Patients taking KYNAMRO should have liver enzyme testing before starting the drug and periodically thereafter.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
For more information about KYNAMRO Cornerstone, or about these support services call 1-877-KYNAMRO (877-596-2676).
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
And there are liver side effects that could be very worrisome, and Kynamro injections can be painful.
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Caution should be exercised when KYNAMRO is used with other medications known to have potential for hepatotoxicity.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
It is recommended that patients taking KYNAMRO should consume no more than one alcoholic drink per day.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
The safety and effectiveness of Kynamro were evaluated in a clinical trial of 51 patients with HoFH.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
No clinically relevant pharmacokinetic interactions were reported between KYNAMRO and warfarin, or between KYNAMRO and simvastatin or ezetimibe.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
Eighteen percent of patients on KYNAMRO and 2% of patients on placebo discontinued treatment due to adverse reactions.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
This was considered important because Kynamro is intended for long-term treatment in order to maintain the cholesterol-lowering effect.
FORBES: CHMP Recommends Against Approval For Mipomersen In Europe
The FDA approval for KYNAMRO is supported by the largest clinical trial conducted to-date in the HoFH patient population.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
The safety and effectiveness of KYNAMRO have not been established in patients with hypercholesterolemia who do not have HoFH.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
Kynamro is an orphan drug approval, meaning it was developed to treat a disorder affecting fewer than 200, 000 people.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
The effect of KYNAMRO on cardiovascular morbidity and mortality has not been determined.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
Patients are advised to read the KYNAMRO medication guide before starting treatment with KYNAMRO, and each time they receive a refill.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
To restrict access to therapy with KYNAMRO to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
The CHMP noted that Kynamro was effective at reducing LDL cholesterol levels in patients with homozygous and severe heterozygous familial hypercholesterolaemia.
FORBES: Read The European Medicines Agency's Smackdown Of Kynamro
Females who become pregnant during KYNAMRO therapy should notify their healthcare provider.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
European regulators recently recommended that Kynamro not be approved, but it did get a muted thumbs up from a panel of FDA advisors.
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As part of its commitment to HoFH patients, Genzyme has developed KYNAMRO CornerstoneSM, an HoFH and KYNAMRO support program for healthcare providers, patients, and their families.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
To educate prescribers about the risk of hepatotoxicity associated with the use of KYNAMRO, and the need to monitor patients during treatment with KYNAMRO as per product labeling.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
After 26 weeks, the approximate average reduction seen in patients taking Kynamro was between 25% and 36%, while it was between 3% and 13% in patients taking placebo.
FORBES: Read The European Medicines Agency's Smackdown Of Kynamro
The question of how many HoFH patients there are is key not only to Aegerion, but to Isis Pharmaceuticals, which has its own HoFH drug, Kynamro, awaiting FDA approval.
FORBES: Aegerion Cholesterol Drug Approved. Will It Treat 300 Patients, Or 3,000?
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency today recommended that mipomersen (Kynamro, Isis and Genzyme) not be approved for use in Europe.
FORBES: CHMP Recommends Against Approval For Mipomersen In Europe
The most recent new cholesterol drugs, Juxtapid from Aegerion Pharmaceuticals and Kynamro from Isis Pharmaceuticals, have focused on patients with a severe genetic disease that causes their cholesterol to be very high.
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See below for Important Safety Information about KYNAMRO.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
That paragraph pretty much describes the problems Kynamro will face even if it is approved, especially since it may face competition from another drug, lomitapide, from Aegerion Pharmaceuticals that appears to be better tolerated by patients.
FORBES: Read The European Medicines Agency's Smackdown Of Kynamro
Kynamro carries a Boxed Warning on the serious risk of liver toxicity because it is associated with liver enzyme abnormalities and accumulation of fat in the liver, which could lead to progressive liver disease with chronic use.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
The FDA approved Kynamro with a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use, including prescriber and pharmacy certification, and documentation of safe-use conditions, which requires a prescription authorization form for each new prescription.
FORBES: FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia
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