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Side Effects With Remodulin
The most common side effects seen with either SC or IV Remodulin are 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.
Before starting therapy, your doctor will explain what side effects are common with Remodulin and offer strategies and recommendations to help manage them. This way, you know what to expect and are prepared if and when a side effect occurs.
You can write down your experiences with side effects and share this information with your healthcare team. Working together, you and your doctor can develop a plan to help manage any side effects that occur with Remodulin.
IV=intravenous; SC=subcutaneous.
What can I do to help minimize and manage side effects with Remodulin?
Talk with your doctor about potential methods and treatments that may be recommended to help minimize and manage the side effects from Remodulin.
The following are some potential approaches to managing the most common side effects with Remodulin. These approaches should not be construed as medical advice. United Therapeutics does not recommend or endorse using healthcare products other than as directed or prescribed.
Pain
- Use of a heating pad, massage, acupuncture, or relaxation techniques
- Medicines to help manage pain (prescription or nonprescription)
- Topical treatments
Headache
- Prescription or nonprescription treatments
Dizziness
- Make sure you are hydrated
- Monitor your blood pressure
Diarrhea
- Anti-diarrhea medication
- Changes to your diet (ie, increase fiber)
Nausea
- Anti-nausea medication
- Eat smaller, more frequent meals
- Consume ginger-based products, like ginger ale
Jaw Pain
- Take slow bites of food or sips of water
- Suck on hard candy
- Chew gum before eating
With the Remodulin Support Program, you can receive additional tips and resources to help with managing PAH and Remodulin treatment. For information on how you can make a proactive plan for potential side effects, download the side effect management brochure.
Site pain with subcutaneous (SC) pumps
If you are on SC Remodulin, it is common to experience infusion site pain and infusion site reactions, such as abnormal redness of the skin, swelling, pain, or rash. Having a plan in place to manage any side effect that occurs is crucial to make sure you get the most from treatment with Remodulin.
Because every patient is different, your experience with site discomfort may vary. In small studies, infusion site pain was shown to be most intense around 2 to 5 days after a site change and to lessen about a week or sooner after a site change in some patients. Although your dose of Remodulin may increase over time, these dose increases are not associated with an increase in infusion site pain.
Remember to talk with your doctor about any discomfort or reaction you may have. He or she can recommend ways to help reduce site pain, such as:
- Minimizing the frequency of infusion site changes
- Changing your infusion site—unmanageable site pain, itching, redness, or bleeding may be a sign that it’s time to change your infusion site
- Over-the-counter or prescription medicines
- Ice, warm bath with Epsom salts, or aloe vera gel
- When it is getting near the time to change your infusion site, create a dry site (one that is not connected to your pump). You can do this by inserting a new infusion set in a different location from your current site and waiting at least 24 hours before switching the pump to the new site
Tips for choosing the best infusion sites
In case of continued discomfort, speak to your doctor about starting a new site.
Commonly recommended good sites include:
- Backs of the upper arms
- Stomach
- Hip area
- Upper buttocks
- Thighs
You should avoid sensitive areas, including:
- Stretch marks
- Scar tissue
- Under the waistband of clothing
- Bruises
- Folds of the belly
Although site pain is common, 93% of patients stayed on Remodulin in clinical studies.
How to help manage infusion site pain
Patients and healthcare professionals talk about site pain with Remodulin SC and ways to help manage it.
How to Deal: Remodulin (treprostinil) Injection SC Site Pain
What should I do if I experience side effects with Remodulin?
You should always talk to your doctor first about what to do if you experience any side effects.
Seek medical attention if you experience signs or symptoms of abrupt withdrawal of therapy or Remodulin overdose.
United Therapeutics does not provide medical advice.
Your doctor is the best source of information about your treatment and side effect management and will offer strategies based on your unique medical needs.
Remodulin® (treprostinil) Injection
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.
The risk information provided here is not comprehensive.
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.
REMISIconMAY2021
To learn more about Remodulin, talk with your healthcare provider. Please see Full Prescribing Information at www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).
PAH=pulmonary arterial hypertension; WHO=World Health Organization.
Remodulin® (treprostinil) Injection
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.
The risk information provided here is not comprehensive.
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.
REMISIconMAY2021
To learn more about Remodulin, talk with your healthcare provider. Please see Full Prescribing Information at www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).
PAH=pulmonary arterial hypertension; WHO=World Health Organization.