Treprostinil Dry Powder Inhaler (DPI)

What is this medication?

TREPROSTINIL (tre PROST in il) treats pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It works by relaxing the blood vessels and lowering the blood pressure in the lungs, which makes it easier for the heart to pump blood to the rest of the body. It can help you breathe easier and be more active.

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

COMMON BRAND NAME(S): TYVASO DPI

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

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

• Liver disease
• Low blood pressure
• Lung or breathing disease (asthma, COPD)
• Wheezing (trouble breathing with loud or whistling sounds)
• An unusual or allergic reaction to treprostinil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is inhaled through the mouth. Take it as directed on the prescription label. Treatment sessions should be about 4 hours apart. Do not use it more often than directed. Keep taking it unless your care team tells you to stop.

This medication must only be used in the Tyvaso DPI Inhaler. Replace the inhaler device every 7 days.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

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?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Certain medications for high blood pressure or heart disease
• 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. Tell your care team if your symptoms do not start to get better or if they get worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or site up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

This medicine may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional 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
• Wheezing or trouble breathing

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

• Cough
• Diarrhea
• Facial flushing, redness
• Headache
• Irritation inside the nose or throat
• 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 medication?

Keep out of the reach of children and pets.

Refrigeration (unopened blister cards or strips): Store in the refrigerator. Do not freeze. Get rid of any unused medication after the expiration date. Remove from the refrigerator 10 minutes before use.

Room temperature: Unopened blister cards or strips may be stored at room temperature between 20 and 25 degrees C (68 and 77 degrees F) for up to 5 weeks. Opened blister strips must be used within 3 days. Do not store opened blister cards or strips in the refrigerator.

Inhaler: The inhaler may be stored at room temperature or in the refrigerator. Remove the inhaler from the refrigerator 10 minutes before use. The inhaler may be used for up to 7 days. After 7 days of use, throw away the inhaler and replace with a new inhaler.

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 pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.