Olezarsen

Olezarsen is a prescription medication indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)

• Olezarsen is available under the following different brand names: Tryngolza.

Common side effects of Olezarsen include:

• injection site reactions (such as redness or pain at the injection site)
• decreased platelet count (blood cells that help to clot blood)
• joint pain or stiffness 

Serious side effects of Olezarsen include:

• allergic reaction symptoms include redness of the skin, red itchy bumps (hives), swelling of the face, chills or trouble breathing

Rare side effects of Olezarsen include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, solution

• 80 mg/0.8mL single dose autoinjector

FCS

Adult dosage

• 80 mg SC once monthly

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Olezarsen has no noted severe interactions with any other drugs
• Olezarsen has no noted serious interactions with any other drugs
• Olezarsen has no noted moderate interactions with any other drugs
• Olezarsen has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity reactions to olezarsen or any of its excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Olezarsen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Olezarsen?”

Cautions

• Hypersensitivity
  • Hypersensitivity reactions reported
  • Advise patients of signs and symptoms and instruct them to promptly seek medical attention and discontinue use if hypersensitivity reactions occur

Pregnancy and Lactation

• Data are unavailable on use in pregnant women to inform drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Clinical considerations
  • During pregnancy, triglyceride levels increase during the third trimester
  • In patients with underlying defects in lipid metabolism (e.g., FCS), severe gestational hypertriglyceridemia may occur, thereby increasing the risk of acute pancreatitis during pregnancy
• Lactation
  • Data are unavailable regarding the presence of olezarsen in either human or animal milk, its effects on breastfed infants, or milk production
  • Unconjugated antisense ASO, which shares the same nucleotide sequence but lacks GalNAc, was present in the milk of lactating mice at low levels
  • Oligonucleotide-based products typically have poor oral bioavailability; therefore, it is considered unlikely that low levels present in milk will lead to clinically relevant levels in breastfed infants
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on breastfed infants from olezarsen or FCS