Frequently Asked Questions

What is Remodulin?

Remodulin is a prescription medication used in adults with pulmonary arterial hypertension (PAH; WHO Group 1), to diminish symptoms associated with exercise. Remodulin is a prostacyclin-class therapy that may increase the blood flow in your arteries.

Remodulin can be taken 1 of 2 ways: as a continuous subcutaneous (SC) infusion or intravenous (IV) infusion. Both have benefits and risks. Speak with your doctor to see which might be right for you.

In people with PAH who need to switch from Flolan® (epoprostenol sodium), Remodulin is approved to slow the worsening of symptoms. The risks and benefits of each drug should be carefully considered before switching.

I read that Remodulin is a type of prostacyclin-class therapy. What does that mean?

Prostacyclin is a natural substance found in the body. It helps keep arteries in the lungs open and working properly. If you have PAH, your body may not produce enough prostacyclin. Remodulin is a prostacyclin analogue, meaning that it mimics some of the natural effects of prostacyclin that your body lacks. It helps open pulmonary arteries, making it easier for your heart to pump blood through your lungs.

What is 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). This may be done 1 of 2 ways

  • By SC infusion—through a small catheter under the skin, usually in the abdominal area
  • By IV infusion—through a catheter that goes directly into a vein, usually placed surgically in the chest

Continuous IV infusions of Remodulin are delivered using a tube placed in a central vein within the chest. This type of delivery is associated with the risk of blood stream infections and sepsis, which may be fatal. Therefore, continuous SC infusion delivered just beneath the skin is the preferred type of delivery.

What is subcutaneous Remodulin?

Remodulin can be taken 1 of 2 ways, one of which is called subcutaneous or SC infusion. With SC infusion, a small catheter (very thin tube) is placed just under the skin, generally in the abdominal (stomach) area. A small, cell phone–sized pump worn outside the body delivers medicine continuously.

What is intravenous Remodulin?

With intravenous, or IV, infusion, medication is delivered directly into the blood stream through a flexible, surgically placed catheter (very, thin tube). The catheter is usually placed into a vein in the chest. A small pump outside the body delivers medication through the catheter.

Your doctor will work with you to determine which administration option is right for you.

How often do I mix my Remodulin?

If you are taking Remodulin SC, there is no mixing required. With Remodulin IV, you have 2 options. You can prepare your Remodulin every 2 days when you refill your pump. You can also premix reservoirs for Remodulin IV up to 14 days when mixing with a sterile high-pH glycine diluent.* Remodulin cannot be stored for 14 days when mixed with Sterile Water for Injection or Sodium Chloride Injection. To confirm that you are using a sterile high-pH glycine diluent or to discuss switching to one, contact your Specialty Pharmacy Services (SPS) provider. The CADD-MS® 3 should not be used for premixing.

*
Stability was demonstrated as low as 0.004 mg/mL.

How long does a patient stay on Remodulin?

Remodulin does not cure pulmonary arterial hypertension (PAH), rather it helps to treat some of the symptoms of the disease. Therefore, therapy with infused Remodulin 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.

Remember that it is important to take Remodulin exactly as prescribed by your doctor. If you'd like to connect with someone on Remodulin, contact the PEER Network, which enables patients considering or taking Remodulin to speak to a patient or caregiver who has personal experience with Remodulin.

Does Remodulin require ice packs to keep it cool?

No. Remodulin does not require ice packs for administration or refrigeration for storage.

Guidelines for use and storage:

  • Patients may administer Remodulin at temperatures up to 104°F regardless of concentration when prepared and used as directed
  • Store unopened vials of Remodulin at room temperature

How often do I have to refill my pump (or cassette)?

Patients can go up to 3 days before refilling an SC infusion cassette and up to 2 days before refilling an IV infusion cassette.

What pumps are used for Remodulin?

Remodulin is the only infused PAH medicine that offers a cell phone–sized pump option. This compact, lightweight pump (about the weight of a deck of cards) is available to both those using Remodulin IV and Remodulin SC.

There are some creative ways to hide your pump, if you would like to do so. It's important, however, that you do so in a manner that does not compromise the delivery of Remodulin. Make sure that your extension tubing is not being pinched and that everyday movements do not pull at your catheter and/or infusion site. For example, the pump can be concealed under clothes or placed in pockets or fanny packs. Remodulin IV offers 2 pump options. Consult your doctor to see which pump option would be best for you.

How do I get Remodulin?

Remodulin is available only by prescription. Once you are prescribed Remodulin, your doctor will contact a Specialty Pharmacy to ensure you have the medicine, supplies, training, and personalized support you need.

Accredo
1-866-344-4874
accredo.com

CVS Specialty
1-877-242-2738
cvsspecialty.com

What are the side effects of Remodulin?

In clinical studies of SC infusion of Remodulin, most people experienced infusion site pain and infusion site reaction (redness and swelling). These symptoms were often severe and sometimes required treatment with narcotics or discontinuation of Remodulin.

The IV infusion of Remodulin has been associated with the risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain. Other common side effects seen with either Remodulin SC or IV were headache, diarrhea, jaw pain, nausea, vasodilatation (widening of the blood vessels), and edema (swelling).

Can I take Remodulin if I take other medications?

Patients being treated for PAH are likely to be taking a number of medications, and it is possible for some of these medications to interact with each other.

  • If you 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
  • Remodulin acts by lowering your blood pressure. In some cases your blood pressure may become too low and cause other side effects. If you also take other drugs that lower your blood pressure, the risk is increased. You should discuss all of your symptoms with your doctor, including those associated with low blood pressure
  • Because Remodulin can reduce the blood's ability to clot, it may increase your risk of bleeding, especially if you are taking anticoagulants (blood thinners)

It is important to tell your doctor about all the drugs you take—even those you can buy without a prescription. If you are considering Remodulin or have been prescribed Remodulin, be sure to discuss all medications you take with your doctor. It's also important to consult your doctor if you start or stop taking any other medications while receiving Remodulin.

I'm a new patient. Are there any resources for me?

Once you start Remodulin, you should receive the Remodulin Patient Starter Kit from your SPS provider. The Remodulin Patient Starter Kit includes resources to help you as you begin treatment with Remodulin, including a patient brochure and DVD; the Preparing and Administering Remodulin Flip Chart and DVD; a Prep Tray; and a journal for recording symptoms, side effects, upcoming appointments, and more.

Are there any resources available for existing patients on Remodulin?

The Remodulin Support Program is a series of communications offering information and resources to support you while you take Remodulin. Register for the Remodulin Support Program now.

Can I speak with a Remodulin patient or caregiver?

The PEER Network is a program that enables patients or caregivers to connect with a mentor, whether they are considering, taking, or caring for someone taking Remodulin. Through the PEER Network, they'll communicate one-on-one with a volunteer patient or caregiver who has personal experience with Remodulin and who can share insights, lifestyle tips, and emotional support.

It can be helpful to connect with people who intimately understand the frustrations, challenges, and everyday experiences of PAH. Connect with a Remodulin PEER Mentor today.

Beginning subcutaneous Remodulin therapy

Important Safety Information for Remodulin

Drug Interactions/Specific Populations

Indication for Remodulin

Remodulin is a prescription medication used in adults with pulmonary arterial hypertension (PAH; WHO Group 1), to diminish symptoms associated with exercise. PAH is high blood pressure in the arteries of your lungs. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. Remodulin is delivered (infused) continuously using a pump connected to a small tube that is either placed under the skin (subcutaneously [SC]) or inserted into a vein in the upper chest (intravenously [IV]). Because there are risks associated with continuous IV infusion, such as serious blood stream infections, IV infusion should be reserved for people who cannot tolerate SC infusion or for those in whom the risks are considered acceptable.

In people with PAH who need to switch from Flolan® (epoprostenol sodium), Remodulin is approved to slow the worsening of symptoms. The risks and benefits of each drug should be carefully considered before switching.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the Full Prescribing Information for Remodulin.

For additional information, 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

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Important Safety Information for Remodulin

  • Continuous intravenous (IV) infusions of Remodulin are delivered using a tube placed in a central vein within the chest. This type of delivery is 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.
  • You should not stop or greatly reduce your Remodulin dose without consulting your doctor, as this may cause your PAH symptoms to worsen.
  • Other medical conditions and medicines may affect your use of Remodulin by increasing the risk of side effects or decreasing the drug's effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking.
  • If you have liver or kidney problems, your ability to tolerate Remodulin may be affected.

Drug Interactions/Specific Populations

  • If you 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.
  • Remodulin acts by lowering your blood pressure. In some cases your blood pressure may become too low and cause other side effects. If you also take other drugs that lower your blood pressure, the risk is increased. You should discuss all of your symptoms with your doctor, including those associated with low blood pressure.
  • Because Remodulin can reduce the blood's ability to clot, it may increase your risk of bleeding, especially if you are taking anticoagulants (blood thinners).
  • If you are pregnant, breast-feeding, or planning to become pregnant, talk with your doctor about whether you should take Remodulin.
  • Side Effects: In clinical studies of SC infusion of Remodulin, most people experienced infusion site pain and infusion site reaction (redness and swelling). These symptoms were often severe and sometimes required treatment with narcotics or discontinuation of Remodulin. The IV infusion of Remodulin has been associated with the risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain. Other common side effects seen with either SC or IV Remodulin were headache, diarrhea, jaw pain, nausea, vasodilatation (widening of the blood vessels), and edema (swelling).

Indication for Remodulin

Remodulin is a prescription medication used in adults with pulmonary arterial hypertension (PAH; WHO Group 1), to diminish symptoms associated with exercise. PAH is high blood pressure in the arteries of your lungs. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. Remodulin is delivered (infused) continuously using a pump connected to a small tube that is either placed under the skin (subcutaneously [SC]) or inserted into a vein in the upper chest (intravenously [IV]). Because there are risks associated with continuous IV infusion, such as serious blood stream infections, IV infusion should be reserved for people who cannot tolerate SC infusion or for those in whom the risks are considered acceptable.

In people with PAH who need to switch from Flolan® (epoprostenol sodium), Remodulin is approved to slow the worsening of symptoms. The risks and benefits of each drug should be carefully considered before switching.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the Full Prescribing Information for Remodulin.

For additional information, call Customer Service at 1-877-UNITHER (1-877-864-8437).