Flolan

Generic Name: epoprostenol (Intravenous route)

e-poe-PROST-en-ol

Commonly used brand name(s)

In the U.S.

  • Flolan
  • Veletri

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Peripheral Vasodilator

Pharmacologic Class: Prostaglandin

Uses For Flolan

Epoprostenol injection is used to treat the symptoms of primary pulmonary hypertension and pulmonary hypertension in patients who have already been treated with other medicines that did not work well. Pulmonary hypertension is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs.

Slideshow: Flashback: FDA Drug Approvals 2013

Epoprostenol belongs to a group of agents called prostaglandins. Prostaglandins occur naturally in the body and are involved in many biological functions. Epoprostenol works by relaxing blood vessels and increasing the supply of blood to the lungs, reducing the workload of the heart.

This medicine is available only with your doctor's prescription.

Before Using Flolan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of epoprostenol injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of epoprostenol injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving epoprostenol injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Desvenlafaxine
  • Duloxetine
  • Milnacipran
  • Venlafaxine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Digoxin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Congestive heart failure, severe or
  • Pulmonary edema (fluid in the lungs)—Should not be used in patients with these conditions.

Proper Use of epoprostenol

This section provides information on the proper use of a number of products that contain epoprostenol. It may not be specific to Flolan. Please read with care.

Your doctor or nurse will teach you or a caregiver how to give this medicine. The medicine is given as an infusion through a catheter that is placed directly into a vein. Do not use more medicine than your doctor tells you to.

Your doctor or nurse will teach you how to prepare the medicine and use the pump for the infusion. Epoprostenol must be administered continuously by a portable pump that is operated by a small computer. The medicine will be delivered directly to the heart through a catheter that will be inserted into a vein in the chest.

Epoprostenol should be reconstituted only with the sterile diluent that is supplied with this medicine. The reconstituted medicine should not be mixed with other solutions or medicines. Use the following procedure for reconstituting your daily supply:

