Treprostinil Sodium Solution for injection

What is this medicine?

TREPROSTINIL is used to treat pulmonary arterial hypertension. This medicine helps to improve symptoms and quality of life.

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:

• kidney disease
• liver disease
• an unusual or allergic reaction to treprostinil, 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 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 medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine 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?

This medicine is given as a constant infusion, which means that a pump will always be injecting the drug. 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 doctor or health care professional. Stopping this medicine may make your condition much worse.

What may interact with this medicine?

• diuretics
• medicines for chest pain
• medicines for high 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 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 health care provider.

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

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
• bruising, pain, or swelling at site where injected
• chest pain
• fast, irregular, or slow heartbeat
• feeling faint or lightheaded, falls
• fever or chills
• pain, tingling, numbness in the hands or feet
• 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):

• bone or jaw pain
• diarrhea
• flushing
• headache
• nausea, vomiting

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 between 15 and 25 degrees C (59 and 77 degrees F). A vial of medicine should be used no more than 30 days after the initial puncture into the vial. Throw away any unused medicine after the expiration date.

During use of the subcutaneous pump (under the skin), a single syringe of medicine can be used for up to 72 hours at 37 degrees C (98.6 degrees F). Throw away any unused medicine after 72 hours.

During use of the intravenous pump (into the vein), this medicine can be used for up to 48 hours at 37 degrees C (98.6 degrees F ). Throw away any unused medicine after 48 hours.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.