Qalsody(Tofersen)

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).

Dosage And Administration

QALSODY is administered intrathecally

• Dosing Information
• Recommended dose: 100 milligrams (15 mL) per administration
• Initiate QALSODY treatment with 3 loading doses administered at 14-day intervals. A maintenance dose should be administered once every 28 days thereafter.
• Preparation and Administration Instructions
• 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

• Myelitis and/or Radiculitis
• Serious events of myelitis and radiculitis have been reported. Monitor for symptoms; diagnostic workup and treatment should be initiated according to the standard of care.
• Papilledema and Elevated Intracranial Pressure
• Serious events of papilledema and elevated intracranial pressure have been reported. Monitor for symptoms; diagnostic workup and treatment should be initiated according to standard of care.
• Aseptic Meningitis
• Serious events of aseptic meningitis have been reported. Monitor for symptoms; diagnostic workup and treatment should be initiated according to standard of care.

If you are considering the import of Qalsody(Tofersen)  to India, please be aware that Qalsody can be imported by patients or government hospitals solely in the name of the patients. The following documentation is essential for the successful import of this medication:

Required Documentation for Import:

• A valid prescription from a qualified medical practitioner.
• Diagnostic reports of the patient.
• Government-issued identification proof for the patient, as recognized by the Government of India.

Order Confirmation Process: 
The order for Elahere will be confirmed upon the receipt of the following documents:
A valid prescription from a qualified doctor.
An import permit, if applicable.

Availability of Qalsody in India: 

Qalsody(Tofersen) is classified as a prescription pharmaceutical drug. Consequently, it legally requires a medical prescription to be dispensed. Indian Pharma Network (IPN) specializes in facilitating the import of cancer medicines through named patient supply (NPS), ensuring transparency and authenticity by sourcing from reputable suppliers in the USA, Canada, Europe, and Australia.

Qalsody(Tofersen) can be made accessible to patients, doctors, and hospitals in various cities across India, including but not limited to Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow, and Pune. To confirm an order, a valid prescription from a doctor and an import permit will be required.

IPN (Indian Pharma Network) is dedicated to facilitating the supply of Qalsody(Tofersen)

(prescription medicines) to locations both within India and worldwide, while adhering to relevant legal requirements.

Our commitment lies in assuring quality and timely delivery to meet the healthcare needs of patients and medical professionals across the globe.

Indian Pharma Network is proficient in sourcing Qalsody(Tofersen) from around the world and ensuring efficient delivery to patients. We provide worldwide access to the best available treatments and expedite prescription dispensing and delivery, with all prescriptions being dispensed and scrutinized by registered pharmacists before dispatching them to the patient’s address, exclusively from New Delhi, India.

Is tofersen approved by FDA?

FDA grants accelerated approval for ALS treatment tofersen from Biogen. Boston- The Federal Drug Administration has approved the use of tofersen, based on its effect reducing neurofilament.

What is the brand name for Qalsody?

The drug name is tofersen and the brand name is Qalsody.

What are the side effects of Qalsody?

The most common adverse reactions reported in patients treated with QALSODY were pain (back pain, pain in arms or legs), feeling tired, muscle and joint pain and increased white blood cell count in the cerebrospinal fluid (CSF).

What is the mechanism of action of Qalsody?

Qalsody (tofersen) is an antisense oligonucleotide (ASO) designed to bind to SOD1 mRNA to reduce SOD1 protein production. Tofersen causes degradation of SOD1 mRNA through binding to SOD1 mRNA, which results in a reduction of SOD1 protein synthesis.

What is the drug tofersen used for?

Tofersen is specifically indicated for ALS patients with a confirmed SOD1 mutation, which can be detected through genetic testing. The drug targets the mRNA produced from mutated SOD1 genes, effectively reducing the synthesis of toxic SOD1 proteins.