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 discussed elsewhere in the labeling: Myelitis and/or Radiculitis [see Warnings and Precautions ( 5.1 )] Papilledema and Elevated Intracranial Pressure [see Warnings and Precautions ( 5.2 )] Aseptic Meningitis [see Warnings and Precautions ( 5.3 )] The most common adverse reactions ( ≥ 10% of patients treated with QALSODY and greater than placebo) were pain, fatigue, arthralgia, cerebrospinal fluid white blood cell increased, and myalgia.
(Section 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-877-725-7639 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of QALSODY cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.
The safety of QALSODY 100 mg was evaluated in 147 patients with SOD1-ALS.
The median patient exposure was 119.4 weeks (range from 4 to 212 weeks).
QALSODY was evaluated in the placebo-controlled Study 1 and in the open label extension Study
In Study 1 Part C, approximately 43% were female;
57% were male;
64% were White and 8% were Asian.
The mean age at entry in Study 1 Part C was 49.8 years (range from 23 to 78 years).
5 WARNINGS AND PRECAUTIONS Myelitis and/ or Radiculitis: Serious events of myelitis and radiculitis have been reported.
Monitor for symptoms;
diagnostic workup and treatment should be initiated according to the standard of care.
( 5.1 ) Papilledema and Elevated Intracranial Pressure: Serious events of papilledema and elevated intracranial pressure have been reported.
Monitor for symptoms;
Like all medications, Qalsody 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: