Talicia

— THERAPEUTIC CATEGORIES —
  • Bacterial infections
  • Hyperacidity, GERD, and ulcers
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Talicia Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Omeprazole 10mg, amoxicillin 250mg, rifabutin 12.5mg; delayed-release caps.

    Pharmacological Class

    Proton pump inhibitor + antibiotics (penicillin + rifamycin).

    How Supplied

    Caps—84, 168

    How Supplied

    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 2 bottles of 84 each.

    • Bottle containing 84 capsules

    • Carton containing 2 bottles of 84 capsules

    Storage

    Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

    Manufacturer

    RedHill Biopharma Inc.

    Generic Availability

    NO

    Mechanism of Action

    Amoxicillin acts through the inhibition of cell wall biosynthesis that leads to the death of bacteria. Rifabutin inhibits DNA-dependent RNA polymerase in susceptible microorganisms but not in mammalian cells. Omeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell.

    Talicia Indications

    Indications

    Treatment of H. pylori infection.

    Talicia Dosage and Administration

    Adult

    Swallow whole. Take with food. ≥18yrs: 4 caps three times daily (at least 4hrs apart, eg, morning, mid-day, and evening) for 14 days. Hepatic or severe renal (GFR <30mL/min) impairment: avoid.

    Children

    <18yrs: not established.

    Talicia Contraindications

    Contraindications

    Omeprazole: concomitant rilpivirine-containing products. Rifabutin: concomitant delavirdine, voriconazole.

    Talicia Boxed Warnings

    Not Applicable

    Talicia Warnings/Precautions

    Warnings/Precautions

    Discontinue if hypersensitivity or severe cutaneous reactions occur. Evaluate if diarrhea occurs. Discontinue and evaluate if acute tubulointerstitial nephritis is suspected. Cutaneous and systemic lupus erythematosus. Avoid in those with mononucleosis. Uveitis: refer for an eye exam if suspected; suspend therapy if needed. Hepatic or severe renal impairment (see Adult dose). Pregnancy: not recommended. Nursing mothers.

    Warnings/Precautions

    Hypersensitivity Reactions

    • Serious and fatal hypersensitivity reactions, eg, anaphylaxis, angioedema, erythema multiforme, exfoliative dermatitis, hypersensitivity vasculitis, acute tubulointerstitial nephritis, and serum sickness have been reported.  

    • Prior to initiating treatment, inquire about the history of hypersensitivity reactions to penicillins, cephalosporins, rifamycins, or PPIs.

    • Discontinue if hypersensitivity reactions occur.

    Severe Cutaneous Adverse Reactions

    • Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the components of Talicia: rifabutin, amoxicillin, and omeprazole.

    • Monitor closely and discontinue Talicia at the first signs of SCAR.

    Clostridioides difficile-Associated Diarrhea (CDAD)

    • Evaluate if diarrhea occurs. 

    • Discontinue if CDAD is confirmed. Institute appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation.

    Reduced Efficacy of Hormonal Contraceptives

    • Talicia may reduce the efficacy of hormonal contraceptives. It is recommended to use an additional non-hormonal highly effective method of contraception during treatment with Talicia.

    Acute Tubulointerstitial Nephritis

    • Acute tubulointerstitial nephritis (TIN) has been observed. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions, to nonspecific symptoms of decreased renal function (eg, malaise, nausea, anorexia). 

    • Discontinue and evaluate if acute tubulointerstitial nephritis is suspected.

    Risk of Adverse Reactions or Loss of Efficacy Due to Drug Interactions

    • Avoid concomitant use with other CYP2C19 or CYP3A4 inducers (eg, St. John’s Wort, rifampin). 

    • Avoid concomitant use with CYP2C19 and/or CYP3A4 inhibitors (eg, fluconazole, itraconazole).

    • Avoid concomitant use with certain protease inhibitors (eg, amprenavir, indinavir) or dose adjustments for a concomitantly administered protease inhibitor(s) may be required.

