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Genzyme And Isis Announce FDA Approval Of KYNAMRO™ (mipomersen Sodium) Injection For The Treatment Of Homozygous Familial Hypercholesterolemia

Stocks in this article: ISIS SAN SNY

KYNAMRO is an antisense drug and is metabolized without affecting the CYP450 pathways used in commonly prescribed drugs, and thus has potential for no drug-drug interactions. No clinically relevant pharmacokinetic interactions were reported between KYNAMRO and warfarin, or between KYNAMRO and simvastatin or ezetimibe.

KYNAMRO contains a Boxed Warning citing the risk of hepatic toxicity. Patients taking KYNAMRO should have liver enzyme testing before starting the drug and periodically thereafter. See below for Important Safety Information about KYNAMRO.

The safety and effectiveness of KYNAMRO have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of KYNAMRO on cardiovascular morbidity and mortality has not been determined.

Because of the risk of hepatotoxicity, KYNAMRO is available only through a Risk Evaluation and Mitigation Strategy (REMS) called the KYNAMRO REMS. The goals of the KYNAMRO REMS are:

  • 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.
  • To restrict access to therapy with KYNAMRO to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).

As part of its commitment to HoFH patients, Genzyme has developed KYNAMRO Cornerstone SM, an HoFH and KYNAMRO support program for healthcare providers, patients, and their families. KYNAMRO Cornerstone services include:

  • Dedicated KYNAMRO Cornerstone Case Managers.
  • Product & disease education for providers, patients, and families.
  • In-person injection training, if requested.
  • Reimbursement support, including out-of-pocket financial support, for patients who qualify.
  • Coordination of KYNAMRO shipment and delivery.

KYNAMRO Cornerstone Case Managers are available live Monday-Friday from 9 am to 6 pm Eastern time. For more information about KYNAMRO Cornerstone, or about these support services call 1-877-KYNAMRO (877-596-2676). For additional information, please visit www.KYNAMRO.com.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEPATOTOXICITY

KYNAMRO can cause elevations in transaminases. In the KYNAMRO clinical trial in patients with HoFH, 4 (12%) of the 34 patients treated with KYNAMRO compared with 0% of the 17 patients treated with placebo had at least one elevation in alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR) or partial thromboplastin time (PTT).

KYNAMRO also increases hepatic fat, with or without concomitant increases in transaminases. In the trials in patients with heterozygous familial hypercholesterolemia (HeFH) and hyperlipidemia, the median absolute increase in hepatic fat was 10% after 26 weeks of treatment, from 0% at baseline, measured by magnetic resonance imaging (MRI). Hepatic steatosis is a risk factor for advanced liver disease; including steatohepatitis and cirrhosis.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT, AST regularly as recommended. During treatment, withhold the dose of KYNAMRO if the ALT or AST are ≥3 x ULN. Discontinue KYNAMRO for clinically significant liver toxicity.

Because of the risk of hepatotoxicity, KYNAMRO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYNAMRO REMS.

OTHER WARNINGS AND PRECAUTIONS

Patients are advised to read the KYNAMRO medication guide before starting treatment with KYNAMRO, and each time they receive a refill. There may be new information. This information does not take the place of talking to a doctor about a medical condition or treatment.

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