Remodulin 2.5mg/ml Inj., 20ml
It is used to treat high blood pressure in the lungs.
Drug Class
Pulmonary Hypertension Agent
Pharmacologic Class
Prostacyclin Analogue
Pregnancy Category
Not available
FDA Approved
May 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Remodulin is a medicine used to treat a serious lung condition called pulmonary arterial hypertension (PAH). It works by relaxing the blood vessels in your lungs, which helps blood flow more easily and reduces the strain on your heart. It is given as a continuous infusion, either under the skin (subcutaneously) or directly into a vein (intravenously), using a small pump.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered continuously into a vein or the fatty part of the skin. Your doctor may instruct you on how to administer it yourself. Before and after handling the medication, wash your hands thoroughly.
If you need to mix this medication with another fluid, ensure you use the correct type of fluid. If you're unsure, consult your doctor or pharmacist. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use it if the solution has changed color.
Safe Disposal
Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or any other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal of Unused Medication
Store unopened vials at room temperature.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered continuously into a vein or the fatty part of the skin. Your doctor may instruct you on how to administer it yourself. Before and after handling the medication, wash your hands thoroughly.
If you need to mix this medication with another fluid, ensure you use the correct type of fluid. If you're unsure, consult your doctor or pharmacist. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use it if the solution has changed color.
Safe Disposal
Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or any other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal of Unused Medication
Store unopened vials at room temperature.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Never stop or interrupt the infusion suddenly without consulting your doctor, as this can lead to a rapid worsening of your condition.
- Learn proper infusion site care and sterile technique to prevent infections, especially if using the intravenous route.
- Always carry extra medication, pump supplies, and batteries, especially when traveling.
- Report any signs of infection at the infusion site (redness, swelling, pain, pus, fever) immediately.
- Avoid activities that could lead to severe bleeding due to the medication's antiplatelet effects.
- Inform all healthcare providers, including dentists, that you are taking Remodulin.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 1.25 ng/kg/min (SC or IV continuous infusion). Titration: Increase by 1.25 ng/kg/min increments at intervals of at least weekly, or bi-weekly, based on clinical response and tolerability. Max dose: Up to 40 ng/kg/min or higher in some cases, depending on patient response and tolerability.
Dose Range:
1.25 - 40 mg
Condition-Specific Dosing:
Pulmonary Arterial Hypertension (PAH):
Continuous subcutaneous or intravenous infusion.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor closely.
Moderate:
No specific adjustment recommended, but monitor closely.
Severe:
No specific adjustment recommended, but monitor closely.
Dialysis:
Not available (limited data, monitor closely)
Hepatic Impairment:
Mild:
Reduce initial dose to 0.625 ng/kg/min. Titrate cautiously.
Moderate:
Reduce initial dose to 0.625 ng/kg/min. Titrate cautiously.
Severe:
Reduce initial dose to 0.625 ng/kg/min. Titrate cautiously.
Pharmacology
Mechanism of Action
Treprostinil is a prostacyclin analogue. It directly dilates pulmonary and systemic arterial vascular beds and inhibits platelet aggregation. In patients with pulmonary arterial hypertension (PAH), it leads to an increase in cardiac index and a decrease in pulmonary vascular resistance, mean pulmonary arterial pressure, and systemic vascular resistance.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV), ~100% (SC)
Tmax:
3-5 hours (SC)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 14 L/70 kg
ProteinBinding:
Approximately 91%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-4 hours (IV), 3-4 hours (SC)
Clearance:
Approximately 10.5 L/hr (IV)
ExcretionRoute:
Mainly renal (79% in urine), with some fecal excretion (13%)
Unchanged:
Approximately 4% (in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes for IV, within hours for SC)
PeakEffect:
Not distinctly defined due to continuous infusion; effects are sustained.
DurationOfAction:
Sustained as long as infusion is maintained.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that increase in size
+ Uncontrollable bleeding
Severe dizziness or fainting
Shortness of breath, sudden weight gain, or swelling in the arms or legs
New or worsening trouble breathing
Abnormal burning, numbness, or tingling sensations
Anxiety or restlessness
Pain or irritation at the injection site
Arm swelling
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Dizziness or headache
Flushing
Jaw pain
Diarrhea
Upset stomach or vomiting
* Irritation at the injection site
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that increase in size
+ Uncontrollable bleeding
Severe dizziness or fainting
Shortness of breath, sudden weight gain, or swelling in the arms or legs
New or worsening trouble breathing
Abnormal burning, numbness, or tingling sensations
Anxiety or restlessness
Pain or irritation at the injection site
Arm swelling
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for guidance:
Dizziness or headache
Flushing
Jaw pain
Diarrhea
Upset stomach or vomiting
* Irritation at the injection site
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden worsening of shortness of breath or chest pain (signs of PAH rebound)
- Severe dizziness or fainting spells (hypotension)
- Unusual bleeding or bruising
- Signs of infection at the infusion site (redness, warmth, swelling, pain, pus, fever, chills)
- Severe headache, nausea, vomiting, or diarrhea (signs of overdose)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the safety and efficacy of the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have or have had in the past
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to help you make informed decisions about your treatment.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the safety and efficacy of the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have or have had in the past
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to help you make informed decisions about your treatment.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Be aware that this medication may increase your risk of bleeding. Take precautions to avoid injury, and use a soft-bristled toothbrush and an electric razor for shaving.
Do not abruptly stop taking this medication without consulting your doctor, as this may worsen symptoms of pulmonary hypertension, such as shortness of breath, dizziness, or weakness. Discuss any concerns with your doctor.
If you receive this medication intravenously, you may be at a higher risk of developing a severe, potentially life-threatening infection. Consult your doctor to understand this risk.
