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Inflecta for the treatment of inflammatory conditions: important safety information


Inflectra, a biosimilar medicine to the reference medicinal product, Remicade ( Infliximab ), has been approved for the treatment of inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis.
Inflectra is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF-alpha but not to lymphotoxin alpha ( TNF-beta ).

There are reports of serious infections, including tuberculosis ( TB ), sepsis and pneumonia, in patients taking Inflecta. Some of these infections have been fatal. Patients should tell their doctors if they have had recent or past exposure to people with tuberculosis. Their doctors will evaluate them for tuberculosis and may perform tests for disease. If patients have latent ( inactive ) tuberculosis, their doctors should begin tuberculosis treatment before they start Inflecta.

Inflecta 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 Inflecta, 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 Inflecta 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 Inflecta 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 Inflecta 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 Inflecta; 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 Inflecta. 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 Inflecta 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 Inflecta. 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 Inflecta.

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. Inflecta should not be administered to patients with known hypersensitivity to Infliximab or any component of Inflecta. Patients should tell their doctors if they have experienced a severe allergic reaction. The most common side effects of Inflecta are: viral infections, headache, upper respiratory-tract infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain. ( Xagena )

Source: Hospira, 2013

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