Actemra Side Effects & Safety
The safety of Actemra in RA was evaluated on the basis of results from all registration trials in which 4,009 patients received at least one dose of Actemra. 3,577 patients received treatment for 6 months or more, 3,309 for 1 year or more, 2,954 for 2 or more years, and 2,189 for 3 years. The most common serious side effects or adverse reactions were serious infections. The percentage of patients who stopped treatment due to any adverse reaction during trials was 5% for Actemra and 3% for placebo with the most common causes of treatment discontinuation being serious infections and elevated liver enzymes (indicating decreased liver function). The most common side effects occurring in at least 5% of patients who received Actemra were upper respiratory tract infections, nasopharyngitis, headache, hypertension, and increased alanine transaminases (ALT).
Side effects with Actemra from 24 week Phase 3 controlled studies
|Actemra 8 mg/kg alone (N=288)||MTX (N=284)||Actemra 4 mg/kg + DMARDs (N=774)||Actemra 8 mg/kg + DMARDs (1,582)||Placebo + DMARDs (N=1,170)|
|Upper respiratory tract infection||7%||5%||6%||8%||6%|
|Abdominal pain (upper)||2%||2%||3%||3%||2%|
|*Adverse reactions that occurred in at least 2% of Actemra + DMARD patients and those that were at least 1% more frequent than observed in placebo + DMARD patients.|
Warnings and precautions
There are several warnings and precautions you should know about before you start treatment with Actemra.
Serious infections. There is an increased risk for developing serious infections with Actemra, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (fungal infection inside the body) such as histoplasmosis, coccidioidomycosis, or blastomycosis (people who live in the Ohio or Mississippi River Valleys are at increased risk for these types of infections), and other opportunistic infections (infections that result from microorganisms that normally do not cause diseases in humans). The increased risk of infection with Actemra occurs because the drug can decrease the ability of the immune system to fight infections. If you develop a serious infection while taking Actemra, you should interrupt the treatment.1
Before starting treatment with Actemra, you should be tested for latent TB, and, if positive, you should receive treatment for TB before starting Actemra. All patients should be monitored for active TB during treatment with Actemra.1
The signs of TB include a cough that persists, a low-grade fever, weight loss, and loss of body fat and muscle.
Other health conditions. Hypersensitivity (allergic) reactions including anaphylaxis have occurred with Actemra. Routine laboratory monitoring of changes in neutrophils, platelets, lipids, and liver enzymes is recommended during treatment with Actemra.1
Pregnancy and nursing
Actemra is a pregnancy category C drug. Studies of Actemra in animals did show adverse effects on the developing fetus. However, there are no well-controlled studies in humans. Therefore, Actemra should only be used in pregnant women if the potential benefits justify the risk to the fetus.1
It is unknown whether Actemra is excreted into human milk. Because of the potential for adverse effects to the nursing infant, a nursing woman should either stop taking the drug or discontinue nursing while taking Actemra.1
Use of live vaccines should be avoided while taking Actemra.1
Taking Actemra may influence the way your body metabolizes other drugs. Therefore, caution must be used when taking these drugs with Actemra and the doses of these drugs may need to be changed. Drugs that are affected in this way include warfarin (Coumadin), cyclosporine, and theophylline, as well as oral contraceptives, statins (cholesterol lowering drugs (eg. lovastatin, simvastatin, atorvastatin), and the proton pump inhibitor omeprazole (Prilosec).1