Generic Name: Epoprostenol Brand Name(s): Epoprostenol.

Uses

What is Epoprostenol used for?

Epoprostenol is commonly used to treat high blood pressure in the lungs (pulmonary arterial hypertension). It helps to increase your ability to exercise and improve symptoms such as shortness of breath and tiredness. It works by relaxing and widening the blood vessels (arteries) in the lungs and other parts of the body so that blood can flow more easily. This medication belongs to a class of drugs known as vasodilators.

How should I take Epoprostenol?

When you first start using this medication, it must be given by a health care professional in a hospital or clinic. This medication is given as a continuous injection into the vein using an infusion pump, or as directed by your doctor.

Follow all instructions from your health care professional about how to properly use and prepare this medication and the infusion pump. Learn how to properly care for your injection site and how to avoid infection. Also learn how to store and discard needles and medical supplies safely. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid, and contact your health care professional right away. If you have any questions about the use of this medication or the infusion pump, consult your health care professional.

Do not suddenly decrease the dose or suddenly stop using this medication because doing either may lead to serious (rarely fatal) worsening of your condition. If you must stop this medication, gradually reduce the dose as directed by your doctor. Consult your doctor right away if your infusion is interrupted or if you develop worsening trouble breathing, dizziness, or weakness. To avoid interruptions in drug treatment, you should have a backup infusion pump and infusion sets available in case your equipment fails. Consult your health care professional for more information.

The dosage is based on your medical condition, weight, and response to treatment. Your doctor may also direct you to use additional medications to treat your condition and prevent problems. Use all prescribed medications exactly as directed.

Tell your doctor if your condition does not improve or if it worsens.

How do I store Epoprostenol?

When used at room temperature (15°C to 25°C; 59°F to 77°F), reconstituted solutions are stable for up to 8 hours following reconstitution or removal from refrigerated storage and may be stored for up to 40 hours refrigerated at 2°C to 8°C (36°F to 46°F) before use.

When used with a cold pack, reconstituted solutions are stable for up to 24 hours use and may be stored refrigerated at 2°C to 8°C (36°F to 46°F) before use as long as the total time of refrigerated storage and infusion does not exceed 48 hours. Change cold packs every 12 hours.

Precautions & warnings

What should I know before using Epoprostenol?

Before using epoprostenol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart failure (on the left side of the heart), bleeding problems (such as bleeding of the stomach/intestines), blood disorders (such as thrombocytopenia), liver disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

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

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using Epoprostenol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Epoprostenol. Epoprostenol is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Epoprostenol?

Nausea, vomiting, diarrhea, dizziness, headache, flushing, sweating, abdominal pain, jaw pain, muscle/joint pain, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 any of these unlikely but serious side effects occur: mental/mood changes (such as anxiety, nervousness, confusion, agitation), signs of infection (such as fever, chills), numb/tingling/pale skin, fast/slow/irregular heartbeat, vision changes, chest pain, unusual bruising/bleeding.

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

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Epoprostenol?

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antiplatelet drugs (such as clopidogrel).

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen, naproxen) that can increase the risk of bleeding or medicines (such as cough-and-cold products, diet aids) that could increase your blood pressure or heart rate. Ask your pharmacist about using those products safely.

However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Epoprostenol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Epoprostenol?

Epoprostenol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Epoprostenol?

Epoprostenol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Epoprostenol.

What is the dose of Epoprostenol for an adult?

Usual Adult Dose for Pulmonary Hypertension

Initial dose: 2 ng/kg/min via continuous IV infusion and titrate up in increments of 2 ng/kg/min every 15 minutes or longer until a tolerance limit is established or further increases in infusion rate not clinically warranted

Comments:

-If the initial infusion rate is not tolerated, a lower dose may be used.

-If dose-limiting pharmacologic effects occur, decrease infusion rate until this drug is tolerated.

