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Tofersen

Tofersen

Generic Name/API:Tofersen
Packaging:Injection: 100 mg/15 mL (6.7 mg/ml) solution in a single-dose vial
Storage:Store refrigerated between 2°C to 8°C (36°F to 46°F).
Dosage:For dosage information, please visit the General Information section.
Strength:Injection: 100 mg/15 mL (6.7 mg/mL) solution in a single-dose vial.
Indication:Qalsody or tofersen is the first FDA-approved treatment for patients with ALS i.e. amyotrophic lateral sclerosis, associated with a specific mutation in SOD1, targeting neurodegeneration and its progression. Approved under accelerated approval, Qalsody demonstrated reduction in plasma neurofilament light (NfL), a biomarker of neuronal injury.

Qalsody or tofersen is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. It is an antisense oligonucleotide that binds to SOD1 mRNA, and thus degrades SOD1 protein and reduces its synthesis by binding to it. Thus, it reduces associated neurodegeneration and its progression. Approved under accelerated approval, Qalsody demonstrated reduction in plasma neurofilament light (NfL), a blood biomarker of neuronal injury, and some studies suggest a slowing of functional decline and preservation of function. 

DOSAGE:  

Administer tofersen 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 tofersen per administration. Initiate tofersen treatment with three (3) loading doses administered at 14-day intervals. Administer a maintenance dose every 28 days thereafter. 

For missed dose: If the second loading dose is missed, administer tofersen as soon as possible, and administer the third loading dose 14 days later. If the third loading dose or a maintenance dose is missed, administer tofersen as soon as possible, and administer the next dose 28 days later. 

STRENGTH 

Injection: 100 mg/15 mL (6.7 mg/mL) solution in a single-dose vial.

SIDE EFFECTS 

Following are the clinically significant adverse reactions associated with tofersen use: 

  • Myelitis and/or Radiculitis
  • Papilledema and Elevated Intracranial Pressure
  • Aseptic Meningitis

STORAGE : 

  • Store refrigerated between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. 
  • Do not freeze. If no refrigeration is available, Qalsody may be stored in its original carton, protected from light at or below 30°C (86°F) for up to 14 days. 
  • If removed from the original carton, unopened vials can be removed from and returned to the refrigerator, if necessary, for not more than 6 hours per day at or below 30°C (86°F) for a maximum of 6 days (36 hours). 

  1. Myelitis and/or Radiculitis

Serious adverse reactions of myelitis and radiculitis have been reported in patients treated with tofersen . In clinical studies, 6 patients treated with tofersen experienced myelitis or radiculitis, 2 patients discontinued treatment and required symptomatic management with full resolution of symptoms, 4 patients, symptoms resolved without discontinuation of treatment.

  1. Papilledema and Elevated Intracranial Pressure

In clinical studies, 4 patients developed elevated intracranial pressure and/or papilledema.

  1. Aseptic Meningitis

1 patient experienced a serious chemical meningitis, resulting in discontinuation of Qalsody. 1 patient experienced aseptic meningitis, which did not lead to discontinuation of Qalsody. Other reported cases of serious reactions include increase in CSF white blood cell and CSF protein.

Monitor for symptoms; diagnostic workup and treatment should be initiated according to the standard of care. Management may require interruption or discontinuation of tofersen .

 

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FAQ

  • What is tofersen ?
  • What is tofersen used for?
  • What are the common side effects of tofersen use?
  • Can tofersen be used in specific populations i.e. for pregnant, breastfeeding , pediatric and geriatric use?
  • What is the cost of Qalsody (Tofersen) Injection Online in India?
  • How to buy Qalsody (Tofersen) Injection Online in India?
  • What are the key criteria for selecting a supplier?
What is tofersen ?

Qalsody or tofersen is the first FDA-approved treatment for patients with ALS i.e. amyotrophic lateral sclerosis, associated with a specific mutation in SOD1, targeting neurodegeneration and its progression.

What is tofersen used for?

It is used for treatment of SOD 1 mutation amyotrophic lateral sclerosis.

What are the common side effects of tofersen use?

The most common adverse reactions were myelitis and/or radiculitis, papilledema and elevated intracranial pressure, aseptic meningitis and associated pain, fatigue, arthralgia, cerebrospinal fluid white blood cell increase, and myalgia.

Can tofersen be used in specific populations i.e. for pregnant, breastfeeding , pediatric and geriatric use?

No data on the presence of tofersen or its metabolites in human milk, or on potential effects on breastfed infants, or on milk production has been established. Safety and effectiveness of tofersen use in pediatric patients is also not established. No overall differences in safety and effectiveness of this treatment was observed in patients above 65 years and those younger than 65 years. Also, no age based special dosage considerations are required .

What is the cost of Qalsody (Tofersen) Injection Online in India?

The cost of Tofersen (Qalsody) Injection in India may vary depending on the supplier, dosage, and import regulations. To get accurate and updated price details, you can contact 24/7QualityMeds directly at +91 9967979080.

How to buy Qalsody (Tofersen) Injection Online in India?

To buy Tofersen (Qalsody) Injection online in India, reach out to 24/7QualityMeds via +91 9967979080. Our team will provide pricing, import assistance, and secure delivery options to help you place your order smoothly.

What are the key criteria for selecting a supplier?

While selecting a supplier, we essentially ensure that the supplier holds a valid Good Distribution Practice (GDP) certificate and possesses a valid operating license. These credentials confirm that the suppliers adherence to International standards for the proper distribution of medicinal product

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