If you experience withdrawal symptoms or suspect that the infusion pump is not functioning correctly, seek immediate medical attention. Always have a backup system readily available in case of emergencies.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.
Be aware that this medication may increase your risk of bleeding. Take precautions to avoid injury, and use a soft-bristled toothbrush and an electric razor for shaving.
Do not abruptly stop taking this medication without consulting your doctor, as this may worsen symptoms of pulmonary hypertension, such as shortness of breath, dizziness, or weakness. Discuss any concerns with your doctor.
If you receive this medication intravenously, you may be at a higher risk of developing a severe, potentially life-threatening infection. Consult your doctor to understand this risk.
If you experience withdrawal symptoms or suspect that the infusion pump is not functioning correctly, seek immediate medical attention. Always have a backup system readily available in case of emergencies.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Flushing
- Headache
- Nausea
- Vomiting
- Diarrhea
- Hypotension (low blood pressure)
- Dizziness
- Jaw pain
What to Do:
Reduce the dose or discontinue the infusion until symptoms resolve. Provide supportive care. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Major Interactions
- CYP2C8 inhibitors (e.g., Gemfibrozil): May increase treprostinil exposure and adverse effects. Consider dose reduction of treprostinil.
- Anticoagulants (e.g., Warfarin): Increased risk of bleeding due to treprostinil's antiplatelet effects. Monitor INR/bleeding.
Moderate Interactions
- CYP2C8 inducers (e.g., Rifampin): May decrease treprostinil exposure and efficacy. Consider dose increase of treprostinil.
- Antihypertensive agents/Vasodilators: Increased risk of systemic hypotension. Monitor blood pressure.
- Diuretics: May exacerbate hypotension.
Monitoring
Baseline Monitoring
Diagnosis of PAH (e.g., right heart catheterization)
Rationale: Confirm diagnosis and severity before initiating therapy.
Timing: Prior to initiation
Liver and Renal Function Tests (LFTs, Cr, BUN)
Rationale: Assess baseline organ function, especially for dose adjustments in hepatic impairment.
Timing: Prior to initiation
Cardiac function (e.g., ECHO, ECG)
Rationale: Assess baseline cardiac status and rule out other causes of dyspnea.
Timing: Prior to initiation
Routine Monitoring
Clinical response (e.g., 6-minute walk distance, dyspnea, functional class)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Improvement or stabilization
Action Threshold: Worsening symptoms or functional class may require dose adjustment or alternative therapy.
Vital Signs (Blood Pressure, Heart Rate)
Frequency: Regularly, especially during dose titration
Target: Maintain within acceptable limits; avoid symptomatic hypotension.
Action Threshold: Symptomatic hypotension or significant changes may require dose reduction.
Infusion site assessment (for SC/IV)
Frequency: Daily
Target: Absence of pain, erythema, induration, infection
Action Threshold: Signs of infection, severe pain, or skin breakdown require immediate attention and potential site rotation/treatment.
Liver Function Tests (LFTs)
Frequency: Periodically, especially in patients with hepatic impairment or those on interacting drugs.
Target: Within normal limits
Action Threshold: Significant elevation may require dose adjustment or investigation.
Symptom Monitoring
- Dyspnea (shortness of breath)
- Fatigue
- Chest pain
- Syncope (fainting)
- Dizziness
- Headache
- Nausea/Vomiting
- Diarrhea
- Jaw pain
- Flushing
- Infusion site pain, erythema, induration, swelling, or infection (for SC/IV)
Special Patient Groups
Pregnancy
Based on animal data, treprostinil may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Animal studies showed teratogenicity (skeletal and cardiovascular malformations) at doses higher than human exposure.
Second Trimester:
Not specifically studied in humans; animal data suggest potential for harm throughout gestation.
Third Trimester:
Not specifically studied in humans; animal data suggest potential for harm throughout gestation.
Lactation
It is not known whether treprostinil is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk cannot be ruled out (L3)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use in pediatric patients is generally not recommended, though it may be used off-label in severe cases with careful titration and monitoring.
Geriatric Use
No specific dose adjustment is required based on age. However, elderly patients may have decreased renal or hepatic function, which could affect drug clearance. Monitor closely for adverse effects and adjust dose based on tolerability and clinical response.
Clinical Information
Clinical Pearls
- Remodulin must be administered as a continuous infusion; abrupt discontinuation can lead to rapid clinical deterioration and rebound pulmonary hypertension.
- Infusion site pain is a common side effect with subcutaneous administration and can be severe, sometimes requiring conversion to intravenous administration.
- Strict aseptic technique is crucial for intravenous administration to prevent catheter-related bloodstream infections (CRBSIs), which are life-threatening.
- Dose titration is highly individualized and based on patient tolerability and clinical response, not solely on body weight.
- Patients should be educated on the importance of continuous infusion, proper pump operation, and emergency procedures in case of pump malfunction or infusion line issues.
Alternative Therapies
- Epoprostenol (Flolan, Veletri) - IV prostacyclin
- Iloprost (Ventavis) - Inhaled prostacyclin
- Selexipag (Uptravi) - Oral prostacyclin receptor agonist
- Macitentan (Opsumit) - Endothelin receptor antagonist (ERA)
- Ambrisentan (Letairis) - ERA
- Bosentan (Tracleer) - ERA
- Sildenafil (Revatio) - PDE5 inhibitor
- Tadalafil (Adcirca) - PDE5 inhibitor
- Riociguat (Adempas) - Soluble guanylate cyclase (sGC) stimulator
Cost & Coverage
Average Cost:
Highly variable, typically >$10,000 - $20,000 per month per 20ml vial (2.5mg/ml)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.