Version May 2024
Polyneuropathy of hereditary transthyretin mediated amyloidosis: SUBQ: 45 mg once monthly.
Missed doses: If a dose is missed, administer the dose as soon as possible. Adjust schedule for subsequent doses to maintain monthly administration.
eGFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
eGFR <30 mL/minute/1.73 m2 or end-stage kidney disease: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Mild impairment (total bilirubin ≤1 × ULN and AST >1 × ULN, or total bilirubin >1.0 to 1.5 × ULN and any AST): No dosage adjustment necessary.
Moderate to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%: Endocrine & metabolic: Vitamin A deficiency (15%)
1% to 10%:
Cardiovascular: Atrioventricular block (2%; complete atrioventricular block [<1%])
Gastrointestinal: Vomiting (9%)
Genitourinary: Proteinuria (8%)
Local: Injection-site reaction (7%; including erythema at injection site, injection-site pruritus, pain at injection site)
Ophthalmic: Blurred vision (6%), cataract (6%)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Vitamin A levels: A decrease in serum vitamin A has been reported with eplontersen treatment. Supplement at the recommended daily allowance (RDA) of vitamin A during treatment. Do not administer doses higher than the RDA to attain a normal serum vitamin A concentration; serum vitamin A levels do not reflect the total vitamin A in the body. If ocular symptoms develop, such as night blindness or dry eye, refer to an ophthalmologist.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous, as sodium [preservative free]:
Wainua: 45 mg/0.8 mL (0.8 mL)
No
Solution Auto-injector (Wainua Subcutaneous)
45 mg/0.8 mL (per 0.8 mL): $49,900.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
SUBQ: If stored under refrigeration, remove autoinjector from refrigeration ≥30 minutes prior to administration to allow to reach room temperature; do not use other warming methods. May self-administer in the abdomen or upper thigh; administration in the upper arm should only be done by another person. Avoid areas within 2 inches of navel, areas with scars or bruising, and areas where skin is damaged, tender, red, or hard. Remove autoinjector cap immediately prior to injection. Placing orange needle shield at a 90-degree angle against the skin, push autoinjector firmly into skin; an audible click will occur as injection starts (a second click may be heard; this is normal, and the injection is not finished). Hold autoinjector in place for 10 seconds; do not move, turn, or change angle of autoinjector during the 10 seconds. Ensure the orange plunger rod has filled the viewing window of the autoinjector; if orange plunger rod does not fill viewing window, full dose may not have been received. Remove by lifting autoinjector straight up. Do not reuse autoinjector.
Polyneuropathy of hereditary transthyretin-mediated amyloidosis: Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Eplontersen may be confused with eplerenone, eteplirsen.
Eplontersen (US) may be confused with Eplerenon brand name for eplerenone (multiple international markets); Eplerenona brand name for eplerenone (multiple international markets); Epleron brand name for eplerenone (Bangladesh); Eplerone brand name for eplerenone (Paraguay).
None known.
There are no known significant interactions.
Adverse events were not observed in animal reproduction studies conducted in mice administered eplontersen or a mouse-specific surrogate.
Eplontersen decreases serum concentrations of vitamin A, which is required for normal fetal development. The effects to the fetus of maternal vitamin A supplementation during eplontersen therapy, or the effects to the fetus of reducing maternal serum transthyretin, are not known.
It is not known if eplontersen is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Eplontersen is an antisense oligonucleotide that binds to TTR mRNA, causing degradation of mutant and wild type TTR mRNA, which reduces serum TTR protein and TTR protein deposit in tissues.
Distribution: Vd (central): 12 L; Vd (peripheral): 11,100 L.
Protein binding: >98%.
Metabolism: Metabolized by endo- and exo-nucleases to oligonucleotides of various lengths.
Half-life elimination: ~3 weeks.
Time to peak: ~2 hours.
Excretion: Urine (<1% as unchanged drug).
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