It works by helping the liver reduce levels of "bad" cholesterol (low-density lipoprotein, or LDL) circulating in your blood. Alirocumab is used in adults with heart disease to lower the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization.
Full Answer
Why was Praluent taken off the market?
A federal judge ruled on Jan. 5, 2016 that Regeneron and Sanofi must pull the monoclonal antibody (mAb) Praluent (alirocumab) from the market because it allegedly infringes two Amgen patents that describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).
What is alirocumab used to treat?
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 ...
When should alirocumab be used?
Alirocumab injection is used along with diet, alone or in combination with other cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins] or ezetimibe [Zetia, in Liptruzet, in Vytorin]), in adults who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be ...
What is the mechanism of action of alirocumab?
MECHANISM OF ACTION9 PCSK9 binds to LDLRs on the surface of hepatocytes, promoting LDLR degradation in the liver and, in turn, elevating LDL-C blood levels. By inhibiting the binding of PCSK9 to LDLR, alirocumab reduces LDL-C levels.
Is weight gain a side effect of PRALUENT?
Weight gain or weight loss has not been reported as a side effect of Praluent in clinical trials. Monoclonal antibodies, such as Praluent, tend to have few drug interactions and are unlikely to cause liver or kidney damage. No overall differences in safety or efficacy were observed in elderly patients.
How long do you have to take PRALUENT?
PRALUENT is taken every 2 weeks or 4 weeks (monthly)
What is the best time of day to take PRALUENT?
Official answer. You can inject Repatha at any time of the day, but usually people prefer injecting Repatha during daylight hours because it takes 30 to 45 minutes for it to warm up to room temperature, and you need to be able to easily see what you are doing while you are injecting it.
How much does PRALUENT reduce cholesterol?
In general, it lowers cholesterol by 50 percent to 70 percent, compared with 25 percent to 55 percent with statins. The $14,600 yearly price of the drug, which is injected under the skin once every two weeks, is a stunner.
What are the possible side effects of PRALUENT?
The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
What is better PRALUENT or Repatha?
These studies have also shown that Repatha may be more effective at reducing LDL-C levels than Praluent when given in certain doses. Although more research is needed, the use of Repatha is also linked to increased HDL levels (the “good” cholesterol).
How many doses are in a PRALUENT pen?
Praluent comes as a liquid solution in a single-dose prefilled pen. It's given as a subcutaneous injection. You'll store Praluent pens in the refrigerator* at 36°F to 46°F (2°C to 8°C). Remove Praluent from the refrigerator 30 to 40 minutes before you inject your dose and allow it to come to room temperature naturally.
How is alirocumab eliminated?
At low concentrations, alirocumab is eliminated through its binding to PCSK9 via lysosomal degradation [16], while at high alirocumab concentrations, PSCK9 becomes saturated and alirocumab elimination occurs via a linear, non-saturable proteolytic pathway.
What are the possible side effects of PRALUENT?
The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Who should not take PRALUENT?
Do not take Praluent if you are allergic to alirocumab or any ingredients contained in this drug. History of serious hypersensitivity reaction to alirocumab; reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization.
What is the new treatment for high cholesterol?
Federal regulators have approved the new drug Leqvio to be used to help lower cholesterol levels in some people. The medication is designed to be taken along with statins and a balanced diet. Leqvio is designed to be taken twice a year, which experts say should help people adhere to a medication schedule.
Is PRALUENT an immunosuppressant?
Praluent (alirocumab) injection is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require ...
What is the extra help program?from praluent.com
It's called the Extra Help Program and it offers: Reduced Medicare Part D premiums. No cost share in the coverage gap or "donut hole". Lower drug copays.
How long does it take for a patient to get reimbursement for a copay?from praluenthcp.com
Patients can submit for reimbursement if they paid their copay in full within 90 days. || Eligible patients with commercial insurance not funded through a government healthcare. program such as Medicare, Medicaid, or TRICARE are subject to program terms and restrictions.
What is praluent used for?
Praluent (alirocumab) is a member of the PCSK9 inhibitors drug class and is commonly used for Cardiovascular Risk Reduction, High Cholesterol, High Cholesterol - Familial Heterozygous, and others.
Does Praluent offer rebates?
Praluent MyPraluent Copay Card Rebate: Eligible commercially insured patients may be eligible for a rebate if they paid for deductibles, copays or coinsurance out-of-pocket;for more information contact the program at 844-772-5836.
How should I use alirocumab?from drugs.com
Take alirocumab exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose .
What should I avoid while using alirocumab?from drugs.com
Do not inject alirocumab into skin that is sunburned, infected, swollen, or otherwise irritated.
How many times can you use Alirocumab?from drugs.com
Each alirocumab injection pen or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.
What happens if you are allergic to Alirocumab?from drugs.com
Get emergency medical help if you have signs of an allergic reaction to alirocumab: hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.
Can you shake alirocumab?from drugs.com
Do not shake the alirocumab syringe. Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors, or has particles in it. Call your pharmacist for new medicine.
Can you share Alirocumab with children?from drugs.com
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use alirocumab only for the indication prescribed.
What is the extra help program?
It's called the Extra Help Program and it offers: Reduced Medicare Part D premiums. No cost share in the coverage gap or "donut hole". Lower drug copays.
How long does it take for a patient to get reimbursement for a copay?
Patients can submit for reimbursement if they paid their copay in full within 90 days. || Eligible patients with commercial insurance not funded through a government healthcare. program such as Medicare, Medicaid, or TRICARE are subject to program terms and restrictions.
What is the name of the type of high cholesterol that requires additional lowering of LDL-C?
along with other LDL-lowering treatments in adults with a type of high cholesterol called homozygous familial hypercholesterolemia who need additional lowering of LDL-C.
Can you use praline if you are allergic to alirocumab?
Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT. Before you start using PRALUENT, tell your healthcare provider about all of your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.
Can you take prudent in the hospital?
PRALUENT can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Stop using PRALUENT and 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, hives, severe itching, trouble breathing or swelling of the face, lips, throat, or tongue.
What is the extra help program?
Extra Help program. If you're faced with limited income and resources, there's a US government–funded program that may help you pay some of your Medicare prescription drug costs for all of your prescription medicines.
Can you get reimbursement for my PRALUENT?
If you are eligible for the MyPRALUENT® Copay Card program and you have paid a copay, deductible, or coinsurance for PRALUENT out of pocket, you may be able to receive reimbursement subject to program terms and conditions.
How often do you give a paluent injection?
PRALUENT is given by injection under your skin (subcutaneously) once every 2 weeks or 4 weeks (monthly dosing option). If your healthcare provider prescribes you the monthly dose, you will give yourself 2 separate injections in a row, using a different pen for each injection and 2 different injection sites.
Where to inject paluent?
You can inject PRALUENT into the following sites: your thigh, the back of your upper arm (generally given by a care provider), or your stomach
What is the best medication for myocardial infarction?
PRALUENT ® (alirocumab) is indicated: 1 to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. 2 as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies in adults with primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C. 3 as an adjunct to other LDL-C-lowering therapies in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
Is paluent contraindicated?
PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. Hypersensitivity reactions, including hypersensitivity vasculitis, angioedema, and other hypersensitivity reactions requiring hospitalization, have been reported with PRALUENT treatment.
