Alirocumab (Subcutaneous route)
Uses of This Medicine:
Alirocumab injection is used together with a proper diet and a statin medicine to treat adults with heterozygous familial hypercholesterolemia or atherosclerotic heart problems, who need additional lowering of LDL cholesterol. 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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alirocumab injection in the elderly.
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.
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.
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 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 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 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 this medicine 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 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.
This medicine should come with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
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 high cholesterol:
- 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 high cholesterol:
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, 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 this medicine within 7 days from the missed dose. Then, resume your original schedule. If the missed dose is not given within 7 days, use this medicine 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.
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.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits. 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 may occur while you are using this medicine. Tell your doctor right away if you have the following symptoms: a rash, itching skin, difficulty with breathing or swallowing, hives, 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:
- More common
- Difficulty with breathing or swallowing
- reddening of the skin, especially around the ears
- swelling of the eyes, face, or inside of the nose
- unusual tiredness or weakness
- Less common
- Cough producing mucus
- tightness in the chest
- More common
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pains
- redness, itching, swelling, pain at the injection site
- sore throat
- stuffy or runny nose
- trouble sleeping
- Less common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- difficulty with moving
- frequent urge to urinate
- lower back or side pain
- muscle pains or stiffness
- muscle spasms
- pain or tenderness around the eyes and cheekbones
- swollen joints
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:
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:
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.
Last Updated: 9/4/2017