Praluent 75 mg, 150 mg, and 300 mg Alirocumab Solution for Injection in a Pre Filled pen
What Is Praluent And What Praluent Used For?
What Praluent is
- Praluent contains the active substance alirocumab.
- Praluent is a monoclonal antibody. Monoclonal antibodies are specialized proteins that recognize and bind to target substances (other unique proteins ) in the body. Alirocumab binds to the protein et PCSK9.
How Praluent works
This medicien helps lower the levels of “bad” cholesterol (also known as “LDL cholesterol”). Praluent blocks a protein called PCSK9.
- PCSK9 is a protein secreted by liver cells.
- “Bad” cholesterol is usually cleared from the blood by binding to specific “receptors” (docking stations) in the liver.
- PCSK9 lowers the number of these receptors in the liver – this causes the “bad” cholesterol to be higher than it should be in the blood.
- By blocking PCSK9, Praluent increases the number of available receptors that can clear away “bad” cholesterol – this lowers “bad” cholesterol levels.
What Praluent used for?
- Adults with high blood cholesterol levels ( hypercholesterolemia, heterozygous familial and non-familial, and mixed dyslipidemia ).
- Adults with high blood cholesterol levels and cardiovascular disease reduce the risk of cardiovascular events.
It is given:- Together with a statin (a common high cholesterol treatment drug ) or statin in combination with other cholesterol-lowering drugs if the highest statin dose does not lower cholesterol levels sufficiently or,
- Alone or in combination with other cholesterol-lowering drugs when statins cannot be used or when the patient is intolerant to statins.
- Continue your cholesterol-lowering diet while you are taking this medicine.
What You Need To Know Before Using Praluent
Do Not Use:
- If you are allergic to alirocumab or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions:
Talk to your doctor, nurse, or pharmacist before using this medicine. If you develop a severe allergic reaction, stop using this medicien and contact a doctor immediately. Severe allergic reactions such as:
- Hypersensitivity, including angioedema e.g.:
- Difficulty breathing or swelling of the face, lips, throat, or tongue
- Mint eczema (red spots on the skin, sometimes with blisters)
- In some cases, allergic vasculitis (a special form of hypersensitivity reaction with symptoms such as:
- Diarrhea with rash or purple spots on the skin) have been seen. For allergic reactions that may occur during Praluent treatment, see section 4.
Tell your doctor about kidney or liver disease before using this medicine. Praluent has only been studied in a few patients with severe kidney disease and not in patients with severe liver disease.
Children And Young People:
Praluent should not be given to children and adolescents under 18 years of age as there is limited experience with drug use in this age group.
Other Medicines And Praluent:
Tell your doctor, nurse, or pharmacist if you have recently taken or might take any other medicines.
Pregnancy And Breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Praluent is not recommended during pregnancy or lactation.
Driving And Using Machines:
This medicine will not affect your ability to drive or use machines.
3. How To Use Praluent?
- Always use this medicine exactly as your doctor, nurse, or pharmacist has told you. If unsure, talk to your doctor, nurse, or pharmacist.
- How much to inject
- Your doctor will tell you which dose is right for you and how often you should inject (75 mg or 150 mg every two weeks or 300 mg every four weeks / once a month). Your doctor will check your cholesterol levels and may adjust your dose (up or down) during treatment.
- Always check the pen’s label to ensure you have the right medicine with the right strength.
- When to inject
- Inject Praluent every two weeks (for a 75 mg or 150 mg dose ) or every four weeks / once a month (for a 300 mg dose ). To take a 300 mg dose, take an injection of 300 mg or two injections of 150 mg in succession at two different injection sites.
- Before you inject
- Praluent should be allowed to warm to room temperature before use.
- Read the detailed instructions for use before injecting Praluent.
- Each injection should be done.
- Praluent is injected under the skin of the thigh, abdomen, or upper arm.
- Read the detailed instructions for use on where to inject.
- To learn how to use the pre-filled pen
- Before using the pen for the first time, your doctor, nurse, or pharmacist will show you how to inject Praluent.
- Always read the Instructions for Use contained in the box.
- Always use the pen as described in the Instructions for Use.
If You Use More Praluent Than You Should:
If you take more Praluent than you should, talk to a doctor, nurse, or pharmacist.