    • Avoid concomitant use with high-dose methotrexate due to risk for methotrexate toxicity.

    • Avoid concomitant use with clopidogrel because Talicia may reduce its effectiveness; consider alternative anti-platelet therapy.

    Cutaneous and Systemic Lupus Erythematosus

    • Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported.

    • Discontinue treatment if symptoms consistent with CLE or SLE deveop.

    Rash in Patients with Mononucleosis

    • Avoid use in patients with mononucleosis.

    Uveitis

    • Monitor carefully if Talicia is used with clarithromycin or other macrolides and/or fluconazole due to the risk for uveitis.

    • Refer for an ophthalmologic evaluation if uveitis is suspected and consider suspending treatment with rifabutin.

    Interactions with Diagnostic Investigations for Neuroendocrine Tumors

    • Assess serum chromogranin A (CgA) levels at least 14 days after Talicia treatment and consider repeating the test if initial CgA levels are high.

    Pregnancy Considerations

    Talicia may cause fetal harm. Use of Talicia is not generally recommended for use in pregnancy.

    Nursing Mother Considerations

    Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Talicia and any potential adverse effects on the breast-fed child from Talicia or from the underlying condition.

    Pediatric Considerations

    Safety and effectiveness of Talicia in pediatric patients aged <18 years with H. pylori infection have not been established. 

    Renal Impairment Considerations

    Avoid use in patients with severe renal impairment.

    Hepatic Impairment Considerations

    Avoid use in patients with hepatic impairment.

    Other Considerations for Specific Populations

    Females and Males of Reproductive Potential

    • Contraception: Female patients taking hormonal contraceptives should use an additional non-hormonal highly effective method of contraception during treatment with Talicia.

    • Infertility: Talicia may impair fertility in males of reproductive potential.

    Talicia Pharmacokinetics

    Absorption

    Amoxicillin

    • Time to reach maximum concentration: 2 hours (range, 1.25–3).

    • Effect of food with a high-fat meal (relative to fasting): 30% reduction in Cmax.

    Omeprazole

    • Time to reach maximum concentration: 1.25 hours (range, 0.75–1.77)

    • Effect of food with a high-fat meal (relative to fasting): 92% reduction in Cmax.

    Rifabutin

    • Time to reach maximum concentration: 3 hours (range, 2–6).

    • Effect of food with a high-fat meal (relative to fasting): 14% increase in Cmax.

    Distribution

    Plasma protein bound: 20% (amoxicillin); 95% (omeprazole); 85% (rifabutin).

    Metabolism

    Amoxicillin

    • Not significantly metabolized.

    Omeprazole

    • Extensively metabolized.

    • CYP2C19 (major), CYP3A4 (minor).

    Rifabutin

    • Of the five metabolites that have been identified, 25-O-desacetyl and 31-hydroxy are the most predominant with a plasma metabolite: parent AUC ratio of 0.10 and 0.07, respectively. 

    • 25-O-desacetylrifabutin has an activity equal to the parent drug with up to 10% to the total antimicrobial activity.

    Elimination

    Amoxicillin

    • Half-life (SD): 1.4 hours (0.2).

    • Renal (60%)

    Omeprazole

    • Half-life (SD): 1 hour (0.3).

    • Renal (77%).

    Rifabutin

    • Half-life (SD): 34 hours (25).

    • Renal (53%), fecal (30%).

