Patisiran Dosage

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

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.

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Further information

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

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