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Remodulin

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Remodulin

Remodulin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Remodulin (treprostinil sodium) is used to treat pulmonary arterial hypertension (PAH). It improves the ability to exercise and prevents the condition from getting worse. It is a vasodilator that works by dilating (widening) the arteries. Common side effects include nausea, vomiting, diarrhea, headache, dizziness, jaw pain, flushing, or redness/swelling/pain at the injection site.

Remodulin is indicated for subcutaneous (SC) or intravenous (IV) use only as a continuous infusion and is administered in a clinical setting. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated because of side effects, the infusion rate may be reduced to 0.625 ng/kg/min. Remodulin may interact with blood pressure medications, bosentan, blood thinners, diuretics (water pills), or medications to treat congestive heart failure. Tell your doctor all medications and supplements you use. During pregnancy, Remodulin should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Remodulin (treprostinil sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Remodulin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;
  • swelling in your hands or feet; or
  • feeling like you might pass out.

Less serious side effects may include:

  • pain, swelling, redness, bleeding, or a hard lump where your catheter is placed;
  • dizziness;
  • mild skin rash;
  • headache or jaw pain;
  • flushing (warmth, redness or tingling); or
  • diarrhea or nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Remodulin (Treprostinil Sodium) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Remodulin Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, headache, dizziness, jaw pain, flushing, loss of appetite, weakness, abdominal pain, and redness/swelling/pain at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: new/worsening swelling of the arms/legs, mental/mood changes (such as restlessness, nervousness).

To avoid infection, follow your health care professional's instructions for proper handling of this medication. Tell your doctor right away if you develop any signs of infection (such as fever, chills).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Remodulin (Treprostinil Sodium)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Remodulin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in labeling: Infections associated with intravenous administration [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Events with Subcutaneously Administered Remodulin

Patients receiving Remodulin as a subcutaneous infusion reported a wide range of adverse events, many potentially related to the underlying disease (dyspnea, fatigue, chest pain, right ventricular heart failure, and pallor). During clinical trials with subcutaneous infusion of Remodulin, infusion site pain and reaction were the most common adverse events among those treated with Remodulin. Infusion site reaction was defined as any local adverse event other than pain or bleeding/bruising at the infusion site and included symptoms such as erythema, induration or rash. Infusion site reactions were sometimes severe and could lead to discontinuation of treatment.

Table 2: Percentages of subjects reporting subcutaneous infusion site adverse events

  Reaction Pain
Placebo Remodulin Placebo Remodulin
Severe 1 38 2 39
Requiring narcotics* NA† NA† 1 32
Leading to discontinuation 0 3 0 7
* based on prescriptions for narcotics, not actual use
† medications used to treat infusion site pain were not distinguished from those used to treat site reactions

Other adverse events included diarrhea, jaw pain, edema, vasodilatation and nausea, and these are generally considered to be related to the pharmacologic effects of Remodulin, whether administered subcutaneously or intravenously.

Adverse Events during Chronic Dosing

Table 3 lists adverse events that occurred at a rate of at least 3% and were more frequent in patients treated with subcutaneous Remodulin than with placebo in controlled trials in PAH.

Table 3: Adverse Events in Controlled 12-Week Studies of Patients with PAH, Occurring with at Least 3% Incidence and More Common on Subcutaneous Remodulin than on Placebo

Adverse Event Remodulin
(N=236)
Percent of Patients
Placebo
(N=233)
Percent of Patients
Infusion Site Pain 85 27
Infusion Site Reaction 83 27
Headache 27 23
Diarrhea 25 16
Nausea 22 18
Rash 14 11
Jaw Pain 13 5
Vasodilatation 11 5
Dizziness 9 8
Edema 9 3
Pruritus 8 6
Hypotension 4 2

Reported adverse events (at least 3%) are included except those too general to be informative, and those not plausibly attributable to the use of the drug, because they were associated with the condition being treated or are very common in the treated population.

The safety of Remodulin was also studied in a long-term, open-label extension study in which 860 patients were dosed for a mean duration of 1.6 years, with a maximum exposure of 4.6 years. Twenty-nine (29%) percent achieved a dose of at least 40 ng/kg/min (max: 290 ng/kg/min). The safety profile during this chronic dosing study was similar to that observed in the 12-week placebo controlled study except for the following suspected adverse drug reactions (occurring in at least 3% of patients): anorexia, vomiting, infusion site infection, asthenia, and abdominal pain

Adverse Events Attributable to the Drug Delivery System

In controlled studies of Remodulin administered subcutaneously, there were no reports of infection related to the drug delivery system. There were 187 infusion system complications reported in 28% of patients (23% Remodulin, 33% placebo); 173 (93%) were pump related and 14 (7%) related to the infusion set. Eight of these patients (4 Remodulin, 4 Placebo) reported non-serious adverse events resulting from infusion system complications. Adverse events resulting from problems with the delivery systems were typically related to either symptoms of excess Remodulin (e.g., nausea) or return of PAH symptoms (e.g., dyspnea). These events were generally resolved by correcting the delivery system pump or infusion set problem such as replacing the syringe or battery, reprogramming the pump, or straightening a crimped infusion line. Adverse events resulting from problems with the delivery system did not lead to clinical instability or rapid deterioration. In addition to these adverse events due to the drug delivery system during subcutaneous administration, the following adverse events may be attributable to the IV mode of infusion including arm swelling, paresthesias, hematoma and pain [see WARNINGS AND PRECAUTIONS].

Post-Marketing Experience

In addition to adverse reactions reported from clinical trials, the following events have been identified during post-approval use of Remodulin. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The following events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, and potential connection to Remodulin. These events are thrombophlebitis associated with peripheral intravenous infusion, thrombocytopenia and bone pain. In addition, generalized rashes, sometimes macular or papular in nature, and cellulitis have been infrequently reported.

Read the entire FDA prescribing information for Remodulin (Treprostinil Sodium) »

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Remodulin - User Reviews

Remodulin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Remodulin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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