Qalsody
Generic name: Tofersen
Dosage form: intrathecal injection (100 mg/15 mL)
Drug class:
Miscellaneous central nervous system agents
Usage of Qalsody
Qalsody (tofersen) is a prescription medicine used to treat amyotrophic lateral sclerosis (ALS) in adults who have a specific genetic mUTAtion in the superoxide dismutase 1 (SOD1) gene. Qalsody is the first FDA-approved treatment that targets a genetic cause of ALS to slow progression of ALS. Qalsody works by reducing the amount of a toxic protein (SOD1 protein) that causes damage to motor neurons and the symptoms of ALS .
ALS patients who have a mutation in the SOD1 gene (SOD1-ALS) make a toxic misfolded form of SOD1 protein that damages the motor neurons which causes muscle weakness, loss of function, and in time even death. Qalsody is an antisense oligonucleotide (ASO) that lowers the amount the toxic SOD1 protein made by binding to SOD1 mRNA, which may help slow the progression of ALS.
Qalsody side effects
Common Qalsody side effects may include:
Less Common but serious side effects include:
Before taking Qalsody
Before taking this medicine it is important to tell your healthcare provider if you are pregnant or planning to become pregnant or are breastfeeding or planning to breastfeed.
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How to use Qalsody
Loading dose: 100 mg intrathecally every 14 days for 3 doses
Maintenance dose: 100 mg intrathecally every 28 days
Comments:
Use: For the treatment of amyotrophic lateral sclerosis in adults who have a mutation in the superoxide dismutase 1 gene. Continued approval for this indication may be contingent upon verification of clinical benefit in cOnfirmatory trial(s).
DoSage form: Injection 100 mg/15 mL (6.7 mg/mL) solution in a single-dose vial that is free of preservatives.
Warnings
Qalsody can cause serious side effects, contact your doctor immediately if you have:
Inflammation of the spinal cord (myelitis) and/ or irritation of the nerve roots (radiculitis) can occur in patients treated with Qalsody. Discuss with your healthcare provider to learn about the symptoms associated with myelitis or radiculitis. Treatment with Qalsody may need to be interrupted or discontinued.
Swelling of the optic nerve (papilledema) and increased pressure inside the skull (elevated intracranial pressure ) can occur in patients treated with Qalsody. Discuss with your healthcare provider what the symptoms associated with papilledema or elevated intracranial pressure are.
Inflammation of the brain linings (aseptic meningitis) can occur in patients treated with Qalsody in patients treated with Qalsody. Discuss with your healthcare provider to learn more about symptoms associated with aseptic meningitis.
Disclaimer
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The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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