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Alirocumab Side Effects

For the Consumer

Applies to alirocumab: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by alirocumab. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking alirocumab:

More common:
  • Difficulty with breathing or swallowing
  • fever
  • hives
  • nausea
  • reddening of the skin, especially around the ears
  • swelling of the eyes, face, or inside of the nose
  • unusual tiredness or weakness
Less common:
  • Cough producing mucus
  • tightness in the chest

Minor Side Effects

Some of the side effects that can occur with alirocumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Chills
  • cough
  • diarrhea
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • redness, itching, swelling, pain at the injection site
  • shivering
  • sore throat
  • stuffy or runny nose
  • sweating
  • trouble sleeping
  • vomiting
Less common:
  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • difficulty with moving
  • frequent urge to urinate
  • lower back or side pain
  • muscle pains or stiffness
  • muscle spasms
  • pain or tenderness around the eyes and cheekbones
  • swollen joints

For Healthcare Professionals

Applies to alirocumab: subcutaneous solution

General

The most common adverse reactions leading to treatment discontinuation were allergic reactions and elevated liver enzymes.[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity reaction, nummular eczema, hypersensitivity vasculitis[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (11.3%)
Common (1% to 10%): Influenza, bronchitis, sinusitis, cough[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Hepatic

Common (1% to 10%): Elevated liver enzyme[Ref]

Immunologic

Common (1% to 10%): Development of antidrug antibody (ADA), neutralizing antibodies (NAb)[Ref]

Local

Patients who developed ADA (antidrug antibody) had a higher incidence of injection site reactions compared with patients who did not develop ADA (10.2% vs 5.9%).[Ref]

Common (1% to 10%): Injection site reaction (erythema, redness, itching, swelling, pain, tenderness)[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, muscle spasm, contusion, musculoskeletal pain[Ref]

Nervous system

Uncommon (0.1% to 1%): Neurocognitive events, confusion or memory impairment[Ref]

References

1. "Product Information. Praluent Pen (alirocumab)." sanofi-aventis, Bridgewater, NJ.

Not all side effects for alirocumab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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