Remodulin 1mg/ml Inj, 20ml
It is used to treat high blood pressure in the lungs.
Drug Class
Antihypertensive, Pulmonary
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 pulmonary arterial hypertension (PAH), a condition where blood pressure in the arteries leading to your lungs is too high. It works by relaxing and widening these blood vessels, making it easier for your heart to pump blood through your lungs. This can help improve your ability to exercise and reduce your symptoms. It is given as a continuous infusion, either under the skin (subcutaneous) or directly into a vein (intravenous), 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 accompanying information carefully. This medication is administered continuously into a vein or the fatty part of the skin. Your doctor may provide guidance on how to administer it.
Before and after handling the medication, wash your hands thoroughly. In some cases, you may need to mix this medication with another fluid before use. If so, ensure you use the correct type of fluid. If you are unsure, consult your doctor or pharmacist.
Important Safety Precautions
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. Dispose of needles and other sharp objects in a designated disposal box. Never reuse needles or 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
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 accompanying information carefully. This medication is administered continuously into a vein or the fatty part of the skin. Your doctor may provide guidance on how to administer it.
Before and after handling the medication, wash your hands thoroughly. In some cases, you may need to mix this medication with another fluid before use. If so, ensure you use the correct type of fluid. If you are unsure, consult your doctor or pharmacist.
Important Safety Precautions
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. Dispose of needles and other sharp objects in a designated disposal box. Never reuse needles or 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
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
- Do not stop Remodulin suddenly, as this can lead to a rapid worsening of your PAH symptoms and can be life-threatening. If you need to stop or change your dose, your doctor will guide you on how to do so safely.
- Learn proper infusion techniques and care for your infusion site to prevent infections, especially if using the intravenous route.
- Always have backup supplies (pump, medication, batteries) readily available.
- Avoid activities that significantly worsen your PAH symptoms.
- Report any new or worsening symptoms, or signs of infection at the infusion site, immediately to your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 1.25 ng/kg/min (subcutaneous or intravenous continuous infusion). Titrate by 1.25 ng/kg/min increments per week for the first 4 weeks, then by 2.5 ng/kg/min increments per week or longer, based on clinical response and tolerability. Max dose is patient-specific, often up to 40-50 ng/kg/min or higher.
Dose Range:
1.25 - 50 mg
Condition-Specific Dosing:
Pulmonary Arterial Hypertension (PAH):
Continuous subcutaneous or intravenous infusion. Titration is crucial and individualized based on clinical response and tolerability (e.g., improvement in exercise capacity, reduction in symptoms, or adverse effects like headache, nausea, diarrhea, flushing, jaw pain).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients. Use in children has been reported in clinical practice, often with similar dosing principles as adults, but requires expert consultation.)
Adolescent:
Not established (See 'child' above)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but monitor closely for adverse effects due to potential for increased exposure.
Dialysis:
Considerations: Treprostinil is not significantly removed by dialysis. Monitor closely for adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Consider reducing initial dose to 0.625 ng/kg/min. Titrate cautiously.
Severe:
Consider reducing initial dose to 0.625 ng/kg/min. Titrate cautiously and monitor closely for adverse effects. Exposure is significantly increased in severe hepatic impairment.
