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Approved for prevention of postoperative nausea and vomiting (PONV)

APONVIE (aprepitant) is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Delivered via a 30-second intravenous infusion, APONVIE was demonstrated to be bioequivalent to oral aprepitant with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved CINVANTI® (aprepitant) injectable emulsion formulation for prevention of chemotherapy-induced nausea and vomiting (CINV).

Important Safety Information

APONVIE should not be used:

  • if you are allergic to aprepitant or any of the ingredients in APONVIE
  • if you are taking pimozide

APONVIE may cause serious side effects. Tell your doctor or nurse right away if you have any of these signs or symptoms of an allergic reaction:

  • trouble breathing or swallowing, shortness of breath or wheezing
  • swelling of your eyes, face, tongue, or throat
  • flushing or redness of your face or skin
  • hives, rash, or itching
  • dizziness, a rapid or weak heartbeat, or you feel faint

APONVIE may affect how other medicines work. Other medicines may affect how APONVIE works. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. If you take the blood-thinner medicine warfarin, your doctor may do blood tests after you receive APONVIE to check your blood clotting.

Women who use birth control medicines containing hormones to prevent pregnancy (birth control pills, skin patches, implants, and certain IUDs) should also use back-up methods of birth control (such as condoms and spermicides) for 1 month after receiving APONVIE.

Before you receive APONVIE, tell your doctor if you are pregnant or plan to become pregnant. APONVIE contains alcohol and may harm your unborn baby.

Before you receive APONVIE, tell your doctor if you are breast-feeding or plan to breastfeed because it is likely APONVIE passes into your milk, and it is not known if it can harm your baby. You and your doctor should decide if you will receive APONVIE, if breast-feeding.

The most common side effects of APONVIE are constipation, low blood pressure, tiredness, and headache.

Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The information provided here is not comprehensive. Please see full Prescribing Information.

 

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