Praluent

Praluent is a prescription medication used to lower cholesterol in certain patients. It is used along with diet and statin drugs in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol.

Praluent belongs to a new class of drugs called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. These drugs work to block a naturally occurring protein called PCSK9 that prevents the liver from removing LDL from the blood.

Praluent is available as an injection. It is injected subcutaneously (under the skin) once every two weeks or once every four weeks. 

Common side effects include itching, swelling, and pain at the injection site. 

Praluent is a prescription medication used to lower cholesterol. Praluent is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL). It is also approved for patients who have atherosclerotic heart problems, such as heart attacks or strokes, who need additional lowering of LDL cholesterol.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sanofi-Aventis U.S. LLC

Serious side effects have been reported with Praluent. See the "Praluent Precautions" section. 

Common side effects of Praluent include the following:

• itching, swelling, and pain/tenderness at the injection site
• common cold symptoms
• flu (influenza) or flu like symptoms
• urinary tract infection
• diarrhea
• Inflammation of the tubes carrying air to and from the lungs (bronchitis)
• muscle pain
• muscle spasms
• sinus infection (sinusitis)
• cough
• bruising (contusion)

This is not a complete list of Praluent side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. 

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

No drug interactions have been determined to be significant by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported. 

Serious side effects have been reported with Praluent including the following:

• Allergic reactions. Praluent may cause allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Praluent, there are no specific foods that you must exclude from your diet when receiving Praluent.

Before taking Praluent, tell your doctor about all of your medical conditions.

Especially tell your doctor if you are:

• allergic to Praluent or any of its ingredients
• are pregnant or plan to become pregnant. It is not known if Praluent will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Praluent.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take Praluent or breastfeed. You should not do both without talking to your healthcare provider first.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No well-controlled studies have been done in humans with Praluent. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Praluent is excreted in human breast milk or if it will harm your nursing baby. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Praluent, nursing is not recommended. You and your healthcare provider should decide if you will take Praluent or breastfeed. You should not do both without talking to your healthcare provider first.

Use Praluent exactly as prescribed.

Praluent comes as a single-dose (1 time) pre-filled pen (autoinjector), or as a single-dose pre-filled syringe.

Your healthcare provider will prescribe the type and dose that is best for you.

If your healthcare provider decides that you or a caregiver can give the injections of Praluent, you or your caregiver should receive training on the right way to prepare and administer Praluent. Do not try to inject Praluent until you have been shown the right way by your healthcare provider or nurse.

Praluent is given as an injection under the skin (subcutaneously) once every two weeks or once every four weeks. 

• Always check the label of your pen or syringe to make sure you have the correct medicine and the correct dose of Praluent before each injection
• Do NOT inject Praluent into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
• Do NOT co-administer Praluent with other injectable drugs at the same injection site.
• If you forget to use Praluent or are not able to take the dose at your regular time, inject your missed dose as soon as you remember, within 7 days of your missed dose. Then, take your next dose 2 weeks from the day you missed your dose. This will put you back on your original schedule. If the missed dose is not given within 7 days, wait until your next scheduled dose to restart Praluent. This will keep you on your original schedule. If you are not sure when to re-start Praluent, ask your healthcare provider or pharmacist.  
• Do not stop using Praluent without talking with your healthcare provider. If you stop using Praluent, your cholesterol levels can increase

Injecting Praluent:

• Allow Praluent to warm to room temperature for 30 to 40 minutes prior to use. Use Praluent as soon as possible after it has warmed up. Do NOT use Praluent if it has been at room temperature [77°F (25°C)] for 24 hours or longer.
• Visually inspect for particulate matter and discoloration prior to administration. If the solution is discolored or contains visible particulate matter, the solution should not be used.
• Follow aseptic (free from contamination) injection technique every time you use Praluent
• Administer Praluent by subcutaneous injection into the thigh, abdomen, or upper arm using a single-dose pre-filled pen or single-dose pre-filled syringe.
• Rotate the injection site with each injection.
• Do not re-use pre-filled pens or pre-filled syringes. Dispose of properly in a puncture-resistant container. Do not recycle the container.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your cholesterol levels
• how you respond to this medication

The recommended starting dose of Praluent to treat high cholesterol is 75 mg administered subcutaneously (under the skin) once every two weeks.

• If the LDL-C response is not enough, your doctor can increase the dose to the maximum dosage of 150 mg administered every two weeks.
• An alternative dose, for those who would like less frequent dosing, is 300 mg once every four weeks (monthly).
• Your doctor will measure your LDL-C levels within 4 to 8 weeks after starting Praluent or changing the dose, to see how the medication is working. Your doctor can change your dose if needed.

If you take too much Praluent call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the outer carton in order to protect from light.
• Do not freeze.
• Do not expose to extreme heat.
• Do not shake.
• Keep this and all medications out of the reach of children.