Eplontersen
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From MedlinePlus, U.S. National Library of Medicine
Antisense Oligonucleotide, Transthyretin-directed RNA Interaction
Dosing in kidney impairment
Renal Impairment No dose adjustment is necessary in patients with mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] ≥30 to <90 mL/min/1.73 m 2 ) [see Clinical Pharmacology ] . WAINUA has not been studied in patients with severe renal impairment or end-stage renal disease.
Dosing in liver impairment
Hepatic Impairment No dose adjustment is necessary in patients with mild hepatic impairment (total bilirubin ≤1 x ULN and AST >1 x ULN, or total bilirubin >1.0 to 1.5 x ULN and any AST) [see Clinical Pharmacology ] . WAINUA has not been studied in patients with moderate or severe hepatic impairment.
Preparation and administration
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General Administration Instructions Each autoinjector and prefilled syringe contains a single dose of WAINUA. Prior to administration of the autoinjector or prefilled syringe:
Do not use if WAINUA has been dropped or damaged, appears to be tampered with, or if the expiration date has passed.
Remove WAINUA from the refrigerator 30 minutes prior to the injection to reach room temperature. Do not use other warming methods.
Visually inspect WAINUA before use. The solution should appear colorless to yellow. Do not use if cloudiness, particulate matter, or discoloration is observed. To deliver a 45 mg dose of WAINUA, administer the entire contents of one autoinjector or prefilled syringe [see Dosage and Administration , ] , as a subcutaneous injection in the upper thigh or the abdomen.
The back of the upper arm can also be used as an injection site if a healthcare provider or caregiver administers the injection. Do not inject WAINUA into the area 2 inches (5 cm) around the navel or into areas where the skin is red, warm, tender, bruised, scaly or hard. Rotate the injection site with each injection .
Administration Instructions for WAINUA Autoinjector The autoinjector is intended for self-administration by patients or administration by caregivers. Prior to initiation, train patients and/or caregivers on proper preparation and administration of WAINUA autoinjector [see Instructions for Use ] .
Administration Instructions for WAINUA Prefilled Syringe (Healthcare Providers Only) The prefilled syringe must be administered by a healthcare provider. Refer to Figure 1 to identify the prefilled syringe components for use in the administration steps. Do not remove the needle cover until you are ready to inject WAINUA.
Do not touch the needle guard activation clips to prevent premature activation of the needle safety guard. Figure 1: WAINUA Prefilled Syringe Components Administration Steps Step 1 Remove the prefilled syringe from its tray. Hold the syringe body and remove the needle cover by pulling straight off. Do not recap. If small air bubbles are present, do not expel them prior to administration.
Step 2 Choose an injection site (i.e., back of upper arm, upper thigh, or abdomen). Gently pinch the skin and insert the needle subcutaneously at approximately a 45° angle into the chosen injection site. Step 3 Once the entire dose has been injected, the needle safety device will be triggered. As you let go of the plunger, the needle is automatically pulled from the skin, and into the device; the entire needle will be covered by the needle guard.
Figure_1
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on WAINUA use in pregnant women to inform drug-associated risk of adverse developmental outcomes. WAINUA treatment leads to a decrease in serum vitamin A levels, and vitamin A supplementation is advised for patients taking WAINUA. Vitamin A is essential for normal embryofetal development; however, excessive levels of vitamin A are associated with adverse developmental effects. The effect of vitamin A supplementation on the fetus in the setting of a reduction in maternal serum TTR caused by WAINUA administration is unknown [see Clinical Pharmacology (12.2) and Warnings and Precautions (5.1) ] .
No adverse developmental effects were observed when eplontersen or a mouse-specific surrogate was administered to mice prior to mating and continuing throughout organogenesis [see Animal Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Data Animal Data Subcutaneous administration of eplontersen (0, 5, 25, or 75 mg/kg) or a mouse-specific surrogate (25 mg/kg) to male and female mice weekly prior to and during mating and administration continued every other day in females throughout the period of organogenesis resulted in no adverse effects on embryofetal development.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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