There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia, in patients taking Inflectra. Some of these infections have been fatal. Patients should tell their doctors if they have had recent or past exposure to people with TB. Their doctors will evaluate them for TB and may perform tests for TB. If patients have latent (inactive) TB, their doctors should begin TB treatment before they start Inflectra. Inflectra can lower patients' ability to fight infections, so if they are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu-like symptoms or warm, red or painful skin while taking Inflectra, patients should tell their doctors right away. Also, patients should tell their doctors if they are scheduled to receive a vaccine or if they have lived in a region where histoplasmosis, blastomycosis or coccidioidomycosis are common.
Reports of a type of blood cancer called lymphoma in patients on Inflectra or other TNF blockers are rare, but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Rarely, children and young adults who have been treated for Crohn's disease or ulcerative colitis with Inflectra in combination with azathioprine or 6-mercaptopurine have developed a rare type of lymphoma, hepatosplenic T cell lymphoma (HSTCL) that often results in death. Patients taking Inflectra or other TNF blockers may be at an increased risk for developing lymphoma or other cancers. Patients should also tell their doctors if they have had or develop lymphoma or other cancers or if they have a lung disease called chronic obstructive pulmonary disease (COPD).
Many people with heart failure should not take Inflectra; so prior to treatment they should discuss any heart condition with their doctors. Patients should tell their doctors right away if they develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of ankles or feet, or sudden weight gain).
Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as Inflectra. Some of these cases have been fatal. All patients should be screened for signs of an infection and a hepatitis B expert should be consulted if a patient tests positive for hepatitis B surface antigen.
There have been rare cases of serious liver injury in people taking infliximab, some fatal. Patients should tell their doctors if they have liver problems and contact their doctors immediately if they develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue.
Blood disorders in people taking Inflectra have been reported, some fatal. Patients should tell their doctors if they develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking Inflectra. Nervous system disorders have also been reported. Patients should tell their doctors if they have or have had a disease that affects the nervous system, or if they experience any numbness, weakness, tingling, visual disturbances or seizures while taking Inflectra.
Allergic reactions, some severe have been reported during or after infusions with infliximab. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Inflectra should not be administered to patients with known hypersensitivity to Inflectra or any component of Inflectra. Patients should tell their doctors if they have experienced a severe allergic reaction. The most common side effects of Inflectra are: viral infections, headache, upper respiratory-tract infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
About Hospira
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness(TM) by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill. Learn more at www.hospira.com.
The head office for Hospira in Europe, Middle East and Africa is in Hurley, UK.
Private Securities Litigation Reform Act of 1995 -- A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Hospira's biosimilars program and approval in Europe of Inflectra. Hospira cautions that these forward-looking statements are subject to risks and uncertainties, including adequate and sustained progress on the company's quality initiatives and device strategy that may cause actual results to differ materially from those indicated in the forward-looking statements. Other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K, filed with the U.S. Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments, except as required by law.
References
1. Gecse K, et al. Biosimilar infliximab in inflammatory bowel disease: first interim results from a prospective nationwide observational cohort. Abstract P314. Presented February 2015 at ECCO-ibd, Barcelona, Spain. 2. Kim J, et al. 5 year budget impact analysis of CT-P13 (infliximab) for the treatment of Crohn's disease in UK, Italy and France. Abstract P137. Presented February 2015 at ECCO-ibd, Barcelona, Spain. 3. The European Federation of Crohn's and Ulcerative Colitis Associations. What is IBD? Available at: www.efcca.org/index.php/about-efcca/what-are-ibd. Last accessed February 2015. 4. Putrik P, Ramiro S, Kvien TK et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014. Jan; 73(1): 198-206. 5. Weise M. et al. Biosimilars: what clinicians should know. Blood. 2012; 120: 5111-5117. 6. Danese S, Colombel J, Reinisch W et al. Review article: infliximab for Crohn's disease treatment -- shifting therapeutic strategies after 10 years of clinical experience. Alimentary Pharmacology and Therapeutics. 2011; 33: 857-869. 7. EMA. Inflectra European Public Assessment Report -- Summary for the public. EMA/402688/2013. Available at http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicin es/002778/human_med_001677.jsp. Last accessed January 2015. 8. Inflectra (infliximab). Summary of Product Characteristics. 2014.
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