Indication

ADCIRCA (tadalafil) is a prescription medication used to treat pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

Important Safety Considerations for ADCIRCA (tadalafil)

You should discuss all of your medical conditions and all medications with your healthcare provider before starting ADCIRCA

Do not take ADCIRCA if you take any medications that contain nitrates (often used for chest pain) or guanylate cyclase stimulators, as the combination could cause a sudden, unsafe drop in blood pressure

Do not take ADCIRCA if you are allergic to tadalafil or any other ingredient in ADCIRCA

ADCIRCA is a type of medication called a phosphodiesterase 5 inhibitor (PDE-5i) that can cause blood vessels to widen, which may result in a decrease in blood pressure. If you have heart-disease or any problems with low blood pressure, tell your healthcare provider before taking ADCIRCA, as these conditions may be affected by the action of ADCIRCA

Talk with your healthcare provider if you are pregnant or planning to become pregnant or if you are breastfeeding or plan to breast feed.

If you have ever had blockage in the veins of your lungs, known as pulmonary veno-occlusive disease (PVOD), ADCIRCA is not recommended for you

Taking ADCIRCA with alcohol, or blood pressure medications, such as alpha-blockers, may lower blood pressure and cause hypotension (light-headedness or fainting)

Do not take ADCIRCA if you are taking rifampin (an antibiotic for certain bacterial infections), or antifungal medications, such as ketoconazole and itraconazole. If you require treatment with both ADCIRCA and ritonavir (Norvir®) at the same time, your dose of ADCIRCA will need to be adjusted. Inform your healthcare provider if you have kidney or liver problems before taking ADCIRCA

ADCIRCA contains the same ingredient (tadalafil) as Cialis®, which is used to treat erectile dysfunction (ED, impotence) and the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). If you are taking ADCIRCA, do not take Cialis or other PDE-5is

In rare cases, patients reported side effects such as decreased eyesight or loss of vision in one or both eyes (NAION), or sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you experience any of these side effects after taking ADCIRCA, seek medical attention right away

In rare cases, men taking PDE-5is (including tadalafil) for erectile dysfunction reported side effects such as an erection lasting more than four hours. If you experience a prolonged erection, seek medical attention right away

The most common side effects of ADCIRCA are headache, muscle pain, getting red or hot in the face (flushing), nausea, pain in the arms, legs or back, upset stomach, stuffy or congested nose

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Important Safety Information for Orenitram

Who should not take Orenitram?

Do not take Orenitram if you have severe liver problems.

What should I tell my healthcare provider before taking Orenitram?

Tell your healthcare provider:

• If you have liver problems or diverticulosis.
• If you are pregnant, breastfeeding, and/or plan to become pregnant or breastfeed. It is not known if Orenitram will harm your unborn baby or if Orenitram passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Orenitram.
• About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orenitram and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your healthcare provider. Especially tell your healthcare provider if you take another medicine that contains treprostinil, such as Remodulin^® or Tyvaso^®.

How should I take Orenitram?

• Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider.
• Orenitram is usually taken 3 times a day (about every 8 hours) or 2 times a day (about every 12 hours). Your healthcare provider will tell you how often you should take Orenitram. If you have side effects, your healthcare provider may tell you to change your dose or when you take Orenitram. Take Orenitram with food.
• Swallow Orenitram tablets whole. Do not split, chew, crush, or break your Orenitram tablets. Do not take Orenitram tablets that are damaged or broken. If Orenitram tablets are not taken whole, they may release too much medicine at one time. This can lead to side effects.
• If you miss your dose of Orenitram, take the missed dose as soon as possible with food.
• If you miss 2 or more doses of Orenitram, call your healthcare provider to see if you need to change your dose.
• If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away.
• You may see the tablet shell in your stools (bowel movements). This is usually normal. The tablet shell is not digested. If you have diverticulosis, the tablet shell may get stuck in a blind pouch or diverticulum in your intestine.

What are the possible side effects of Orenitram?

Orenitram can cause serious side effects, including worsening of PAH symptoms.

• Stopping Orenitram suddenly may cause worsening of your PAH symptoms. Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider.
• The most common side effects of Orenitram include headache, diarrhea, nausea, vomiting, flushing, and pain in arms, legs, and jaw. These are not all of the possible side effects of Orenitram. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
• Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

What is Orenitram?

Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs. Orenitram can help slow down the progression of your disease and improve your ability to exercise. It is not known if Orenitram is safe and effective in children.

The risk information provided here is not comprehensive. To learn more about Orenitram, talk with your healthcare provider. Please see Full Prescribing Information and Patient Information at www.orenitram.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).

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What is Remodulin?

Remodulin is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. Remodulin can reduce symptoms associated with exercise. Remodulin was studied mainly in patients with NYHA Functional Class II-IV symptoms. It is not known if Remodulin is safe and effective in children.

In people with PAH who need to switch from epoprostenol, Remodulin is approved to slow the worsening of symptoms.

Important Safety Information for Remodulin

Before you take Remodulin, tell your healthcare provider if you:

• Have other medical conditions or take other medicines that may affect your use of Remodulin by increasing the risk of side effects or decreasing the drug’s effectiveness.
• Have liver or kidney problems. Your Remodulin dose may need to be adjusted if you have liver problems.
• Have low blood pressure or bleeding problems.
• Are taking gemfibrozil (for high cholesterol), rifampin (for infection) or other drugs that affect liver enzymes. Your doctor may need to adjust your Remodulin dosage.
• Are pregnant, breastfeeding, or planning to become pregnant. It is not known if Remodulin will harm your unborn baby or if Remodulin passes into your breast milk.

