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: Infusion Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.3) ] The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were NMOSD: urinary tract infection and arthralgia.
( 6.1 ) IgG4-RD: urinary tract infections and lymphopenia.
( 6.1 ) gMG: headache and infusion-related reactions.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc.
at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trial 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.
Adverse Reactions NMOSD The safety of UPLIZNA was evaluated in Study 1, in which 161 patients were exposed to UPLIZNA at the recommended dosage regimen during the randomized, controlled treatment period;
during which 52 patients received placebo [see Dosage and Administration (2.1) and Clinical Studies (14) ] .
Subsequently, 198 patients were exposed to UPLIZNA during an open-label treatment period.
Two-hundred and eight patients in the randomized and open-label treatment periods had a total of 324 person-years of exposure to UPLIZNA, including 165 patients with exposure for at least 6 months and 128 with exposure for one year or more.
5 WARNINGS AND PRECAUTIONS Infusion reactions: Administer premedications prior to infusion.
( 2.2 ) Management recommendations for infusion reactions depend on the type and severity of the reaction.
Permanently discontinue UPLIZNA if a life-threatening or disabling infusion reaction occurs.
( 5.1 ) Infections: Serious, including life-threatening and fatal infections, have occurred in patients treated with B-cell depleting therapies, including UPLIZNA.
Delay UPLIZNA administration in patients with an active infection until the infection is resolved.
Like all medications, Uplizna 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: