ALYQ

ALYQ- tadalafil tablet, film coated
Teva Pharmaceuticals USA, Inc.

1 INDICATIONS AND USAGE

1.1 Pulmonary Arterial Hypertension

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%).

2 DOSAGE AND ADMINISTRATION

2.1 Pulmonary Arterial Hypertension

The recommended dose of ALYQ™ is 40 mg (two 20 mg tablets) taken once daily with or without food. Dividing the dose (40 mg) over the course of the day is not recommended.

2.2 Use in Special Populations

Renal Impairment

  • Mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability.
  • Severe (creatinine clearance <30 mL/min and on hemodialysis): Avoid use of ALYQ™ because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].

Hepatic Impairment

  • Mild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day.
  • Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid use of ALYQ™ [see Warnings and Precautions (5.4) and Use in Specific Populations (8.7) ].

Geriatric Patients

  • No dose adjustment is required in patients >65 years of age without renal impairment or hepatic impairment.

2.3 Use with Ritonavir

Coadministration of ALYQ™ in Patients on Ritonavir
In patients receiving ritonavir for at least one week, start ALYQ™ at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Coadministration of Ritonavir in Patients on ALYQ™
Avoid use of ALYQ™ during the initiation of ritonavir. Stop ALYQ™ at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume ALYQ™ at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

20 mg, orange, oval-shaped, film-coated tablets (not scored) debossed with “TEVA” on one side and with “3334” on the other side.

4 CONTRAINDICATIONS

4.1 Concomitant Organic Nitrates

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. This potentiation is thought to result from the combined effects of nitrates and ALYQ™ on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].

4.2 Concomitant Guanylate Cyclase (GC) Stimulators

Do not use ALYQ™ in patients who are using a GC stimulator, such as riociguat. ALYQ™ may potentiate the hypotensive effects of GC stimulators.

4.3 Hypersensitivity Reactions

ALYQ™ is contraindicated in patients with a known serious hypersensitivity to tadalafil (ALYQ™ or CIALIS®). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Effects

Discuss with patients the appropriate action to take in the event that they experience anginal chest pain requiring nitroglycerin following intake of ALYQ™. At least 48 hours should elapse after the last dose of ALYQ™ before taking nitrates. If a patient has taken ALYQ™ within 48 hours, administer nitrates under close medical supervision with appropriate hemodynamic monitoring. 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. Prior to prescribing ALYQ™, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with severely impaired autonomic control of blood pressure or with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) 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). Since there are no clinical data on administration of ALYQ™ to patients with veno-occlusive disease, administration of ALYQ™ to such patients is not recommended. Should signs of pulmonary edema occur when ALYQ™ is administered, the possibility of associated PVOD should be considered.

There is a lack of data on safety and efficacy in the following groups who were specifically excluded from the PAH clinical trials:

  • Patients with clinically significant aortic and mitral valve disease
  • Patients with pericardial constriction
  • Patients with restrictive or congestive cardiomyopathy
  • Patients with significant left ventricular dysfunction
  • Patients with life-threatening arrhythmias
  • Patients with symptomatic coronary artery disease
  • Patients with hypotension (<90/50 mm Hg) or uncontrolled hypertension

Use with Alpha Blockers and Antihypertensives
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. In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)] , which may lead to symptomatic hypotension (e.g., fainting). 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 [see Drug Interactions (7.1)].

Use with Alcohol
Both alcohol and tadalafil are mild vasodilators. When mild vasodilators are taken in combination, blood pressure-lowering effects are increased [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)].

5.2 Use with Potent CYP3A Inhibitors or Inducers

Coadministration of ALYQ™ in Patients on Ritonavir
In patients receiving ritonavir for at least one week, start ALYQ™ at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Dosage and Administration (2.3), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Coadministration of Ritonavir in Patients on ALYQ™
Avoid use of ALYQ™ during the initiation of ritonavir. Stop ALYQ™ at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume ALYQ™ at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Dosage and Administration (2.3), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Other Potent Inhibitors of CYP3A
Tadalafil is metabolized predominantly by CYP3A in the liver. In patients taking potent inhibitors of CYP3A such as ketoconazole and itraconazole, avoid use of ALYQ™ [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Potent Inducers of CYP3A
For patients chronically taking potent inducers of CYP3A, such as rifampin, avoid use of ALYQ™ [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

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