ONPATTRO (patisiran sodium, lipid complex)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 5 severe adverse reactions.

More Frequent	Less Frequent
Vitamin A deficiency	Atrioventricular block

Rare/Very Rare
Extravasation injury Hypotension Syncope

There are 17 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Back pain Dyspnea Flushing Nausea Upper respiratory infection	Arthralgia Blurred vision Bronchitis Dry eye Dyspepsia Headache disorder Muscle spasm Vertigo Vitreous floater

Rare/Very Rare
Pruritus of skin Skin inflammation

There are no available data on patisiran use in pregnant women to inform a drug-associated risk of adverse developmental effects. Developmental toxicity has been observed in animal reproductive studies. Weekly administration of moderate to high doses of patisiran to pregnant rabbits during the period of organogenesis resulted in embryofetal mortality, reduced fetal body weights, and maternal toxicity.

No adverse developmental effects or effects on fertility were noted when patisiran (or a rodent-specific, pharmacologically active surrogate) was administered weekly to female rats starting 2 weeks prior to mating and continuing throughout pregnancy and lactation. A pregnancy registry has been established; encourage patients to enroll by calling 1-877-256-9526 or contacting alnylampregnancyprogram@iqvia.com.

It is not known whether patisiran is distributed into human milk. The drug was not detected in the milk of lactating rats; however, some lipid components of the formulation were present. The effects of patisiran on breast-fed infants or on milk production are not known. Consider the benefits of breast-feeding and the woman's clinical need for patisiran along with any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Among patients receiving patisiran in the principal efficacy study, 42% were >=65 years of age and 6% were >=75 years of age. Although no overall differences in safety or efficacy have been observed between geriatric patients and younger adults, the possibility of increased sensitivity to patisiran in some older individuals cannot be ruled out.