Use: For the treatment of PAH (WHO Group 1) to improve exercise capacity; studies establishing efficacy included predominately patients with New York Heart Association (NYHA) Class III to IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated connective tissue disorders

Dose Adjustments

Changes in the chronic infusion rate should be based on persistence, recurrence, or worsening of the patient’s symptoms of pulmonary hypertension and the occurrence of adverse events due to excessive doses of epoprostenol. In general, increases in dose from the initial chronic dose should be expected.

PAH symptoms which persist or recur after improving:

-Consider increasing the infusion in increments of 1 to 2 ng/kg/min at intervals of at least 15 minutes

-Following establishment of a new chronic infusion rate, observe patient and monitor standing and supine blood pressure and heart rate for several hours to ensure that the new dose is tolerated.

Occurrence of dose-limiting pharmacologic events:

-Dose decreases should occur gradually in 2 ng/kg/min decrements every 15 minutes or longer until dose-limiting effects are resolved

-Adverse events may occasionally resolve without dose adjustments

-Avoid abrupt withdrawal or sudden large reductions in infusion rates

Patients receiving lung transplants: Taper dose after initiation of cardiopulmonary bypass

Elderly: Cautious dose selection recommended due to increased likelihood of concomitant hepatic, renal, or cardiac dysfunctions or concomitant disease or other drug therapy.

Other Comments

Administration advice:

-Once prepared as directed, administer by continuous IV infusion via a central venous catheter using an ambulatory infusion pump; may be administered temporarily using peripheral IV infusion during initiation until central access is established.

-Each vial for single use only; any unused solution should be discarded.

-Use immediately after reconstitution and immediate dilution to final concentration.

-Infusion sets with an in-line 0.22-micron filter should be used.

-To avoid potential interruptions in drug delivery, the patient should have immediate access to a backup infusion pump and IV infusion sets.

-Do not mix Veletri(R) with any other parenteral medications or solutions prior to or during administration.

-The ambulatory infusion pump should be small and lightweight, be able to adjust infusion rates in 2 ng/kg/min increments, have occlusion, end-of-infusion, and low-battery alarms, be accurate to +/-6% of the programmed rate, and be positive-pressure-driven (continuous or pulsatile) with intervals between pulses not exceeding 3 minutes at infusion rates used to deliver this drug.

-The reservoir should be made of polyvinyl chloride, polypropylene, or glass.

-The manufacturer product information should be consulted for appropriate infusion rates and further administration advice.

Storage requirements:

-Unopened vials are stable until the date on the package when stored at room temperature in the carton and protected from light.

-Avoid exposing diluted solutions to direct sunlight.

-Refrigerated at 2C to 8C (35.6F to 46.4F) if not used immediately.

-Do not freeze.

-The manufacturer product information should be consulted for maximum administration of fully diluted solutions.

Reconstitution/preparation techniques:

-Reconstitute Veletri(R) only as directed using sterile water for injection USP, or sodium chloride 0.9% injection USP.

-Reconstitute Flolan(R) with the supplied diluent.

-All products must be reconstituted as directed by the manufacturer of individual products; the manufacturer product information should be consulted for dilution instructions.

IV compatibility: The manufacturer product information should be consulted.

General:

-Initiate in a setting with adequate personnel and equipment for physiologic monitoring and emergency care.

-Except in life-threatening situations, (e.g., unconsciousness, collapse), infusion rates should only be adjusted under direction of a physician.

Monitoring:

-Cardiovascular: Monitor blood pressure regularly during initiation and following dose changes; monitor standing and supine blood pressure and heart rate closely for several hours following dose adjustments.

Patient advice:

-Adhere to sterile technique in preparing this drug for administration as well as in caring for the catheter.

What is the dose of Epoprostenol for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Epoprostenol available?

Epoprostenol is available in the following dosage forms and strengths:

  • Intravenous powder for injection

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Epoprostenol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 25, 2018 | Last Modified: January 25, 2018

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