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Prescribing Tadliq
Tadliq is available through select specialty pharmacies

The First and Only FDA-approved Oral Suspension of Tadalafil

Do You Know The Risks of Crushing/Compounding?

Tadliq® is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.

Available in: 150mL bottle

ABOUT TADLIQ

For patients with issues swallowing, Tadliq® is the only FDA-approved oral liquid suspension of tadalafil for patients with Pulmonary Arterial Hypertension (PAH).

  • The only ready-made, once-daily liquid formulation
  • Eliminates lengthy and complex preparation of powder formulations
  • Removes risks associated with unapproved compounded formulations
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The Right Medication for the Right Patient

Choosing Tadliq ensures that patients are getting a safe and ready-made FDA-approved oral liquid formulation that does not require any additional preparation by a pharmacist

Tadliq (Tadalafil) Oral Suspension Crushed & Compounded Tadalafil*/Sildenafil Tablets Sildenafil Powder
FDA-approved oral liquid formulation: Yes No Only after powder has been properly reconstituted by a pharmacist.
Ready made: Yes No No
Liquid Formulation is FDA tested to ensure potency, efficacy & safety: Yes No Only after powder has been properly reconstituted by a pharmacist.
Shelf life of liquid formulation: 24 months Unknown 60 days
Minimal Preparation: Yes. Shake & dispense No No. Time consuming 10-step process that must be performed by a pharmacist.
Illustration of crushed pills warning

*IMPORTANT: Tadalafil tablets should never be broken, split, or crushed.1

Tadliq Educational Resources

Dysphagia & The Need For Liquid Alternatives

Patients with pulmonary arterial hypertension (PAH) may also suffer from dysphagia, the medical term used to describe difficulty swallowing. Co-morbidities are often a factor in the prevalence of dysphagia. For instance, scleroderma is a co-morbid condition that can affect up to 40% of PAH patients.2 Scleroderma presents with significant gastrointestinal involvement commonly in the esophagus, leading to dysphagia.

Dysphagic Patients:

Dysphagia can include difficulty starting a swallow (oropharyngeal dysphagia), issues in the throat (pharyngeal dysphagia), and the sensation of food being stuck (esophageal dysphagia). Given these complications it’s important to optimize treatment plans for these patients.

Unfortunately, liquids derived from crushed/compounded tablets raise concerns about patient safety and efficacy, and they have come under increasing scrutiny from the FDA.

Patients Who Have
Difficulty Swallowing


Patients who need a liquid formulation may
also have a comorbid condition that
creates difficulty swallowing.

“Compounded drugs should only be distributed to meet the needs of patients whose medical needs cannot be met by an FDA-approved drug”

Scott Gottlieb, MD: Former FDA Commissioner

READ THIS BEFORE YOU CRUSH/COMPOUND ANOTHER TABLET

THE RISKS AND CONCERNS OF CRUSHING/COMPOUNDING

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

Prescribing Tadliq

Tadliq is available through select specialty pharmacy (SP) providers

How to prescribe tadliq:

  1. Download a Tadliq prescription form at tadliq.com/specialty
  2. Make sure all necessary information has been provided
  3. Complete the entire form and fax to a specialty pharmacy or submit via an e-prescribing platform.
  4. The chosen specialty pharmacy will contact your patient to collect any incomplete information, review their insurance coverage with estimated co-pays, and schedule their prescription shipment

Download Specialty Prescription Form

Commercially insured patients may pay as little as $0* on each prescription with the EasyPay Co-pay Program

* Void where prohibited by law. CMP Pharma reserves the right to rescind, revoke or amend this program without notice. Offer not valid for patients eligible for benefits under Medicaid (including Medicaid managed care), Medicare, TRICARE, Veterans Affairs, FEHBP, or similar state or federal programs. Offer void where prohibited, taxed, or otherwise restricted. Offer good only in the U.S.A. No generic substitution with this offer.

Get an EasyPay Card

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.

Indication

TADLIQ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

Contraindications

TADLIQ® is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently.