TAKE THE FIRST STEP FORWARD TO A SOLID FOUNDATION WITH ADCIRCA® (tadalafil)

A first-line PDE-5 inhibitor that can help improve exercise ability

ADCIRCA® (tadalafil) 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 US Healthcare Professionals Only

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Important Safety Information for ADCIRCA® (tadalafil) tablets

CONTRAINDICATIONS

  • Nitrates and Guanylate Cyclase (GC) Stimulators: Do not use ADCIRCA in patients taking medicines that contain nitrates or guanylate cyclase stimulators (such as riociguat), 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) and the signs and symptoms of benign prostatic hyperplasia (BPH). 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: Patients who experience a sudden loss of vision in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), or sudden decrease or loss of hearing after taking ADCIRCA should seek immediate medical attention
  • Prolonged Erection: In rare instances, men taking PDE-5is (including tadalafil) for ED reported an erection lasting more than four hours. Male patients who experience a prolonged erection 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%)

ADC.ISI.HCP.KCGLB-4-109.v1

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

HOW ADCIRCA WORKSPATIENT ASSISTANCEREGISTER FOR SITE UPDATES

Important Safety Information for ADCIRCA® (tadalafil) tablets

CONTRAINDICATIONS

  • Nitrates and Guanylate Cyclase (GC) Stimulators: Do not use ADCIRCA in patients taking medicines that contain nitrates or guanylate cyclase stimulators (such as riociguat), 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) and the signs and symptoms of benign prostatic hyperplasia (BPH). 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: Patients who experience a sudden loss of vision in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), or sudden decrease or loss of hearing after taking ADCIRCA should seek immediate medical attention
  • Prolonged Erection: In rare instances, men taking PDE-5is (including tadalafil) for ED reported an erection lasting more than four hours. Male patients who experience a prolonged erection 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%)

ADC.ISI.HCP.KCGLB-4-109.v1


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

-Thomas A Gieseke - 3 illustrations for Adcirca: pillbox with empty "Sunday" compartment, isolated dog and isolated pedometer. Indefinite buyout of rights for use in print and electronic media (iPad presentation) for use by Adcirca only -Copyright Clearance Center - Wolters Kluwer Health, Circulation, Nazzareno Galie, Bruce H. Brundage, Hossein A. Ghofrani, Ronald J. Oudiz, Gerald Simmonneau, Zeenat Safdar, Shelley Shapiro..., Tadalafil Therapy for Pulmonary Arterial Hypertension, License No: 3177700012726 -Nicholais Photography - Unlimited use of photos in print, digital, web for pro and consumer in the US -Bella Agency - Victoria Gardner, unlimited use in print, digital and web