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QALSODY is a brand name for Tofersen, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: QALSODY (tofersen injection) is indicated for: • The treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. The clinical benefit of QALSODY for the indication remains to be confirmed as this indication is issued market authorization with…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment • The recommended dose of QALSODY is 100 mg (15 mL). • QALSODY treatment should be initiated with three (3) loading doses administered at 14-day intervals (Day 0, Day 14, Day 28). ). Pediatric Health Canada has not authorized an indication for pediatric use.
Safety and effectiveness in pediatric patients below the age of 18 years have not been established. 4 Special Populations, Geriatrics). Renal Impairment QALSODY has not been studied in patients with renal impairment. 3 Pharmacokinetics).
4 Administration QALSODY is administered intrathecally by healthcare professionals experienced in performing lumbar punctures. Aseptic technique must be used when preparing and administering QALSODY intrathecally (see 7 WARNINGS AND PRECAUTIONS, General).
Preparation Vial preparation instructions: • Prior to administration, the refrigerated vial should be allowed to warm to room temperature (25°C) without external heat sources (see 11 STORAGE, STABILITY AND DISPOSAL). • The vial containing QALSODY should not be shaken.
• The solution should be visually inspected prior to removal of QALSODY from the vial. The solution should be free of visible particles. Only clear and colorless to slightly yellow solution should be administered. If not, the vial must not be used.
Procedural preparation instructions • If indicated by the clinical condition of the patient, sedation can be considered. • If indicated by the clinical condition of the patient, imaging to guide intrathecal administration of QALSODY can be considered.
• An unopened vial can be returned to the refrigerator for total time permitted (see 11 STORAGE, STABILITY AND DISPOSAL). • Patients should be evaluated prior to and after intrathecal injection for the presence of potential conditions related to lumbar puncture to avoid serious procedural complications.
Administration • Just prior to administration, the plastic cap should be removed from the vial and a non-spinal anesthesia needle attached to the syringe for the purpose of withdrawing tofersen from the vial. The syringe needle is inserted into the vial through the center of the over-seal to withdraw the required dose of 15 mL (equivalent to 100 mg) from the vial.
o QALSODY must not be diluted. o External filters are not required. • It is recommended that approximately 10 mL of cerebrospinal spinal fluid (CSF) is removed using a lumbar puncture needle prior to administration of QALSODY. • QALSODY is administered as an intrathecal bolus injection using a lumbar puncture needle over 1 to 3 minutes.
). Driving and Operating Machinery Studies on the effects on the ability to drive or use machines during treatment with QALSODY have not been performed. Patients who develop visual disturbance during QALSODY use should be cautioned to avoid driving or operating machinery.
Hematologic Coagulation abnormalities and acute severe thrombocytopenia have been observed after subcutaneously and intravenous administration of antisense oligonucleotides. If clinically indicated, platelet and coagulation laboratory testing is recommended prior to lumbar puncture procedure.
Neurologic Aseptic or chemical meningitis Serious adverse reactions of aseptic or chemical meningitis have been reported in patients treated with QALSODY. 4%). Both patients were symptomatic and received 5 and 7 doses of QALSODY respectively before the onset of aseptic or chemical meningitis.
One patient discontinued QALSODY. If symptoms consistent with aseptic or chemical meningitis develop, diagnostic evaluation and treatment should be initiated according to the standard of care. Myelitis and/or radiculitis Serious events of myelitis and radiculitis have been reported in patients treated with tofersen.
7%). The number of QALSODY doses received before the onset of myelitis ranged from 5 to 15 doses. Two patients were symptomatic. All four patients had abnormal magnetic resonance imaging (MRI) findings related to the event. Two patients discontinued treatment, with resolution of the event.
Two patients required immunomodulatory treatment. 4%) after receiving 1 dose and 24 doses, respectively. Both adverse reactions were symptomatic. One patient had abnormal MRI findings related to the event. No patients discontinued treatment.
One patient had sequelae of bilateral foot sensory loss. If symptoms consistent with these adverse reactions develop, diagnostic evaluation and treatment NOC/c QALSODY tofersen injection Page 8 of 25 should be initiated according to the standard of care.
, General). Preparation Vial preparation instructions: • Prior to administration, the refrigerated vial should be allowed to warm to room temperature (25°C) without external heat sources (see 11 STORAGE, STABILITY AND DISPOSAL). • The vial containing QALSODY should not be shaken.
• The solution should be visually inspected prior to removal of QALSODY from the vial. The solution should be free of visible particles. Only clear and colorless to slightly yellow solution should be administered. If not, the vial must not be used.
Procedural preparation instructions • If indicated by the clinical condition of the patient, sedation can be considered. • If indicated by the clinical condition of the patient, imaging to guide intrathecal administration of QALSODY can be considered.
• An unopened vial can be returned to the refrigerator for total time permitted (see 11 STORAGE, STABILITY AND DISPOSAL). • Patients should be evaluated prior to and after intrathecal injection for the presence of potential conditions related to lumbar puncture to avoid serious procedural complications.