Pharmacology
Mechanism of Action
Treprostinil is a prostacyclin analogue. It directly vasodilates pulmonary and systemic arterial beds and inhibits platelet aggregation. In patients with pulmonary arterial hypertension (PAH), it improves exercise capacity and symptoms by reducing pulmonary vascular resistance, pulmonary arterial pressure, and mean right atrial pressure, and increasing cardiac output.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV), 92% (SC relative to IV)
Tmax:
3-5 hours (subcutaneous)
FoodEffect:
Not applicable (administered via continuous infusion)
Distribution:
Vd:
14 L/70 kg
ProteinBinding:
96% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
2-4 hours (subcutaneous/intravenous)
Clearance:
29.5 L/hr (total body clearance)
ExcretionRoute:
Primarily renal (91% in urine, 9% in feces)
Unchanged:
Less than 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; effects dissipate within hours of discontinuation due to short half-life.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 enlarge
+ Uncontrollable bleeding
Severe dizziness or fainting
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Worsening or new breathing difficulties
Abnormal burning, numbness, or tingling sensations
Anxiety or restlessness
Pain or irritation at the injection site
Arm swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor 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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 enlarge
+ Uncontrollable bleeding
Severe dizziness or fainting
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Worsening or new breathing difficulties
Abnormal burning, numbness, or tingling sensations
Anxiety or restlessness
Pain or irritation at the injection site
Arm swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor 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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- Severe shortness of breath or chest pain (worsening PAH)
- Dizziness or fainting spells
- Signs of infection at the infusion site (redness, swelling, warmth, pus, fever, chills)
- Unusual bleeding or bruising
- Severe headache, nausea, vomiting, or diarrhea that does not improve
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 use of this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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 use of this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from a sitting or lying down position to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
As this medication may increase your risk of bleeding, it is crucial to be careful and avoid injuries. To reduce the risk of bleeding, 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 high pressure in the lungs, such as shortness of breath, dizziness, or weakness. Discuss any concerns with your doctor.
Receiving this medication intravenously may increase your risk of developing a severe, potentially life-threatening infection. Consult your doctor to understand this risk.
If you experience symptoms of withdrawal or suspect that the 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, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from a sitting or lying down position to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
As this medication may increase your risk of bleeding, it is crucial to be careful and avoid injuries. To reduce the risk of bleeding, 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 high pressure in the lungs, such as shortness of breath, dizziness, or weakness. Discuss any concerns with your doctor.
Receiving this medication intravenously may increase your risk of developing a severe, potentially life-threatening infection. Consult your doctor to understand this risk.
If you experience symptoms of withdrawal or suspect that the 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, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Severe flushing
- Headache
- Nausea
- Vomiting
- Diarrhea
- Hypotension (low blood pressure)
- Dizziness
- Syncope
What to Do:
Seek immediate medical attention. Reduce or discontinue the infusion until symptoms resolve. Call 911 or your local emergency number. For general overdose information, call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Antihypertensives (e.g., calcium channel blockers, ACE inhibitors, diuretics): May cause additive hypotensive effects. Monitor blood pressure.
- Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding due to treprostinil's antiplatelet effects. Monitor for signs of bleeding.
- Anticoagulants (e.g., warfarin, heparin): Increased risk of bleeding. Monitor INR/aPTT and for signs of bleeding.
- CYP2C8 inhibitors (e.g., gemfibrozil): May increase treprostinil exposure, leading to increased adverse effects. Consider dose reduction of treprostinil.
- CYP2C8 inducers (e.g., rifampin): May decrease treprostinil exposure, leading to reduced efficacy. Consider dose increase of treprostinil.
Moderate Interactions
- PDE5 inhibitors (e.g., sildenafil, tadalafil): Additive vasodilatory effects, potentially leading to increased hypotension. Monitor blood pressure.
- Endothelin Receptor Antagonists (e.g., bosentan, ambrisentan): Additive vasodilatory effects. Monitor for hypotension.
Monitoring
Baseline Monitoring
Diagnosis of PAH
Rationale: Confirm eligibility for treprostinil therapy.
Timing: Prior to initiation
Baseline hemodynamics (e.g., right heart catheterization)
Rationale: Assess severity of PAH and establish baseline for response assessment.
Timing: Prior to initiation
Liver and renal function tests (LFTs, Cr, BUN)
Rationale: Assess organ function, especially for hepatic impairment which requires dose adjustment.
Timing: Prior to initiation
6-minute walk distance (6MWD)
Rationale: Establish baseline exercise capacity.
