Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.

Talicia is contraindicated in patients receiving rilpivirine-containing products.

Talicia is contraindicated in patients receiving delavirdine or voriconazole.

Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.

Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.

Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy.

Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.

Talicia should not be used in patients with hepatic impairment or severe renal impairment.

Acute Interstitial Nephritis has been observed in patients taking PPIs and penicillins.

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.

The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

Talicia: Highly effective.
Zero-to-minimal H. pylori resistance.

Talicia – Highly effective. Zero-to-minimal H. pylori resistance.

A different way to eradicate H. pylori.

Because of increased H. pylori antibiotic resistance and its link to cancer risks, Talicia is an important therapy for your patients. In fact, Talicia was given priority review by the FDA due to the serious public threat posed by H. pylori resistance to current therapies.

In the pivotal, phase 3 study, Talicia demonstrated excellent eradication of H. pylori.

Talicia demonstrated statistically superior eradication
vs dual therapy (PPI + amoxicillin)

Talicia demonstrated statistically superior eradication vs dual therapy (PPI + amoxicillin)

Findings from the intent-to-treat (ITT) population in the Talicia phase 3 confirmatory study, a two-arm, randomized, double-blind, active comparator-controlled study in 455 dyspepsia patients with confirmed H. pylori infection at 55 clinical sites across the U.S.

In patients with blood levels of study drug at day 13, Talicia demonstrated even better eradication.1

In patients with blood levels of study drug at day 13, Talicia demonstrated significantly superior eradication vs dual therapy (PPI + amoxicillin)

Findings in the prespecified, protocol-defined population of patients with confirmed blood levels of study drug at day 13 of the 14-day regimen in the Talicia phase 3 confirmatory study, a two-arm, randomized, double-blind, active comparator-controlled study in 455 dyspepsia patients with confirmed H. pylori infection conducted at 55 clinical sites across the U.S.

The rifabutin component of Talicia consistently contributed a greater than 25% treatment effect over treating with a dual therapy of amoxicillin and a proton pump inhibitor (P<0.0001).1

Talicia outsmarts resistance to traditional therapies for H. pylori.

Talicia is different because it is the only H. pylori treatment that includes the antibiotic rifabutin. In clinical trials, in vitro testing demonstrated H. pylori isolates had zero-to-minimal resistance to the antibiotics in Talicia.1

*Resistance rates of 345 H. pylori isolates cultured from the 2017 phase 3 clinical trial including sites across 20 states. EUCAST breakpoints for all except clarithromycin (CLSI).

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REFERENCE:

1. Data on file, RedHill Biopharma.