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ADCIRCA is a phosphodiesterase 5 inhibitor (PDE-5i) indicated 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%).
For U.S. Healthcare Professionals Only

About ADCIRCA

ADCIRCA is the only PDE-5 inhibitor for PAH with once-daily dosing1

  • 40 mg once-daily starting and maintenance dose for most patients1
    • Tadalafil is metabolized predominately by CYP3A in the liver. Use of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on ADCIRCA therapy that require treatment with ritonavir, ADCIRCA should be discontinued at least 24 hours prior to starting ritonavir. For patients on ritonavir therapy that require treatment with ADCIRCA, start ADCIRCA at 20 mg once a day. Use of ADCIRCA with potent inducers of CYP3A, such as rifampin, should be avoided The use of ADCIRCA is not recommended for patients with severe renal or hepatic impairment. For patients with mild or moderate hepatic or renal impairment, dose adjustment is required. The starting dose of ADCIRCA should be 20 mg daily
  • 35-hour half-life in patients with PAH not receiving concomitant bosentan1
  • Steady-state plasma concentrations were attained within 5 days in patients with PAH1

ADCIRCA is available through retail and the following specialty pharmacy service providers

Important Safety Information

CONTRAINDICATIONS

  • Nitrates: ADCIRCA should not be used in patients taking medicines that contain nitrates, as the combination could cause a sudden, unsafe drop in blood pressure
  • Hypersensitivity Reactions: Patients with a known serious hypersensitivity to tadalafil should not take ADCIRCA

WARNINGS AND PRECAUTIONS

  • Cardiovascular: Patients who experience anginal chest pain after taking ADCIRCA should seek immediate medical attention
  • Cardiovascular: Phosphodiesterase 5 inhibitors (PDE-5is), including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such actions. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and administration of ADCIRCA to these patients is not recommended
  • Cardiovascular: The use of ADCIRCA with alpha blockers, blood pressure medications, or alcohol may lower blood pressure significantly and may lead to symptomatic hypotension (light-headedness or fainting)
  • Potential Drug Interactions: Tadalafil is metabolized predominantly by CYP3A in the liver. Use of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on ADCIRCA therapy that require treatment with ritonavir, ADCIRCA should be discontinued at least 24 hours prior to starting ritonavir. For patients on ritonavir therapy that require treatment with ADCIRCA, start ADCIRCA at 20 mg once a day. Use of ADCIRCA with potent inducers of CYP3A, such as rifampin, should be avoided
  • Special Populations: The use of ADCIRCA is not recommended for patients with severe renal or hepatic impairment. Please see Full Prescribing Information for dosing recommendations for patients with mild to moderate renal or hepatic impairment
  • Potential Drug Interactions: ADCIRCA contains the same ingredient (tadalafil) as Cialis®, which is used to treat erectile dysfunction (ED). The safety and efficacy of combinations of ADCIRCA with Cialis or other PDE-5is have not been studied. Therefore, the use of such combinations is not recommended
  • Vision/Hearing: In rare instances, men taking PDE-5is (including tadalafil) for ED reported a sudden decrease or loss of vision or hearing, or an erection lasting more than four hours. A patient who experiences any of these symptoms should seek immediate medical attention

ADVERSE REACTIONS

  • Adverse Reactions: The most common adverse event with ADCIRCA is headache (42% ADCIRCA vs 15% placebo). Other common adverse events (reported by ≥9% of patients on ADCIRCA and more frequent than placebo by 2%) include myalgia (14% vs 4%), nasopharyngitis (13% vs 7%), flushing (13% vs 2%), respiratory tract infection (13% vs 6%), extremity pain (11% vs 2%), nausea (11% vs 6%), back pain (10% vs 6%), dyspepsia (10% vs 2%), and nasal congestion (9% vs 1%)

For more information about ADCIRCA, please see the Full Prescribing Information and
Patient Information or call 1-800-545-5979.

Reference:

  • ADCIRCA [package insert]. Indianapolis, IN: Eli Lilly and Company; 2011.
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© 2011 Lung Rx, LLC. All rights reserved. ADCIRCA and Cialis are registered trademarks of Eli Lilly and Company, 2011. ADC_WEB_AUG11v.8

Important Safety Information

CONTRAINDICATIONS

  • Nitrates: ADCIRCA should not be used in patients taking medicines that contain nitrates, as the combination could cause a sudden, unsafe drop in blood pressure
  • Hypersensitivity Reactions: Patients with a known serious hypersensitivity to tadalafil should not take ADCIRCA

WARNINGS AND PRECAUTIONS

  • Cardiovascular: Patients who experience anginal chest pain after taking ADCIRCA should seek immediate medical attention
  • Cardiovascular: Phosphodiesterase 5 inhibitors (PDE-5is), including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such actions. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and administration of ADCIRCA to these patients is not recommended
  • Cardiovascular: The use of ADCIRCA with alpha blockers, blood pressure medications, or alcohol may lower blood pressure significantly and may lead to symptomatic hypotension (light-headedness or fainting)
  • Potential Drug Interactions: Tadalafil is metabolized predominately by CYP3A in the liver. Use of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on ADCIRCA therapy that require treatment with ritonavir, ADCIRCA should be discontinued at least 24 hours prior to starting ritonavir. For patients on ritonavir therapy that require treatment with ADCIRCA, start ADCIRCA at 20 mg once a day. Use of ADCIRCA with potent inducers of CYP3A, such as rifampin, should be avoided
  • Special Populations: The use of ADCIRCA is not recommended for patients with severe renal or hepatic impairment. Please see Full Prescribing Information for dosing recommendations for patients with mild to moderate renal or hepatic impairment
  • Potential Drug Interactions: ADCIRCA contains the same ingredient (tadalafil) as Cialis®, which is used to treat erectile dysfunction (ED). The safety and efficacy of combinations of ADCIRCA with Cialis or other PDE-5is have not been studied. Therefore, the use of such combinations is not recommended
  • Vision/Hearing: In rare instances, men taking PDE-5is (including tadalafil) for ED reported a sudden decrease or loss of vision or hearing, or an erection lasting more than four hours. A patient who experiences any of these symptoms should seek immediate medical attention

ADVERSE REACTIONS

  • Adverse Reactions: The most common adverse event with ADCIRCA is headache (42% ADCIRCA vs 15% placebo). Other common adverse events (reported by ≥9% of patients on ADCIRCA and more frequent than placebo by 2%) include myalgia (14% vs 4%), nasopharyngitis (13% vs 7%), flushing (13% vs 2%), respiratory tract infection (13% vs 6%), extremity pain (11% vs 2%), nausea (11% vs 6%), back pain (10% vs 6%), dyspepsia (10% vs 2%), and nasal congestion (9% vs 1%)

For more information about ADCIRCA, please see the Full Prescribing Information and
Patient Information or call 1-800-545-5979.