    Talicia Interactions

    Interactions

    See Contraindications. May be antagonized by other CYP2C19 or CYP3A4 inducers (eg, St. John's wort, rifampin); avoid. May antagonize hormonal contraceptives; use additional or alternative non-hormonal methods. Omeprazole antagonizes clopidogrel; consider alternative anti-platelet therapy. May be potentiated by CYP2C19 and/or CYP3A inhibitors (eg, fluconazole, itraconazole, posaconazole, clarithromycin); avoid. May potentiate CYP2C19 substrates (eg, citalopram, cilostazol, phenytoin, diazepam), high-dose methotrexate (avoid), digoxin, tacrolimus; monitor. Avoid concomitant amprenavir, indinavir, lopinavir/ritonavir, saquinavir/ritonavir, ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, nelfinavir, alcohol. Amoxicillin potentiated by probenecid. Increased incidence of skin rash with allopurinol; discontinue allopurinol if occurs. Monitor INR, PT with warfarin or other oral anticoagulants. May alter absorption of pH-dependent drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram). May interfere with neuroendocrine diagnostic tests; discontinue Talicia 14 days prior to CgA level assessment; may need to repeat test. Amoxicillin may cause false (+) glucose test with Benedict's soln. May cause false (+) results with secretin stimulation test or urine tests for tetrahydrocannabinol.

    Talicia Adverse Reactions

    Adverse Reactions

    Diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, vulvovaginal candidiasis; possible C. difficile-associated diarrhea, severe cutaneous reactions (eg, SJS, TEN, AGEP, DRESS).

    Talicia Clinical Trials

    Clinical Trials

    Study 1

    • In a randomized, double-blind, controlled study, the efficacy and safety of Talicia was evaluated in treatment-naïve H. pylori-positive adult patients complaining of epigastric pain/discomfort (Study 1, NCT03198507). Patients were randomly assigned to receive either Talicia or control (total daily dose of amoxicillin 3000 mg and omeprazole 120 mg) for 14 consecutive days.

    • Results demonstrated that treatment with Talicia achieved an 83.8% eradication of H. pylori infection compared with 57.7% in the control arm (P <.0001).

    Study 2

    • In a randomized, double-blind, placeo-controlled study, the efficacy and safety of Talicia was evaluated in H. pylori-positive adult patients complaining of epigastric pain/discomfort. Patients were randomly assigned to receive either Talicia or placebo.

    • Results demonstrated that treatment with Talicia achieved a 76.6% eradication of H. pylori infection compared with 2.4% in the placebo arm.

    Talicia Note

    Not Applicable

    Talicia Patient Counseling

    Patient Counseling

    Hypersensitivity Reactions

    • Advise patients to contact their healthcare provider immediately if they develop new rash, skin lesions, muscle or joint pains, swelling, severe flu-like symptoms, difficulty breathing or visual symptoms.

    Severe Cutaneous Adverse Reactions

    • Advise patients to discontinue Talicia immediately if signs or symptoms of serious skin manifestations occur (eg, skin rash, mucosal lesions, or any other sign of hypersensitivity).

    Diarrhea 

    • Advise patients to contact their healthcare provider immediately if they experience bloody diarrhea, persistent abdominal pain, fever, or chronic diarrhea that does not resolve.

    Brown-Orange Discoloration

    • Urine, feces, saliva, sputum, perspiration, tears, and skin may be colored brown-orange. Soft contact lenses may be permanently stained.

    • Inform patients of these risks and counsel the patient that these should resolve after therapy is completed.

    Drug Interactions

    • Advise patients not to take St. John’s Wort, amoxicillin or other penicillin products, rifabutin or other rifamycins, over-the counter (OTC) omeprazole or other PPIs during treatment with Talicia.

    Contraception

    • Counsel females of reproductive potential who are taking oral or other forms of hormonal birth-control medications to use an additional non-hormonal highly effective method of contraception while taking Talicia.

    Embryo-Fetal Toxicity

    • Advise females taking Talicia that it is not recommended for use during pregnancy.

    • Inform patients to contact their healthcare provider if they have known or are suspected to be pregnant.

    Cutaneous or Systemic Lupus

    • Report any symptoms associated with cutaneous or systemic lupus erythematosus.

    Acute Tubulointerstitial Nephritis

    • Advise patients to contact their healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis (TIN).