If You Forget To Use Praluent:
If you miss a dose of Praluent, inject the missed dose as soon as you can. Then take your next dose at the usual time. This will return you to the original injection schedule. If you are unsure when to inject this medicien, talk to a doctor, nurse, or pharmacist.
If You Stop Using Praluent:
Do not stop using Praluent without talking to a doctor. If you stop using this medicine, your cholesterol levels may increase. If you have any further questions on using this product, ask your doctor, nurse, or pharmacist.
Possible Praulent Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. Stop using Praluent and contact a doctor immediately if you develop a severe allergic reaction. Severe allergic reactions such as:
- Hypersensitivity (e.g., difficulty breathing)
- Mint eczema (red spots on the skin, sometimes with blisters)
- Allergic vasculitis (a special form of hypersensitivity reaction with symptoms such as:
- Diarrhea with rash or purple spots on the skin) have, in some cases have, been seen (may affect up to 1 in 1,000 people).
Additional praluent injection side effects: Common (may affect up to 1 in 10 people)
- Redness
- Itching
- Swelling
- Pain or tenderness where the medicine was injected (injection site reactions)
- Signs or symptoms of upper respiratory tract infection such as:
- Sore throat
- Nasal congestion
- Sneezing
- Itching
Rare (may affect up to 1 in 1,000 people)
- Red and itchy bumps or hives ( urticaria )
No known frequency
The following side effects have been reported after the marketing of this medicien, but there is no known frequency of occurrence:
- Flu-like illness
- Difficulty breathing, or swelling of the face, lips, throat, or tongue ( angioedema )
How To Store Praluent?
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C to 8 ° C). Do not freeze.
- Store the pen in the outer carton. Sensitive to light.
- If necessary, individual pre-filled pens can be stored outside the refrigerator at
- not more than 25 ° C, protected from light for a continuous period not exceeding 30 days. After removing this medicien from the refrigerator must be used within 30 days or discarded.
- Do not use this medicine if it is discolored, cloudy, or contains flakes or visible particles.
- After use, place the pen in a non-stick container. Ask the pharmacy staff how to dispose of the container. Do not reuse the container.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information:
Content Declaration:
- The active substance is alirocumab.
Praluent 75 mg solution for injection in pre-filled penEach pre-filled pen contains 75 milligrams of alirocumab. - Praluent 150 mg solution for injection in pre-filled penEach pre-filled pen contains 150 milligrams of alirocumab. Praluent 300 mg solution for injection in pre-filled pen
- Each pre-filled pen contains 300 milligrams of alirocumab.
- The other ingredients are histidine, sucrose, polysorbate 20, and water for injections.
What The Medicine Looks Like, And The Contents of The Pack?
- This medicien is a clear, colorless to pale yellow solution for injection that comes in a pre-filled pen.
- Praluent 75 mg solution for injection in pre-filled pen
- 1 pre-filled pen with a green button contains 1 ml solution and gives a dose of 75 mg alirocumab.
- It is available in packs of 1, 2, or 6 pre-filled pens.
1 pre-filled pen without an activation button contains 1 ml solution and gives a dose of 75 mg alirocumab. - It is available in pack sizes of 1, 2, or 6 pre-filled pens without an activation button.
- Praluent 150 mg solution for injection in pre-filled pen
- 1 pre-filled pen with a gray button contains 1 ml solution and gives a dose of 150 mg alirocumab.
- It is available in packs of 1, 2, or 6 pre-filled pens.
- 1 pre-filled pen without an activation button contains 1 ml solution and gives a dose of 150 mg alirocumab.
- It is available in pack sizes of 1, 2, or 6 pre-filled pens without an activation button.
Praluent 300 mg solution for injection in pre-filled pen - 1 pre-filled pen without an activation button contains 2 ml solution and gives a dose of 300 mg alirocumab.
- It is available in packs of 1 or 3 pre-filled pens without an activation button.
- Not all strengths and pack sizes may be marketed.
Marketing Authorisation Holder
sanofi-aventis groupe
54, rue La Boétie
F – 75008 Paris
France
Manufacturer
Sanofi-Aventis Deutschland GmbH
Industrial park Hoechst
Brüningstraße 50
65926 Frankfurt am Main
Germany
Manufacturer
Genzyme Ireland Ltd
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sanofi AB
Tel: +46 (0) 8 634 50 00