Moxetumomab pasudotox-tdfk is available as a liquid which should be given very slowly intravenously (IV) or deep into the vein as an infusion.
Patients should be intravenously given 1 liter of isotonic fluids such as 0.9% sodium chloride or 5% dextrose for 2 to 4 hours before and after each moxetumomab pasudotox-tdfk infusion.
Moxetumomab pasudotox-tdfk should be mixed or diluted under a controlled environment free from pathogens. Add IV solution stabilizer to the mixing bag before adding moxetumomab pasudotox-tdfk for uninterrupted flow.
Gently invert the IV bag for mixing. Do not shake. The diluted solution must be used immediately. If kept in cold storage, it should be allowed to come to room temperature before infusing but not more than 4 hours.
In patients with low body weight (below 50 kg), only half liter of hydration with isotonic fluids is recommended.
Patients who have a history of blood clots should take a low dose of aspirin from day 1 to 8 in a 28-day treatment cycle.
Patients must be given certain medications before and after the moxetumomab pasudotox-tdfk to reduce the severity of the side effects.
Premedications given 30 to 90 minutes before moxetumomab pasudotox-tdfk infusion include-
• Medicine for allergies (e.g., Diphenhydramine or Hydroxyzine)
• Fever medication (e.g., Paracetamol or Acetaminophen)
• Ulcer healing agents (e.g., Ranitidine or Famotidine)
Steroid taken by mouth or given as an injection is advised half an hour before starting the moxetumomab pasudotox-tdfk infusion.
Medications to be given after moxetumomab pasudotox-tdfk infusion:
• Allergy or fever-reducing pills taken by mouth for up to 24 hours after the infusion
• Steroids (e.g. Dexamethasone 4 mg) taken by mouth to reduce nausea and vomiting
Patients must be provided with adequate water or oral fluids (milk or juice) intake after the moxetumomab pasudotox-tdfk infusion from day 1 to 8 in a treatment cycle - patients with a healthy weight get 3 liters and patients who are below 50 kg get 2 liters.
• The recommended dose of moxetumomab pasudotox-tdfk is 0.04 mg/kg given very slowly over 30 minutes on days 1, 3, and 5 of every treatment cycle (28-days).
• The treatment with moxetumomab pasudotox-tdfk should be continued for a maximum of 6 cycles.
• Moxetumomab pasudotox-tdfk can be given until the patient shows any progression of the disease or until the treatment with the drug does not result in intolerable toxicity.
• If there is an allergy to moxetumomab pasudotox
• Pregnancy and breastfeeding
• History of severe kidney disease
Children under 18 years of age should not be given moxetumomab pasudotox-tdfk due to lack of safety and effectiveness data in these groups.
Patients should be intravenously given 1 liter of isotonic fluids such as 0.9% sodium chloride or 5% dextrose for 2 to 4 hours before and after each moxetumomab pasudotox-tdfk infusion.
Moxetumomab pasudotox-tdfk should be mixed or diluted under a controlled environment free from pathogens. Add IV solution stabilizer to the mixing bag before adding moxetumomab pasudotox-tdfk for uninterrupted flow.
Gently invert the IV bag for mixing. Do not shake. The diluted solution must be used immediately. If kept in cold storage, it should be allowed to come to room temperature before infusing but not more than 4 hours.
In patients with low body weight (below 50 kg), only half liter of hydration with isotonic fluids is recommended.
Patients who have a history of blood clots should take a low dose of aspirin from day 1 to 8 in a 28-day treatment cycle.
Patients must be given certain medications before and after the moxetumomab pasudotox-tdfk to reduce the severity of the side effects.
Premedications given 30 to 90 minutes before moxetumomab pasudotox-tdfk infusion include-
• Medicine for allergies (e.g., Diphenhydramine or Hydroxyzine)
• Fever medication (e.g., Paracetamol or Acetaminophen)
• Ulcer healing agents (e.g., Ranitidine or Famotidine)
Steroid taken by mouth or given as an injection is advised half an hour before starting the moxetumomab pasudotox-tdfk infusion.
Medications to be given after moxetumomab pasudotox-tdfk infusion:
• Allergy or fever-reducing pills taken by mouth for up to 24 hours after the infusion
• Steroids (e.g. Dexamethasone 4 mg) taken by mouth to reduce nausea and vomiting
Patients must be provided with adequate water or oral fluids (milk or juice) intake after the moxetumomab pasudotox-tdfk infusion from day 1 to 8 in a treatment cycle - patients with a healthy weight get 3 liters and patients who are below 50 kg get 2 liters.
Dosage & When it is to be taken
• The dose of moxetumomab pasudotox-tdfk is calculated based on the individual patient’s body weight.• The recommended dose of moxetumomab pasudotox-tdfk is 0.04 mg/kg given very slowly over 30 minutes on days 1, 3, and 5 of every treatment cycle (28-days).
• The treatment with moxetumomab pasudotox-tdfk should be continued for a maximum of 6 cycles.
• Moxetumomab pasudotox-tdfk can be given until the patient shows any progression of the disease or until the treatment with the drug does not result in intolerable toxicity.
When it is not to be taken (Contraindications)
Moxetumomab pasudotox-tdfk should not be used in patients-• If there is an allergy to moxetumomab pasudotox
• Pregnancy and breastfeeding
• History of severe kidney disease
Children under 18 years of age should not be given moxetumomab pasudotox-tdfk due to lack of safety and effectiveness data in these groups.
