• Patisiran injection should be given by intravenous (IV) injection directly into the vein only by the healthcare personnel.
• Calculate the required dose of patisiran and withdraw the necessary contents from the vial. Filter patisiran injections by using a sterile filter and dilute with 0.9% sodium chloride to make a total volume of 200 ml into an infusion bag.
• The diluted patisiran solution should be used immediately after preparation. If it is not used immediately, store the infusion bag at room temperature (below 25°C) but use within 16 hours from the preparation time.
• The infusion should be given intravenously or deep into the vein very slowly over a period of 80 minutes under the supervision of a medical specialist.
• The time of infusion can be extended in patients who show infusion-related side effects.
• Use a separate IV set for administering patisiran infusion; the set should be mainly free from DHEP (Di (2-ethylhexyl) phthalate) to avoid serious side effects.
• Flush the IV set with 0.9% sodium chloride solution once the infusion of patisiran is complete.
For patients weighing below 100 kg:
• The recommended dose of patisiran is 0.3 mg/kg given once every three weeks.
For patients weighing more than 100 kg:
• The recommended dose of patisiran is 30 mg once every three weeks.
Patients must be premedicated at least 1 hour before giving patisiran injection to minimize infusion-related reactions (IRRs).
The premedication involves the following medicines-
The dose of steroids (dexamethasone) can be reduced by 5 mg if the patient is unable to tolerate or shows side effects due to dexamethasone 10 mg.
The infusion-related reactions may vary according to the individual patient and the dose of the premedications can either be decreased or increased based on the severity of the infusion-related reactions.
No dose adjustment of patisiran is required for treating patients with a history of mild to moderate liver or kidney disease.
• Allergic to patisiran
• Children below 18 years of age (due to lack of safety and effectiveness data in these age groups)
Patisiran injections should not be given to patients with severe liver or kidney disease as patisiran has not been tested in the concerned patients.
• Calculate the required dose of patisiran and withdraw the necessary contents from the vial. Filter patisiran injections by using a sterile filter and dilute with 0.9% sodium chloride to make a total volume of 200 ml into an infusion bag.
• The diluted patisiran solution should be used immediately after preparation. If it is not used immediately, store the infusion bag at room temperature (below 25°C) but use within 16 hours from the preparation time.
• The infusion should be given intravenously or deep into the vein very slowly over a period of 80 minutes under the supervision of a medical specialist.
• The time of infusion can be extended in patients who show infusion-related side effects.
• Use a separate IV set for administering patisiran infusion; the set should be mainly free from DHEP (Di (2-ethylhexyl) phthalate) to avoid serious side effects.
• Flush the IV set with 0.9% sodium chloride solution once the infusion of patisiran is complete.
Dosage & When it is to be taken
The dose of patisiran should be calculated based on the body weight of the individual patient.For patients weighing below 100 kg:
• The recommended dose of patisiran is 0.3 mg/kg given once every three weeks.
For patients weighing more than 100 kg:
• The recommended dose of patisiran is 30 mg once every three weeks.
Patients must be premedicated at least 1 hour before giving patisiran injection to minimize infusion-related reactions (IRRs).
The premedication involves the following medicines-
- Fever-reducing medicine (Paracetamol or acetaminophen)
- Injections into the deep vein (intravenous)
- Steroid (e.g., Dexamethasone 10 mg)
- Anti-allergic drug (e.g., Diphenhydramine 50 mg)
- Ulcer healing medication (e.g., Ranitidine 50 mg)
The dose of steroids (dexamethasone) can be reduced by 5 mg if the patient is unable to tolerate or shows side effects due to dexamethasone 10 mg.
The infusion-related reactions may vary according to the individual patient and the dose of the premedications can either be decreased or increased based on the severity of the infusion-related reactions.
No dose adjustment of patisiran is required for treating patients with a history of mild to moderate liver or kidney disease.
When it is not to be taken (Contraindications)
Patisiran should not be used in patients who are -• Allergic to patisiran
• Children below 18 years of age (due to lack of safety and effectiveness data in these age groups)
Patisiran injections should not be given to patients with severe liver or kidney disease as patisiran has not been tested in the concerned patients.
