 10 mg twice-daily dose.
FDA has approved XELJANZ with a Risk Evaluation and Mitigation Strategy (REMS) designed to inform healthcare providers and patients about the serious risks associated with XELJANZ treatment. The approved REMS includes a Medication Guide for patients, a communication plan for healthcare providers and pharmacists, and periodic submissions of assessments of the REMS. Pfizer has agreed to conduct post-marketing clinical trials to evaluate the long-term safety of XELJANZ and to assess XELJANZ in the pediatric population with polyarticular juvenile idiopathic arthritis (JIA).For full prescribing information, including boxed warning and Medication Guide, please visit www.XELJANZ.com . About XELJANZ XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is used to treat adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well.
- It is not known if XELJANZ is safe and effective in people with hepatitis B or C.
- XELJANZ is not for people with severe liver problems.
- It is not known if XELJANZ is safe and effective in children.
- XELJANZ can lower the ability of the immune system to fight infections. Some people have serious infections while taking XELJANZ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Healthcare providers should test patients for TB before starting XELJANZ, and monitor them closely for signs and symptoms of TB and other infections during treatment.
- XELJANZ may increase the risk of certain cancers by changing the way the immune system works. Lymphoma and other cancer can happen in patients taking XELJANZ.
- Some people taking XELJANZ get tears in their stomach or intestines. Patients should tell their healthcare provider right away if they have fever and stomach-area pain that does not go away or a change in bowel habits.
- XELJANZ can cause changes in certain lab test results including low blood cell counts, increases in certain liver tests and increases in cholesterol levels. Normal cholesterol levels are important to good heart health. Healthcare providers may stop XELJANZ treatment because of changes in blood cell counts or liver test results.
- Patients should tell their healthcare providers if they plan to become pregnant or are pregnant.
- It is not known if XELJANZ will harm an unborn baby. To monitor the outcomes of pregnant women exposed to XELJANZ, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.
- Patients should tell their healthcare providers if they plan to breastfeed or are breastfeeding. Patients and their healthcare provider should decide if they will take XELJANZ or breastfeed. They should not do both.
- In carriers of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while using XELJANZ. Healthcare providers may do blood tests for hepatitis before and during treatment with XELJANZ.
- Common side effects include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis).
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