Mipomersen
Mipomersen
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Mipomersen

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Mipomersen

Mipomersen (INN; trade name Kynamro) is a withdrawn drug that was used to treat homozygous familial hypercholesterolemia and is administered by subcutaneous injection. There is a serious risk of liver damage from this drug and it was only prescribed in the context of a risk management plan.

Kynamro was used to treat homozygous familial hypercholesterolemia and was administered by injection.

It was not freely prescribed; every person put on mipomersen was enrolled in a Risk Evaluation and Mitigation Strategies (REMS) program approved by the FDA.

Mipomersen is pregnancy category B; women who are pregnant or intending to become pregnant should only use this drug if needed. It is unknown if it is secreted in human breast milk, but it was found to be secreted in the breast milk of rats.

The drug is contraindicated in people with moderate to severe liver impairment, active liver diseases, and unexplained high levels of transaminase liver enzymes.

The drug had a black box warning about the risk of liver damage; specifically it can cause elevations in the levels of transaminases and causes fatty liver disease.

In clinical trials, 18% of subjects taking mipomersen stopped using the drug due to adverse effects; the most common adverse effects leading to discontinuation were injection site reactions, increases of transaminases, flu-like symptoms (fever, chills, abdominal pain, nausea, vomiting), and abnormal liver tests.

Other adverse effects include: heart problems including angina and palpitations, edema, pain in legs or arms, headache, insomnia, and hypertension.

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