Olezarsen Side Effects

Applies to olezarsen: subcutaneous solution.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Stop using olezarsen and call your doctor at once if you have:

• bronchospasm (wheezing, chest tightness, trouble breathing);

• chills, muscle pain;

• severe itching; or

• skin redness or a rash that spreads.

Common side effects may include:

• pain, redness, bruising, swelling, or irritation where the medicine was injected;

• low levels of platelets in your blood; or

• joint pain or stiffness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to olezarsen: subcutaneous solution.

General adverse events

The most common side effects were injection site reactions, decreased platelet count, and arthralgia.^[Ref]

Hematologic

• Very common (10% or more): Decreased platelet count (12%)

In a clinical trial, the baseline mean platelet count in the 80 mg group was 188,000/mm3, and the mean percent change in platelet count was -10% at Week 53. None of the familial chylomicronemia syndrome (FCS) patients treated with this drug experienced a platelet count less than 50,000/mm3, and no significant bleeding events were associated with a low platelet count.

Hepatic

• Frequency not reported: Increased Liver enzymes

Increased liver enzymes occurred within the first 3 months of treatment and stabilized. Liver enzymes returned towards baseline after discontinuing this drug.

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions

Local

• Very common (10% or more): Injection site reactions (19%)

Metabolic

• Very common (10% or more): Hyperglycemia (52%)
• Frequency not reported: Increased fasting glucose, increased hemoglobin A1c

In a clinical trial, FCS patients showed small increases in fasting glucose (17 mg/dL or less) and hemoglobin A1c (less than 0.2 percentage points) over time with this drug. The incidence of hyperglycemia was higher in patients without a medical history of diabetes at baseline who were treated with this drug compared to those on placebo

Musculoskeletal

• Common (1% to 10%): Arthralgia

Other

• Very common (10% or more): Developed antidrug antibodies (42%)
• Frequency not reported: Increased low-density lipoprotein cholesterol (LDL-C), increased apolipoprotein B

A clinical trial with a treatment duration of up to 53 weeks showed that 42% of patients treated with this drug developed treatment-emergent antidrug antibodies.

Despite increases in LDL-C, the maximum LDL-C value remained low for most patients (i.e., less than 70 mg/dL for 74% of patients treated with this drug).

See also:

Further information

Olezarsen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer