Safety and Side Effects
Warnings and Precautions
- 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
The most common side effects of Remodulin include those related to the method of infusion.
If you are on Remodulin SC, it is common to experience infusion site pain and infusion site reaction. Infusion site reaction was defined as symptoms such as abnormal redness of the skin, inflammation, or rash. While not everyone experiences these symptoms, they occur in the majority of patients. These symptoms can be severe. Your doctor may prescribe prescription medications to help manage these symptoms.
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. 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).
Percentage of patients with PAH receiving Remodulin SC who experienced adverse reactions at least 3% more frequently than patients receiving placebo in controlled, 12-week studies*
|Adverse Reaction||Remodulin (n=236)||Placebo (n=233)|
|Infusion site pain||85%||27%|
|Infusion site reaction||83%||27%|
The IV infusion of Remodulin has been associated with a risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain.
Long-term IV infusion of Remodulin is delivered via a surgically implanted central venous catheter. The use of central venous catheters may lead to the development of serious blood stream infections and sepsis. Although rare, these events can be fatal. For that reason, SC infusion is the preferred route of administration for Remodulin. Remodulin IV infusion is reserved for patients in whom the SC route is not appropriate.
Talk with your doctor
Before starting therapy with Remodulin, ask your doctor how you may be able to manage side effects if they occur. By knowing what to expect, you may be able to successfully stay on Remodulin.
Connect with a Remodulin PEER Mentor
Remodulin PEER Mentors are Remodulin patients who volunteer their time to help people who are considering, or already taking, Remodulin. Meet the PEER Mentors.