Following an earlier than expected favorable court ruling, Hikma has accelerated the launch of its Icosapent Ethyl Capsules in order to quickly provide patients with access to this important medicine. Initially, Hikma will be releasing limited quantities to ensure a consistent supply for customers.  The Company is working to scale up manufacturing and increase availability as soon as possible.

“Hikma’s launch of this important medicine for US patients and healthcare providers once again underscores our ability to put better health, within reach, every day for millions of people who rely on our medicines," said Brian Hoffmann, President of Hikma Generics. "Today's launch demonstrates Hikma's ability to successfully challenge patents and launch complex products, bringing greater value to our customers and patients."

Hikma’s FDA-approved Icosapent Ethyl Capsule product is indicated for the following indication:  as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Hikma’s product is not approved for any other indication for the reference listed drug VASCEPA®. 

Important Safety Information for Icosapent Ethyl Capsules, 1gm:

CONTRAINDICATIONS

Icosapent ethyl is contraindicated in patients with known hypersensitivity (eg, anaphylactic reaction) to icosapent ethyl or any of its components.

WARNINGS AND PRECAUTIONS

• Atrial Fibrillation/Flutter
  In a double-blind, placebo-controlled trial, icosapent ethyl was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.

• Potential for Allergic Reactions in Patients With Fish Allergy
  It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to icosapent ethyl. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions and advise them to discontinue use and seek medical attention if any reactions occur.

• Bleeding
  In a double-blind, placebo-controlled trial, icosapent ethyl was associated with an increased risk (12% vs 10%) of bleeding. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.

ADVERSE REACTIONS

The following important adverse reactions are described in the full Prescribing Information for Icosapent Ethyl capsules:

• Atrial Fibrillation or Atrial Flutter
• Potential for Allergic Reactions in Patients With Fish Allergy
• Bleeding

Common adverse reactions (incidence ≥3% on icosapent ethyl and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout and atrial fibrillation.

In hypertriglyceridemia trials, adverse reactions reported with icosapent ethyl (incidence ≥1% more frequent than placebo) included arthralgia and oropharyngeal pain.

DRUG INTERACTIONS

• Increased Bleeding Risk With Anticoagulants and Antiplatelet Agents
  Monitor patients receiving icosapent ethyl and concomitant anticoagulants and/or antiplatelet agents for bleeding.

USE IN SPECIFIC POPULATIONS

• Lactation
  Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for icosapent ethyl and any potential adverse effects on the breastfed child from icosapent ethyl or from the underlying maternal condition.
• Pediatric Use
  Safety and effectiveness in pediatric patients have not been established.
• Hepatic Impairment
  In patients with hepatic impairment, alanine aminotransferase and aspartate aminotransferase levels should be monitored periodically during therapy with icosapent ethyl.

INDICATIONS AND USAGE

Icosapent ethyl is indicated:

• as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

Limitations of use

The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

For more information, please see the full Prescribing Information and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

Manufactured by: Catalent Pharma Solutions, LLC., St. Petersburg, Florida 33716

Distributed by: Hikma Pharmaceuticals USA Inc., Eatontown, NJ 07724