Important Prescribing Information - Temporary Supply Shortage Actemra 20 mg/mL Concentrate for Solution for Infusion (IV) September 2021
Apr 2020 - Shipping short-dated Actemra (tocilizumab) 400 mg/20 mL vial for IV with dark blue cap
IMPORTANT SAFETY INFORMATION Regarding ACTEMRA® (tocilizumab) REMS, October 2013
Actemra for RA and SJIA - June 2011
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
ACTEMRA is indicated for the treatment of giant cell arteritis (GCA) in adult patients.
ACTEMRA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.
ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older.
ACTEMRA is indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
ACTEMRA is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
RISK OF SERIOUS INFECTIONS:
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
Reported infections include:
The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development 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.
ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.
Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations. Use ACTEMRA with caution in patients who may be at risk for GI perforations.
Monitor patients for signs and symptoms of hepatic injury. Modify or discontinue ACTEMRA if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests.
Hypersensitivity reactions, including anaphylaxis and death, have occurred.
Avoid use of live vaccines concurrently with ACTEMRA, as clinical safety has not been established.
Other potential risks of ACTEMRA include demyelinating disorders and malignancies.
Treatment with ACTEMRA is not recommended in patients with active hepatic disease or hepatic impairment.
Most common adverse reactions (≥ 5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions (SC only).
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see additional Important Safety Information in accompanying full Prescribing Information, including BOXED WARNING.