Brand Name
Praluent
Generic Name
Alirocumab
View Brand Information FDA approval date: July 24, 2015
Classification: PCSK9 Inhibitor
Form: Injection
What is Praluent (Alirocumab)?
PRALUENT ® is indicated: To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol -lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia , to reduce LDL-C. As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia to reduce LDL-C. As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C. PRALUENT is a proprotein convertase subtilisin kexin type 9 inhibitor indicated: To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. As adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol -lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia , to reduce LDL-C. As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia to reduce LDL-C. As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.
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Brand Information
Praluent (alirocumab)
1INDICATIONS AND USAGE
PRALUENT
- To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease
- As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.
- As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
- As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 8 years and older with HeFH to reduce LDL-C.
2DOSAGE FORMS AND STRENGTHS
PRALUENT injection is a clear, colorless to pale yellow solution available as follows:
- 75 mg/mL single-dose pre-filled pen
- 150 mg/mL single-dose pre-filled pen
3CONTRAINDICATIONS
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, and hypersensitivity reactions requiring hospitalization have occurred
4ADVERSE REACTIONS
The following adverse reactions are also discussed in the other sections of the labeling:
- Hypersensitivity Reactions
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
The following adverse reactions have been reported during post-approval use of PRALUENT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Hypersensitivity reactions: Angioedema
- Influenza-like illness
5DESCRIPTION
Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa.
PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe.
Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.
Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.
6HOW SUPPLIED/STORAGE AND HANDLING
PRALUENT injection is a clear, colorless to pale yellow solution, supplied as follows:
The needle shield is not made with natural rubber latex.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
8Instructions For Use
PRALUENT® (PRAHL-u-ent)
Keep this leaflet. If you have questions, ask your healthcare provider or call 1-844-PRALUENT (1-844-772-5836).
The parts of the PRALUENT pen are shown in this picture.
Step A: Getting ready for your injection.
Before you start you will need:
- the PRALUENT pen
- 1 alcohol wipe
- 1 cotton ball or gauze
- a sharps container or a puncture-resistant container (see
A1: Look at the label on the pen.
- Check that you have the correct product and the correct dose.
- Check the expiration date (EXP):
A2: Look at the window.
- Check the liquid is clear, colorless to pale yellow and free from particles (see
- You may see air bubbles. This is normal.
- Do not use if the window appears solid yellow (see Figure B).
- Do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles.
A3: Let the pen warm up at room temperature for 30 to 40 minutes.
- This is important for administering the entire dose and helps minimize discomfort.
- Take PRALUENT out of the refrigerator to warm up before using.
- Do not heat the pen, let it warm up on its own.
- Do not put the pen back in the refrigerator.
A4: Prepare the injection site.
- Wash your hands with soap and water and dry with a towel.
- Clean skin in the injection area with an alcohol wipe.
- You can inject into your (see
- You can stand or sit to give yourself an injection.
Important:
- Change (rotate) your injection site each time you give yourself an injection. If you need to use the same injection site, make sure it is not the same spot on the site you used last time.
- Do not inject into areas where the skin is tender, bruised, hard, or red. Do not inject PRALUENT into areas with visible veins, scars or stretch marks.
Step B: How to give your injection.
B1: After completing all steps in "Step A: Getting ready for your injection", pull off the blue cap.
- Do not pull off the cap until you are ready to inject.
- Do not put the blue cap back on.
B2: Hold the PRALUENT pen like this.
- Do not touch the yellow safety cover.
- Make sure you can see the window.
B3: Press the yellow safety cover on your skin at roughly a 90° angle.
- For children younger than 12 years of age, pinching the skin before and during the injection is required.
- In adults and children aged 12 years and older, pinching of skin may be required to make the injection site firm.
- Press and firmly hold the pen against your body until the yellow safety cover is no longer visible. The pen will not work if the yellow safety cover is not depressed fully.
B4: Push and immediately release the green button with your thumb.
- You will hear a click. Your injection has now started.
- The window will start to turn yellow.
B5: Keep holding the pen against your skin after releasing the button.
- The injection may take up to 20 seconds.
B6: Check the window has turned yellow, before removing the pen.
- Do not remove the pen until the entire window has turned yellow.
- Your injection is complete when the window has turned completely yellow, you may hear a second click.
- If the window does not turn completely yellow, call 1-844-772-5836 for help.
B7: Pull pen away from your skin.
- Do not rub the skin after the injection.
- If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.
B8: Throw away (Discard) pen and cap.
- Do not put the blue cap back on.
- Throw away pen and cap in a puncture-resistant container immediately after they have been used.