  • Clear an area to work in and clean the area with alcohol. Gather your supplies. Wash your hands thoroughly with soap and water and then open all packages. Remove the vial cap from the vial containing the sterile diluent, clean the tops of the vials with alcohol swabs, and let the vial tops dry before proceeding.
  • To withdraw the sterile diluent:
  • If not already attached, attach a needle to the syringe. Gently pull the plunger out slightly and push it back to break the syringe seal. Draw air into the syringe that is about equal to the amount of sterile diluent you've been instructed to withdraw from the vial. Insert the needle at an angle, completely through the rubber seal of the vial. Turn the vial and syringe upside down (the syringe-vial unit is now vertical) and carefully press the plunger, injecting some or all of the air into the vial. Then aim the tip of the needle into the fluid and carefully pull the plunger slowly back to withdraw the diluent and/or allow the pressure to fill the syringe with the diluent. Continue pushing the remaining air into the vial, allowing the liquid to enter the syringe until the prescribed amount of diluent has been drawn into the syringe. Without withdrawing the needle, tap the syringe gently so that any air bubbles trapped in the syringe rise toward the top of the syringe. If air bubbles appear, depress the plunger gently to force the air bubbles out (into the vial) and then withdraw enough additional diluent to restore the needed volume in the syringe. (Holding the syringe-vial as a unit in a vertical position and keeping the needle tip in the fluid while withdrawing the diluent may help minimize the amount of air drawn into the syringe.) Once the required volume has been drawn into the syringe, let the syringe-vial pressure equalize and slowly withdraw the needle from the vial.
  • To reconstitute the epoprostenol:
  • Insert the same needle through the rubber seal of the vial of epoprostenol and inject the sterile diluent gently onto the side of the vial. The flow of the sterile diluent should be directed toward the side of the vial and injected slowly in order to prevent the medicine from foaming. Once the pressure has equalized, withdraw the needle from the vial. Gently swirl the vial to mix the epoprostenol. Turn the vial upside down to catch any undissolved powder near the top of the vial. Never shake the vials. Repeat this process if you need to mix more than one vial of epoprostenol.
  • To draw out the reconstituted epoprostenol:
  • Wipe the top of the reconstituted epoprostenol vial with an alcohol swab and let it dry. Change the needle on the syringe and then gently pull back the syringe plunger and fill the syringe with the amount of air that is equal to the amount of reconstituted epoprostenol you have been instructed to withdraw. Insert the needle through the seal of the vial and inject the air into the vial. Be sure to keep the needle tip below the fluid line and then pull the plunger back gently to withdraw the reconstituted epoprostenol into the syringe. Remove any air that may be trapped in the syringe as described above. Withdraw the needle and replace the needle cap on the syringe.
  • To inject the reconstituted epoprostenol into the cassette:
  • Remove the end cap from the cassette tubing. Carefully remove the needle from the syringe (be sure to discard the needle in an appropriate manner) and attach the syringe to the cassette tubing. Hold the cassette in one hand and push the plunger to inject the reconstituted solution into the cassette (alternatively, you may find it useful to use a tabletop or other solid structure to steady the plunger while pushing down on the syringe to inject the solution). When the syringe is empty, clamp the cassette tubing near the syringe. Disconnect the syringe and replace the cassette tubing end cap.
  • To inject the remaining diluent into the partially filled cassette
  • Using a 60 mL syringe, attach a new needle to the syringe and follow the above procedures for breaking the syringe seal and wiping the tops of the sterile diluent vials. Fill the syringe with the amount of air that is equal to the amount of sterile diluent you will remove from the first vial. Insert the needle through the rubber seal and slowly inject some of the air into the vial, allowing the fluid to flow into the syringe. Continue to push air gently into the vial until all of the fluid in the vial has flowed into the syringe. Remove any air that may be in the syringe as described above. Allow the pressure to equalize before you pull the needle out or you may lose fluid from the syringe. (If this occurs, the whole process needs to be repeated.) Withdraw the needle and replace the needle cap on the syringe. You may find it easier to hold the larger syringe in an upside down, vertical position while withdrawing the fluid in the vial.
  • To inject the sterile diluent into the cassette:
  • Uncap the clamped cassette tube and carefully remove the needle from the syringe (discarding the needle in an appropriate manner). Attach the syringe to the cassette tubing. Unclamp the cassette tubing and carefully inject the solution into the cassette. When the syringe is empty, clamp the cassette tube near the syringe and disconnect the syringe. Replace the cap on the cassette tube. If more diluent is needed to fill the cassette, repeat steps 6 and 7 with an additional vial of diluent; however, after completing the transfer of all of the required diluent, clamp the tubing, but leave the syringe attached to the cassette tubing while you mix the solution. Gently turn the cassette upside down at least 10 times to thoroughly mix the reconstituted epoprostenol with the additional diluent.
  • To remove air from the cassette:
  • To remove the air from inside the cassette, slowly turn the cassette until all of the small bubbles of air join to form one air pocket. Tilt the cassette gently so that the air pocket is in the corner where the tubing connects to the cassette. Unclamp the tube and pull back the plunger of the syringe until you see fluid fill the tubing. Clamp the tube near the connector and remove the syringe and replace the cap on the tubing. Label the cassette with the current time and date. Store the cassette in the refrigerator (preferably, on the top shelf to avoid spilling any food or drink on it) until it is time to use it. Make up a new cassette each day and use the cassette you refrigerated the day before so that you will always have a back-up cassette.
  • To use the pump:
  • The instructions for the use of the pump may vary depending on the particular make and model of the pump. Your doctor or nurse will give detailed instructions on how to use and care for the particular pump and accessories that you will use for administering your medicine. These instructions should include how to change the pump battery, cassette, and tubing. Remember to change the gel packs every 12 hours or every 8 hours if the surrounding temperature approaches 86 °F.
  • Maintain sterile technique at all times. If you suspect that you have contaminated anything, throw away the accessories and begin again.

During use, the mixed solution can be administered by the pump at room temperature for up to 24 hours if you mixed the entire vial with the 5 milliliter solution provided. If you are using a lower concentration, the mixture is only good for 12 hours. Protect the solution from direct sunlight.

Ask your doctor who to call if you have any problems with the infusion pump. You may be given a second infusion pump to have in case the first pump stops working. Make sure you have access to this pump as a backup at all times.

You will need to continue using this medicine for a long period of time, possibly for many years. Talk with your doctor if you have any concerns about this.

