Praluent

1 What is Praluent?

Brand: Praluent

Generic: Alirocumab

Praluent injection is used together with a proper diet and a statin medication to treat adults with heterozygous familial hypercholesterolemia or atherosclerotic heart problems, who need additional lowering of LDL cholesterol.

This medication is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor. This medication is only available with your doctor’s prescription.

This medication is available in the following forms:

  • Solution

2 What to Know Before Using

Before using Praluent, you must know all about the risks and complications associated with it. This is a decision that you and your doctor will make together. For this medication, there are many things that need to be considered:

Allergies

Inform your doctor if you have ever had an allergic reaction to doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric

No appropriate studies have been performed on the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.

Geriatric

Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population.

Breastfeeding

There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions

Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any over the counter or prescription medications.

Other Interactions

Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain mediations may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

3 Proper Usage

Proper usage of Praluent requires strict adherence to your doctor’s orders. This medication is given as a shot under your skin (subcutaneously), normally in the abdomen or stomach, thighs or upper arms.

This medication comes with a patient information brochure. It is very important that your read this information. Ask your doctor if you have any questions.

This medication can be given at home to patients who do not need to be in the hospital. If you are using this medication at home, your doctor will teach you how to prepare and inject the medication.

This medication comes in two forms:

  • single-dose pre-filled pens (autoinjector)
  • single dose pre-filled syringe.

Your doctor will prescribe the type and dose that is right for you.

Your doctor will show you the areas of the body that the shot may be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot so that you can accurately rotate body areas. This will prevent skin problems from the injection.

Do not inject other medications along with alirocumab at the same injection site. Do not inject on skin areas that have cuts, scrapes, infection, scars, sunburn or tattoos.

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

Only use a pen or syringe once. Do not save an open pen or syringe. If the medication in the pen or syringe has changed colour, or you see particles in it, do not use it.

Along with prescribing this medication, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. It is important that you follow this diet.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

  • Adults - 75mg injected under the skin (subcutaneously) once every 2 weeks. Your doctor may increase the dose as needed. The dose is not normally more than 150mg injected subcutaneously once ever 2 weeks.

Missed Dose

If you miss a dose, use the medication within 7 days from the missed dose, then resume your normal dosing schedule. If the missed dose is not given within 7 days, wait until your next dose to restart your medication. If you are not sure when to restart the medication, ask your doctor or pharmacist.

Storage

Store this medication in a closed container in the refrigerator. Keep it away from heat, moisture, and direct light. Do not freeze.

Keep our of the reach of children

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

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

4 Precautions to Take

In using Praluent, you must be careful and take some precautions as advised by your doctor. It is very important that your doctor checks in with you often while you are receiving this medication to make sure that it is working properly and to decide if you should continue using it.

Blood tests may be needed to check for unwanted effects. Serious allergic reactions may occur while you are using this medication.

Inform your doctor immediately if you have:

  • a rash
  • itching skin
  • difficulty breathing or swallowing
  • hives
  • nausea
  • reddening of the skin (especially around the ears)
  • swelling of the face, eyes or inside of the nose
  • unusual fatigue or weakness

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Praluent. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More common:

Less common:

  • A cough producing mucus
  • Tightness in the chest

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More common:

  • Chills
  • Cough
  • Diarrhea
  • General feeling of discomfort or illness (malaise)
  • Headache
  • Joint pain
  • Loss of appetite
  • Muscle aches and pains
  • Redness, itching, swelling, pain at the injection site
  • Shivering
  • Sore throat
  • Stuffy or a runny nose
  • Sweating
  • Trouble sleeping (insomnia)
  • Vomiting

Less common:

  • Bladder pain
  • Bloody or cloudy urine
  • Difficult, burning, or painful urination
  • Difficulty moving
  • Frequent urge to urinate (polyuria)
  • Lower back or side pain
  • Muscle pains or stiffness
  • Muscle spasms
  • Pain or tenderness around the eyes and cheekbones
  • Swollen joints

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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

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