Disposing of used pens:
- Put your used pens in a FDA-cleared sharps disposal container right away after use.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Keep PRALUENT and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
9Instructions For Use
PRALUENT® (PRAHL-u-ent)
Keep this leaflet. If you have questions, ask your healthcare provider or call 1-844-PRALUENT (1-844-772-5836).
The parts of the PRALUENT pen are shown in this picture.
Step A: Getting ready for your injection.
Before you start you will need:
- the PRALUENT pen
- 1 alcohol wipe
- 1 cotton ball or gauze
- a sharps container or a puncture-resistant container (see
A1: Look at the label on the pen.
- Check that you have the correct product and the correct dose.
- Check the expiration date (EXP):
A2: Look at the window.
- Check the liquid is clear, colorless to pale yellow and free from particles (see
- You may see air bubbles. This is normal.
- Do not use if the window appears solid yellow (see Figure B).
- Do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles.
A3: Let the pen warm up at room temperature for 30 to 40 minutes.
- This is important for administering the entire dose and helps minimize discomfort.
- Take PRALUENT out of the refrigerator to warm up before using.
- Do not heat the pen, let it warm up on its own.
- Do not put the pen back in the refrigerator.
A4: Prepare the injection site.
- Wash your hands with soap and water and dry with a towel.
- Clean skin in the injection area with an alcohol wipe.
- You can inject into your (see
- You can stand or sit to give yourself an injection.
Important:
- Change (rotate) your injection site each time you give yourself an injection. If you need to use the same injection site, make sure it is not the same spot on the site you used last time.
- Do not inject into areas where the skin is tender, bruised, hard, or red. Do not inject PRALUENT into areas with visible veins, scars or stretch marks.
Step B: How to give your injection.
B1: After completing all steps in "Step A: Getting ready for your injection", pull off the blue cap.
- Do not pull off the cap until you are ready to inject.
- Do not put the blue cap back on.
B2: Hold the PRALUENT pen like this.
- Do not touch the yellow safety cover.
- Make sure you can see the window.
B3: Press the yellow safety cover on your skin at roughly a 90° angle.
- For children younger than 12 years of age, pinching the skin before and during the injection is required.
- In adults and children aged 12 years and older, pinching of skin may be required to make the injection site firm.
- Press and firmly hold the pen against your body until the yellow safety cover is no longer visible. The pen will not work if the yellow safety cover is not depressed fully.
B4: Push and immediately release the gray button with your thumb.
- You will hear a click. Your injection has now started.
- The window will start to turn yellow.
B5: Keep holding the pen against your skin after releasing the button.
- The injection may take up to 20 seconds.
B6: Check the window has turned yellow, before removing the pen.
- Do not remove the pen until the entire window has turned yellow.
- Your injection is complete when the window has turned completely yellow, you may hear a second click.
- If the window does not turn completely yellow, call 1-844-772-5836 for help.
B7: Pull pen away from your skin.
- Do not rub the skin after the injection.
- If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.
B8: Throw away (Discard) pen and cap.
- Do not put the blue cap back on.
- Throw away pen and cap in a puncture-resistant container immediately after they have been used.
Disposing of used pens:
- Put your used pens in a FDA-cleared sharps disposal container right away after use.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Keep PRALUENT and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
10PRINCIPAL DISPLAY PANEL - 75 mg/mL Pen Carton
NDC 0024-
Praluent
alirocumab
Injection
75 mg/mL
alirocumab
Injection
75 mg/mL
One Pre-filled Pen
For subcutaneous injection only. Single-dose.
Carton contains:
75 mg/mL
↓
REGENERON
SANOFI
SANOFI
11PRINCIPAL DISPLAY PANEL - 150 mg/mL Pen Carton
NDC 0024-
Praluent
alirocumab
Injection
150 mg/mL
alirocumab
Injection
150 mg/mL
One Pre-filled Pen
For subcutaneous injection only. Single-dose.
Carton contains:
150 mg/mL
↓
REGENERON
SANOFI
SANOFI
12PRINCIPAL DISPLAY PANEL - 75 mg/mL Syringe Carton
NDC 0024-
Praluent
alirocumab
Injection
75 mg/mL
alirocumab
Injection
75 mg/mL
One Pre-filled Syringe
For subcutaneous injection only. Single-dose.
Carton contains:
75 mg/mL
▶ OPEN
REGENERON
SANOFI
SANOFI
13PRINCIPAL DISPLAY PANEL - 150 mg/mL SyringeCarton
NDC 0024-
Praluent
alirocumab
Injection
150 mg/mL
alirocumab
Injection
150 mg/mL
One Pre-filled Syringe
For subcutaneous injection only. Single-dose.
Carton contains:
150 mg/mL
▶ OPEN
REGENERON
SANOFI
SANOFI
