GHP April 2016

ghp April 2016 | 51 Research & Development Worsening and new onset congestive heart failure (CHF) and increased mortality due to CHF have been reported with another TNF blocker. Simponi has not been studied in patients with CHF. Simponi should be used with caution in patients with mild heart failure and must be discontinued if new or worsening symp- toms of heart failure appear.9 TNF-blocking agents, including Simponi, have been associated in rare cases with new onset or exacer- bation of demyelinating disorders, including multiple sclerosis. The benefits and risks of anti-TNF treatment should be carefully considered before initiation of Simponi therapy in patients with pre-existing or recent onset of demyelinating disorders.9 There is limited safety experience of Simponi treatment in patients who have undergone surgical procedures, including arthroplasty. A patient who requires surgery while on Simponi should be closely monitored for infections, and appropriate actions should be taken.9 The possibility exists for TNF-blocking agents, includ- ing Simponi, to affect host defenses against infections and malignancies. Treatment with Simponi may result in the formation of auto-antibodies and, rarely, in the development of a lupus-like syndrome.9 There have been postmarketing reports of pancyto- penia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF block- ers. Cytopenias including pancytopenia, have been infrequently reported with Simponi in clinical trials. Discontinuation of Simponi should be considered in patients with significant hematologic abnormalities.9 The concurrent administration of TNF-antagonists with anakinra or abatacept is not recommended. Concurrent administration has been associated with increased infections, including serious infections without increased clinical benefit.9 Patients treated with Simponi may receive concurrent vaccinations, except for live vaccines. Non-serious allergic reactions associated with Simponi occurred in clinical trials, and included urticaria, bronchospasm, and hypersensitivity. In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following Simponi administration. Some of these reactions occurred after the first administration of Simponi. If an anaphylactic reaction or other serious allergic reactions occur, administration of Simponi should be discontinued immediately and appropriate therapy initiated.9 The needle cover on the syringe in the pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individu- als sensitive to latex. Simponi also contains sorbitol; patients with rare hereditary problems of fructose intolerance should not take Simponi. All patients should be monitored for anaphylactic or other serious allergic reactions.9 Patients should be given detailed instructions on how to administer Simponi. After proper training, patients may self-inject if their physician determines that this is appropriate. The full amount of Simponi should be administered at all times. Mild injection site reactions commonly occur. In case of severe reaction(s) Sim- poni should be discontinued.9 Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least six months after the last Simponi treatment. Women must not breastfeed during and for at least six months after Simponi treatment.9 The most common adverse reaction reported from the controlled period of pivotal trials was upper respiratory tract infection (12.6 percent of Simponi -treated pa- tients compared with 10.7 percent in control-treated patients). In the controlled period of pivotal trials, 5.1 percent of Simponi treated patients had injection site reactions compared with 2.0 percent in control-treated patients. The majority of the injection site reactions were mild and moderate, and the most frequent mani- festation was injection site erythema.9 The Simponi Patient Alert Card provides safety information to the patient. It should be given and ex- plained to all patients before treatment. Patients must show the Alert Card to any doctor involved in his/her treatment, during and up to six months after Simponi treatment.9 For complete EU prescribing information, please visit www.ema.europa.eu References: 1. Dalén J, Svedbom A, Black CM, et al. Treatment persistence among patients with immune-mediat- ed rheumatic disease newly treated with subcuta- neous TNF-alpha inhibitors and costs associated with non-persistence. Rheumatol Int. Advance online publication. doi: 10.1007/s00296-016- 3423-5. 2. Cramer JA, Roy A, Burrell A, et al. Medication compliance and persistence: terminology and definitions. Value Health 2008;11:44-47. 3. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-481. 4. Mayo Clinic. Rheumatoid arthritis website. Availa- ble at: http://www.mayoclinic.org/diseases-condi- tions/rheumatoid-arthritis/basics/symptoms/con- 20014868?p=1. Last accessed January 2016. 5. World Health Organisation (WHO). Chronic rheu- matic conditions website. Available at: http://www. who.int/chp/topics/rheumatic/en. Last accessed January 2016. 6. American College of Rheumatology (ACR). Psoriatic arthritis website. Available at: http://www. rheumatology.org/I-Am-A/Patient-Caregiver/Dis- eases-Conditions/Psoriatic-Arthritis. Last accessed January 2016. 7. American College of Rheumatology (ACR). Spon- dylarthritis (Spondylarthropathy) website. Available at: https://www.rheumatology.org/Practice/Clinical/ Patients/Diseases_And_Conditions/Spondylarthri- tis_(Spondylarthropathy)/. Last accessed January 2016. 8. National Ankylosing Spondylitis society (NASS) website. Available at: http://nass.co.uk/. Last accessed January 2016. 9. SIMPONI. Summary of product characteristics. Available at: https://www.medicines.org.uk/emc/ medicine/23766. Last accessed January 2016.