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Voquezna Triple Pak FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 10, 2022.

FDA Approved: Yes (First approved May 3, 2022)
Brand name: Voquezna Triple Pak
Generic name: amoxicillin, clarithromycin, and vonoprazan
Dosage form: Co-Packaged Capsules and Tablets
Company: Phathom Pharmaceuticals, Inc.
Treatment for: Helicobacter Pylori Infection

Voquezna Triple Pak (amoxicillin, clarithromycin, and vonoprazan) is a co-packaged product containing amoxicillin (penicillin class antibacterial), clarithromycin (macrolide antimicrobial), and vonoprazan (potassium-competitive acid blocker (PCAB)) indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults.

  • Voquezna Triple Pak contains vonoprazan, a novel, first-in-class potassium-competitive acid blocker (PCAB) that works to block acid secretion in the stomach. Vonoprazan is currently approved in combination with antibiotics (Voquezna Triple Pak and Voquezna Dual Pak) for the treatment of Helicobacter pylori (H. pylori) infection. The Voquezna Triple Pak contains amoxicillin, clarithromycin, and vonoprazan and the Voquezna Dual Pak contains amoxicillin and vonoprazan, with no clarithromycin.
  • Due to the clarithromycin component, Voquezna Triple Pak is contraindicated in patients with any known hypersensitivity to clarithromycin or any macrolide antibiotic, in patients receiving pimozide, lomitapide, lovastatin, simvastatin, ergotamine, dihydroergotamine, colchicine in patients with renal or hepatic impairment, or those with a history of cholestatic jaundice/hepatic dysfunction.
  • Each dose of Voquezna Triple Pak contains two capsules and two tablets (2 amoxicillin 500 mg capsules, 1 clarithromycin 500 mg tablet and 1 vonoprazan 20 mg tablet). Each dose is given twice daily (morning and evening, 12 hours apart), with or without food, for 14 days.
  • Warnings and precautions associated with Voquezna Triple Pak include hypersensitivity reactions; severe cutaneous adverse reactions (SCAR); clostridioides difficile-associated diarrhea (CDAD); QT prolongation in certain patients; hepatotoxicity; serious adverse reactions due to concomitant use with other drugs; embryo-fetal toxicity; and myasthenia gravis.
  • Common adverse reactions include dysgeusia, diarrhea, vulvovaginal candidiasis, headache, abdominal pain, and hypertension.

Development timeline for Voquezna Triple Pak

May  4, 2022Approval FDA Approves Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults
Apr 29, 2021Phathom Pharmaceuticals Announces Positive Topline Results from Pivotal Phase 3 Trial of Vonoprazan in Helicobacter pylori (H. pylori) Infection; Study Met All Primary and Secondary Endpoints
Dec 23, 2019Phathom Pharmaceuticals Announces Initiation of Pivotal Phase 3 Clinical Trial for Vonoprazan in Helicobacter Pylori (H. pylori) Infection

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.