Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Serious Infections [see Warnings and Precautions ( 5.1 )] • Gastrointestinal Perforations [see Warnings and Precautions ( 5.2 )] • Laboratory Parameters [see Warnings and Precautions ( 5.4 )] • Immunosuppression [see Warnings and Precautions ( 5.5 )] • Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions ( 5.6 )] • Demyelinating Disorders [see Warnings and Precautions ( 5.7 )] • Active Hepatic Disease and Hepatic Impairment [see Warnings and Precautions ( 5.8 )] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.
Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience in Rheumatoid Arthritis Patients Treated with Intravenous Tocilizumab (tocilizumab-IV) The tocilizumab-IV data in rheumatoid arthritis (RA) includes 5 double-blind, controlled, multicenter studies.
In these studies, patients received doses of tocilizumab-IV 8 mg per kg monotherapy (288 patients), tocilizumab-IV 8 mg per kg in combination with DMARDs (including methotrexate) (1582 patients), or tocilizumab-IV 4 mg per kg in combination with methotrexate (774 patients).
The all exposure population includes all patients in registration studies who received at least one dose of tocilizumab-IV.
Of the 4009 patients in this population, 3577 received treatment for at least 6 months, 3309 for at least one year;
2954 received treatment for at least 2 years and 2189 for 3 years.
All patients in these studies had moderately to severely active rheumatoid arthritis.
The study population had a mean age of 52 years, 82% were female and 74% were Caucasian.
The most common serious adverse reactions were serious infections [see Warnings and Precautions ( 5.1 )] .
5 WARNINGS AND PRECAUTIONS • Serious Infections – do not administer TYENNE during an active infection, including localized infections.
If a serious infection develops, interrupt TYENNE until the infection is controlled.
( 5.1 ) • Gastrointestinal (GI) perforation-use with caution in patients who may be at increased risk.
( 5.2 ) • Hepatotoxicity- Monitor patients for signs and symptoms of hepatic injury.
Modify or discontinue TYENNE if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
Like all medications, Tyenne can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: