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Qalsody is a brand name for Tofersen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Qalsody is indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with tofersen should only be initiated by a physician with experience in the management of ALS. Qalsody should be administered by, or under the direction of, healthcare professionals experienced in performing lumbar punctures.
Posology The recommended dose is 100 mg of tofersen per treatment. Tofersen treatment should be initiated with 3 loading doses administered at 14-day intervals. A maintenance dose should be administered once every 28 days thereafter.
Missed or delayed doses If the second loading dose is delayed or missed, tofersen should be administered as soon as possible, and the third loading dose should be administered 14 days later. 3 If the third loading dose is delayed or missed, tofersen 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, tofersen should be administered as soon as possible. Subsequent maintenance doses should be administered every 28 days from the last dose. Duration of treatment The need for continuation of therapy should be reviewed regularly and considered on an individual basis depending on the patient’s clinical presentation and response to the therapy.
Special populations Elderly Experience with the use of tofersen in the elderly is limited. However, from the clinical data available, the efficacy and safety of tofersen are expected to be similar to that of other age groups studied.
There is no evidence for special dose considerations based on age when tofersen is administered. Renal impairment Tofersen has not been studied in patients with renal impairment. Hepatic impairment Tofersen has not been studied in patients with hepatic impairment.
Paediatric population The safety and efficacy of Qalsody in paediatric patients below the age of 18 years has not been established. No data are available. Method of administration Qalsody is for intrathecal use by lumbar puncture. • It is recommended to ensure intrathecal access prior to removing the plastic cap from the vial and drawing up the tofersen dose.
• Just prior to administration, the plastic cap should be removed from the vial and a nonspinal 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 overseal to withdraw the required dose of 15 ml (equivalent to 100 mg) from the vial.
4%). 4%). Tabulated list of adverse reactions The adverse reactions are listed by system organ class and frequency using the following convention: Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1 000 to <1/100); Rare (≥1/10 000 to <1/1 000); Very Rare (<1/10 000); not known (cannot be estimated from the available data).
6 Table 1: Adverse reactions with Qalsody-treated participants in Study 101 and Study 102 System Organ Class (SOC) Adverse reaction Frequency Nervous system disorders CSF white blood cell increased* Very common CSF protein increased Very common Papilloedema‡ Common Neuralgia Common Aseptic meningitis†† Common Radiculitis† Common Myelitis§ Common Musculoskeletal and connective tissue disorders Arthralgia Very common Myalgia Very common Musculoskeletal stiffness Common General disorders and administration site conditions Pain‡‡ Very common Fatigue Very common Pyrexia Very common * CSF white blood cell increased includes preferred terms of CSF white blood cell increased and pleocytosis.
† Radiculitis includes preferred terms of radiculopathy and lumbar radiculopathy. ‡ Papilloedema includes preferred terms of papilloedema and intracranial pressure increased. See discussion in Description of selected adverse reactions (ARs).
§ Myelitis includes preferred terms of myelitis, myelitis transverse, and neurosarcoidosis. See discussion in Description of selected adverse reactions. †† Aseptic meningitis includes preferred terms of meningitis chemical and meningitis aseptic.
See discussion in Description of selected adverse reactions. ‡‡ Pain includes preferred terms of pain, back pain, and pain in extremity. Description of selected adverse reactions Lumbar puncture procedure Adverse reactions associated with the administration of tofersen by lumbar puncture have been observed.
The adverse reactions commonly associated with lumbar puncture are headache, back pain, post lumbar puncture syndrome, infection. The incidence and severity of these events were consistent with events expected to occur with lumbar puncture.
g. headache, back pain, post lumbar puncture syndrome, infection). Myelitis and/or radiculitis Serious cases of myelitis and radiculitis have been reported in patients treated with tofersen. If symptoms consistent with these adverse reactions develop, diagnostic evaluation and treatment should be initiated according to the standard of care.
Increased intracranial pressure and/or papilloedema Serious cases of increased intracranial pressure and/or papilloedema have been reported in patients treated with tofersen. If symptoms consistent with these adverse reactions develop, diagnostic evaluation and treatment should be initiated according to the standard of care.
Thrombocytopenia and coagulation abnormalities Thrombocytopenia and coagulation abnormalities, including acute severe thrombocytopenia, have been observed after administration of subcutaneously or intravenously administered antisense oligonucleotides.
If clinically indicated, platelet and coagulation laboratory testing is recommended prior to administration of tofersen. Renal toxicity Renal toxicity has been observed after administration of subcutaneously and intravenously administered antisense oligonucleotides.
If clinically indicated, urine protein testing (preferably using a first morning urine specimen) is recommended. For persistent elevated urinary protein, further evaluation should be considered. Excipients Sodium This medicinal product contains 52 mg sodium in each 15 ml, equivalent to 3% of the WHO recommended maximum daily dietary intake of 2 g sodium for an adult.
, essentially ‘potassium-free’.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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− Qalsody must not be diluted. − External filters, including bacterial or particulate 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 tofersen.
• Tofersen is administered as an intrathecal bolus injection using a lumbar puncture needle over 1 to 3 minutes. Procedural preparation instruction: • 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 tofersen can be considered. • Prior to removing the vial’s cap on the aluminium overseal, readiness of the patient should be confirmed.
3. • 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. 4 Following injection, standard post-lumbar-puncture care is recommended.
1%). The number of tofersen doses received before the onset of myelitis ranged from 5 to 58 doses. Four participants were symptomatic and 2 participants were asymptomatic. All 6 participants had abnormal magnetic resonance imaging (MRI) findings related to the event.
Two participants discontinued treatment, and the event resolved. 4). 4%). The number of tofersen doses received before the onset of radiculitis ranged from 1 to 24 doses. Both reactions were symptomatic. One participant had abnormal MRI findings related to the event and one participant had a normal MRI.
4). 7%). The number of tofersen doses received before the onset of increased intracranial pressure and/or papilloedema ranged from 7 to 18 doses. All 4 reactions of increased intracranial pressure and/or papilloedema were symptomatic.
Four participants had an MRI with no findings pertinent to the event. One reaction finally led to permanent discontinuation of tofersen, one reaction led to interruption of tofersen treatment. 4). 4%). The number of tofersen doses received before the onset of aseptic or chemical meningitis ranged from 5 to 7 doses.
Both reactions of aseptic or chemical meningitis were symptomatic. One participant had an MRI with no findings pertinent to the event. One participant discontinued tofersen, and the other participant did not. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.