ADCIRCA® (tadalafil): Proven to improve exercise ability
- 6MWD improvement was apparent as early as 8 weeks and was sustained at weeks 12 and 162
*33 meters is approximately 108
feet.
†Includes patients on monotherapy and
background bosentan therapy.2,3
PROVEN RESULTS AS MONOTHERAPY2,3
- ADCIRCA significantly improved 6MWD vs placebo in the monotherapy subgroup2,3
*44 meters is approximately 144 feet.
STUDIED FOR USE WITH BACKGROUND BOSENTAN2,3
- 53% of patients were on background therapy with bosentan in the PHIRST-1 pivotal trial2,3
DECREASED CLINICAL WORSENING2,3
-
ADCIRCA reduced the risk of clinical worsening vs placebo at
16 weeks.2,3
- Clinical worsening is defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy (prostacyclin or analog, endothelin receptor antagonist, PDE-5 inhibitor), or worsening WHO functional class.3
LONG-TERM RESULTS2
- In a long-term extension study, at a median of 356 days (N=357), the survival rate was 96.5 per 100 patient-years. Without a control group, these data must be interpreted cautiously3
- Most common adverse events were generally transient and mild to moderate in intensity3
- Discontinuations due to adverse events were similar to placebo (4% ADCIRCA, 5% placebo)3
- No monthly liver function tests required3
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. Do not use nitrates within 48 hours of the last dose of ADCIRCA.
- 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
- Hypotension: Phosphodiesterase 5 inhibitors (PDE-5is), including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, carefully consider whether patients with underlying cardiovascular disease could be adversely affected by such actions.
- Worsening Pulmonary Vascular Occlusive Disease: 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
- 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
SPECIAL POPULATIONS AND POTENTIAL DRUG INTERACTIONS:
- Special Populations (Pregnant or Expecting Pregnancy): Limited data from case series with tadalafil use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.
- Special Populations (Renal or Hepatic Impairment): 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: 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
- 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
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.SEP2020
For more information about ADCIRCA, please see the
Full Prescribing Information
and
Patient Information
or call 1-800-545-5979.
References:
- Data on file, June 2016.
- ADCIRCA [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.
- Galiè N, Brundage BH, Ghofrani HA, et al; on behalf of the Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009;119(22):2894-2903.