ACTEMRA PACKAGE INSERT PDF

27 Oct PRODUCT MONOGRAPH. Pr. ACTEMRA. ® tocilizumab. 20 mg/mL Concentrate Solution for Infusion. mg/ mL Solution for Injection. 27 Oct Pronounced: ac-TEM-ra. This leaflet is part III of a three-part “Product ACTEMRA treatment should be initiated and supervised by specialist. Find valuable ACTEMRA® (tocilizumab) RA patient education information, including The majority resolved without any treatment and none necessitated drug.

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References

Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Some people have died from these infections.

The most commonly reported serious infections included pneumonia, gastroenteritis, varicella, and otitis media. In the open-label extension over an average duration of 73 weeks of treatment, the overall rate of serious infections was Adults weighing kg or more.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. For the treatment of active systemic juvenile idiopathic arthritis.

If tocilizumab is initiated or discontinued in a patient taking warfarin, check the Inser warfarin dose adjustment may be needed. For the treatment of active polyarticular juvenile idiopathic arthritis. Tell your healthcare provider right away if you are experiencing any side effects. Do not administer as an intravenous push or bolus.

Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Rheumatoid arthritis and giant cell arteritis, weighing kg or less: Tofacitinib may be used as monotherapy or concomitantly with methotrexate or other nonbiologic DMARDs.

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The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. The majority resolved without any treatment and none necessitated drug discontinuation.

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In patients with severe or life-threatening cytokine release syndrome CRS who also have cytopenias due to lymphodepleting chemotherapy or the CRS, consider the potential benefit of treating the CRS versus the risks of short-term treatment with tocilizumab. The rate of infections was Major Closely observe patients for signs of infection if immunosuppressive biologic agents such as Muromonab-CD3 are used concomitantly with tocilizumab. For example, the soluble IL-6 receptor can bind to IL-6 and can associate with gp to transduce the IL-6 signal into cells.

The most common ISRs were erythema, pruritus, pain, and actemta at the injection site. Elevated transaminases have been noted with tocilizumab, and drug interruption or discontinuation may be needed.

Your use of pqckage websites is at your own risk and subject to the terms and conditions of use for such sites. The total clearance is concentration-dependent and is the sum of the linear and nonlinear clearance. Cautious tocilizumab use is warranted by patients with diverticulitis.

Promptly evaluate patients presenting with new-onset abdominal symptoms for early identification of GI perforation. In the 6-month control period, in SC-I, the frequency of injection-site reactions was 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 ACTEMRA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

IL-6 is a proinflammatory cytokine that can cause malaise, fatigue, and anemia. Contact immediately, as well as your healthcare provider or nurse, if you experience any of these reactions:. Two additional patients inset MAS during the long-term extension.

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Using a dart-like motion, insert the needle at a 45 or 90 degree angle to the skin. A dose of mg subcutaneously once every other week, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations.

Bacterial, viral, and other infections due to opportunistic pathogens have been reported. Tocilizumab is onsert P-gp inhibitor, and may interact with P-gp substrates. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Dosage modifications may be required.

Moderate The formation of CYP enzymes may be suppressed by increased concentrations of cytokines such as IL-6 during chronic inflammation.

For the treatment of temporal arteritis, also known as giant cell arteritis GCA. Have appropriate medical treatment available for immediate use in the event of a serious hypersensitivity reaction.

Actemra (tocilizumab) dose, indications, adverse effects, interactions from

One of these events, urticaria, was considered serious. These elevations did not result in apparent permanent or clinically evident hepatic injury in clinical trials. Manage patients according to clinical guidelines [e. Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required.

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