QALSODY 100 mg/15mL
tofersen · INJECTION · Biogen Inc.
Qalsody (tofersen) is an antisense oligonucleotide injection given directly into the fluid around the spinal cord to treat ALS (amyotrophic lateral sclerosis) caused by SOD1 gene mutations. It works by reducing the production of a harmful protein linked to this form of ALS.
Key Facts
- Brand Name
- QALSODY
- Generic Name
- tofersen
- NDC Code (Product)
64406-109- Manufacturer
- Biogen Inc.
- Strength
- 100 mg/15mL
- Dosage Form
- INJECTION
- Route
- INTRATHECAL
- Marketing Status
- Application #
- NDA215887
- Drug Class
- Antisense Oligonucleotide [EPC]
- Marketing Start
- 04/25/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE QALSODY is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain (NfL) observed in patients treated with QALSODY [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). QALSODY is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain observed in patients treated with QALSODY. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION QALSODY is administered intrathecally ( 2.1 ) Dosing Information ( 2.1 ) Recommended dose: 100 milligrams (15 mL) per administration Initiate QALSODY treatment with 3 loading doses administered at 14day intervals. A maintenance dose should be administered once every 28 days thereafter. Preparation and Administration Instructions ( 2.2 ) Allow to warm to room temperature prior to administration Administer within 4 hours of removal from vial Prior to administration, remove approximately 10 mL of cerebrospinal fluid Administer as an intrathecal bolus injection over 1 to 3 minutes 2.1. Dosing Information Recommended Dosage Administer QALSODY intrathecally using a lumbar puncture by, or under the direction of, healthcare professionals experienced in performing lumbar punctures. The recommended dosage is 100 mg (15 mL) of QALSODY per administration. Initiate QALSODY treatment with three (3) loading doses administered at 14-day intervals. Administer a maintenance dose every 28 days thereafter. Missed Dose If the second loading dose is missed, administer QALSODY as soon as possible, and administer the third loading dose 14 days later. If the third loading dose o…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
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. 6.1. 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 2. In Stu…
Frequently Asked Questions
What is QALSODY used for?
Qalsody (tofersen) is an antisense oligonucleotide injection given directly into the fluid around the spinal cord to treat ALS (amyotrophic lateral sclerosis) caused by SOD1 gene mutations. It works by reducing the production of a harmful protein linked to this form of ALS.
Is QALSODY a controlled substance?
QALSODY is not classified as a controlled substance by the DEA.
What is the generic name for QALSODY?
The generic name for QALSODY is tofersen. There are no other listed brand versions of tofersen.
What is the NDC code for QALSODY 100 mg/15mL?
The NDC (National Drug Code) for QALSODY 100 mg/15mL is 64406-109, listed by Biogen Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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