Treating PAH

Prostacyclin Therapy Is One Way to Treat PAH

This section helps to explain why treatment with REMODULIN^® (treprostinil sodium) Injection is so important.

The levels of prostacyclin, endothelin, and nitric oxide in the body can become unbalanced. When this happens, it can cause the blood vessels — specifically those in the lungs — to narrow. This can lead to PAH.

Increasing prostacyclin with prostacyclin therapy can help. This was the first type of drug used specifically to treat PAH, and continues to be important therapy.

Prostacyclin is a substance naturally present in the body and helps keep blood vessels open and working properly
Prostacyclin medications work by opening the blood vessels and may reduce buildup of cells around the blood vessel wall
Prostacyclins were the first type of drugs introduced specifically to treat PAH and continue to be an important therapy
Some prostacyclins are delivered by a method called continuous infusion

REMODULIN Is Delivered by Continuous Infusion

Continuous infusion means the drug is delivered steadily to the patient through a small pump outside of the body and a catheter (tube).

Remodulin may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.

This may be done in 2 ways:

Subcutaneously (through a small catheter under the skin, usually in the abdominal area)
Intravenously (through a catheter that goes directly into a vein, usually placed surgically in the chest)

Streamlined Therapy

For patients with PAH with NYHA Class II−IV symptoms:

REMODULIN is a unique therapy for patients with PAH. Here is a brief overview of some of the features of REMODULIN.

No Ice Packs

Because it is stable at room temperature, patients who use REMODULIN do not have to use ice packs to keep the drug cold.

Miniature Pump Options

REMODULIN offers a variety of pump options.

Limited Reservoir Changes

Patients can go up to 72 hours before changing an SC reservoir and up to 48 hours before changing an IV reservoir.

4-Hour Half-Life

The medicine in REMODULIN stays in the blood longer than your body’s natural prostacyclin.

For complete prescribing information, please refer to the REMODULIN package insert.

REMODULIN Pump Options

There are several different small and convenient pump models available.

Subcutaneous (SC) REMODULIN

Example SC pump option:

Smiths Medical CADD-MS™ 3 Microinfusion pump

Intravenous (IV) REMODULIN

Example IV pump options:

Smiths Medical CADD-MS 3 Microinfusion pump

Canè Crono Five Expanded reservoir miniature pump

CADD-Legacy® 1 Portable electronic infusion pump

Information for Patients

REMODULIN is infused continuously through a subcutaneous or surgically placed indwelling central venous catheter, via an infusion pump. Therapy with REMODULIN will be needed for prolonged periods, possibly years, and the patient’s ability to accept and care for a catheter and to use an infusion pump should be carefully considered. In order to reduce the risk of infection, aseptic (clean) technique must be used in the preparation and administration of REMODULIN. Additionally, patients should be aware that subsequent disease management may require the initiation of an alternative intravenous prostacyclin therapy, Flolan® (epoprostenol sodium) for Injection.

What to Expect on Infused Prostacyclin Therapy

Your doctor may need to increase the amount of medicine you receive—the goal being to maximize the benefits of treatment while minimizing side effects
Therapy with infused prostacyclin will be needed for a prolonged period of time, possibly years
It is important for patients to understand the commitment involved with infused drug delivery, including using and caring for the pump
Aseptic (clean) techniques must be used when preparing and using REMODULIN in order to reduce the risk of infection
Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal
The goal of chronic dosage adjustments is to establish a dose at which PAH symptoms are improved, while minimizing excessive pharmacologic effects of Remodulin (headache, nausea, emesis, restlessness, anxiety and infusion site pain or reaction).