Epoprostenol Sodium Solution for injection

What is this medicine?

EPOPROSTENOL (e poe PROST en ole) is used to treat primary pulmonary hypertension.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart failure

• low blood pressure

• an unusual or allergic reaction to epoprostenol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast feeding

How should I use this medicine?

This medicine is for infusion into a vein at home using a portable infusion pump. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take it more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Do not stop the infusion for any reason without contacting your doctor or health care professional. Even short periods of time without this medicine may make your condition much worse.

What may interact with this medicine?

• diuretics

• medicines for chest pain

• medicines for blood pressure

• medicines that treat or prevent blood clots like warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Report any unusual or severe side effects promptly.

While you are receiving this medicine, you may be more susceptible to infection because of your intravenous catheter. Unfortunately, symptoms of infection can be similar to some of the side effects of this medicine, such as fever, chills or other 'flu-like' symptoms. Contact your doctor or health care professional if you experience any unusual symptoms. Inspect the area around your catheter frequently. Alert your doctor or health care professional if there is any unusual redness or pain.

Despite receiving this medicine, your condition may worsen and you may need your dose adjusted. Call your doctor or health care professional if your condition gets worse.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• chills or sweating

• feeling faint or lightheaded, falls

• fever

• pain at site where injected

• pain, tingling, numbness in the hands or feet

• slow, fast, or irregular heart beat

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• flushing

• headache

• jaw pain

• nausea, vomiting

• nervousness, anxiety, or agitation

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store unopened vials of this medicine at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Protect from light. Store unopened vials of the sterile diluent at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medicine after the expiration date.

After mixing the injection solution, store in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F) for a total of 48 hours. The solution can be used at room temperature between 15 and 25 degrees C (59 and 77 degrees F) for only 8 hours after having been in the refrigerator for up to 40 hours.

You may also use 2 frozen 6-oz gel packs in a cold pouch to cool the solution while it is infusing, but you must change the gel pack every 12 hours. If you use the cold packs, the solutions can be infused for up to 24 hours, after having been in the refrigerator for up to 24 hours.