The amount of medicine that you take depends on the concentration of the reconstituted medicine and the rate at which the infusion pump delivers the medicine.

Look at the liquid in the vial (glass container). If the liquid has solid pieces or specks in it or if the liquid has changed color, do not use the vial.

Use only the supplies provided in the medication kit to inject Flolan®. The mixed medicine must be injected using the provided infusion tubing, which has a filter to remove any solid pieces or specks (eg, glass particles) in the liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form (solution):
    • For primary pulmonary hypertension and pulmonary hypertension secondary to scleroderma spectrum of disease:
      • Adults—Dose is based on body weight and must be determined by your doctor. The initial dose is usually 2 nanograms (ng) per kilogram (kg) (0.9 nanogram per pound) of body weight per minute. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine vial in the original carton at room temperature. Keep the carton away from heat, moisture, and direct light. Do not freeze.

Store the mixed solution in the refrigerator for 5 days, away from direct light. Keep the medicine from freezing. Any medicine that has been frozen should be thrown away. Mixed solutions can be stored at room temperature (up to 25 degrees C) for no more than 48 hours. Discard the mixed solution if it is kept in the refrigerator for more than 5 days or at room temperature for more than 48 hours.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

Precautions While Using Flolan

It is important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly and to change the dosage if needed.

Report any signs of infection or reaction at the catheter site to your doctor right away. Also, if you develop a sudden fever, contact your doctor as soon as possible.

Prepare this medicine exactly as directed. Do not add anything or use any substitutions when mixing the solution.

This medicine may cause your blood pressure to decrease, which can cause dizziness, lightheadedness, or fainting.

Do not suddenly stop using this medicine. Stopping or changing the dose of this medicine suddenly may bring on symptoms of your condition and can be dangerous. Check with your doctor before stopping or changing your dose.

Your doctor may want you to carry a medical identification card stating that you are using this medicine.

Flolan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Abdominal or stomach pain
  • arm, back, or jaw pain
  • bladder pain
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • changes in skin color
  • chest congestion
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • cold hands and feet
  • confusion
  • constipation
  • convulsions
  • cough or hoarseness
  • coughing up blood
  • decreased urine
  • depression
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with breathing or swallowing
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • extreme fatigue
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • fever
  • headache
  • incoherent speech
  • increased menstrual flow or vaginal bleeding
  • increased thirst
  • increased urination
  • local infection at the catheter site
  • loss of appetite
  • metallic taste
  • muscle pain or cramps
  • muscle weakness
  • nausea or vomiting
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • pain at the injection site
  • pain, redness, or swelling in the arm or leg
  • paleness of the skin
  • prolonged bleeding from cuts
  • rapid weight gain
  • red or black, tarry stools
  • redness of the face, neck, arms, and occasionally, upper chest
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • tightness in the chest
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • weight gain or loss
Less common
  • Altered or abnormal touch sensation or sensitivity
  • blue lips and fingernails
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • coughing that sometimes produces a pink frothy sputum
  • difficult, fast, or noisy breathing
  • inability to speak
  • increased sweating
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the arms, jaw, back, or neck
  • seizures
  • severe or sudden headache
  • severe pain in the chest
  • slurred speech
  • sudden onset of severe breathing
  • temporary blindness
  • weakness in the arm or leg on one side of the body, sudden and severe
  • weakness or heaviness of the legs
Incidence not known
  • Feeling of fullness
  • high fever
  • pinpoint red spots on the skin
  • sensitivity to heat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • trouble sleeping
  • troubled breathing with exertion

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Change in vision
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • heartburn
  • hives or welts
  • impaired vision
  • itching
  • joint pain
  • lack of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • muscle pains or stiffness
  • redness of the skin
  • shakiness in the legs, arms, hands, or feet
  • skin rash, encrusted, scaly and oozing
  • sores on the skin
  • swollen joints
  • tiredness
  • trembling or shaking of the hands or feet
  • trouble concentrating
Less common
  • Acid or sour stomach
  • belching
  • blurred vision or other changes in vision
  • excess air or gas in the stomach or intestines
  • indigestion
  • leg cramps
  • passing gas
  • sleepiness or unusual drowsiness
  • stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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