Praluent (alirocumab) Side Effects, Costs, Dosing, And Prescribing Information For Reducing Cholesterol | Daniel Elmatari, PharmD | RxEconsult
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Praluent (alirocumab) Side Effects, Costs, Dosing, And Prescribing Information For Heterozygous Familial Hypercholesterolemia (HeFH) And Clinical Atherosclerotic Disease Category: Cholesterol by - August 3, 2015 | Views: 59150 | Likes: 1 | Comment: 1  

What is the dosage of Praluent?

Praluent is available in 1 milliliter (mL)  single-dose pre-filled pens or syringes in 2 dosage strengths: 75 mg/ml and 150 mg/ml.

Recommended starting dose of Praluent is 75 mg administered via subcutaneous (under the skin) injection once every 2 weeks. A maximum dose of 150 mg every 2 weeks can be used if adequate LDL lowering is not achieved from the 75 mg dose.

Store pens and syringes at 36°F to 46°F (2°C to 8°C). Do not freeze, expose to extreme heat, or shake Praluent devices. Store in the outer carton to protect from light.

Warm pens or syringes to room temperature 30 to 40 minutes prior to use. Praluent should not be stored at room temperature for longer than 24 hours.

What are the side effects and precautions for Praluent?

Local injection site reactions such as redness, itching, swelling and tenderness were experienced by 7.2% of patients treated with Praluent.

Serious allergic reactions such as hypersensitivity, nummular eczema, and hypersensitivity vasculitis were reported. If signs and symptoms of allergic reactions occur, discontinue Praluent and treat the patient according to the standard of care.

Liver enzyme abnormalities were reported in 2.5% of patients taking Praluent.

Confusion or memory impairment were reported in a small population of patients.

In the clinical trials, 4.8% of patients  developed anti-drug antibodies (ADA) against Praluent. Those who developed ADA experienced more injection site reactions. 

What are Praluent drug interactions?

Praluent does not appear to affect cytochrome P450 liver enzymes or transporter proteins such as P-gp and OATP.

Can pregnant or breastfeeding women take Praluent?

There is no data to determine the safety of Praluent during pregnancy or breastfeeding in humans.

What is the cost of Praluent?

The wholesale price for all strengths of Praluent is $40 per day ($1,120 every 28 days). The manufacturers provide patient assistance to uninsured or underinsured patients, including free medicine to eligible patients. Patients can request additional resources, including a sharps disposal container and Praluent travel kit. More details can be found at MyPraluent.

Resources

Praluent Prescribing Information (Package Insert)

FDA News Release - FDA.gov

Heart Disease Facts – CDC.gov

What is Cholesterol? – American Heart Association

George Yuan, Jian Wang, Robert A. Hegele. Heterozygous familial hypercholesterolemia: an under recognized cause of early cardiovascular disease. CMAJ. 2006 April 11; 174(8): 1124–1129

 

Editor: Karine Wong. PharmD

 

 



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