Remodulin is an injectable medication containing treprostinil, a prostacyclin mimetic, for subcutaneous or intravenous use. It is available in multiple dosage strengths ranging from 2 mg (0.1 mg/mL) to 400 mg (20 mg/mL) in 20-mL multidose vials. The key inactive ingredients include sodium chloride, metacresol, and sodium citrate dihydrate, with pH adjustments made using sodium hydroxide or hydrochloric acid. Remodulin is intended for use in treating conditions related to prostacyclin mimetic activity.

How should I use this medication?

This medication is for infusion under your skin or into a vein via a catheter attached to a portable infusion pump. You will be taught how to prepare and give this medication. Use exactly as directed. Take your medication at regular intervals. Do not take your medication 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 care team to get one.

Talk to your care team about the use of this medication 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?

This medication is given as a continuous infusion, which means that a pump will always be infusing the medication. It is recommended that you have a second pump and start a new infusion at a different site when your first pump is close to running out. Do not stop the infusion for any reason without contacting your care team. Stopping this medication may make your condition much worse.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store unopened vials between 15 and 25 degrees C (59 and 77 degrees F). Do not open the vial until you are ready to use it. Throw the opened vial away after 30 days. Get rid of any unopened vials or unused medication after the expiration date.

If you are using a subcutaneous (under the skin) pump or intravenous (into a vein) pump, you will be instructed on how to store this medication.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacist or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Stomach pain, unusual weakness or fatigue, nausea, vomiting, diarrhea, or fever that lasts longer than expected

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

• Diarrhea
• Facial flushing, redness
• Headache
• Pain, redness, or irritation at injection site
• Swelling of the ankles, hands, or feet

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.

What should I tell my care team before I take this medication?

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

• Kidney disease
• Liver disease
• An unusual or allergic reaction to treprostinil, epoprostenol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Certain medications for blood pressure
• Certain medications that treat or prevent blood clots, such as warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• Diuretics
• Gemfibrozil
• Rifampin

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 medication?

Visit your care team for regular checks on your progress. You will need to be seen regularly. Report any unusual or severe side effects immediately. If you are having trouble inserting your catheter or using the pump, contact your care team.

Inspect the area around your catheter frequently. Alert your care team if there is any unusual redness, pain, or discharge.

Despite receiving this medication, your condition may worsen, and you may need your dose adjusted. Call your care team if your condition gets worse.