Is mipomersen available in the US?

Kynamro (mipomersen) is an injectable medication that helps lower cholesterol levels in people with a condition called homozygous familial hypercholesterolemia (HoFH). It’s used together with other cholesterol-lowering medications and diet. This medication is no longer available in the United States.

When was mipomersen approved by the FDA?

January 2013
In January 2013, the FDA approved mipomersen (Kynamro, Genzyme), an antisense oligonucleotide inhibitor of apo B, as an orphan drug for the management of HoFH.

When was mipomersen discontinued?

Mipomersen was rejected by the European Medicines Agency in 2012 and again in 2013 due to concerns about the liver and cardiovascular adverse effects. In January 2013, The United States Food and Drug Administration approved mipomersen for the treatment of homozygous familial hypercholesterolemia.

Is mipomersen discontinued?

As a matter of fact, mipomersen therapy is more likely discontinued and associated with increased risk of injection-site reactions, hepatic steatosis, hepatic enzyme elevation, and flu-like symptoms.

How does LDL apheresis work?

LDL apheresis is a nonsurgical therapy that removes low-density lipoprotein (LDL) cholesterol from a patient’s blood. During LDL apheresis, the plasma portion of the blood, which contains cholesterol, is separated and run through a machine that removes the LDL.

What is mipomersen used for?

Mipomersen injection is used to decrease levels of cholesterol and other fatty substances in the blood in people who have homozygous familial hypercholesterolemia (HoFH; a rare inherited condition that causes very high levels of cholesterol in the blood, increasing the risk of serious heart disease).

How long does LDL apheresis work?

Studies have shown that LDL apheresis can lower LDL cholesterol approximately 70 to 83 percent after a single treatment. The liver will continue to produce LDL following treatment, but it will take approximately two weeks to return to baseline levels.

Is LDL apheresis safe?

LDL Apheresis: What to Expect One procedure lowers LDL cholesterol by 65% to 70%. Repeated procedures, generally every one to two weeks, are needed to maintain low cholesterol levels for patients with familial hypercholesterolemia. LDL apheresis is a safe procedure with a few possible side effects.

What injections are given to the navel?

Enoxaparin is usually injected in the stomach area. You must use a different area of the stomach each time you give the shot. If you have questions about where to give the shot, ask your healthcare provider. Each syringe has enough drug in it for one shot.

How often is LDL apheresis done?

To maintain lowest possible LDL levels over time, patients will typically require treatment every two weeks.

What does LDL apheresis remove from the blood?