Teva Announces Launch of ALYQ (Tadalafil Tablets USP)
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.