Last update: March 2019
Common adverse reactions of patients treated with Praluent (table 1):
- local injection site reactions (most were transient and of mild intensity)
- upper respiratory tract signs and symptoms
- pruritus (typically mild and transient)
Table 1: Adverse events reported in patients treated with Praluent1
|System organ class||Common
(≥1/100 to <1/10)
(≥1/10,000 to <1/1,000)
|Immune system disorders||Hypersensitivity
|Respiratory, thoracic and mediastinal disorder||Upper respiratory tract signs and symptoms*|
|Skin and subcutaneous tissue disorders||Pruritus||Urticaria
|General disorders and administration site conditions||Injection site reactions**||Flu-like illness|
|* Including mainly oropharyngeal pain, rhinorrhoea, sneezing|
|** Including erythema/redness, itching, swelling, pain/tenderness|
General allergic reactions were reported more frequently in the Praluent group (8.1% of patients) than in the control group (7.0% of patients), mainly due to the incidence of pruritus.
Most common adverse reactions leading to treatment discontinuation in patients treated with Praluent were local injection site reactions1
- Local injection site reactions including erythema/redness, itching, swelling and pain/tenderness were reported in 6.1% of patients treated with Praluent versus 4.1% in the control group (receiving placebo injections).1
- The discontinuation rate due to local injection site reactions was comparable between Praluent and placebo (0.2% in the Praluent group verses 0.3% in the control group).
- Praluent Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/medicine/30956. Accessed March 2019.
- European Medicines Agency (2015). European Public Assessment Report (EPAR) alirocumab EMA/CHMP/392430/2015. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003882/WC500194524.pdf. Accessed August 2018.