Wainua (eplontersen sodium)

Dosage of eplontersen sodium is expressed in terms of eplontersen.

Eplontersen sodium is administered by subcutaneous injection only. It may be prepared and administered by the patient or their caregiver after appropriate training.

Eplontersen sodium is commercially available in single-dose autoinjectors as a clear, colorless-to-yellow solution. Store the autoinjectors at 2-8oC in the original carton and protect from light until time of use; do not freeze the drug or expose to heat. If necessary, the autoinjectors may be stored at room temperature (up to 30degreesC) in the original carton for up to 6 weeks; discard the drug if it is not used within this time period.

Remove the autoinjector from the refrigerator 30 minutes prior to injection and allow it to reach room temperature; other warming methods (e.g., microwave, hot water) should not be used. Inspect the solution visually prior to administration, and do not use if any cloudiness, particulate matter, or discoloration is present. Do not use the autoinjector if it appears damaged or if the clear cap is missing or not attached.

Inject eplontersen subcutaneously into the abdomen or upper thigh region; if the drug is being administered by a healthcare provider or caregiver, the back of the upper arm may also be used. Avoid injecting eplontersen into areas of the skin that are tender, bruised, red, hard, damaged, or scarred.

If a dose of eplontersen is missed, the missed dose should be administered as soon as possible. Resume dosing at monthly intervals from the date of the most recently administered dose.

No dosing information is available for this tab.

Formal drug interaction studies have not been conducted with eplontersen. In vitro studies indicate that eplontersen is not an inhibitor or inducer of cytochrome P-450 (CYP) isoenzymes, does not interact with highly plasma protein bound drugs, and is not an inhibitor of transporters. Eplontersen is also not a substrate for transporters and is not typically a substrate for CYP enzymes.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Adverse effects reported in >=9% of patients receiving eplontersen in clinical studies included decreased vitamin A and vomiting.

There are no severe adverse reactions for this drug.

More Frequent

• Vitamin A deficiency
• Vomiting

Less Frequent

• Blurred vision
• Cataracts
• Injection site pain
• Injection site sequelae
• Proteinuria

Rare or Very Rare

• Atrioventricular block

No enhanced messaging available.

Safety and efficacy of eplontersen have not been established in pediatric patients.

There are no available data on eplontersen use in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

No adverse developmental effects were noted when eplontersen (or a rodent-specific surrogate) was administered weekly to male and female mice prior to and during mating and continued every other day in female mice throughout the period of organogenesis.

Eplontersen treatment leads to decreased vitamin A levels, and vitamin A supplementation is advised for patients receiving eplontersen. Vitamin A is essential for normal embryofetal development, but excessive vitamin A levels have been associated with adverse developmental outcomes. The effect of vitamin A supplementation on the fetus in the setting of eplontersen therapy is unknown.

It is not known whether eplontersen is distributed in human milk. The effects of eplontersen on the breast-fed infant or on milk production are not known. Consider the developmental and health benefits of breast-feeding and the woman's clinical need for eplontersen along with any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

No dosage adjustment is required in patients >=65 years of age.

In the principal clinical study of eplontersen, 31% of patients were 65-74 years of age and 5.6% of patients were >=75 years of age. Although no overall differences in efficacy or safety have been observed between geriatric patients and younger adults, greater sensitivity of some older patients cannot be ruled out. The manufacturer states that no dosage adjustment of eplontersen is required in patients >=65 years of age.