Timing: Prior to initiation
Routine Monitoring
Clinical symptoms (dyspnea, fatigue, chest pain, syncope)
Frequency: Daily/Weekly (patient self-monitoring), Monthly/Quarterly (clinical assessment)
Target: Improvement or stabilization
Action Threshold: Worsening symptoms may indicate need for dose adjustment or re-evaluation of therapy.
Blood pressure and heart rate
Frequency: Daily (patient self-monitoring), at each clinic visit
Target: Within acceptable limits, avoiding symptomatic hypotension
Action Threshold: Symptomatic hypotension or significant bradycardia/tachycardia may require dose adjustment.
Infusion site assessment (for SC/IV)
Frequency: Daily (patient/caregiver), at each clinic visit
Target: Absence of pain, swelling, erythema, induration, infection
Action Threshold: Signs of infection, severe pain, or skin breakdown require immediate medical attention and potential change in infusion site/route.
Liver and renal function tests
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated), especially with hepatic impairment
Target: Within normal limits or stable
Action Threshold: Significant changes may warrant dose adjustment or investigation.
6-minute walk distance (6MWD)
Frequency: Every 3-6 months
Target: Improvement or stabilization
Action Threshold: Decline may indicate need for dose adjustment or re-evaluation of therapy.
Symptom Monitoring
- Dyspnea (shortness of breath)
- Fatigue
- Chest pain
- Syncope (fainting)
- Dizziness
- Headache
- Nausea
- Vomiting
- Diarrhea
- Flushing
- Jaw pain
- Infusion site pain, redness, swelling, induration, or infection (for SC/IV)
Special Patient Groups
Pregnancy
Pregnancy Category B (older classification). Available data from published case reports and postmarketing experience are insufficient to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Insufficient data to determine risk.
Second Trimester:
Insufficient data to determine risk.
Third Trimester:
Insufficient data to determine risk.
Lactation
There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Remodulin and any potential adverse effects on the breastfed infant from Remodulin or from the underlying maternal condition. Caution should be exercised.
Infant Risk:
Unknown
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use in children has been reported in clinical practice, but generally not recommended as first-line therapy and requires expert consultation.
Geriatric Use
No specific dose adjustment is required based on age alone. However, older patients may have decreased hepatic or renal function or concomitant diseases, which may require careful monitoring and individualized dosing.
Clinical Information
Clinical Pearls
- Remodulin is a life-sustaining medication for many PAH patients; abrupt discontinuation can be fatal.
- Continuous infusion is critical; patients and caregivers must be thoroughly trained on pump operation, sterile technique, and troubleshooting.
- Subcutaneous administration is associated with significant infusion site pain and reactions in a high percentage of patients, which can lead to discontinuation. Intravenous administration avoids this but carries a higher risk of serious bloodstream infections.
- Dose titration is highly individualized and guided by clinical response and tolerability. Patients often require significant dose increases over time.
- Patients should carry a medical alert card or wear a medical alert bracelet indicating their condition and medication use.
- Ensure patients have a backup pump and adequate medication supply at all times, especially when traveling.
Alternative Therapies
- Epoprostenol (Flolan, Veletri) - another prostacyclin, IV only, very short half-life
- Iloprost (Ventavis) - inhaled prostacyclin
- Selexipag (Uptravi) - prostacyclin receptor agonist (oral)
- Macitentan (Opsumit) - endothelin receptor antagonist (ERA)
- Ambrisentan (Letairis) - endothelin receptor antagonist (ERA)
- Bosentan (Tracleer) - endothelin receptor antagonist (ERA)
- Sildenafil (Revatio) - PDE5 inhibitor
- Tadalafil (Adcirca) - PDE5 inhibitor
- Riociguat (Adempas) - soluble guanylate cyclase (sGC) stimulator
Cost & Coverage
Average Cost:
Extremely high (e.g., $10,000 - $30,000+ per month depending on dose) per month
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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.