DIAGNOSIS

How PAH is diagnosed

The symptoms of pulmonary arterial hypertension (PAH; WHO Group 1) are similar to those of other conditions, such as low blood pressure and asthma. Specific tests can help doctors identify the cause of the symptoms.

If you think you are experiencing symptoms of PAH, talk to your doctor.

To diagnose PAH, your doctor will need to obtain a thorough medical history and a physical exam, and he or she will assess results from certain tests and procedures.

Common tests

There are several tests your doctor may run to diagnose PAH:

Test to confirm diagnosis: right heart catheterization

Once PAH is suspected, a diagnosis can only be confirmed with a procedure known as right heart catheterization (RHC). This procedure allows your doctor to test heart function and blood pressure in the heart and pulmonary arteries. It also helps evaluate the severity of PAH.

Four levels of PAH

The New York Heart Association (NYHA) created a scale called the NYHA Functional Classification System to describe the 4 levels of activities that cause symptoms in patients with heart disease. The more severe the symptoms are in a patient with PAH, the higher the functional class. Doctors often use this scale to help determine the severity of PAH and the type of treatment for their patients.

Class I- No symptoms with ordinary physical activity

Class II- Some symptoms with ordinary activity and slight limitation of physical activity

Class III- Symptoms with less than ordinary activity and increased limitation of physical activity

Class IV- Symptoms with any activity, possibly even while at rest

Studies establishing the effectiveness of Remodulin included patients with PAH in NYHA Functional Class II-IV.

Selected Important Safety Information

What are the serious side effects of Remodulin?

Learn about the different treatment options

Remodulin® (treprostinil) Injection

What is Remodulin?

Remodulin is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. Remodulin can reduce symptoms associated with exercise. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. It is not known if Remodulin is safe and effective in children.

In people with PAH who need to switch from epoprostenol, Remodulin is approved to slow the worsening of symptoms.

Important Safety Information for Remodulin

Before you take Remodulin, tell your healthcare provider if you:

What are the serious side effects of Remodulin?

What are the possible side effects of Remodulin?

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

REMISIdtcJUL18

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit http://www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).

This information is provided for an informational purpose and is not intended as treatment advice. Patients should consult a healthcare professional for treatment advice.

Important Safety Information and Indication

EXPAND ^

Remodulin® (treprostinil) Injection

What is Remodulin?

Remodulin is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. Remodulin can reduce symptoms associated with exercise. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. It is not known if Remodulin is safe and effective in children.

In people with PAH who need to switch from epoprostenol, Remodulin is approved to slow the worsening of symptoms.

Important Safety Information for Remodulin

Before you take Remodulin, tell your healthcare provider if you:

  • Have other medical conditions or take other medicines that may affect your use of Remodulin by increasing the risk of side effects or decreasing the drug’s effectiveness.
  • Have liver or kidney problems. Your Remodulin dose may need to be adjusted if you have liver problems.
  • Have low blood pressure or bleeding problems.
  • Are taking gemfibrozil (for high cholesterol), rifampin (for infection) or other drugs that affect liver enzymes. Your doctor may need to adjust your Remodulin dosage.
  • Are pregnant, breastfeeding, or planning to become pregnant. It is not known if Remodulin will harm your unborn baby or if Remodulin passes into your breast milk.

What are the serious side effects of Remodulin?

  • Continuous intravenous (IV) infusions of Remodulin delivered using an external infusion pump, with a tube placed in a central vein within the chest, are associated with the risk of blood stream infections and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion delivered just beneath the skin is the preferred type of delivery.
  • Worsening of PAH symptoms. Do not stop taking or greatly reduce your Remodulin dose without consulting your doctor.
  • Low blood pressure (symptomatic hypotension). If you have low blood pressure or are taking drugs that lower your blood pressure, the risk of low blood pressure is increased.
  • Bleeding problems. Remodulin may increase the risk of bleeding in people who take blood thinners (anticoagulants).

What are the possible side effects of Remodulin?

  • In clinical studies of SC infusion of Remodulin, most people experienced infusion site pain and infusion site reaction (redness, swelling, and rash). These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin.
  • IV infusion of Remodulin delivered through an external pump has been associated with the risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain.
  • The most common side effects seen with either SC or IV Remodulin were headache, diarrhea, nausea, rash, jaw pain, widening of the blood vessels (vasodilatation), and swelling from fluid retention (edema). These are not all the possible side effects of Remodulin. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

REMISIdtcJUL18

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit http://www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).

This information is provided for an informational purpose and is not intended as treatment advice. Patients should consult a healthcare professional for treatment advice.