Treprostinil Nebulizer solution

What is this medicine?

TREPROSTINIL is used to treat pulmonary arterial hypertension. This medicine helps to improve exercise ability 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
• low blood pressure
• lung infection
• lung or breathing disease, like asthma or COPD
• 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 used in the Tyvaso Inhalation System. It is inhaled through your mouth into your lungs. Follow the detailed Tyvaso Inhalation System Instructions for Use. Follow the directions on your prescription label. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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

Overdosage: If you think you've 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?

If you miss a dose, take it as soon as you can. Do not take double or extra doses.

What may interact with this medicine?

• diuretics
• gemfibrozil
• medicines for chest pain
• medicines for high blood pressure
• medicines that treat or prevent blood clots like warfarin
• 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 medicine?

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

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.

Do not let this medicine get into your eyes or onto your skin. If it does, rinse your skin or eyes right away with water.

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
• feeling faint or lightheaded, falls
• unusual bleeding or bruising

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

• cough
• flushing
• headache
• nausea
• sore throat

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 the unopened foil pouch at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Once the foil pouch is opened, ampules should be used within 7 days. Keep unopened ampules in the foil pouch to protect them from light. Once the medicine is put into the medicine cup of the Tyvaso Inhalation System, it should stay in the device for no more than 24 hours. Discard any unused medicine at the end of the day. Throw away any unused medicine after the expiration date.

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.