Positive health story opportunity: Monday 5 July 2021
Interviews and video content available
- XELJANZ® is a medicine for the treatment of adults living with moderate-to-severely active ulcerative colitis (UC)1
- XELJANZ® is an oral treatment alternative for patients with moderate-to-severe UC1
- Approximately 87,000 Australians currently live with inflammatory bowel disease, which includes UC2
- International research has shown that the majority of patients feel their condition controls their lives, including their employment4
SYDNEY, AUSTRALIA 5 July 2021 — Pfizer Australia has welcomed the Federal Government's announcement that XELJANZ® (tofacitinib citrate) will be available to eligible Australians living with moderate-to-severe ulcerative colitis (UC) from July 2021.
XELJANZ® is a twice daily oral medicine and is classified as a JAK (Janus kinase) inhibitor. The active ingredient, tofacitinib citrate, limits the activation of the immune system that is involved in auto-immune conditions, such as ulcerative colitis and other inflammatory conditions.1
Ulcerative colitis is one of the two major inflammatory bowel diseases which in total affect approximately 87,000 Australians2. UC is characterised by chronic inflammation of the innermost lining of the large intestine and can cause bleeding, diarrhoea, urgency of bowel movements, abdominal pain, tiredness and weight loss.3
Data from an international survey conducted as part of the UC Narrative initiative4 showed that the majority of patients with moderate-to-severe UC found the condition mentally exhausting (84%). Respondents also felt their condition controlled their lives (65%), with most patients spending more time in the bathroom than anywhere else (67%).
The majority of survey respondents (83%) confirmed that ulcerative colitis impacted their work, with some reporting diagnoses of anxiety (21%) or depression (15%).4
The reimbursement of XELJANZ® reflects Pfizer Australia's ongoing effort to bring innovative treatments to market for Australian patients.
According to Professor Jakob Begun, a leading specialist for inflammatory bowel disease, this PBS listing is an important step that has the potential to help many Australian patients experiencing the burden of the disease.
"Ulcerative colitis is a chronic inflammatory condition of the large bowel characterised by 'flares', which can be unpredictable and have a debilitating impact on a patient's physical, social and emotional wellbeing. This announcement from the government will provide clinicians caring for these patients the ability to explore additional treatment options," said Professor Begun.
Crohn's and Colitis Australia, a not-for-profit organisation representing the inflammatory bowel disease community, also welcomed the news today.
"Inflammatory bowel disease continues to have a devastating effect on our community. Given the high prevalence of these conditions and broad range impact on daily lives, it is important that we continue to look at ways to improve treatments and support for people living with ulcerative colitis," said Leanne Raven, CEO of Crohn's and Colitis Australia.
Pfizer Australia and New Zealand Managing Director, Anne Harris, said today is a significant step forward in delivering innovative medicines to patients and clinicians.
"We thank the Government for recognising the need to deliver additional solutions to those living with this condition and the burden of ill health. We are proud to be playing a positive role in developing and supplying emerging treatments for patients with inflammatory bowel disease," said Ms Harris.
About XELJANZ®1
XELJANZ® is a medicine that is used to treat the following inflammatory diseases in adult patients:
- rheumatoid arthritis
- psoriatic arthritis
- ulcerative colitis
XELJANZ® contains the active ingredient tofacitinib. Tofacitinib belongs to a group of medicines called Janus kinase (JAK) inhibitors. This medicine blocks the activation of parts of your immune system involved in rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. XELJANZ® works by helping to reduce inflammation.
Rheumatoid arthritis
XELJANZ® is used to treat adult patients with moderate-to-severe active rheumatoid arthritis, a long-term disease that mainly causes pain and swelling of your joints. XELJANZ® may be used alone or in combination with other oral medicines (such as methotrexate) when used to treat rheumatoid arthritis.
Psoriatic arthritis
XELJANZ® is used to treat adult patients with active psoriatic arthritis, an inflammatory disease of the joints that is often accompanied by psoriasis. XELJANZ® should be used in combination with other oral medicines (such as methotrexate) when used to treat psoriatic arthritis.
Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large bowel. If you have ulcerative colitis, you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, your doctor may give you XELJANZ® to reduce the signs and symptoms of your disease. XELJANZ® may be used together with other medicines, such as corticosteroids and aminosalicylates, to treat ulcerative colitis. Your doctor will tell you which of these other medicines you should use.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. This medicine is only available on a prescription from your specialist doctor. The safety and effectiveness of this medicine in children and adolescents have not been established.
Important Safety Information
Therapy with XELJANZ® should be prescribed and monitored by a specialist physician with expertise in the management of ulcerative colitis, rheumatoid arthritis and psoriatic arthritis.
XELJANZ® must not be used in combination with biological medicines or other medicines used to strongly suppress the immune system. It should also not be used in a patient who is allergic to the active ingredient, tofacitinib, or any other ingredient of XELJANZ®. XELJANZ® must also not be used in patients with severe liver problems.
Before starting XELJANZ®, patients will be screened for tuberculosis and monitored during treatment. Patients who are carriers of the hepatitis B or C virus may get active infection while taking XELJANZ®. Patients should complete all appropriate immunisations according to the immunisation guidelines. Live vaccines should not be given with XELJANZ®. Some medicines may be affected by XELJANZ® or may affect how well it works.
XELJANZ® should not be used during pregnancy or breastfeeding, or when planning to conceive. Using an effective birth control during treatment and after the last dose is recommended.
Common side effects of XELJANZ® include nose and throat infections, cold and flu, headache, dizziness, cough, stomach pain, nausea, joint or back pain, weight gain, cold sores, and red or itchy skin. Some patients have had a reduction in the number of white or red blood cells, increase in liver function test results and increase in cholesterol level.
XELJANZ® may reduce your body's ability to respond to infections, worsen an existing infection or increase the chance of getting a new infection, including a serious infection. Inflammation in parts of the large intestine, or ulcers in the stomach or intestines have also been reported with treatment. Regular skin checks will be conducted in patients as XELJANZ® may increase the risk of skin cancer.
XELJANZ® should be taken at the lowest effective dose and for the shortest duration needed for the treatment of ulcerative colitis. Patients taking the higher dose (10 mg twice a day) of XELJANZ® may have a higher risk of certain side effects, including serious infections, shingles, skin cancers other than melanoma, blood clots and death. An increased risk of blood clots and death has been seen in patients with rheumatoid arthritis, who are 50 years of age and older with at least one additional heart disease (cardiovascular) risk factor. Patients over 65 years old, those with diabetes or chronic lung disease may have an increased risk of infections. Asian patients may have an increased risk of shingles or lung problems.
Patients should inform their healthcare provider if they have had heart problems. An increased rate of major cardiovascular events (MACE) and cancers for XELJANZ® has been seen in rheumatoid arthritis patients who are 50 years of age or older with at least one additional cardiovascular risk factor.
Review the Consumer Medicine Information here for additional safety information on XELJANZ®.
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.
