Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of ALYQ, a generic version of ADCIRCA (tadalafil)
tablets, 20 mg in the U.S.
ALYQ™ is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to
improve exercise ability. PAH is high blood pressure in the blood
vessels of the lungs.buyaas Tadalafil
Brendan O’Grady, EVP and Head of North America Commercial at Teva
said, “This launch is an important addition to our portfolio of generic
medicines that treat complex conditions and we’re proud to offer an
affordable treatment option for this rare disease.”
With over 550 generic medicines available, Teva has the largest
portfolio of FDA-approved generic products on the market and holds the
leading position in first-to-file opportunities, with over 100 pending
first-to-files in the U.S. Currently, one in seven generic prescriptions
dispensed in the U.S. is filled with a Teva generic product.
ADCIRCA had annual total sales of approximately $490 million in the
U.S., according to IQVIA data as of November 2018.ALYQ is 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%).
Do not use ALYQ in patients who are using any form of organic
nitrate, either regularly or intermittently. ALYQ potentiates the
hypotensive effect of nitrates. Do not use ALYQ™ in patients who are
using a guanylate cyclase (GC) stimulator, such as riociguat. ALYQ may
potentiate the hypotensive effects of GC stimulators. ALYQ is
contraindicated in patients with a known serious hypersensitivity to
tadalafil. Hypersensitivity reactions have been reported, including
Stevens-Johnson syndrome and exfoliative dermatitis.
Patients who experience anginal chest pain after taking ALYQ™ should
seek immediate medical attention. PDE5 inhibitors, including tadalafil,
have mild systemic vasodilatory properties that may result in transient
decreases in blood pressure. Patients with severely impaired autonomic
control of blood pressure or with left ventricular outflow obstruction
may be particularly sensitive to the actions of vasodilators, including
PDE5 inhibitors. Pulmonary vasodilators may significantly worsen the
cardiovascular status of patients with pulmonary veno-occlusive disease
(PVOD).
PDE5 inhibitors, including ALYQ™, and alpha-adrenergic blocking
agents are vasodilators with blood pressure-lowering effects. When
vasodilators are used in combination, an additive effect on blood
pressure may be anticipated. Safety of combined use of PDE5 inhibitors
and alpha blockers may be affected by other variables, including
intravascular volume depletion and use of other antihypertensive drugs.
Both alcohol and tadalafil are mild vasodilators. When mild vasodilators
are taken in combination, blood pressure-lowering effects are
increased.
Use of ALYQ™ in patients taking ritonavir requires dosage
adjustment. Avoid use of ALYQ™ in patients taking potent inhibitors of
CYP3A such as ketoconazole and itraconazole, and in patients chronically
taking potent inducers of CYP3A, such as rifampin. A lower starting
dose of ALYQ™ should be used in patients with mild or moderate renal or
hepatic impairment. Avoid use of ALYQ™ in patients with severe renal or
hepatic impairment.