    Cost Savings Program

    Talicia Savings Program

    Talicia Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Omeprazole 10mg, amoxicillin 250mg, rifabutin 12.5mg; delayed-release caps.

    Pharmacological Class

    Proton pump inhibitor + antibiotics (penicillin + rifamycin).

    How Supplied

    Caps—84, 168

    How Supplied

    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 2 bottles of 84 each.

    • Bottle containing 84 capsules

    • Carton containing 2 bottles of 84 capsules

    Storage

    Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

    Manufacturer

    RedHill Biopharma Inc.

    Generic Availability

    NO

    Mechanism of Action

    Amoxicillin acts through the inhibition of cell wall biosynthesis that leads to the death of bacteria. Rifabutin inhibits DNA-dependent RNA polymerase in susceptible microorganisms but not in mammalian cells. Omeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell.

    Talicia Indications

    Indications

    Treatment of H. pylori infection.

    Talicia Dosage and Administration

    Adult

    Swallow whole. Take with food. ≥18yrs: 4 caps three times daily (at least 4hrs apart, eg, morning, mid-day, and evening) for 14 days. Hepatic or severe renal (GFR <30mL/min) impairment: avoid.

    Children

    <18yrs: not established.

    Talicia Contraindications

    Contraindications

    Omeprazole: concomitant rilpivirine-containing products. Rifabutin: concomitant delavirdine, voriconazole.

    Talicia Boxed Warnings

    Not Applicable

    Talicia Warnings/Precautions

    Warnings/Precautions

    Discontinue if hypersensitivity or severe cutaneous reactions occur. Evaluate if diarrhea occurs. Discontinue and evaluate if acute tubulointerstitial nephritis is suspected. Cutaneous and systemic lupus erythematosus. Avoid in those with mononucleosis. Uveitis: refer for an eye exam if suspected; suspend therapy if needed. Hepatic or severe renal impairment (see Adult dose). Pregnancy: not recommended. Nursing mothers.

    Warnings/Precautions

    Hypersensitivity Reactions

    • Serious and fatal hypersensitivity reactions, eg, anaphylaxis, angioedema, erythema multiforme, exfoliative dermatitis, hypersensitivity vasculitis, acute tubulointerstitial nephritis, and serum sickness have been reported.  

    • Prior to initiating treatment, inquire about the history of hypersensitivity reactions to penicillins, cephalosporins, rifamycins, or PPIs.

    • Discontinue if hypersensitivity reactions occur.

    Severe Cutaneous Adverse Reactions

    • Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the components of Talicia: rifabutin, amoxicillin, and omeprazole.

    • Monitor closely and discontinue Talicia at the first signs of SCAR.

    Clostridioides difficile-Associated Diarrhea (CDAD)

    • Evaluate if diarrhea occurs. 

    • Discontinue if CDAD is confirmed. Institute appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation.

    Reduced Efficacy of Hormonal Contraceptives

    • Talicia may reduce the efficacy of hormonal contraceptives. It is recommended to use an additional non-hormonal highly effective method of contraception during treatment with Talicia.

    Acute Tubulointerstitial Nephritis

    • Acute tubulointerstitial nephritis (TIN) has been observed. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions, to nonspecific symptoms of decreased renal function (eg, malaise, nausea, anorexia). 

    • Discontinue and evaluate if acute tubulointerstitial nephritis is suspected.

    Risk of Adverse Reactions or Loss of Efficacy Due to Drug Interactions

    • Avoid concomitant use with other CYP2C19 or CYP3A4 inducers (eg, St. John’s Wort, rifampin). 

    • Avoid concomitant use with CYP2C19 and/or CYP3A4 inhibitors (eg, fluconazole, itraconazole).

    • Avoid concomitant use with certain protease inhibitors (eg, amprenavir, indinavir) or dose adjustments for a concomitantly administered protease inhibitor(s) may be required.

