Daclizumab Subcutaneous and Vorapaxar Sulfate

• Generic Name: daclizumab
• Dosage Forms: n.a.
• Other Brand Names: Zinbryta, Zenapax

Daclizumab injection is used to treat the relapsing forms of multiple sclerosis (MS). Daclizumab will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease. It should only be used when other medicines to treat MS did not work well.

Daclizumab was available only under a restricted distribution program called the Zinbryta® REMS (Risk Evaluation and Mitigation Strategy) Program.

Daclizumab was voluntarily withdrawn from the worldwide market on March 2, 2018 due to safety concerns.

• Generic Name: vorapaxar
• Dosage Forms: n.a.
• Other Brand Names: Zontivity

Reduction of the risk of thrombotic cardiovascular events (e.g., cardiovascular death, MI, stroke, urgent coronary revascularization) in patients with a history of MI or with peripheral arterial disease (PAD).

Use in conjunction with aspirin and/or clopidogrel; data lacking on use of vorapaxar in combination with other antiplatelet agents (e.g., prasugrel, ticagrelor) or as monotherapy.

Efficacy and safety established in patients with stable atherosclerotic disease; favorable benefit versus risk not established in the setting of acute coronary syndrome (ACS). (See Acute Coronary Syndrome under Uses.)

The American Heart Association (AHA), American College of Cardiology Foundation (ACCF), American College of Chest Physicians (ACCP), and other experts recommend long-term antiplatelet therapy (e.g., aspirin and/or clopidogrel) in patients with established coronary artery disease. Long-term antiplatelet therapy (e.g., clopidogrel, aspirin) also recommended in patients with symptomatic PAD, including those with intermittent claudication, critical limb ischemia, or prior revascularization or amputation of the lower extremity. When added to aspirin and/or clopidogrel therapy, vorapaxar reduces cardiovascular events (e.g., composite outcome of cardiovascular death, MI, stroke, and urgent coronary revascularization) but increases risk of bleeding, including intracranial hemorrhage.

Balance incremental benefits against risk of bleeding; certain patients (e.g., those with a history of MI who are at high risk of recurrence but low risk of bleeding and who have not had a previous stroke or TIA) may have greater potential for net clinical benefits. Overall risk-benefit of vorapaxar in routine clinical practice remains to be fully elucidated.

Has been used in patients with ACS; however, current evidence suggests that the addition of vorapaxar to standard antiplatelet therapy in such patients does not substantially reduce rate of ischemic events but substantially increases risk of clinically important bleeding.

Many clinicians currently advise against use of vorapaxar in patients with ACS.