Adcirca^® (tadalafil) Tablets

INDICATION

Adcirca is a prescription medication used for the treatment of 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 INFORMATION for Adcirca

• You should discuss all of your medical conditions and all medications with your doctor before starting Adcirca.
• Do not take Adcirca if you take any medications that contain nitrates (often used for chest pain), 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.
• If you experience chest pain after taking Adcirca, contact your doctor.
• Adcirca is a type of medication called a phosphodiesterase type 5 (PDE5) inhibitor. PDE5 inhibitors 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 doctor before taking Adcirca, as these conditions may be affected by the action of Adcirca.
• 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 (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 doctor 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 (impotence). If you are taking Adcirca, do not take Cialis or other PDE5 inhibitors.
• In rare cases, men taking PDE5 inhibitors (including tadalafil) for erectile dysfunction reported side effects such as a sudden decrease or loss of vision or hearing, or an erection lasting more than four hours. If you experience any of these side effects, 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.

For more information about Adcirca, please see the Full Prescribing Information and Patient Information, visit http://www.ADCIRCA.com, or call 1-800-545-5979.

Remodulin^® (treprostinil) Injection

INDICATION

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.

In patients with PAH requiring transition from Flolan^® (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

IMPORTANT SAFETY INFORMATION for Remodulin

• Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion is the preferred mode of administration.
• Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH.
• Remodulin is a potent pulmonary and systemic vasodilator. It lowers blood pressure, which may be further lowered by other drugs that also reduce blood pressure.
• Remodulin inhibits platelet aggregation and therefore, may increase the risk of bleeding, particularly in patients on anticoagulants.
• Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.
• Initiation of Remodulin must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care.
• Therapy with Remodulin may be used for prolonged periods, and the patient’s ability to administer Remodulin and care for an infusion system should be carefully considered.
• Remodulin dosage should be increased for lack of improvement in, or worsening of, symptoms and it should be decreased for excessive pharmacologic effects or for unacceptable infusion site symptoms.
• Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of PAH symptoms and should be avoided.
• Caution should be used in patients with hepatic or renal insufficiency.
• The most common side effects of Remodulin included those related to the method of infusion. For subcutaneous infusion, infusion site pain and infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment with narcotics or discontinuation of Remodulin. For intravenous infusion, line infections, sepsis, arm swelling, tingling sensations, bruising, and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilatation and edema.

For additional information about Remodulin, please see the Full Prescribing Information, visit http://www.REMODULIN.com, or call 1-877-864-8437.

Tyvaso^® (treprostinil) Inhalation Solution

INDICATION

Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH) (WHO Group 1), which is high blood pressure in the arteries of your lungs. Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase-5 inhibitor). The effects decrease over 4 hours; treatment timing can be adjusted for planned activities.

Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

IMPORTANT SAFETY INFORMATION for Tyvaso

• Tyvaso is breathed in (inhaled) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System.
• The effects of Tyvaso are unknown in patients with lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age.
• If you have low blood pressure, tyvaso may cause symptomatic hypotension (low blood pressure).
• Because Tyvaso reduces the ability of your blood to clot (coagulate), it may increase your risk for bleeding if you are taking blood thinners (anticoagulants), such as warfarin or heparin.
• The use of Tyvaso with diuretics (water pills), antihypertensives (medications used to treat high blood pressure or heart disease), or other vasodilators (medications that lower blood pressure) may increase your risk for hypotension (low blood pressure).

Other medical conditions and medicines may affect your use of Tyvaso by increasing the risk of side effects or decreasing effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking, including:

• If you are taking gemfibrozil (for high cholesterol) or rifampin (for infection), your Tyvaso dosage may need adjustment.
• If you have liver or kidney problems, your ability to tolerate Tyvaso may be affected.
• If you are pregnant, breast-feeding, or planning to become pregnant, talk with your healthcare provider about whether you should take Tyvaso.

The most common side effects of Tyvaso are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), and fainting or loss of consciousness. These are not all the possible side effects of Tyvaso. Tell your doctor about any side effects that bother you or do not go away. Your doctor may be able to help you manage the side effects.

For additional information about Tyvaso, please see the Full Prescribing Information, Patient Package Insert, and the Tyvaso Inhalation System Instructions for Use manual, visit http://www.TYVASO.com, or call 1-877-864-8437.