    • Avoid concomitant use with high-dose methotrexate due to risk for methotrexate toxicity.

    • Avoid concomitant use with clopidogrel because Talicia may reduce its effectiveness; consider alternative anti-platelet therapy.

    Cutaneous and Systemic Lupus Erythematosus

    • Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported.

    • Discontinue treatment if symptoms consistent with CLE or SLE deveop.

    Rash in Patients with Mononucleosis

    • Avoid use in patients with mononucleosis.

    Uveitis

    • Monitor carefully if Talicia is used with clarithromycin or other macrolides and/or fluconazole due to the risk for uveitis.

    • Refer for an ophthalmologic evaluation if uveitis is suspected and consider suspending treatment with rifabutin.

    Interactions with Diagnostic Investigations for Neuroendocrine Tumors

    • Assess serum chromogranin A (CgA) levels at least 14 days after Talicia treatment and consider repeating the test if initial CgA levels are high.

    Pregnancy Considerations

    Talicia may cause fetal harm. Use of Talicia is not generally recommended for use in pregnancy.

    Nursing Mother Considerations

    Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Talicia and any potential adverse effects on the breast-fed child from Talicia or from the underlying condition.

    Pediatric Considerations

    Safety and effectiveness of Talicia in pediatric patients aged <18 years with H. pylori infection have not been established. 

    Renal Impairment Considerations

    Avoid use in patients with severe renal impairment.

    Hepatic Impairment Considerations

    Avoid use in patients with hepatic impairment.

    Other Considerations for Specific Populations

    Females and Males of Reproductive Potential

    • Contraception: Female patients taking hormonal contraceptives should use an additional non-hormonal highly effective method of contraception during treatment with Talicia.

    • Infertility: Talicia may impair fertility in males of reproductive potential.

    Talicia Pharmacokinetics

    Absorption

    Amoxicillin

    • Time to reach maximum concentration: 2 hours (range, 1.25–3).

    • Effect of food with a high-fat meal (relative to fasting): 30% reduction in Cmax.

    Omeprazole

    • Time to reach maximum concentration: 1.25 hours (range, 0.75–1.77)

    • Effect of food with a high-fat meal (relative to fasting): 92% reduction in Cmax.

    Rifabutin

    • Time to reach maximum concentration: 3 hours (range, 2–6).

    • Effect of food with a high-fat meal (relative to fasting): 14% increase in Cmax.

    Distribution

    Plasma protein bound: 20% (amoxicillin); 95% (omeprazole); 85% (rifabutin).

    Metabolism

    Amoxicillin

    • Not significantly metabolized.

    Omeprazole

    • Extensively metabolized.

    • CYP2C19 (major), CYP3A4 (minor).

    Rifabutin

    • Of the five metabolites that have been identified, 25-O-desacetyl and 31-hydroxy are the most predominant with a plasma metabolite: parent AUC ratio of 0.10 and 0.07, respectively. 

    • 25-O-desacetylrifabutin has an activity equal to the parent drug with up to 10% to the total antimicrobial activity.

    Elimination

    Amoxicillin

    • Half-life (SD): 1.4 hours (0.2).

    • Renal (60%)

    Omeprazole

    • Half-life (SD): 1 hour (0.3).

    • Renal (77%).

    Rifabutin

    • Half-life (SD): 34 hours (25).

    • Renal (53%), fecal (30%).