What are the serious side effects of Remodulin?

• Continuous intravenous (IV) infusions of Remodulin delivered using an external infusion pump, with a tube placed in a central vein within the chest, are associated with the risk of blood stream infections and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion delivered just beneath the skin is the preferred type of delivery.
• Worsening of PAH symptoms. Do not stop taking or greatly reduce your Remodulin dose without consulting your doctor.
• Low blood pressure (symptomatic hypotension). If you have low blood pressure or are taking drugs that lower your blood pressure, the risk of low blood pressure is increased.
• Bleeding problems. Remodulin may increase the risk of bleeding in people who take blood thinners (anticoagulants).

What are the possible side effects of Remodulin?

• In clinical studies of SC infusion of Remodulin, most people experienced infusion site pain and infusion site reaction (redness, swelling, and rash). These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin.
• IV infusion of Remodulin delivered through an external pump has been associated with the risk of blood stream infections, arm swelling, tingling sensations, bruising, and pain.
• The most common side effects seen with either SC or IV Remodulin were headache, diarrhea, nausea, rash, jaw pain, widening of the blood vessels (vasodilatation), and swelling from fluid retention (edema). These are not all the possible side effects of Remodulin. Call your doctor for medical advice about side effects.

For more information about REMODULIN, please visit www.remodulin.com

What are TYVASO and TYVASO DPI?

TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines used in adults to treat:

• Pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. TYVASO or TYVASO DPI can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO or TYVASO DPI. It is not known if TYVASO or TYVASO DPI is safe and effective in children under 18 years of age.
• Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), which is high blood pressure in the lungs due to inflammation and sometimes scarring in the lungs. TYVASO or TYVASO DPI can improve the ability to exercise.

IMPORTANT SAFETY INFORMATION

Before you take TYVASO or TYVASO DPI, tell your healthcare provider about all of your medical conditions, including if you:

• Have low blood pressure
• Have or have had bleeding problems
• Have asthma or chronic obstructive pulmonary disease (COPD)
•  Are pregnant or plan to become pregnant. It is not known if either product will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if either product passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Either product and other medicines may affect each other.

Especially tell your healthcare provider if you take:

• Medicines used to treat high blood pressure or heart disease
• Medicines that decrease blood clotting (anticoagulants)
• Water pills (diuretics)
• Gemfibrozil (Lopid^®) or rifampin (Rimactane^®, Rifadin^®, Rifamate^®, Rifater^®)

What are the possible side effects of TYVASO or TYVASO DPI?

Both products can cause serious side effects, including:

• Low blood pressure (symptomatic hypotension).If you have low blood pressure, either product may lower your blood pressure more.
• Bleeding problems. Either product may increase the risk of bleeding, especially in people who take blood thinners (anticoagulants).

The most common side effects of both products are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, diarrhea, and shortness of breath. Like other inhaled prostaglandins, you may have trouble breathing after taking TYVASO or TYVASO DPI because it may cause the muscles around your airway to tighten (bronchospasm). These are not all the possible side effects. Call your doctor for medical advice about side effects or if you have trouble breathing.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive. To learn more about TYVASO or TYVASO DPI, talk with your healthcare provider. Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO^® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at www.tyvaso.com or call 1-877-UNITHER (1-877-864-8437).

What are TYVASO and TYVASO DPI?

TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines used in adults to treat:

• Pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. TYVASO or TYVASO DPI can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO or TYVASO DPI. It is not known if TYVASO or TYVASO DPI is safe and effective in children under 18 years of age.
• Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), which is high blood pressure in the lungs due to inflammation and sometimes scarring in the lungs. TYVASO or TYVASO DPI can improve the ability to exercise.

IMPORTANT SAFETY INFORMATION

Before you take TYVASO or TYVASO DPI, tell your healthcare provider about all of your medical conditions, including if you:

• Have low blood pressure
• Have or have had bleeding problems
• Have asthma or chronic obstructive pulmonary disease (COPD)
•  Are pregnant or plan to become pregnant. It is not known if either product will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if either product passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Either product and other medicines may affect each other.

Especially tell your healthcare provider if you take:

• Medicines used to treat high blood pressure or heart disease
• Medicines that decrease blood clotting (anticoagulants)
• Water pills (diuretics)
• Gemfibrozil (Lopid^®) or rifampin (Rimactane^®, Rifadin^®, Rifamate^®, Rifater^®)

What are the possible side effects of TYVASO or TYVASO DPI?

Both products can cause serious side effects, including:

• Low blood pressure (symptomatic hypotension).If you have low blood pressure, either product may lower your blood pressure more.
• Bleeding problems. Either product may increase the risk of bleeding, especially in people who take blood thinners (anticoagulants).

The most common side effects of both products are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, diarrhea, and shortness of breath. Like other inhaled prostaglandins, you may have trouble breathing after taking TYVASO or TYVASO DPI because it may cause the muscles around your airway to tighten (bronchospasm). These are not all the possible side effects. Call your doctor for medical advice about side effects or if you have trouble breathing.

You may report side effects to the FDA at www.fda.gov/MedWatch or call 1-800-FDA-1088.

The risk information provided here is not comprehensive. To learn more about TYVASO or TYVASO DPI, talk with your healthcare provider. Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO^® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at www.tyvaso.com or call 1-877-UNITHER (1-877-864-8437).