Patients who have difficulty swallowing are often given crushed/compounded formulations of the prescriptions. However, crushed/compounded formulations can exhibit a wide variation in potency due to non-uniformity of compounded materials. These dosing inconsistencies of compounded suspensions have long been a persistent challenge for pharmacists and patients.⁴

Crushed/compounded formulations are not tested for safety or efficacy.

Due to fatalities related to contamination, the FDA recently released stricter guidance regarding crushing/compounding and recommended against using crushed/compounded products considered “essentially copies of a commercially available drug product” without permission, especially if an FDA-approved alternative exists.⁵

1. How to take ADCIRCA. Accessed August 17, 2022. https://adcirca.com/patient/how-to-take-adcirca.aspx 2. Pulmonary Hypertension in Scleroderma. University of Michigan Health. Accessed September 19, 2022. https://www.uofmhealth.org/conditions-treatments/rheumatology/pulmonary-hypertension-scleroderma 3. Gudeman, Jennifer, Michael Jozwiakowski, John Chollet, and Michael Randell. “Potential Risks of Pharmacy Compounding.” Drugs in R&D 13, no. 1 (2013): 1-8. doi:10.1007/s40268-013-0005-9. 4. Kindy K, Sun L, Crites A. Compounding pharmacies have been linked to deaths, illnesses for years. Washington Post. February 7, 2013. 5. Food Drug Administration Center for Drug Evaluation & Research (2016). Guidance for Industry: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDA, Maryland) 1-8. doi:10.1007/s40268-013-0005-9. 6. Data on File 0003 Tadliq Clinical Study for Oral Bioequivalence and Food Effect. 6. How to take ADCIRCA. Accessed August 17, 2022. https://adcirca.com/patient/how-to-take-adcirca.aspx

Important Safety Information

INDICATIONS AND USAGE

TADLIQ® 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%).

CONTRAINDICATIONS

• Concomitant organic nitrates
• Concomitant Guanylate Cyclase (GC) Stimulators
• History of known serious hypersensitivity reaction to TADLIQ, ADCIRCA® or CIALIS®

WARNINGS AND PRECAUTIONS

• Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of TADLIQ. Not recommended in patients with pulmonary veno-occlusive disease.
• Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent.
• Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with tadalafil.
• Concomitant PDE5 inhibitors: Avoid use with CIALIS, ADCIRCA or other PDE5 inhibitors.
• Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours.

ADVERSE REACTIONS

The most common adverse reaction is headache.

To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc. at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Nitrates: Administration of nitrates within 48 hours after the last dose of TADLIQ is contraindicated
• Alpha-Blockers: PDE5 inhibitors, including TADLIQ, and alpha-adrenergic blocking agents are both vasodilators with blood- pressure-lowering effects.
• Antihypertensives: PDE5 inhibitors, including TADLIQ, are mild systemic vasodilators.
• Alcohol: Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators.
• CYP3A Inhibitors/Inducers: Ritonavir, Potent Inhibitors of CYP3A, Potent Inducers of CYP3A

DOSAGE AND ADMINISTRATION

The recommended dose of TADLIQ is 40 mg (10 mL) taken once daily with or without food.

Please see Prescribing Information for additional safety information.