Raplixa

Raplixa is a prescription medication used to control bleeding during surgery.

Raplixa contains two proteins normally found in human blood that help the blood clot: fibrinogen and thrombin.

Raplixa is available as a topical spray and can be used as needed during surgery to control bleeding. It should be used in conjunction with an absorbable gelatin sponge.

Common side effects of Raplixa include surgical pain, nausea, constipation, fever, and decreased blood pressure.

Raplixa is a prescription medication used to control bleeding during surgery when standard surgical techniques are ineffective at controlling bleeding.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• The Medicines Company

Serious side effects have been reported with Raplixa. See the “Raplixa Precautions” section.

Common side effects of Raplixa include the following:

• surgical pain
• nausea
• constipation
• fever
• decreased blood pressure

This is not a complete list of Raplixa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No Raplixa drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Raplixa including the following:

• the transmission of serious infectious agents, such as viruses and Creutzfeldt-Jakob disease agents. Tell your healthcare provider right away if you have any of the following symptoms of an infection:
  • fever
  • drowsiness
  • chills
  • rash
  • joint pain
  • loss of appetite
  • abdominal pain
  • dark urine
  • yellowing of the skin or eyes
• thromboembolism. Tell your healthcare provider right away if you have any of the following symptoms of a thromboembolism:
  • chest pain
  • shortness of breath
  • difficulty speaking or swallowing
  • leg tenderness or swelling

Do not use Raplixa if you:

• are allergic to Raplixa or to any of its ingredients
• have had hypersensitivity reactions to any human blood products

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Raplixa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Raplixa or to any of its ingredients or to any human blood products
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Animal reproduction studies have not been conducted with Raplixa. It is also not known whether Raplixa can cause fetal harm when administered to pregnant women or can affect reproductive capacity. Raplixa should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Raplixa crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, caution should be exercised when administering Raplixa to a nursing woman.

Use Raplixa exactly as prescribed.

Raplixa is available as a topical spray and can be used as needed during surgery to control bleeding. It should be used in conjunction with an absorbable gelatin sponge.

Do not inject Raplixa into a vein.

Do not use Raplixa for the treatment of severe or brisk arterial bleeding.

Use this medication exactly as indicated.

The dose your doctor uses may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication

The required dose of Raplixa depends on the size of the bleeding area to be treated.

If you take too much Raplixa, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Raplixa is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Raplixa between 2°C and 25°C (36°F and 77°F). Refrigeration is not required. Do not freeze.
• Use Raplixa within 1 hour of opening vial.
• Keep this and all medicines out of the reach of children.