Pronunciation:

al-i-ROK-ue-mab

Brand Names:

• Praluent

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Alirocumab injection is used together with a proper diet and other medicines (eg, ezetimibe, statin medicine) to treat patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) or with homozygous familial hypercholesterolemia (HoFH), who need additional lowering of their bad cholesterol (LDL). It is also used to reduce the risk of heart attack, stroke, and unstable angina (chest pain) requiring hospitalization in adults with existing heart or blood vessel disease. This medicine is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alirocumab injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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.

Other 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.

Other interactions—

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 This Medicine:

This medicine is given as a shot under your skin, usually in the 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 this medicine 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.

This medicine should come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine 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 alirocumab injection at the same injection site.

Do not inject on skin areas that are bruised, red, hard, or tender.

Allow the medicine to warm to room temperature for at least 30 to 40 minutes before using it. Do not warm it in any other way. 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 this medicine, 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.

Dosing—

The dose of this medicine 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 this medicine. 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 primary hyperlipidemia and lowering the risk of heart attack, stroke, and chest pain:
    • 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.
  • For homozygous familial hypercholesterolemia:
    • Adults—150 milligrams (mg) injected under your skin once every 2 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

This medicine 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 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 alirocumab. If you are not sure when to re-start alirocumab, ask your doctor or pharmacist.

Every 4-week dose: If you missed a 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 this medicine right away and re-start alirocumab based on this date. If you are not sure when to re-start alirocumab, 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.

You may also store this medicine in its original carton at room temperature for up to 30 days. Do not expose to extreme heat. After removing this medicine from the refrigerator, use it within 30 days. Throw away any unused medicine after 30 days.

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

Precautions While Using This Medicine:

It is very important that your doctor check your progress within 4 to 8 weeks of using this medicine. This will allow your doctor to see if the medicine is working properly to lower your cholesterol levels and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

Serious allergic reactions (eg, angioedema, vasculitis) may occur while you are using this medicine. Tell your doctor right away if you have a rash, itching skin, difficulty with breathing or swallowing, fever, hives, sores, welting, or blisters, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, nausea, reddening of the skin, especially around the ears, swelling of the eyes, face, or inside of the nose, or unusual tiredness or weakness.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chest pain or tightness

difficulty with breathing or swallowing

fast heartbeat

fever

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

nausea

reddening of the skin, especially around the ears

swelling of eyelids, face, lips, hands, or feet

unusual tiredness or weakness

Less common

Cough producing mucus

Incidence not known

Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

chills

cough

diarrhea

general feeling of discomfort or illness

headache

loss of appetite

muscle aches, cramps, stiffness, or pains

shivering

sore throat

stuffy or runny nose

sweating

trouble sleeping

vomiting

Less common

Bladder pain

bloody or cloudy urine

bone pain

bruise

difficult, burning, or painful urination

difficulty with moving

frequent urge to urinate

lower back or side pain

muscle spasms

pain or tenderness around the eyes and cheekbones

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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