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.

In clinical trials, Talicia demonstrated
a favorable safety and tolerability profile

An important element in getting patients to complete their course of therapy is the tolerability of the therapy prescribed.

In clinical trials, Talicia demonstrated a favorable safety and tolerability profile

An important element in getting patients to complete their course of therapy is the tolerability of the therapy prescribed.

As the table below shows, Talicia was well-tolerated and demonstrated
a favorable safety profile.

In addition to being well-tolerated, Talicia showed a very low discontinuation rate.

Treatment discontinuation due to an adverse reaction occurred in only 1% (4/305) of patients receiving Talicia, <1% (1/227) of patients receiving amoxicillin and omeprazole, and 2% (1/41) of patients receiving placebo. Adverse reactions leading to discontinuation of Talicia were nausea and vomiting, nausea, nasal congestion, and nasopharyngitis, in one patient each.

A note about chromaturia

Chromaturia is a brown-orange discoloration of the urine, feces, saliva, sputum, perspiration, tears, and skin. This condition can occur due to the rifabutin component of Talicia and some of its metabolites. While this may occur during therapy, it should resolve after therapy is completed.

The difference in the incidence of chromaturia seen above is because riboflavin was administered in Study 1 to prevent unintentional unblinding and may have contributed to under-reporting of chromaturia.