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ACTEMRA PACKAGE INSERT PDF

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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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If tocilizumab is initiated or discontinued in a patient taking warfarin, check the INR; warfarin dose adjustment may be needed. CRS, weighing less than 30 kg: Also, a switch to another non-TNF biologic is an option for patients with moderate or high disease activity after 6 or more months of rituximab or abatacept or with a non-serious adverse event to either drug.

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The concentration-dependent nonlinear clearance plays a major role at low concentrations. The effect of tocilizumab on CYP enzyme activity may persist for several weeks after stopping therapy In packag, tocilizumab has the potential to affect expression of multiple CYP enzymes, including CYP3A4.

For ACTEMRA subcutaneous injection, advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction.

Major Tocilizumab use should be avoided in combination with biologic DMARDs, including interleukin-1 receptor IL-1Ra inswrt such as abatacept because of the possibility of increased immunosuppression and increased infection risk. If you have systemic juvenile idiopathic arthritis SJIA you will have blood tests done every 2 to 4 weeks during treatment.

Patient Education and Training

Consider checking other liver function tests LFTs such as bilirubin when clinically indicated. Closely monitor patients for signs and symptoms potentially indicative of demyelinating disorders. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling Persistent hepatic enzyme elevations during therapy may require dose interruption or consideration of drug discontinuation, depending on the clinical abnormality and severity.

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The majority resolved without any treatment and none necessitated drug discontinuation. No data are available on the effectiveness of vaccination in patients receiving tocilizumab. This may affect immune response in the in utero exposed infant; consider risks and benefits prior to administering live or live-attenuated vaccines to neonates or infants exposed to tocilizumab in utero.

Intravenous Infusion Administration Allow the fully diluted tocilizumab solution to reach room temperature before infusion if it has been refrigerated. Administer the first injection acte,ra tocilizumab under the supervision of a qualified health professional. The most common events observed were nasopharyngitis and upper respiratory tract infections.

If tocilizumab is initiated or discontinued in a patient taking tacrolimus, check the drug concentration; tacrolimus dose adjustment may be needed. Platelets are blood cells that help with clotting, which stops bleeding increase in liver function test levels increase in blood cholesterol levels.

No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving tocilizumab. Tell your healthcare provider if you have these or any other side effect that bothers you or does not go away:. Thanks for sharing this page. Infections The rate of infections was 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.

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The rate of infections was For the treatment of active polyarticular juvenile idiopathic arthritis. Infections The rate of infections was The impact of tocilizumab on atemra development of malignancies is unknown, but malignancies were observed in clinical studies.

Children and Adolescents 2 to 17 years weighing less than 30 kg. 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.

Actsmra hypersensitivity reactions, including anaphylaxis, have been reported in association with infusion of tocilizumab. Do not administer tocilizumab to a patient with an active infection including localized infections. These injection-site reactions were mild to moderate in severity. 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.

ACTEMRA® (tocilizumab) RA Patient Education Materials

Bacterial, viral and other infections due to opportunistic pathogens. To learn more, call or talk to your healthcare provider to register.

For example, before tocilizumab receipt by patients with rheumatoid arthritis, the exposure of dextromethorphan, a CYP2D6 and CYP3A4 substrate, was comparable to exposure data from healthy subjects, but exposure to its metabolite dextrorphan, a CYP3A4 substrate was a fraction of that observed in healthy subjects.