patisiran sodium: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
patisiran sodium: clinical details
Prescribing considerations
- Initiate under a clinician experienced in managing amyloidosis.
- Correct low serum vitamin A and assess related ocular symptoms before initiation.
- Exclude pregnancy and discuss effective contraception with people who could become pregnant.
- Use premedication and monitor during infusion for infusion-related reactions and extravasation.
- Moderate or severe hepatic impairment and severe renal impairment or end-stage renal disease have not been adequately studied; use requires an individual benefit–risk assessment.
Contraindications and cautions
- Severe hypersensitivity, including anaphylaxis, to patisiran or any excipient.
Monitoring
- Assess for infusion-related reactions during administration and afterwards when clinically indicated.
- Monitor for reduced night vision, dry eyes, corneal symptoms or other evidence of vitamin A deficiency; arrange ophthalmological assessment when indicated.
- Do not use serum vitamin A concentration to adjust supplementation during treatment.
- In an unplanned pregnancy, arrange specialist maternal and fetal monitoring, particularly early in pregnancy.
Clinical pharmacology
Patisiran is a double-stranded small interfering RNA delivered to hepatocytes in lipid nanoparticles. It promotes degradation of transthyretin messenger RNA and is metabolised by nucleases rather than cytochrome P450 enzymes.
Formulation and product differences
- The selected product is a refrigerated, single-use intravenous concentrate formulated as lipid nanoparticles. It requires filtration and dilution in sodium chloride solution and must not be mixed with other medicines.
patisiran sodium preparations and strengths
Solution for infusion
Route: Intravenous
Strengths: 2 mg/mL
patisiran sodium interactions
Formal clinical interaction studies are limited. Tell the specialist team about all medicines and supplements.
Bupropion or efavirenz
An uncertain effect involving the CYP2B6 enzyme was seen in laboratory studies, so concomitant treatment should be reviewed.
Vitamin A supplements
Use only the amount directed by the specialist; blood vitamin A results during treatment do not reliably represent total body vitamin A.
Other cytochrome P450 substrates, inhibitors or inducers
Clinically important interactions are not generally expected because patisiran is not a cytochrome P450 substrate.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.