HEALTHCARE PROFESSIONALS

Side Effects Associated With VELETRI® (epoprostenol) for Injection

You should know that all medications affect each person differently. VELETRI does have side effects and unique characteristics that must be routinely monitored by qualified medical personnel. Be sure to tell your healthcare professional about all of the medications you are taking before you begin VELETRI.

Symptoms associated with starting treatment and dose increases1

Once your body gets used to VELETRI, your healthcare professional may determine that you need a slight change in dose. Talk to your healthcare professional if you experience any of the symptoms below and have questions about them:

  • 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

Symptoms of too much VELETRI1

You may also experience symptoms if there's too much VELETRI in your body. Talk to your healthcare professional if you experience any of the following symptoms:

  • Flushing
  • Headache
  • Low blood pressure
  • Fast heartbeat
  • Nausea
  • Vomiting
  • Diarrhea

Most common side effects in people with PAH due to unidentified or hereditary factors1

At least 10% more people in the group that received epoprostenol compared to the group that received conventional therapy alone experienced the following symptoms:

  • 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

Most common side effects in people with PAH due to connective tissue disease1

At least 10% more people in the group that received epoprostenol compared to the group that received conventional therapy alone experienced the following symptoms:

  • Flushing
  • Low blood pressure
  • Lack of appetite
  • Nausea/vomiting
  • Diarrhea
  • Jaw pain
  • Neck/joint pain
  • Headache
  • Skin ulcer
  • Rash

Since every individual is different, you may or may not experience one or more of these symptoms. If you have these or other symptoms, contact your healthcare professional.

Read about starting VELETRI


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.

What is VELETRI?

VELETRI is a prescription medicine that is given intravenously (in a vein). It is used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH) (WHO Group 1), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. VELETRI may improve your ability to exercise as measured by how far you can walk in 6 minutes (6-minute walk test).

Studies showing VELETRI is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors or connective tissue disease.

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 is VELETRI?

VELETRI is a prescription medicine that is given intravenously (in a vein). It is used to treat adults with certain kinds of severe pulmonary arterial hypertension (PAH) (WHO Group 1), a condition in which blood pressure is too high in the blood vessels between the heart and the lungs. VELETRI may improve your ability to exercise as measured by how far you can walk in 6 minutes (6-minute walk test).

Studies showing VELETRI is effective included mainly patients with NYHA Functional Class III-IV PAH. In these patients, PAH was caused by unidentified or hereditary factors or connective tissue disease.

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, and 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, and 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, and 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.

1. VELETRI® (epoprostenol) for Injection Full Prescribing Information. Actelion Pharmaceuticals US, Inc. July 2016.