Voquezna Dual Pak and Triple Pak From Phathom Pharmaceuticals, Inc

The FDA has approved copackaged amoxicillin capsules and vonoprazan tablets (Voquezna Dual Pak; Phathom Pharmaceuticals, Inc) and copackaged amoxicillin capsules, clarithromycin tablets, and vonoprazan tablets (Voquezna Triple Pak; Phathom Pharmaceuticals, Inc) for the management of Helicobacter pyloriinfection in adults.

The approval specifies that the medication and other antibacterial agents should be used only to prevent or manage infections that are proven or strongly suspected to be caused by bacteria.¹ An estimated 50% of the world population and 36% of the US population are infected with H pylori, which can cause chronic inflammation and lead to dyspepsia, mucosa-associated lymphoid tissue lymphoma, noncardia gastric cancer, and peptic ulcer disease.²

Pharmacology and Pharmacokinetics

Vonoprazan is a potassium-competitive acid blocker. It inhibits the hydrogen potassium adenosine triphosphatase enzyme system in a potassium-competitive manner to suppress basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell. Amoxicillin is an antibacterial agent in the penicillin class, and clarithromycin is a macrolide antimicrobial.¹

Dosage and Administration

The dosage for Voquezna Dual Pak is amoxicillin 1000 mg 3 times daily plus vonoprazan 20 mg twice daily for 14 days. The dosage for Voquezna Triple Pak is amoxicillin 1000 mg plus clarithromycin 500 mg plus vonoprazan 20 mg twice daily for 14 days. The medications can be taken with or without food. Voquezna Dual Pak or Voquezna Triple Pak should not be used in patients with moderate or severe hepatic impairment or severe renal impairment.¹

Clinical Trials

Voquezna Dual Pak and Voquezna Triple Pak were evaluated in a controlled, double-blind, randomized, triple-therapy/open-label dual therapy study of treatment-naïve adultswho had attained positive results for H pylori. Participants were randomly assigned 1:1:1 to receive Voquezna Dual Pak, Voquezna Triple Pak, or lansoprazole 30 mg twice daily plus amoxicillin 1000 mg twice daily plus clarithromycin 500 mg twice daily (LAC) for 14 days. Both Voquezna Dual Pak and Voquezna Triple Pak were found to be noninferior to LAC in participants without an amoxicillin- or clarithromycin-resistant strain of H pylori at baseline. In participants with a clarithromycin-resistant strain of H pylori at baseline and in the overall population, both Voquezna Dual Pak and Voquezna Triple Pak were found to be superior to LAC.^1,2

Contraindications, Warnings, and Precautions

Voquezna Dual Pak and Voquezna Triple Pak are contraindicated in patients with a known hypersensitivity to amoxicillin, β-lactams, clarithromycin, macrolide antimicrobials, vonoprazan, or anycomponent of the medication. Both are also contraindicated in combination with rilpivirine.

Because of the clarithromycin component of the medication, Voquezna Triple Pak is contraindicated in patients who are concomitantly using ergot alkaloids, lomitapide, lovastatin, pimozide, or simvastatin. It is also contraindicated in patients with hepatic or renal impairment who are using colchicine and in patients with a history of cholestatic jaundice or hepatic dysfunction while using clarithromycin.

Hypersensitivity reactions and severe cutaneous adverse reactions have been reported with components of Voquezna Dual Pak and Voquezna Triple Pak. The presence of Clostridioides difficileshould be considered if diarrhea occurs during treatment. Because clarithromycin has been associated with QT interval prolongation, Voquezna Triple Pak should be avoided in patients with hypokalemia, hypomagnesemia, known QT prolongation, significant bradycardia, and ventricular arrhythmia and during treatment with class IA or III antiarrhythmic agents or medications known to prolong the QT interval. Voquezna Triple Pak should be discontinued if signs and symptoms of hepatotoxicity occur. Exacerbation of myasthenia gravis can occur with Voquezna Triple Pak. Serious adverse reactions can occur because of drug interactions with clarithromycin.

Voquezna Triple Pak should not be used during pregnancy, and neither Voquenza Dual Pak nor Voquezna Triple Pak should be used while breastfeeding.

The most common adverse reactions with Voquezna Dual Pak are abdominal pain, diarrhea, nasopharyngitis, and vulvovaginal candidiasis.

The most common adverse reactions with Voquezna Triple Pak are abdominal pain, diarrhea, dysgeusia, headache, hypertension, and vulvovaginal candidiasis.¹

References

1. Voquezna. Prescribing information. Phathom Pharmaceuticals Inc; 2022. Accessed September 6, 2022. http://www.phathompharma.com/wp-content/uploads/VOQUEZNA-TRIPLE-PAK-and-VOQUEZNA-DUAL-PAK-FDA-Final-Label-3.pdf

2.Phathom Pharmaceuticals announces FDA approval of Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of H. pylori infection in adults. News release. Phathom Pharmaceuticals. May 3, 2022. Accessed September 6, 2022. https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-announces-fda-approval-voqueznatm-triple

About the Author

Monica Holmberg, PharmD, BCPS, is a pharmacist in Phoenix, Arizona, and Pharmacy Times® contributor.