Version July 2025
Familial chylomicronemia syndrome: Note: Use as an adjunct to a low-fat diet (≤20 g of fat per day).
SUBQ: 80 mg once monthly.
Missed dose: If scheduled dose is missed, administer as soon as possible, and resume monthly dosing interval from the date of the most recently administered dose.
eGFR ≥30 mL/minute: No dosage adjustment necessary.
eGFR <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Mild liver impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin <1.5 times ULN and any AST): No dosage adjustment necessary.
Moderate to severe liver impairment (total bilirubin >1.5 times ULN and any AST): 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 and may include non-FDA approved dosing.
>10%:
Endocrine & metabolic: Hyperglycemia
Hematologic & oncologic: Decreased platelet count
Immunologic: Antibody development
Local: Injection-site reaction
1% to 10%: Neuromuscular & skeletal: Arthralgia
Frequency not defined:
Endocrine & metabolic: Increased apolipoprotein B, increased LDL cholesterol
Hepatic: Increased liver enzymes
Hypersensitivity: Hypersensitivity reaction
Serious hypersensitivity (eg, bronchospasm, diffuse erythema, facial swelling) to olezarsen or any component of the formulation.
Concerns related to adverse effects:
• Hematologic effects: A reduced platelet count (eg, <100,000/microliter) was reported more frequently in patients who received olezarsen versus placebo (Bergmark 2024).
• Hepatic impairment: Elevations in liver transaminases (1 to 3 times the ULN) were reported in patients receiving olezarsen versus placebo (Bergmark 2024).
• Hypercholesterolemia: Increased low-density lipoprotein cholesterol and total apolipoprotein from baseline were observed in patients receiving olezarsen.
• Hyperglycemia: An increased incidence of hyperglycemia was observed more frequently in nondiabetic olezarsen recipients versus similar controls.
• Immunogenicity: Antidrug antibodies have been detected in patients treated with olezarsen; however, their presence does not appear to impact efficacy or safety in early data.
• Injection site reactions: Injection site reactions, most reported as erythema, were reported in patients receiving olezarsen (Tardif 2022).
• Musculoskeletal effects: Arthralgias were reported more frequently in patients who received olezarsen versus placebo.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous, as sodium [preservative free]:
Tryngolza: 80 mg/0.8 mL (0.8 mL)
No
Solution Auto-injector (Tryngolza Subcutaneous)
80 mg/0.8 mL (per 0.8 mL): $59,500.80
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: Allow autoinjector to warm to room temperature (for 30 minutes) prior to administration. Inspect injection for particulate matter; solution should be clear and colorless to yellow. Do not use if particulate matter or discoloration is present. Inject SUBQ into the abdomen, front of the thigh, or back of the upper arm (if administered by a caregiver). If hypersensitivity reaction develops, advise patients to seek medical attention and discontinue use.
Familial chylomicronemia syndrome: Adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.
None known.
There are no known significant interactions.
Animal reproduction studies were not conducted with olezarsen. Olezarsen is an ASO-GalNAc3 conjugate. Adverse events were not observed in animal reproduction studies conducted with SUBQ injection of unconjugated ASO in doses up to ~20 times the maximum recommended human dose (based on BSA).
It is not known if olezarsen is present in breast milk. Based on chemical properties, maternal use of olezarsen is not expected to lead to clinically relevant levels in breastfed infants.
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.
Use with a low-fat diet, defined as a diet with ≤20 g of fat per day.
Baseline fasting lipid panel, liver transaminases, platelet count, and fasting glucose level. Fasting lipid panels at 1, 3, 6, 9, and 12 months were evaluated in approval clinical trials. Periodic assessment and/or as clinically indicated: injection site reactions, low-fat diet adherence, liver transaminases, platelet count, and fasting glucose level.
Olezarsen is an ASO-Ga1NAc3 conjugate that binds to apoC-III mRNA resulting in reduced serum apoC-III protein, which increases clearance of triglycerides and very low-density lipoprotein.
Distribution: 91.9 L central Vd, 2,960 L peripheral Vd; distributes primarily into the liver and kidneys.
Protein binding: 99% bound to plasma proteins.
Metabolism: Liver metabolism via endo- and exonucleases into short oligonucleotide fragments.
Half-life elimination: ~4 weeks.
Time to peak: ~2 hours.
Excretion: <1% eliminated unchanged in the urine within 24 hours.
