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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Younger than 2 years: A tocilizumab dose greater than mg per infusion is not recommended. The fully diluted tocilizumab solutions for infusion using 0. Consider the risks and benefits of tocilizumab before treatment initiation in patients with a known malignancy. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling ACTEMRA is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies.

To learn more, call or talk to your healthcare provider to register. The formation of CYP enzymes may be suppressed by increased concentrations of cytokines such as IL-6 during chronic inflammation. Major Avoid using tocilizumab with other biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection. Your email has been sent!

Tell your healthcare provider right away if you see any of these side effects: Varicella-Zoster Virus Vaccine, Live: Patient Education and Training. The gpmediated IL-6 signaling pathway works even for cells that do not express the IL-6 receptor on their surface. For the treatment of temporal arteritis, also known as giant cell arteritis GCA. Most patients taking tocilizumab who developed serious infections were taking concomitant immunosuppressives such as systemic corticosteroids.

Withdraw the amount of tocilizumab for intravenous infusion from the vial s and slowly add to the infusion bag or bottle. Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required.

Do not administer tocilizumab to a patient with an active infection including localized infections.

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Monoclonal antibodies, like tocilizumab, are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Clinically relevant drug interactions may occur with CYP substrates that have a narrow therapeutic index such as warfarin.

References

Maternal immunoglobulin G IgG is present in human milk. In PJIA patients, infusion-related reactions are defined as all events occurring during or within 24 hours of an infusion. The prefilled syringe is for single-use only, as it does not have a preservative. Most patients who developed serious infections were taking concomitant immunosuppressives such as methotrexate or corticosteroids. If you had hives, a rash, or experienced flushing after injecting, you should tell your healthcare provider or nurse before your next injection.

Events of gastrointestinal GI perforation have been reported in clinical trials, primarily as complications of diverticulitis in RA patients.

Click “OK” if you are a healthcare professional. Cytochrome Ps in the liver are down-regulated by infection insertt inflammation stimuli including cytokines such as IL The information contained in this section of the site is intended for U.

Moderate Monitor for clinical response in patients taking everolimus concurrently with tocilizumab. IL-6 is involved in diverse physiological processes such as T-cell activation, immunoglobulin secretion induction, hepatic acute phase protein synthesis initiation, and hematopoietic precursor cell proliferation and differentiation stimulation.

Utilize caution when using tocilizumab in combination with CYP3A4 substrate drugs where a decrease in effectiveness is undesirable. Among patients with a body weight of at least kg, the mean exposure values were higher than those from jnsert patient population. Steady-state was reached after the first dose for Cmax, after the second dose for AUC, and after the aftemra dose for Cmin.

The most common serious adverse reactions were serious infections. Increase to mg subcutaneously once weekly based on clinical response.

Tell your healthcare provider right actemrq if you see any signs of these symptoms:. Your email has been sent! Intravenous Infusion Administration Allow the fully diluted tocilizumab solution to reach room temperature before infusion if it has been refrigerated.

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Rheumatoid Arthritis Treatment | ACTEMRA® (tocilizumab)

Utilize caution when using tocilizumab in combination with CYP3A4 substrate drugs where a decrease in effectiveness is undesirable such as atorvastatin. 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. Laboratory Parameters Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests.

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. Dextromethorphan; Guaifenesin; Potassium Guaiacolsulfonate: Use caution when using tocilizumab in combination with CYP-metabolized drugs where a decrease in effectiveness is undesirable.

ACTEMRA® (tocilizumab) RA, SJIA & PJIA References

Infants, labor, neonates, obstetric delivery, pregnancy. If tocilizumab is initiated or discontinued in a patient taking tacrolimus, check the drug concentration; tacrolimus dose adjustment may be needed. Tocilizumab may be used alone following discontinuation of glucocorticoids.

Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: Sweating or chills Shortness of breath Warm, red or painful skin or sores qctemra your body Feel 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.

An infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Avoid use of live vaccines concurrently with tocilizumab as clinical safety has not been established. Onsert Chlorpheniramine; Dextromethorphan; Pseudoephedrine: Genentech does not recommend and does not endorse the content on any third-party websites.