Products Affected - Description

• • Eptifibatide injection, Amneal, 0.75 mg/mL, 100 mL vial, 1 count, NDC 70121-1003-01
  • Eptifibatide injection, Amneal, 2 mg/mL, 10 mL vial, 1 count, NDC 70121-1002-01
  • Eptifibatide injection, Eugia US, 0.75 mg/mL, 100 mL vial, 1 count, NDC 55150-0218-99
  • Eptifibatide injection, Eugia US, 2 mg/mL, 100 mL vial, 1 count, NDC 55150-0220-99
  • Eptifibatide injection, Sagent, 0.75 mg/mL, 100 mL vial, 1 count, NDC 70860-0305-51 - discontinued
  • Eptifibatide injection, Sagent, 2 mg/mL, 10 mL vial, 1 count, NDC 25021-0409-10 - discontinued

Reason for the Shortage

• • Accord has temporarily discontinued eptifibatide injection.
  • Amneal did not provide a reason for the shortage.
  • Avenacy has eptifibatide injection available.
  • Baxter has eptifibatide injection available.
  • Eugia did not provide a reason for the shortage.
  • Merck discontinued Integrilin in October 2020. Wholesalers may continue to sell inventory until product expires.
  • Viatris has eptifibatide injection available.
  • Sagent states the shortage was due to manufacturing delay.
  • Slate Run has eptifibatide injection available.

Available Products

• • Eptifibatide injection, Baxter, 0.75 mg/mL, 100 mL vial, 1 count, NDC 00338-9558-10
  • Eptifibatide injection, Eugia US, 2 mg/mL, 10 mL vial, 1 count, NDC 55150-0219-10
  • Eptifibatide injection, Mylan Institutional (Viatris), 0.75 mg/mL, 100 mL vial, 1 count, NDC 67457-0631-10
  • Eptifibatide injection, Mylan Institutional (Viatris), 2 mg/mL, 10 mL vial, 1 count, NDC 67457-0629-10
  • Eptifibatide injection, Mylan Institutional (Viatris), 2 mg/mL, 100 mL vial, 1 count, NDC 67457-0630-10
  • Eptifibatide injection, Sagent, 0.75 mg/mL, 100 mL vial, 1 count, NDC 25021-0408-51
  • Eptifibatide injection, Slate Run Pharmaceuticals, 0.75 mg/mL, 100 mL vial, 1 count, NDC 70436-0027-80
  • Eptifibatide injection, Slate Run Pharmaceuticals, 2 mg/mL, 10 mL vial, 1 count, NDC 70436-0026-80

• • Amneal has eptifibatide 0.75 mg/mL 100 mL vials and 2 mg/mL in 10 mL vials on long-term back order and the company cannot estimate a release date.
  • Eugia has all eptifibatide 2 mg/mL 100 mL vials and 0.75 mg/mL 100 mL vials presentations on intermittent back order and the company is releasing supplies as they become available.

• • Eptifibatide is an FDA-approved glycoprotein IIb/IIIa antagonist to be used in adult patients for treatment of acute coronary syndrome (unstable angina/NSTEMI) and/or undergoing percutaneous coronary intervention.
  • According to the 2014 AHA/ACC Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes, glycoprotein IIb/IIIa antagonists can be administered to patients with NSTE-ACS and high-risk features, who are either not adequately pretreated with clopidogrel/ticagrelor or treated with UFH and adequately pretreated with clopidogrel at the time of PCI.
  • According to the 2021 ACC/AHA/SCAI Clinical Practice Guideline for Coronary Artery Revascularization, glycoprotein IIb/IIIa antagonists are generally reserved for patients with a high thrombus burden or no-reflow or slow flow that is attributable to distal embolization of thrombus as an adjunct therapy to dual antiplatelet therapy (DAPT).
  • Intravenous glycoprotein IIb/IIIa inhibitors are not recommended in patients with stable ischemic heart diseases (SIHD) undergoing PCI (no benefit in reducing ischemic events or mortality). Other glycoproteins IIb/IIIa inhibitors are tirofiban and abciximab. However, abciximab is discontinued in the United States

• • Tirofiban - guidelines recommend a glycoprotein IIb/IIIa inhibitor and do not specify one agent over another.

• 1. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. https://www.ahajournals.org/doi/epub/10.1161/CIR.0000000000001038
  2. 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes https://www.ahajournals.org/doi/10.1161/cir.0000000000000134#sec-4
  3. Aggrastat. [package insert] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e850111f-e713-41a2-9c65-21c517cf5511