Find valuable ACTEMRA® (tocilizumab) information, including an ACR= American College of Rheumatology; DMARD=disease-modifying antirheumatic drug. Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Actimmune (tocilizumab). 27 Oct PRODUCT MONOGRAPH. Pr. ACTEMRA. ® tocilizumab. 20 mg/mL Concentrate Solution for Infusion. mg/ mL Solution for Injection.
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Your cholesterol levels should be checked 4 to 8 weeks after the start of your treatment, and then every 6 months after that. Recommended SJIA Dosage Every 2 Weeks Patients less than 30 kg weight 12 mg per kg Patients at or above 30 kg weight 8 mg oackage kg A change in dose should not be made based solely on a single visit body weight measurement, as weight may fluctuate.
Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Withdraw a volume of 0. Bacterial, actemra package insert and other infections due to opportunistic pathogens. Bacterial, viral and other inssrt due to opportunistic pathogens. Injectable solutions of ACTEMRA are formulated in an aqueous solution containing disodium actemra package insert dodecahydrate and sodium dihydrogen phosphate dehydrate as a 15 mmol per Inseft phosphate buffer actemra package insert, polysorbate 80 0.
The four polypeptide chains are linked intra- and inter-molecularly by disulfide actemra package insert. You may also have changes in other laboratory tests, such as your actemra package insert cholesterol levels. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. If visibly opaque particles, discoloration or other foreign particles are observed, the solution should not be used.
Infection signs, with or without a fever, include sweating or chills; shortness of breath; warm, red or painful skin or sores on your body; feeling very tired; muscle aches; blood in phlegm; diarrhea or stomach pain; cough; weight loss; burning when you urinate or urinating more often than normal Any of the following conditions that may give you a higher chance of getting infections.
Rheumatoid Arthritis Treatment | ACTEMRA® (tocilizumab)
Tell your healthcare provider right actemra package insert if you see any of these side effects: Promptly evaluate patients presenting with new-onset abdominal symptoms for early identification of GI perforation. Tell your healthcare provider right away if you see any signs of these actemra package insert ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Platelets are blood cells that help with clotting, which stops bleeding increase in liver function test levels increase in blood cholesterol levels.
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General Considerations for Administration: In the open-label extension over actemra package insert average duration of 73 weeks of treatment, the overall rate of infections was per patient-years.
Physicians are encouraged to register patients actemra package insert pregnant women are encouraged to register themselves by calling actrmra Dosage Modifications ACTEMRA treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Patients treated with ACTEMRA are at increased risk actemra package insert developing serious infections that may actemmra to hospitalization or death, including tuberculosis TBbacterial, invasive fungal, viral, or other opportunistic infections.
The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or actemra package insert infection.
Contact immediately, as well as your healthcare provider or nurse, if actemra package insert experience any of these reactions:. Some people have died from these infections. Learn how it may help your RA symptoms.
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Serious allergic reactions, including death, can happen with ACTEMRA infusions or injections, even if actemra package insert did not occur with an earlier infusion or injection. If you had hives, a rash, or experienced flushing after injecting, you should tell your healthcare provider or nurse before your next injection. Monitor patients for signs and symptoms of demyelinating disorders. The purpose of this registry is actemra package insert check the health of the pregnant mother and her baby.
Individually packaged, single-use vials: You should not do both. If you have polyarticular juvenile idiopathic arthritis PJIA you will have blood tests done every 4 to 8 weeks during treatment. Gastrointestinal GI perforation — use with caution in patients who may be at increased risk. Patients should be closely monitored actemra package insert the development of signs acteemra symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Systemic Juvenile Idiopathic Arthritis Patients less than 30 kg: Reporting side effects Tell your healthcare provider right away if you are experiencing any side effects. Laboratory Parameters Laboratory monitoring is recommended due to potential consequences of treatment-related packafe abnormalities in neutrophils, platelets, lipids, and liver function tests. Demyelinating Disorders The impact of treatment with ACTEMRA on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in clinical studies.
The most common events observed were nasopharyngitis and upper respiratory tract infections.
Laboratory monitoring — recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests.
Increased blood pressure also called hypertension.
ACTEMRA for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis.
This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. Thanks for actemra package insert this page. Your healthcare provider may stop your ACTEMRA treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results.
Actemra package insert risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. In PJIA patients, infusion-related reactions are defined as all events occurring during or within 24 hours of an infusion.
Events of gastrointestinal GI perforation have been reported in clinical trials, primarily as complications of diverticulitis in RA patients. When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg followed by an increase to 8 actemra package insert per kg based on clinical response. Patients with invasive fungal actemra package insert may present with disseminated, rather than localized, disease.
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