What is the most important information I should know about alirocumab?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
What is alirocumab?
Alirocumab is a human monoclonal antibody. It works by helping the liver reduce levels of "bad" cholesterol (low-density lipoprotein, or LDL) circulating in your blood.
Alirocumab is used together with a low-fat diet and a "statin" medication in people with heterozygous familial hypercholesterolemia (an inherited type of high cholesterol). This condition can cause high blood levels of LDL cholesterol, and can also cause plaque to build up inside your arteries.
Alirocumab is also used to treat heart disease with plaque build-up in the arteries (atherosclerosis, sometimes called hardening of the arteries).
Alirocumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using alirocumab?
You should not use alirocumab if you are allergic to it.
To make sure alirocumab is safe for you, tell your doctor about all your medical conditions or allergies.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether alirocumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Alirocumab is not approved for use by anyone younger than 18 years old.
How should I use alirocumab?
Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Alirocumab is injected under the skin, once every 2 to 4 weeks. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.
Your care provider will show you the best places on your body to inject alirocumab. Use a different place each time you give an injection. Do not inject into the same place two times in a row.
If you use alirocumab only once every 4 weeks, you will give yourself 2 separate injections at the same time. Use a new syringe or injection pen for each injection. Give each injection into a different place on your body.
Each single-use injection pen or prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Store this medicine in the refrigerator, do not freeze. Protect from light and high heat.
Take the medicine out of the refrigerator and allow it to reach room temperature for 30 to 40 minutes before injecting your dose. Do not heat an injection pen or prefilled syringe, and do not leave the pen at room temperature for longer than 24 hours.
Do not shake this medicine. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
While using alirocumab, you may need frequent blood tests.
You should not stop using alirocumab without your doctor's advice, or your LDL cholesterol levels may increase.
Alirocumab is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. Follow your doctor's instructions very closely.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
What happens if I miss a dose?
If you inject once every 2 weeks: Use the missed dose within 7 days after the injection was due. Then go back to your original schedule and use the medicine again when your next scheduled dose is due.
If you inject once every 4 weeks: Use the missed dose within 7 days after the injection was due. Then give the next injection 4 weeks later to start a new schedule based on the date you used the missed injection.
Skip the missed dose if you are more than 7 days late for the injection. Do not use extra medicine to make up a missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using alirocumab?
Do not inject alirocumab into skin that is sunburned, infected, swollen, or otherwise irritated.
What are the possible side effects of alirocumab?
Get emergency medical help if you have signs of an allergic reaction: hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.
Common side effects may include:
- redness, itching, soreness, or swelling where an injection was given;
- flu symptoms; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect alirocumab?
Other drugs may interact with alirocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about alirocumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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