Olezarsen
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Nehal Eid
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Overview
Olezarsen is an Oligonucleotide that is FDA approved for the treatment of It is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).. Common adverse reactions include 1-Injection site reactions 2-Decreased platelet count 3-Arthralgia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended dosage is 80 mg administered once monthly.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Olezarsen in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Olezarsen in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Olezarsen FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Olezarsen in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Olezarsen in pediatric patients.
Contraindications
It is contraindicated in patients with a history of serious hypersensitivity to olezarsen or any other components.
Warnings
Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of olezarsen if hypersensitivity reactions occur.
Adverse Reactions
Clinical Trials Experience
Hypersensitivity reactions, injection site reactions, decreased platelet count, and arthralgia.
Postmarketing Experience
There is limited information regarding Olezarsen Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Olezarsen Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Olezarsen in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Olezarsen in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Olezarsen during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Olezarsen in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Olezarsen in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Olezarsen in geriatric settings.
Gender
There is no FDA guidance on the use of Olezarsen with respect to specific gender populations.
Race
There is no FDA guidance on the use of Olezarsen with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Olezarsen in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Olezarsen in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Olezarsen in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Olezarsen in patients who are immunocompromised.
Administration and Monitoring
Administration
Administered through subcutaneous injection
Monitoring
There is limited information regarding Olezarsen Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Olezarsen and IV administrations.
Overdosage
There is limited information regarding Olezarsen overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Olezarsen Pharmacology in the drug label.
Mechanism of Action
Olezarsen is an ASO-GalNAc3 conjugate that binds to apoC-III mRNA leading to mRNA degradation and resulting in a reduction of serum apoC-III protein. Reduction of apoC-III protein leads to increased clearance of plasma TG and VLDL.
Structure
There is limited information regarding Olezarsen Structure in the drug label.
Pharmacodynamics
Fasting apoC-III: Olezarsen decreased fasting apoC-III following administration of 80 mg dosage every 4 weeks to patients with FCS.
Cardiac Electrophysiology: At a dose 1.5-times the maximum approved recommended dosage, it does not prolong the QT interval to any clinically relevant extent.
Pharmacokinetics
There is limited information regarding Olezarsen Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Olezarsen Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Olezarsen Clinical Studies in the drug label.
How Supplied
Olezarsen injection is a sterile, preservative-free, clear, colorless to yellow solution supplied in a single-dose autoinjector. Each autoinjector of Olezarsen is filled to deliver 0.8 mL of solution containing 80 mg of olezarsen.
Olezarsen is available in cartons containing one 80 mg single-dose autoinjector each.
Storage
Store the autoinjector in the refrigerator between 2°C and 8°C (36°F and 46°F) in the original carton.
Once taken out of the refrigerator, the autoinjector can be stored at room temperature between 15°C and 30°C (59°F and 86°F) in the original carton for up to 6 weeks. If not used within the 6 weeks stored at room temperature, discard the drug.
Do not freeze. Do not expose to heat. Protect from light.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
-Hypersensitivity: Inform patients that serious hypersensitivity reactions, including bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgia.
Advise patients on the signs and symptoms of hypersensitivity reactions and instruct them to stop taking Olezarsen and seek medical advice promptly if such symptoms occur.
-Adherence to Diet Advise patients with FCS that use of lipid-regulating agents does not reduce the importance of adhering to a low-fat diet.
-Missed Dose: Instruct patients to take Olezarsen as prescribed. If a dose is missed, instruct patients to take it as soon as they remember. Resume dosing at monthly intervals from the date of the most recently administered dose.
Precautions with Alcohol
Alcohol-Olezarsen interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Olezarsen Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Olezarsen Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.