Talicia is the first new
product to combat H. pylori
infection in over 10 years
Talicia is the first new product to combat H. pylori infection in over 10 years
Due to the increasing resistance of H. pylori to traditionally used antibiotics and its link to greater health risks such as stomach ulcers and stomach cancer, the FDA has placed a high priority on the development of new antibiotics to fight H. pylori infection.1
Now there is Talicia
Talicia is the first H. pylori therapy to utilize the antibiotic rifabutin and was designed with patients in mind, combining all three medications (omeprazole magnesium, amoxicillin and rifabutin) in an all-in-one capsule.
Talicia was shown to be highly effective
In the pivotal, phase 3 study, Talicia demonstrated excellent eradication of H. pylori with an 84% overall eradication rate. In patients with confirmed blood levels of any Talicia component at day 13, Talicia had an even greater eradication rate of 90%.2
Zero to minimal H. pylori resistance
Talicia is different because it is the only H. pylori treatment that includes the antibiotic rifabutin. In vitro testing of 345 H. pylori isolates in the phase 3 study demonstrated 0% resistance to rifabutin and 6.4% resistance to amoxicillin, the antibiotics in Talicia. 2
Talicia demonstrated a favorable safety and tolerability profile
Treatment discontinuation due to an adverse event occurred in only 1% of patients receiving Talicia.
Talicia is therapy designed with patients in mind
Rather than having to manage multiple medications with different dosing schedules throughout the day, Talicia combines all three medications into one capsule.
The medication is dosed as 4 capsules, q8h with food for 14 days. Capsules should be swallowed whole and not chewed or crushed. Patients should not take Talicia with alcohol.
And, because the medications are all together in one pill, patients only need one Rx and will have only one copay.
1. U.S. Food & Drug Administration. CFR-Code of Federal Regulations Title 21. Section 21CFR317.2.
2. Data on file, RedHill Biopharma.
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.