HEALTHCARE PROFESSIONALS

Important Safety Information

Who should not take VELETRI?

VELETRI should not be used if you have heart failure due to severe left heart disease, if you develop fluid in the lungs (pulmonary edema) when starting therapy, or if you are allergic to epoprostenol.

Some medications may interact with VELETRI. Please talk to your doctor about all of your medications.

What is the most important information I should know about VELETRI?

It is important to use VELETRI as directed by your doctor. VELETRI should be used only with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix VELETRI with other intravenous medications. Each vial is for single use only; discard any unused medication. Use at room temperature (77°F/25°C). Do not expose VELETRI to direct sunlight.

When you take epoprostenol for the first time, you must be in a setting (hospital or clinic) where you can be monitored for any serious side effects or in case of emergency. Your blood pressure and heart rate should also be monitored with any dose changes. If you are taking VELETRI, your doctor may prescribe another kind of medicine used to prevent blood clots. It is the use of these medications concomitantly (in combination) with VELETRI that may potentially cause an increase in the risk of bleeding.

Sudden and dramatic changes in dose may lead to unstable blood pressure, a return of pulmonary hypertension symptoms, or fatal low blood pressure (hypotension). Do not stop using VELETRI without first talking to your doctor.

To reduce the risk of infection in the bloodstream, it is important to know how to properly care for the catheter and infusion pump.

What are the possible side effects of VELETRI?

You may have side effects at the start of treatment or with dose increases. The most common side effects seen in at least 1% of patients were:

  • flushing
  • headache
  • nausea/vomiting
  • low blood pressure
  • anxiety/nervousness
  • chest pain
  • dizziness
  • slow heartbeat
  • abdominal pain
  • pain in the muscles and/or ligaments and bones
  • shortness of breath
  • back pain
  • sweating
  • upset stomach
  • numbness/increased sensitivity
  • fast heartbeat

The most common side effects in patients with PAH due to unidentified or hereditary factors with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:

  • flu-like symptoms
  • fast heartbeat
  • flushing
  • diarrhea
  • nausea/vomiting
  • jaw pain
  • pain in the muscles and/or ligaments and bones
  • anxiety/nervousness
  • dizziness
  • headache
  • numbness/increased sensitivity/tingling

The most common side effects in patients with PAH due to connective tissue disease with at least 10% difference between the group that received epoprostenol and the group that received conventional therapy alone were:

  • flushing
  • low blood pressure
  • lack of appetite
  • nausea/vomiting
  • diarrhea
  • jaw pain
  • neck/joint pain
  • headache
  • skin ulcer
  • rash

Talk to your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VELETRI. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

Read about side effects associated with VELETRI