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 clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions (5.1) ] • Malignancies [see Warnings and Precautions (5.2) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] • Hepatitis B Virus Reactivation [see Warnings and Precautions (5.4) ] • Neurologic Reactions [see Warnings and Precautions (5.5) ] • Hematological Reactions [see Warnings and Precautions (5.6) ] • Heart Failure [see Warnings and Precautions (5.8) ] • Autoimmunity [see Warnings and Precautions (5.9) ] Most common adverse reactions (>10%) are: infections (e.g.
upper respiratory, sinusitis), injection site reactions, headache, and rash.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.
at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reaction with adalimumab was injection site reactions.
In placebo-controlled trials, 20% of subjects treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of subjects receiving placebo.
Most injection site reactions were described as mild and generally did not necessitate drug discontinuation.
The proportion of subjects who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies in subjects with RA (i.e., Studies RA-I, RA-II, RA-III and RA-IV) was 7% for subjects taking adalimumab and 4% for placebo-treated subjects.
The most common adverse reactions leading to discontinuation of adalimumab in these RA studies were clinical flare reaction (0.7%), rash (0.3%) and pneumonia (0.3%).
5 WARNINGS AND PRECAUTIONS • Serious infections: Do not start ABRILADA during an active infection.
If an infection develops, monitor carefully, and stop ABRILADA if infection becomes serious.
( 5.1 ) • Invasive fungal infections: For patients who develop a systemic illness on ABRILADA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic.
( 5.1 ) • Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls.
( 5.2 ) • Anaphylaxis or serious hypersensitivity reactions may occur.
Like all medications, Abrilada 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: