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Praluent

Generic Name: alirocumab (AL i ROK ue mab)
Brand Names: Praluent Pen, Praluent Syringe
Praluent (alirocumab) is a PCSK9 inhibitor used to treat high cholesterol. Includes Praluent side effects, interactions and indications.
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Drug Information:
Praluent (alirocumab) is a human monoclonal antibody. It works by helping the liver reduce levels of "bad" Cholesterol (low-density lipoprotein, or LDL) circulating in your blood. Praluent is used in adults with heart disease to reduce the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization. Praluent is used together with a low-fat diet, alone or together with other Cholesterol-lowering medicines in adults with high blood Cholesterol levels called primary hyperlipidemia (including a type of high Cholesterol called heterozygous familial hyperCholesterolemia), an inherited type of high Cholesterol. This condition can cause high blood levels of LDL Cholesterol, and can also cause plaque to build up inside your arteries. Learn more

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Praluent Side Effects

Note: This document contains side effect information about alirocumab. Some of the dosage forms listed on this page may not apply to the brand name Praluent.

For the Consumer

Applies to alirocumab: subcutaneous solution

Along with its needed effects, alirocumab (the active ingredient contained in Praluent) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while 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

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

More common

  • Chills
  • cough
  • diarrhea
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • redness, itching, swelling, or 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 stiffness or spasms
  • pain or tenderness around the eyes and cheekbones
  • swollen joints

For Healthcare Professionals

Applies to alirocumab: subcutaneous solution

General

The most commonly reported adverse reactions have included nasopharyngitis, injection site reactions, and influenza.

Hypersensitivity

Common (1% to 10%): Hypersensitivity reaction, nummular eczema, hypersensitivity vasculitis

Respiratory

Very common (10% or more): Nasopharyngitis (11.3%)

Common (1% to 10%): Influenza, bronchitis, sinusitis, cough

Gastrointestinal

Common (1% to 10%): Diarrhea

Genitourinary

Common (1% to 10%): Urinary tract infection

Hepatic

During clinical trials, 2.5% of patients treated with this drug reported abnormal liver enzymes (placebo=1.8%); treatment discontinuation occurred in 0.4% and 0.2% of patients receiving this drug and placebo, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with this drug (placebo=1.4%).

Common (1% to 10%): Elevated liver enzymes

Immunologic

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

Postmarketing reports: Flu-like illness

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%).

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

Musculoskeletal

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

Nervous system

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

Metabolic

During clinical trials with both every 2 week or every 4 week dosing, reports of 2 consecutive calculated LDL-C values less than 25 mg/dL, and less than 15 mg/dL were reported in 914 and 335 patients, respectively. Low LDL-C values were observed more frequently in patients treated with 150 mg every 2 weeks or 400 mg every 4 weeks. Changes to background lipid therapy was not made and adverse consequences were not identified, but the long-term effects of very low levels of LDL-C are not known.

Frequency not reported: Low LDL-C values

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Praluent (www.drugs.com/praluent.html).