Products

REMODULIN® (treprostinil) Injection

Indication

REMODULIN is indicated for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. 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:

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 REMODULIN dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.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 more information about REMODULIN, please see the Full Prescribing Information. Questions? Call the Customer Service Line at 877-UNITHER (877-864-8437).

TYVASO® (treprostinil) Inhalation Solution

Indication

TYVASO is indicated to increase walk distance in patients with WHO Group I pulmonary arterial hypertension and NYHA Class III symptoms. The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.

Important Safety Information:

• TYVASO is intended for oral inhalation only. TYVASO is approved for use only with the TYVASO Inhalation System.
• The safety and efficacy of TYVASO have not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age. Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and loss of drug effect. TYVASO may increase the risk of bleeding, particularly in patients receiving anticoagulants.
• In patients with low systemic arterial pressure, TYVASO may cause symptomatic hypotension. The concomitant use of TYVASO with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
• Hepatic or renal insufficiency may increase exposure to TYVASO and decrease tolerability. TYVASO dosage adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn.
• The most common adverse events seen with TYVASO in ? 4% of PAH patients and more than 3% greater than placebo in the placebo-controlled clinical study were cough (54% vs 29%), headache 41% vs. 23%), throat irritation/pharyngolaryngeal pain (25% vs. 14%), nausea (19% vs. 11%), flushing (15% vs. <1%), and syncope (6% vs. <1%). TYVASO should be used in pregnancy only if clearly needed. Caution should be exercised when TYVASO is administered to nursing women.

For more information about TYVASO, please see the Full Prescribing Information, Patient Package Insert and the TYVASO Inhalation System Instructions for Use manual. Questions? Call the Customer Service Line at 877-UNITHER (877-864-8437).

ADCIRCA® (tadalafil) Tablets

Indication

Adcirca is a prescription medication used to treat pulmonary arterial hypertension (WHO Group 1) to improve exercise ability.

Important Safety Information:

• 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, visit www.ADCIRCA.com, or call 1-800-545-5979.