A closer look at new FDA actions: Kapidex
Dr. Holmberg is the pharmacy coordinator at Desert Vista Behavioral Health Center in Mesa, Arizona.
Takeda Pharmaceutical Company Ltd and Takeda Pharmaceuticals North America Inc’s Kapidex (dexlansoprazole) delayed-release capsules has received FDA approval for the treatment of heartburn associated with nonerosive gastroesophageal reflux disease (GERD), healing of all grades of erosive esophagitis (EE), and maintenance healing of EE.1 GERD— heartburn occurring 2 or more days a week, even after diet changes and treatment— is estimated to affect 19 million Americans. Triggers often include specific foods, stress, or pressure on the stomach.2
Kapidex is an oral, once-daily option that can be taken without regard to meals. It is the first drug in its class to use a dual delayed-release (DDR) formulation. The DDR delivery system consists of 2 kinds of enteric-coated granules and ensures 2 releases of medication: 1 to 2 hours after administration and 4 to 5 hours after administration.2
Mechanism of Action
Kapidex is a proton pump inhibitor (PPI). It exerts its effect by inhibition of (H+, K+)-ATPase in the gastric parietal cell, thus suppressing the final step of acid production and suppressing gastric acid secretion.1 Clinical Trials
The role of Kapidex in symptomatic, nonerosive GERD was evaluated in a multicenter, double-blind, placebocontrolled, randomized, 4-week study. Patients were randomized to receive either Kapidex 30 mg daily, Kapidex 60 mg daily, or placebo. Patients taking 30 mg Kapidex daily were found to have a statistically significant greater percent of days that were heartburn-free for 24 hours. The 60-mg dose was not found to provide any additional clinical benefit over the 30-mg dose.
The role of Kapidex in healing EE was evaluated in 2 multicenter, doubleblind, active-controlled, randomized, 8-week studies to test for noninferiority. Patients were randomized to receive either Kapidex 60 mg daily, Kapidex 90 mg daily, or lansoprazole 30 mg daily. Kapidex 60 mg daily was determined to be noninferior to lansoprazole 30 mg daily. The 90-mg dose was not found to provide any additional clinical benefit over the 60-mg dose.
Kapidex for the maintenance of healed EE was evaluated in a multicenter, double-blind, placebo-controlled, randomized, 6-month study. Patients were randomized to receive Kapidex 30 mg, Kapidex 60 mg, or placebo. It was found that Kapidex 30 mg daily resulted in a higher median percent of 24-hour heartburn-free days than placebo. The 60-mg dose was not found to provide any additional clinical benefit over the 30-mg dose.1
Dosage and Administration
Kapidex should be dosed as follows:
• For the treatment of symptomatic nonerosive GERD: 30 mg once daily for 4 weeks
• For the healing of EE: 60 mg once daily for up to 8 weeks
• For the maintenance of healed EE: 30 mg once daily for up to 6 months
A maximum daily dose of 30 mg should be considered for patients with moderate hepatic impairment (Child- Pugh Class B). The capsules should be swallowed whole or can be opened, sprinkled on 1 tablespoon of applesauce, and swallowed immediately.1
Contraindications, Warnings, Precautions, and Adverse Reactions
Kapidex is contraindicated in patients with a known hypersensitivity to any of its ingredients. Symptomatic response with Kapidex does not preclude the presence of gastric malignancy.
Kapidex should not be used concomitantly with atazanavir; this combination may result in a substantial decrease in atazanavir levels. When administered with warfarin during clinical trials, Kapidex did not affect the international normalized ratio (INR); however, concomitant use of warfarin and other PPIs has resulted in reports of increased INR and prothrombin time. As a result, patients using both Kapidex and warfarin should be monitored closely for an increase in the INR. Kapidex may alter the absorption of pH-dependent medications. Examples of medications in which gastric pH may impact bioavailability include ampicillin esters, digoxin, iron salts, and ketoconazole.
Kapidex is a pregnancy category B drug. It should not be used by patients who are breast-feeding. Its use has not been evaluated in patients younger than 18 years old. The most commonly reported adverse reactions were diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence.1References1. Kapidex [prescribing information]. Kapidex Web site. www.kapidex.com/pi.aspx. Accessed February 2009.
2. FDA Approves Kapidex (dexlansoprazole) delayed release capsules for the treatment of GERD. Kapidex Web site. www.kapidex.com/Press.aspx. Accessed February 2009.