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Patisiran Dosage

Medically reviewed by Drugs.com. Last updated on Nov 14, 2022.

Applies to the following strengths: 2 mg/mL

Usual Adult Dose for Amyloidogenic Transthyretin Amyloidosis

Recommended dose based on actual body weight:

  • Weight less than 100 kg: 0.3 mg/kg intravenously once every 3 weeks
  • Weight 100 kg or greater: 30 mg intravenously once every 3 weeks

Infuse at an initial rate of approximately 1 mL/min for the first 15 minutes, then increase to approximately 3 mL/min over 80 minutes.

PREMEDICATION: Administer on the day of infusion at least 60 minutes prior to the start of infusion:
  • Oral acetaminophen 500 mg
  • Intravenous Corticosteroid (e.g., dexamethasone 10 mg or equivalent)
  • Intravenous H1 blocker (e.g., diphenhydramine 50 mg or equivalent)
  • Intravenous H2 blocker (e.g., ranitidine 50 mg or equivalent)

Comments:
  • The duration of infusion may be extended in the event of an infusion-related reaction (IRR).
  • If intravenous premedications are not available or not tolerated, oral equivalents may be used.
  • If patients are tolerating the infusion, but experiencing adverse reactions to corticosteroid premedication, reduce corticosteroid in 2.5 mg increments to a minimum dexamethasone 5 mg intravenous dose or equivalent.
  • Some patients may require additional or higher doses of one or more premedications to reduce the risk of IRRs.

Use: For the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis.

Renal Dose Adjustments

  • Mild or moderate renal impairment (eGFR 30 to less than 90 mL/min/1.73 m [2]): No adjustment recommended
  • Severe renal impairment or end-stage renal disease: Data not available

Liver Dose Adjustments

  • Mild Liver Dysfunction (bilirubin 1 or less times the upper limit of normal [1 x ULN] and AST greater than 1 x ULN; OR bilirubin greater than 1 to 1.5 x ULN): No adjustment recommended
  • Moderate or severe Liver Dysfunction: Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • For intravenous use only.
  • All patients should receive premedication to reduce the risk of infusion-related reactions (IRRs).
  • If a dose is missed, it should be administered as soon as possible. If administration is within 3 days of the missed dose, dosing may be resumed on the original schedule. If administered more than 3 days after the missed dose, continue dosing every 3 weeks, thereafter.
  • See manufacturer product information for detailed infusion instructions.

Storage requirements:
  • Store vials in refrigerator at 36F to 46F (2C to 8C). Do not freeze. Discard if frozen.
  • May store at room temperature up to 77F (25C) for up to 14 days.

Reconstitution/preparation techniques:
  • The manufacturer's product information should be consulted for detailed instructions.

Monitoring:
  • Metabolic: Vitamin A deficiency

General:
  • Physicians are encouraged to enroll pregnant patients or pregnant women may register by calling 1-877-256-9526 or via email at alnylampregnancyprogroam@iqvia.com.

Patient advice:
  • Infusion-related reactions may occur during therapy. Contact your healthcare provider as soon as signs and symptoms occur.
  • This medication potentially decreases vitamin A levels. The healthcare personnel will provide specific information about vitamin A supplementation. Notify your healthcare professional of any sight problem you experience.
  • Female patients of childbearing potential who are pregnant or planning to become pregnant should first consult your healthcare provider.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.