TALICIA is supplied as an orange, opaque capsule containing omeprazole 10 mg (equivalent to omeprazole magnesium 10.3 mg), amoxicillin 250 mg and rifabutin 12.5 mg with "RHB" imprinted in black on the capsule cap and "105" imprinted in black on the capsule body. TALICIA capsules are supplied in a carton containing two bottles of 84 capsules each. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TALICIA� safely and effectively. See full prescribing information for TALICIA. TALICIA (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules, for oral use Initial U.S. Approval: 2019 ---------------------------INDICATIONS AND USAGE---------------------------�TALICIA is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. (1) To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. -----------------------DOSAGE AND ADMINISTRATION ----------------------��Administer four (4) TALICIA capsules every 8 hours with food for 14 days. (2) �Swallow whole. Do not crush or chew. (2) �Do not take TALICIA with alcohol. (2) ---------------------DOSAGE FORMS AND STRENGTHS---------------------�Delayed Release Capsule: Omeprazole 10 mg, ( equivalent to 10.3 mg of omeprazole magnesium) amoxicillin 250 mg and rifabutin 12.5 mg. (3) ------------------------------CONTRAINDICATIONS -----------------------------��Known hypersensitivity to omeprazole, amoxicillin or any other beta�lactam antibacterial drugs, rifabutin or any other rifamycin, or any component of TALICIA. (4.1) �Rilpivirine-containing products. (4.2) �Delavirdine. (4.3) �Voriconazole. (4.4) -----------------------WARNINGS AND PRECAUTIONS ----------------------��Hypersensitivity Reactions: Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of TALICIA. If hypersensitivity reactions occur, discontinue TALICIA and institute immediate therapy (e.g., anaphylaxis management). (5.1) �Clostridioides difficile-Associated Diarrhea (CDAD): Evaluate if diarrhea occurs. (5.2) �Reduction in the Efficacy of Hormonal Contraceptives: Additional non-hormonal highly effective methods of contraception should be used while taking TALICIA. (5.3) �Acute Interstitial Nephritis (AIN): Observed in patients taking (P roton Pump Inhibitors (PPIs) and penicillins. Discontinue TALICIA if AIN develops. (5. 4) �Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue TALICIA and evaluate. (5.5) ------------------------------ADVERSE REACTIONS -----------------------------�Most common adverse reactions (?1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma Inc. at 1- 833-ADRHILL (1-833-237-4455) or FDA at 1- 800-FDA-1088 or www.fda.gov/medwatch. ------------------------------DRUG INTERACTIONS------------------------------�Components of TALICIA have the potential for clinically important drug interactions. See Full Prescribing Information for important drug interactions with TALICIA. ( 4, 5.5, 7) -----------------------USE IN SPECIFIC POPULATIONS ----------------------��TALICIA may cause fetal harm. (8.1) �Renal Impairment: Avoid use in severe renal impairment. (8.6) �Hepatic Impairment: Avoid use. (8.7) See 17 for PATIENT COUNSELING INFORMATION. Revised: 11 /201