    Talicia Interactions

    Interactions

    See Contraindications. May be antagonized by other CYP2C19 or CYP3A4 inducers (eg, St. John's wort, rifampin); avoid. May antagonize hormonal contraceptives; use additional or alternative non-hormonal methods. Omeprazole antagonizes clopidogrel; consider alternative anti-platelet therapy. May be potentiated by CYP2C19 and/or CYP3A inhibitors (eg, fluconazole, itraconazole, posaconazole, clarithromycin); avoid. May potentiate CYP2C19 substrates (eg, citalopram, cilostazol, phenytoin, diazepam), high-dose methotrexate (avoid), digoxin, tacrolimus; monitor. Avoid concomitant amprenavir, indinavir, lopinavir/ritonavir, saquinavir/ritonavir, ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, nelfinavir, alcohol. Amoxicillin potentiated by probenecid. Increased incidence of skin rash with allopurinol; discontinue allopurinol if occurs. Monitor INR, PT with warfarin or other oral anticoagulants. May alter absorption of pH-dependent drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram). May interfere with neuroendocrine diagnostic tests; discontinue Talicia 14 days prior to CgA level assessment; may need to repeat test. Amoxicillin may cause false (+) glucose test with Benedict's soln. May cause false (+) results with secretin stimulation test or urine tests for tetrahydrocannabinol.

    Talicia Adverse Reactions

    Adverse Reactions

    Diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, vulvovaginal candidiasis; possible C. difficile-associated diarrhea, severe cutaneous reactions (eg, SJS, TEN, AGEP, DRESS).

    Talicia Clinical Trials

    Clinical Trials

    Study 1

    • In a randomized, double-blind, controlled study, the efficacy and safety of Talicia was evaluated in treatment-naïve H. pylori-positive adult patients complaining of epigastric pain/discomfort (Study 1, NCT03198507). Patients were randomly assigned to receive either Talicia or control (total daily dose of amoxicillin 3000 mg and omeprazole 120 mg) for 14 consecutive days.

    • Results demonstrated that treatment with Talicia achieved an 83.8% eradication of H. pylori infection compared with 57.7% in the control arm (P <.0001).

    Study 2

    • In a randomized, double-blind, placeo-controlled study, the efficacy and safety of Talicia was evaluated in H. pylori-positive adult patients complaining of epigastric pain/discomfort. Patients were randomly assigned to receive either Talicia or placebo.

    • Results demonstrated that treatment with Talicia achieved a 76.6% eradication of H. pylori infection compared with 2.4% in the placebo arm.

    Talicia Note

    Not Applicable

    Talicia Patient Counseling

    Patient Counseling

    Hypersensitivity Reactions

    • Advise patients to contact their healthcare provider immediately if they develop new rash, skin lesions, muscle or joint pains, swelling, severe flu-like symptoms, difficulty breathing or visual symptoms.

    Severe Cutaneous Adverse Reactions

    • Advise patients to discontinue Talicia immediately if signs or symptoms of serious skin manifestations occur (eg, skin rash, mucosal lesions, or any other sign of hypersensitivity).

    Diarrhea 

    • Advise patients to contact their healthcare provider immediately if they experience bloody diarrhea, persistent abdominal pain, fever, or chronic diarrhea that does not resolve.

    Brown-Orange Discoloration

    • Urine, feces, saliva, sputum, perspiration, tears, and skin may be colored brown-orange. Soft contact lenses may be permanently stained.

    • Inform patients of these risks and counsel the patient that these should resolve after therapy is completed.

    Drug Interactions

    • Advise patients not to take St. John’s Wort, amoxicillin or other penicillin products, rifabutin or other rifamycins, over-the counter (OTC) omeprazole or other PPIs during treatment with Talicia.

    Contraception

    • Counsel females of reproductive potential who are taking oral or other forms of hormonal birth-control medications to use an additional non-hormonal highly effective method of contraception while taking Talicia.

    Embryo-Fetal Toxicity

    • Advise females taking Talicia that it is not recommended for use during pregnancy.

    • Inform patients to contact their healthcare provider if they have known or are suspected to be pregnant.

    Cutaneous or Systemic Lupus

    • Report any symptoms associated with cutaneous or systemic lupus erythematosus.

    Acute Tubulointerstitial Nephritis

    • Advise patients to contact their healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis (TIN).

    Cost Savings Program

    Talicia Savings Program

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