Patient assistance | ADCIRCA (tadalafil) tablets Once-daily treatment for PAH

Important Safety Information for ADCIRCA^® (tadalafil) tablets

CONTRAINDICATIONS

• Nitrates and Guanylate Cyclase (GC) Stimulators: It is critical to avoid the use of ADCIRCA in patients who are currently taking medications that contain nitrates or guanylate cyclase stimulators, including drugs such as riociguat. The combination of these substances may result in a sudden and potentially dangerous drop in blood pressure. Additionally, patients should refrain from using nitrates for at least 48 hours following their last dose of ADCIRCA.
• Hypersensitivity Reactions: Patients who have a known serious hypersensitivity to tadalafil must not take ADCIRCA, as this could result in severe adverse reactions.

WARNINGS AND PRECAUTIONS

• Cardiovascular: Any patients who experience anginal chest pain after taking ADCIRCA should seek immediate medical assistance without delay.
• Hypotension: PDE-5 inhibitors, including tadalafil, can cause mild systemic vasodilation which may potentially lead to transient reductions in blood pressure. It is essential to carefully consider whether patients with existing cardiovascular issues would be adversely impacted by such effects before prescribing ADCIRCA.
• Worsening Pulmonary Vascular Occlusive Disease: The administration of pulmonary vasodilators to patients with pulmonary veno-occlusive disease (PVOD) may greatly deteriorate their cardiovascular condition; therefore, the use of ADCIRCA in these patients is strongly discouraged.
• Vision/Hearing: If patients experience a sudden loss of vision in one or both eyes, which may indicate non-arteritic anterior ischemic optic neuropathy (NAION), or a sudden decrease or loss of hearing while taking ADCIRCA, it is imperative for them to seek immediate medical intervention.
• Prolonged Erection: There have been rare reports of men experiencing an erection lasting longer than four hours while taking PDE-5 inhibitors, including tadalafil for erectile dysfunction (ED). Any male patients encountering a prolonged erection should seek immediate medical attention to mitigate potential complications.

SPECIAL POPULATIONS AND POTENTIAL DRUG INTERACTIONS:

• Special Populations (Pregnant or Expecting Pregnancy): While limited data from case studies involving tadalafil use in pregnant women have not indicated a significant drug-associated risk of major birth defects or negative maternal or fetal outcomes, it is crucial to note that pregnant women with untreated pulmonary arterial hypertension are at increased risk for serious conditions such as heart failure, stroke, preterm delivery, and even maternal and fetal death.
• Special Populations (Renal or Hepatic Impairment): The administration of ADCIRCA is not advisable for patients suffering from severe renal or hepatic impairment. For more detailed dosing recommendations concerning patients with mild to moderate renal or hepatic issues, please refer to the Full Prescribing Information.
• Potential Drug Interactions: Combining ADCIRCA with alpha blockers, blood pressure medications, or alcohol can potentially lower blood pressure significantly and may result in symptoms of hypotension, such as light-headedness or fainting.
• Potential Drug Interactions: Tadalafil is primarily metabolized by CYP3A enzymes in the liver. Co-administration of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided to prevent adverse reactions. In cases where patients on ADCIRCA therapy require ritonavir treatment, it is recommended to discontinue ADCIRCA at least 24 hours prior to starting ritonavir. Alternatively, if a patient on ritonavir requires treatment with ADCIRCA, they should begin with a dose of 20 mg once daily. Care should also be taken to avoid using ADCIRCA in conjunction with potent CYP3A inducers like rifampin.
• Potential Drug Interactions: ADCIRCA contains tadalafil, the same active ingredient found in Cialis^®, which is prescribed for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). The safety and effectiveness of using ADCIRCA in combination with Cialis or other PDE-5 inhibitors have not been adequately studied. Therefore, it is not advisable to use these combinations concurrently.

ADVERSE REACTIONS

• Adverse Reactions: The most frequently reported adverse event associated with ADCIRCA is headache, occurring in 42% of patients taking the medication compared to 15% in placebo groups. Other common adverse events (experienced by 9% or more of patients on ADCIRCA and more frequent than in the placebo group by at least 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 further details about ADCIRCA, please consult the Full Prescribing Information and
Patient Information or call 1-800-545-5979.

References:

• Data on file, June 2016.