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Talicia®  (omeprazole, amoxicillin and rifabutin)

Talicia® (omeprazole, amoxicillin and rifabutin)

On November 4, 2019, RedHill announced that the U.S. Food and Drug Administration (FDA) had approved Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg1/250 mg/12.5 mg for the treatment of Helicobacter pylori (H. pylori) infection in adults.

RedHill expects to launch Talicia in the U.S. in the first quarter of 2020 with its dedicated sales force.

(Each delayed-release capsule contains omeprazole 10 mg (equivalent to 10.3 mg omeprazole magnesium), amoxicillin 250 mg, and rifabutin 12.5 mg).

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.

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.

Important Safety Information

Contraindications

  • Known hypersensitivity to omeprazole, amoxicillin or any other beta-lactam antibacterial drugs, rifabutin or any other rifamycin, or any component of Talicia.
  • Rilpivirine-containing products.
  • Delavirdine.
  • Voriconazole.


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).
  • Clostridioides difficile-Associated Diarrhea (CDAD): Evaluate if diarrhea occurs.
  • Reduction in the Efficacy of Hormonal Contraceptives: Additional non-hormonal highly effective methods of contraception should be used while taking Talicia.
  • Acute Interstitial Nephritis (AIN): Observed in patients taking (Proton Pump Inhibitors (PPIs) and penicillins. Discontinue Talicia if AIN develops.
  • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Talicia and evaluate.


Adverse Reactions

Most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. Components of Talicia have the potential for clinically important drug interactions. See full prescribing information for important drug interactions with Talicia.

Drug Interactions

Components of TALICIA have the potential for clinically important drug interactions. See full prescribing information for important drug interactions with TALICIA.

Use in Specific Populations

  • Talicia may cause fetal harm.
  • Renal Impairment: Avoid use in severe renal impairment.
  • Hepatic Impairment: Avoid use.

Please also see full Prescribing Information 


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 ww.fda.gov/medwatch