Alirocumab (al-i-ROK-ue-mab)

Treats high levels of LDL cholesterol. Reduces the risk of heart attack, stroke, and unstable angina (chest pain) in patients with heart and blood vessel disease.

Brand Name(s):

Praluent

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. This medicine is usually given once every 2 weeks or once every 4 weeks.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. It is usually given in the stomach, thighs, or upper arms.
• Allow the pen or syringe to warm to room temperature for at least 30 to 40 minutes before you use it. Do not heat or shake the medicine.
• Use each pen or syringe only once. Do not save leftover medicine.
• Do not inject the medicine on skin areas that are bruised, red, hard, or tender.
• Do not inject any other medicines together with this medicine at the same injection site.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Missed dose:
  • Every 2-week dose: Use this medicine within 7 days from the missed dose. Then, go back to your original schedule. If the missed dose is not given within 7 days, wait until your next scheduled dose to re-start this medicine. If you are not sure when to re-start this medicine, ask your doctor or pharmacist.
  • Every 4-week dose: Use this medicine within 7 days from the missed dose. Then, go back to your original schedule. If the missed dose is not given within 7 days, use it right away and re-start this medicine based on this date. If you are not sure when to re-start this medicine, ask your doctor or pharmacist.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may also store this medicine in its original carton at room temperature for up to 30 days. Do not expose this medicine to extreme heat. After removing this medicine from the refrigerator, use it within 30 days. Throw any unused medicine after 30 days.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Severe rash

If you notice these less serious side effects, talk with your doctor:

• Cough, runny or stuffy nose, sore throat, body aches
• Redness, pain, swelling, or itching where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088