Olezarsen Side Effects

Applies to olezarsen: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Use only as directed.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

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).

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