Praluent

The recommended starting dose of Praluent (Alirocumab) is 75 mg injected subcutaneously (under the skin) every 2 weeks. Depending on the effectiveness of the medication, your doctor may increase your dose to 150 mg every 2 weeks, but most people find that the lower dose is enough. Alternatively, your doctor may recommend a dose of 300 mg injected once every 4 weeks. This will involve 2 separate injections of 150 mg of Praluent (Alirocumab).

Subcutaneous injections are administered in the abdomen, upper arm, or thigh area. Change the injection site with each injection to keep your skin healthy.

Do not use the injection if it is discoloured or if particles are present.

If you are injecting Praluent (Alirocumab) yourself, your doctor will show you how to use Praluent (Alirocumab) properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using Praluent (Alirocumab), thoroughly read the patient information provided and ask your doctor if you have any questions. If a family member or caregiver will be giving you the injections, your doctor should instruct them on how to give the injection.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Praluent (Alirocumab) exactly as prescribed by your doctor. If you are injecting Praluent (Alirocumab) every 2 weeks and you miss a dose, and it is within 7 days of the missed dose, take it as soon as possible and continue with your regular dosing schedule. If it is more than 7 days since the missed dose, skip the missed dose and continue with your regular dosing schedule. If you are injecting Praluent (Alirocumab) every 4 weeks and it is within 7 days of the missed dose, take it as soon as possible and continue with your regular dosing schedule. If it is more than 7 days since the missed dose, take the missed dose, and start a new schedule from the day you remember to take your dose. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Praluent (Alirocumab) in the refrigerator, protect it from light and moisture, and keep it out of the reach of children. Do not freeze Praluent (Alirocumab). Allow the medication to warm to room temperature for 30 to 40 minutes before you inject it. Once it is removed from the refrigerator, it must be used within 24 hours and must not be put back into the refrigerator.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause diarrhea; it may cause muscle pain; it may cause redness and swelling at the injection site; it may cause a cough. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Pre-filled syringe

75 mg/mL
Each 1 mL single-use, pre-filled syringe contains a clear, colourless-to-pale yellow, sterile, preservative-free solution that contains 75 mg of Praluent (Alirocumab). Nonmedicinal ingredients: histidine, sucrose, polysorbate 20, and water for injection (USP), to pH 6.0.

150 mg/mL
Each 1 mL single-use, pre-filled syringe contains a clear, colourless-to-pale yellow, sterile, preservative-free solution that contains 150 mg of Praluent (Alirocumab). Nonmedicinal ingredients: histidine, sucrose, polysorbate 20, and water for injection (USP), to pH 6.0.

Pre-filled pen

75 mg/mL
Each 1 mL single-use, pre-filled pen contains a clear, colourless-to-pale yellow, sterile, preservative-free solution that contains 75 mg of Praluent (Alirocumab). Nonmedicinal ingredients: histidine, sucrose, polysorbate 20, and water for injection (USP), to pH 6.0.

150 mg/mL
Each 1 mL single-use, pre-filled pen contains a clear, colourless-to-pale yellow, sterile, preservative-free solution that contains 150 mg of Praluent (Alirocumab). Nonmedicinal ingredients: histidine, sucrose, polysorbate 20 and water for injection (USP), to pH 6.0.

The rubber needle shield does NOT contain natural latex.

Do not take Praluent (Alirocumab) if you are allergic to Praluent (Alirocumab) or any ingredients of the medication.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Praluent (Alirocumab).

Allergic reactions: As with other monoclonal antibodies, Praluent (Alirocumab) may cause your body to produce antibodies to "defend" your body from the medication. When this happens, an allergic reaction develops. Often, allergic reactions are experienced as a rash, hives or itching. On rare occasions, a Anaphylaxis (severe allergic reaction) may occur, causing difficulty breathing, abdominal cramps, nausea and vomiting, or swelling of the throat (anaphylaxis). Another form of allergic reaction that may occur is hypersensitivity vasculitis, where the blood vessels become inflamed, causing small purplish spots to form on the skin. If you experience any unusual symptoms, contact your doctor.

Pregnancy: Praluent (Alirocumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Praluent (Alirocumab), contact your doctor immediately.

Breast-feeding: It is not known if Praluent (Alirocumab) passes into breast milk. If you are a breast-feeding mother and are taking Praluent (Alirocumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Praluent (Alirocumab) have not been established for children and adolescents less than 18 years old.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. This medication is typically used only once every two weeks. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, contact your pharmacist. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this.