Expand Safety Information ▲
Important Safety Information for ADCIRCA®
(tadalafil) tablets
CONTRAINDICATIONS
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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
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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:
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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
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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.