What are the most common side effects of ALIROCUMAB?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for ALIROCUMAB. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is ALIROCUMAB the same as Praluent?

Praluent is a brand name for ALIROCUMAB. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

ALIROCUMAB

Q: What is ALIROCUMAB used for?

ALIROCUMAB (brand name Praluent) is a PCSK9 Inhibitor indicated for 1 INDICATIONS AND USAGE PRALUENT ® is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke.

Q: How does ALIROCUMAB work?

ALIROCUMAB works through the following mechanism: 12.1 Mechanism of Action Alirocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein (LDL) receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels..

PCSK9 Inhibitor

Brand names: Praluent

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action Alirocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein (LDL) receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.

Indications

1 INDICATIONS AND USAGE PRALUENT ® is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death

myocardial infarction

stroke

myocardial infarction

stroke

Contraindications

• 4 CONTRAINDICATIONS PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. Hypersensitivity vasculitis
• angioedema

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: hypersensitivity vasculitis, angioedema, and other hypersensitivity reactions requiring hospitalization, have been reported with PRALUENT treatment
If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve
If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve
PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any excipient in PRALUENT [see Contraindications (4) ]

Known Side Effects

8 documented side effects by frequency

Muscle Pain

>10%

Injection Site Pain

1-10%

Joint Pain

1-10%

Fatigue

1-10%

Limb Pain

1-10%

Diarrhea

1-10%

Headache

1-10%

Cough

0.1-1%

Community Discussions

No community discussions found for ALIROCUMAB yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → ALIROCUMAB openFDA label JSON → ALIROCUMAB FAERS adverse-event reports → ALIROCUMAB ClinicalTrials.gov → completed Phase 2+ trials of ALIROCUMAB

Compare With

10 available comparisons

Formulations

Dosage Forms

Tablet

Route

Subcutaneous