Note: This document contains side effect information about tofersen. Some dosage forms listed on this page may not apply to the brand name Qalsody.
Applies to tofersen: intrathecal solution.
Serious side effects of Qalsody
Along with its needed effects, tofersen (the active ingredient contained in Qalsody) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking tofersen:
More common
- Arm, leg, or back pain
- difficulty in moving
- joint pain or swelling
- muscle aches, cramps, pains, or stiffness
- nerve pain
- unusual tiredness or weakness
Less common
- Back numbness, tingling, or weakness
- blurred vision
- change in ability to see colors, especially blue or yellow
- confusion
- fever
- headache
- severe nausea or vomiting
- stiff neck
For Healthcare Professionals
Applies to tofersen: intrathecal solution.
General
The most common adverse reactions occurring in 10% of patients or greater included pain, fatigue, arthralgia, increased cerebrospinal fluid white blood cells, and myalgia.[Ref]
Immunologic
Very common (10% or more): Anti-drug antibodies (58.4%)[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (14%), myalgia (14%), musculoskeletal stiffness (6%)[Ref]
Nervous system
Very common (10% or more): Cerebrospinal fluid white blood cells increased or pleocytosis (14%)
Common (1% to 10%): Cerebrospinal fluid proteins increased (8%), neuralgia (6%), myelitis and radiculitis (4%), elevated intracranial pressure and/or papilledema (2.7%), aseptic meningitis (1.4%)[Ref]
Other
Very common (10% or more): Pain including extremity and back pain (42%), fatigue (17%)
Frequency not reported: Pyrexia[Ref]
