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.

Tell your healthcare provider about all of the medicines you take, including prescription or non-prescription medications or herbal supplements before starting Talicia. Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works. Do not start any new medications while taking Talicia without first speaking with your healthcare provider.

  • You should not take Talicia if you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins.
  • You should not take Talicia if you are taking rilpivirine-containing products, delavirdine or voriconazole

Before you take Talicia, tell your healthcare provider about all of your medical conditions, including if you:

  • Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia.
  • Have severe kidney disease or liver disease

When taking Talicia, do not crush or chew capsules. Do not take Talicia with alcohol.

Call your healthcare provider immediately if while taking Talicia you develop:

  • New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight.

What are the common side effects of Talicia?

  • The most common side effects of Talicia are diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, and vaginal yeast infection. Call your healthcare professional for medical advice about side effects.
  • Tell your healthcare provider if you experience tiredness, weakness, achiness, headaches, dizziness, depression, increased sensitivity to light or pain when taking a deep breath.
  • Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia.
  • You may experience a brown-orange discoloration of your urine or tears while taking Talicia.

Please see full Prescribing Information for Talicia.

You are encouraged to report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Understanding H. pylori
and other important
information on Talicia

Downloadable Patient Education Sheets

English

Spanish

Chinese

Russian

Understanding H. pylori and other important information on Talicia

Downloadable Patient Education Sheets

English

Spanish

Chinese

Russian

Understanding H. pylori and other important information on Talicia

Downloadable Patient Education Sheets

English

Spanish

Chinese

Russian

What is Talicia?

Talicia is for the treatment of a bacteria, Helicobacter pylori (H. pylori), in the stomach of adults. Talicia combines three medications into one capsule. Amoxicillin, a penicillin-like medication, and rifabutin are antibiotics which help kill the bacteria. It also includes omeprazole magnesium, a medication which helps reduce stomach acid and makes it easier for the antibiotics to kill the H. pylori bacteria.
The dosage for Talicia is 4 capsules taken every 8 hours with food for 14 days. Capsules should be swallowed whole with a full glass of water. Do not chew or crush capsules. Do not take Talicia with alcohol.

What is H. pylori?

H. pylori is bacteria that can cause an infection in your stomach. It is estimated that 50% of the world’s population is infected with H. pylori, and in the U.S., 36% of the population is believed to have the bacteria living in their stomach.

Is H. pylori infection dangerous?

H. pylori can irritate the lining of your stomach and can cause a variety of symptoms including stomach pain and nausea. If left untreated, H. pylori infection can cause ulcers, which are painful, open sores in your stomach lining that can bleed. Studies have shown that people infected with H. pylori are also more likely to develop stomach cancer. Getting rid of H. pylori from your stomach may reduce the risk of developing stomach irritation, ulcers, and stomach cancer. That is why if your healthcare provider suspects you have H. pylori, you’ll want to take your Talicia as recommended to get rid of the infection.

How is Talicia different?

Talicia is different because it is the only treatment that includes the antibiotic rifabutin along with another antibiotic, amoxicillin. The H. pylori bacteria is more likely to be killed by these antibiotics than older antibiotics that have been used to treat H. pylori in the past.

Does Talicia work?

Talicia was highly effective in killing H. pylori infection in the stomachs of patients in studies. 84% of patients overall no longer had the bacteria in their stomach after 14 days of therapy. In the patients who were confirmed to have taken the medication at the end of the study, 90% no longer had the bacteria in their stomach after 14 days of Talicia therapy.1

Do I have to take the full 14 days of therapy?

H. pylori is a very tough bacteria that can survive if not gotten rid of completely. If it is not removed from your stomach, the infection can also cause other problems.

You may feel better before the end of the 14 days, however, just because symptoms are gone does not mean that H. pylori has been completely killed.

Talicia should be taken exactly as directed and for the entire 14 days. Skipping doses or not completing the therapy may not rid H. pylori from your stomach and may increase the chance that the bacteria will become stronger and may make it more difficult to treat with Talicia or other medications in the future.

It is also recommended that your healthcare professional perform testing about 1 month after you complete therapy to make sure the bacteria is no longer in your stomach.2

What does Talicia look like?

Talicia is an orange-colored capsule with RHB 105 printed on the capsule.

How should I take Talicia?

Talicia should be taken as directed – 4 capsules every 8 hours with food for 14 days. Skipping doses or not completing the therapy may not rid H. pylori from your stomach and may increase the chance that the bacteria will become stronger. The capsules should be swallowed whole with a full glass of water and not crushed or chewed. You should not take Talicia with alcohol.

Download the Talicia Dosing Reminder App to help you stay on schedule

What are the side effects?

Talicia is well tolerated. Only 1% of patients discontinued therapy due to side effects. The most common side effects experienced by 1% or more of patients taking Talicia were diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, vaginal yeast infection and a brown-orange discoloration of the urine, sweat or skin, which goes away after therapy is completed or discontinued.

What should I know about taking Talicia safely?

Most importantly, Talicia should be taken as directed – 4 capsules every 8 hours with food for 14 days. The entire course of therapy should be completed to help make sure the H. pylori bacteria has been killed. The capsules should be swallowed whole with a full glass of water and not crushed or chewed. You should not take Talicia with alcohol.

IMPORTANT SAFETY INFORMATION for Patients

Tell your healthcare provider about all of the medicines you take, including prescription or non-prescription medications or herbal supplements before starting Talicia. Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works. Do not start any new medications while taking Talicia without first speaking with your healthcare provider.

  • You should not take Talicia if you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins.
  • You should not take Talicia if you are taking rilpivirine-containing products, delavirdine or voriconazole

Before you take Talicia, tell your healthcare provider about all of your medical conditions, including if you:

  • Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia.
  • Have severe kidney disease or liver disease

When taking Talicia, do not crush or chew capsules. Do not take Talicia with alcohol.

Call your healthcare provider immediately if while taking Talicia you develop:

  • New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight.

What are the common side effects of Talicia?

  • The most common side effects of Talicia are diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, and vaginal yeast infection. Call your healthcare professional for medical advice about side effects.
  • Tell your healthcare provider if you experience tiredness, weakness, achiness, headaches, dizziness, depression, increased sensitivity to light or pain when taking a deep breath.
  • Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia.
  • You may experience a brown-orange discoloration of your urine or tears while taking Talicia.

Please see full Prescribing Information for Talicia.

You are encouraged to report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PLEASE SEE FULL PRESCRIBING INFORMATION

REFERENCES:

  1. Graham DY, Canaan Y, Maher J, Wiener G, Hulten KG, Kalfus IN. Rifabutin-based triple therapy (RHB-105) for Helicobacter pylori eradication: a double-blind, randomized, controlled trial. Ann Intern Med. 2020;172(12):795-802.
  2. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017;112(2):212-239.