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.

Author: Grogami Tami
Country: Spain
Language: English (Spanish)
Genre: History
Published (Last): 15 March 2008
Pages: 308
PDF File Size: 3.52 Mb
ePub File Size: 5.70 Mb
ISBN: 892-6-39334-224-4
Downloads: 86474
Price: Free* [*Free Regsitration Required]
Uploader: Kishura

Infections The rate of infections was ACTEMRA is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies.

PDR Search

In clinical trials, the frequency of serious infections among geriatric patients was higher as compared with the packags among younger adult patients. Click “OK” if you are a healthcare professional. The safety and efficacy of tocilizumab in infants and children less than 2 years of age have not been established. 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 inseet either drug.

ACTEMRA® (tocilizumab) RA Patient Education Materials

The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Laboratory Parameters Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests.

Have appropriate medical treatment available for immediate use actmera the event of a serious hypersensitivity reaction. A tocilizumab dose greater insedt mg per infusion is not recommended. Reporting side effects Tell your healthcare provider right away if you are experiencing any side effects. The most common ISRs were erythema, pruritus, pain, and acteemra at the injection site.

In contrast, the maximum tocilizumab concentration increased dose-proportionally. Adults, Adolescents, and Children 2 years old and older, weighing less than 30 kg.

  FRANZ BIEBL AVE MARIA PDF

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. Serious hypersensitivity reactions, including anaphylaxis, have been reported in association with infusion of tocilizumab.

Dosage modifications may be required. Yellow Fever Vaccine, Live: 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. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling Major Tocilizumab should be avoided in combination with other biologic DMARDs, including interleukin-1 receptor antagonists Ijsert such as anakinra because of the possibility of increased immunosuppression and increased infection risk.

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

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. Tocilizumab may have an effect on labor and obstetric actenra.

packkage Tocilizumab has been designated an orphan drug by the FDA for this indication. Remove the prefilled syringe from the refrigerator and allow it to sit at room temperature outside of the carton for 30 minutes. No data are available on the effectiveness of vaccination in patients receiving tocilizumab. Tocilizumab has not been studied in patients with moderate to severe renal impairment, but it appears that no dosage adjustments are needed. For the treatment of temporal arteritis, also known as giant cell arteritis GCA.

Initiate treatment for latent infection before tocilizumab use.

Patient Education and Training

In the open-label extension over an average duration of 73 weeks of treatment, the overall rate of infections was per patient-years. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

  HATHA YOGA PRADIPIKA SWAMI MUKTIBODHANANDA EPUB DOWNLOAD

It is expected that the formation of CYP enzymes could be normalized during tocilizumab receipt. A total of For ACTEMRA subcutaneous injection, advise achemra to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. Packaye example, before tocilizumab receipt by patients with rheumatoid arthritis, the exposure of dextromethorphan, a CYP2D6 and CYP3A4 substrate, was comparable to exposure packsge from healthy subjects, but exposure to its metabolite dextrorphan, a CYP3A4 substrate was a fraction of that observed in healthy subjects.

Tell your healthcare provider right away if you are experiencing any side effects. Patients should be closely monitored for the inserrt of signs and 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.

Only the intravenous route should be used for the treatment of CRS; subcutaneous administration is imsert approved for this use. Do not use unused product remaining in vials; tocilizumab does not contain preservatives. Most patients taking tocilizumab who developed serious infections were taking concomitant immunosuppressives.

Fully diluted tocilizumab solutions are compatible with polypropylene, polyethylene, and polyvinyl chloride infusion bags and polypropylene, polyethylene, and glass infusion bottles.

The concentration-dependent nonlinear clearance plays a major role at low concentrations. Also, test patients for latent tuberculosis before and during tocilizumab receipt. Most patients who developed serious infections were taking concomitant immunosuppressives such as methotrexate or corticosteroids. In patients who develop an ANC less than per mm 3 treatment is not recommended. In PJIA patients, infusion-related acremra are defined as all events occurring during or within 24 hours of an infusion.