Administration • Just prior to administration, the plastic cap should be removed from the vial and a non-spinal anesthesia needle attached to the syringe for the purpose of withdrawing tofersen from the vial. The syringe needle is inserted into the vial through the center of the over-seal to withdraw the required dose of 15 mL (equivalent to 100 mg) from the vial.
o QALSODY must not be diluted. o External filters are not required. • It is recommended that approximately 10 mL of cerebrospinal spinal fluid (CSF) is removed using a lumbar puncture needle prior to administration of QALSODY. • QALSODY is administered as an intrathecal bolus injection using a lumbar puncture needle over 1 to 3 minutes.
QALSODY tofersen injection Page 6 of 25 o QALSODY contains no preservatives (see 11 STORAGE, STABILITY AND DISPOSAL). • Any unused content of the single-dose vial should be discarded. Following injection, no additional monitoring procedures are recommended apart from standard post- lumbar-puncture care.
QALSODY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 0 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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QALSODY tofersen injection Page 6 of 25 o QALSODY contains no preservatives (see 11 STORAGE, STABILITY AND DISPOSAL). • Any unused content of the single-dose vial should be discarded. Following injection, no additional monitoring procedures are recommended apart from standard post- lumbar-puncture care.
5 Missed Dose If the second loading dose is delayed or missed, QALSODY should be administered as soon as possible, and the third loading dose should be administered 14 days later. If the third loading dose is delayed or missed, QALSODY should be administered as soon as possible, and the first maintenance dose should be administered 28 days later.
If a maintenance dose is delayed or missed, QALSODY should be administered as soon as possible. Subsequent maintenance doses should be administered every 28 days from the last dose.
7%). The number of QALSODY doses received before the onset of increased ICP and/or papilledema ranged from 7 to 18. All four adverse reactions were symptomatic. All patients had an MRI with no findings pertinent to the event. Management included long-term treatment with acetazolamide in several patients, and IV methylprednisolone with tofersen dosing in one patient.
One adverse reaction led to permanent discontinuation of QALSODY, and one adverse reaction led to interruption of QALSODY treatment. If symptoms consistent with these adverse reactions develop, diagnostic evaluation and treatment should be initiated according to the standard of care.
Renal Renal toxicity, including potentially fatal glomerulonephritis, has been observed after subcutaneous and intravenous administration of antisense oligonucleotides. If clinically indicated, urine protein testing is recommended. For persistent elevated urinary protein, further evaluation should be considered.
Reproductive Health:
Female and Male Potential • Fertility There are no data available on the potential effects on fertility in humans. 1 Pregnant Women and 16 NON-CLINICAL TOXICOLOGY). 1 Pregnant Women There are no data from clinical trials on the use of tofersen during pregnancy.
Administration of tofersen in mice and rabbits had no impact on fertility, embryo-fetal development, or pre/postnatal development (see 16 NON-CLINICAL TOXICOLOGY). Tofersen is not recommended during pregnancy and in patients of childbearing potential not using contraception.
2 Breastfeeding There are no data on the use of QALSODY during lactation in humans. It is unknown whether tofersen or its metabolites are excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk.
A risk to the newborn or infants cannot be excluded. Tofersen is not recommended during breastfeeding. In rodent studies, tofersen was detected in milk samples from all tofersen-dosed animals. There were no tofersen-related effects on either the maternal dams or offspring (see 16 NON-CLINICAL TOXICOLOGY).
3 Pediatrics Pediatrics (< 18 years of age): QALSODY is not indicated for pediatric use. Safety and effectiveness in pediatric patients have not been established. 2% (2/162) patients were 75 years of age and older at initiation of treatment in clinical trials.
Evidence from clinical studies suggests that use in the geriatric population is not associated with differences in safety or effectiveness. Data are limited, and a greater sensitivity of some older individuals cannot be ruled out. 1 Adverse Reaction Overview The safety of QALSODY 100 mg was evaluated in 147 SOD1-ALS patients.
4 weeks (range 4 to 212 weeks). QALSODY was evaluated in the placebo-controlled Study 1 and in the open label extension Study 2. 4%). A total of 12 serious neuroinflammatory adverse reactions were reported in 10 (7%) tofersen-treated patients in […]
5 Missed Dose If the second loading dose is delayed or missed, QALSODY should be administered as soon as possible, and the third loading dose should be administered 14 days later. If the third loading dose is delayed or missed, QALSODY should be administered as soon as possible, and the first maintenance dose should be administered 28 days later.
If a maintenance dose is delayed or missed, QALSODY should be administered as soon as possible. Subsequent maintenance doses should be administered every 28 days from the last dose. 5 OVERDOSAGE No cases of overdose associated with QALSODY were reported in clinical trials.
In the event of overdose, medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient. For management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
7 mg/mL) solution in a single-dose glass vial with stopper not made with natural rubber latex, and an aluminum over-seal with flip-off plastic button. QALSODY is available in a pack of 1 vial. Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Intrathecal Solution, 100 mg / 15 mL calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic dihydrate, water for injection QALSODY tofersen injection Page 7 of 25 7 WARNINGS AND PRECAUTIONS General QALSODY should be administered by healthcare professionals who are experienced in performing lumbar puncture procedures.
, skin infection near site of lumbar puncture, suspicion of increased intracranial pressure, uncorrected coagulopathy, acute spinal cord trauma), and all necessary precautions should be taken to avoid serious procedural complications.
Adverse reactions associated with the administration of QALSODY by lumbar puncture have been observed, including headache, back pain, post lumbar puncture syndrome, and infection (see