Alirocumab Subcutaneous

Name: Alirocumab Subcutaneous

Commonly used brand name(s)

In the U.S.

  • Praluent

Available Dosage Forms:

  • Solution

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Monoclonal Antibody

Before Using alirocumab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For alirocumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to alirocumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of alirocumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alirocumab injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of alirocumab

alirocumab is given as a shot under your skin, usually in the abdomen or stomach, thighs, or upper arms.

Alirocumab may sometimes be given at home to patients who do not need to be in the hospital. If you are using alirocumab at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

alirocumab comes in 2 forms: single-dose prefilled pen (autoinjector) and single-dose prefilled syringe. Your doctor will prescribe the type and dose that is right for you.

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. This will help prevent skin problems from the injections.

Do not inject other medicines together with Praluent™ at the same injection site.

Do not inject on skin areas that have cuts, scrapes, infection, scars, sunburns, or tattoos.

The autoinjector pen or prefilled syringe should be removed from the refrigerator and allowed to reach room temperature for at least 30 to 40 minutes prior to injection. Do not use alirocumab if it has been at room temperature for 24 hours or longer. Do not shake the medicine.

Use each autoinjector pen or syringe only one time. Do not save an open pen or syringe. If the medicine in the pen or syringe has changed color, or if you see particles in it, do not use it.

In addition to alirocumab, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet.

alirocumab should come with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Dosing

The dose of alirocumab will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of alirocumab. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form:
    • For high cholesterol:
      • Adults—
        • Every-2-week dose: 75 milligrams (mg) injected under your skin once every 2 weeks. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg injected under your skin once every 2 weeks.
        • Every-4-week dose: 300 mg injected under your skin once every 4 weeks, given as two 150 mg injections at two different sites. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg injected under your skin once every 2 weeks.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

alirocumab needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Every-2-week dose: If you missed a dose, use alirocumab within 7 days from the missed dose. Then, resume your original schedule. If the missed dose is not given within 7 days, wait until your next scheduled dose to re-start Praluent™. If you are not sure when to re-start Praluent™, ask your doctor or pharmacist.

Every-4-week dose: If you missed a dose, use alirocumab within 7 days from the missed dose. Then, resume your original schedule. If the missed dose is not given within 7 days, use alirocumab right away and re-start Praluent™ based on this date. If you are not sure when to re-start Praluent™, ask your doctor or pharmacist.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Do not expose to extreme heat.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Side Effects

Redness, itching, swelling, or pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Alirocumab Syringe side effects by likelihood and severity.

Precautions

Before using alirocumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as LDL cholesterol levels) should be done while you are using this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, use it as soon as you remember if it is within 7 days from the missed dose. Then, follow your regular dosing schedule for your next dose. If it is longer than 7 days from the missed dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store in the refrigerator away from light and moisture. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised April 2017. Copyright(c) 2017 First Databank, Inc.

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