ACTEMRA PACKAGE INSERT PDF

In the 6-month control period, in SC-I, the frequency of injection-site reactions was In SC-II, the frequency of injection-site reactions was 7. These injection-site reactions were mild to moderate in severity. The majority resolved without any treatment and none necessitated drug discontinuation. Infections The rate of infections was The rate of serious infections was 9.

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In the 6-month control period, in SC-I, the frequency of injection-site reactions was In SC-II, the frequency of injection-site reactions was 7. These injection-site reactions were mild to moderate in severity. The majority resolved without any treatment and none necessitated drug discontinuation.

Infections The rate of infections was The rate of serious infections was 9. The most common events observed were nasopharyngitis and upper respiratory tract infections. Infusion Reactions In PJIA patients, infusion-related reactions are defined as all events occurring during or within 24 hours of an infusion. The most common events occurring during infusion were headache, nausea and hypotension, and occurring within 24 hours of infusion were dizziness and hypotension.

During the 1-year study, a frequency of These ISRs occurred in a greater proportion of patients at or above 30 kg There was no clear relationship between decreases in neutrophils below 1 x per L and the occurrence of serious infections.

In the open-label extension over an average duration of 73 weeks of treatment, the overall rate of infections was per patient-years. In the open-label extension over an average duration of 73 weeks of treatment, the overall rate of serious infections was The most commonly reported serious infections included pneumonia, gastroenteritis, varicella, and otitis media. Two additional patients developed MAS during the long-term extension. One of these events, urticaria, was considered serious.

A total of The most common ISRs were erythema, pruritus, pain, and swelling at the injection site. The majority of ISRs reported were Grade 1 events and all ISRs reported were non-serious and none required patient withdrawal from treatment or dose interruption.

Cytochrome Ps in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling The limited available data with ACTEMRA in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage.

You may also report side effects to Genentech at Jones G, et al. Ann Rheum Dis. Kremer JM, et al. Arthritis Rheumatol. Maini RN, et al. Arthritis Rheum. Bykerk VP, et al. Dougados M, et al.

Weinblatt ME. Arthritis Care Res. Ogata A, et al. Gabay C, et al. Emery P, et al. Burmester GR, et al. Genovese MC, et al. Data on file. Clinical Study Report. Genentech, Inc. Kivitz A, et al. Smolen JS, et al.

De Benedetti F, et al. N Engl J Med. Brunner HI, et al. Yazici Y, et al. Bingham CO, et al. Scheller J, et al. Med Microbiol Immunol. McGrath H, et al. Browning JL, et al. Nat Rev Discov. Choy, E, et al. Rheum Dis Clin N Am.

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WARNING: RISK OF SERIOUS INFECTIONS

In the 6-month control period, in SC-I, the frequency of injection-site reactions was In SC-II, the frequency of injection-site reactions was 7. These injection-site reactions were mild to moderate in severity. The majority resolved without any treatment and none necessitated drug discontinuation. Infections The rate of infections was

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This can make you more likely to get infections or make any current infection worse. Some people have serious infections while taking ACTEMRA, including tuberculosis TB , and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Before starting ACTEMRA, tell your healthcare provider if you have: an infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return.

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