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Drug Interactions between Helidac and nivolumab

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

tetracycline bismuth subsalicylate

Applies to: Helidac (bismuth subsalicylate / metronidazole / tetracycline) and Helidac (bismuth subsalicylate / metronidazole / tetracycline)

Using bismuth subsalicylate together with tetracycline may decrease the effects of tetracycline. Administration of tetracycline and bismuth subsalicylate should be separated by two to three hours. If your doctor does prescribe these medications together, you may need a dose adjustment or special test to safely use both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Moderate

tetracycline nivolumab

Applies to: Helidac (bismuth subsalicylate / metronidazole / tetracycline) and nivolumab

Consumer information for this interaction is not currently available.

MONITOR: Use of systemic antibiotics during or close to therapy with immune checkpoint inhibitors (ICIs) such as anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 monoclonal antibodies and/or inhibitors of programmed cell death-1 (PD-1)/programmed death ligand-1 (PD-L1) may result in reduced clinical efficacy of the ICI. The exact mechanism of this interaction has not been fully characterized, but may be related to alterations in the gut microbiota by the systemic antibiotic, potentially resulting in immune dysregulation and a decreased response to the ICI. A meta-analysis of 6 studies involving nivolumab for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) found that the median progression-free survival (PFS) and overall survival (OS) were reduced by 1.6 months and 8.8 months, respectively, in patients who were exposed to systemic antibiotics before, during, or after nivolumab therapy. Similarly, a single-site retrospective review of patients (n=291) with advanced cancer (melanoma, NSCLC, or renal cell carcinoma) treated with ICI(s) also revealed poorer clinical outcomes associated with the receipt of systemic antibiotics. This study divided patients into 3 groups: no antibiotics, single course of antibiotics, or cumulative courses of antibiotics (i.e., administration of concurrent or successive antibiotics for >7 days) during the 2 weeks prior to and 6 weeks after ICI treatment. The median PFS (6.3 months vs. 3.7 months vs. 2.8 months, respectively) and median OS (21.7 months vs. 17.7 months vs. 6.3 months, respectively) decreased as the antibiotic use increased, though the difference between no antibiotic use and cumulative courses of antibiotics was the only difference determined to be clinically significant. Additionally, a different retrospective analysis of patients (n=635) with advanced cancer treated with ICIs found that antibiotic use was associated with significantly shorter median OS (8 months vs. 23 months), median PFS (4 months vs. 7 months), as well as a reduction in tumor response (57% vs. 71%) when compared to patients who did not receive antibiotics. In contrast, a retrospective study of patients (n=302) with stage IV NSCLC treated with first-line chemo-immunotherapy combinations (i.e., ICI and cytotoxic chemotherapy) had similar OS, PFS, and objective response rate between those who did and did not receive antibiotics during the 30 days prior to initiating an ICI. The receipt of concurrent systemic antibiotics in this patient population was likewise not associated with changes in OS nor PFS.

MANAGEMENT: Until more information is available, caution and clinical monitoring for reduced efficacy of immune checkpoint inhibitors (ICIs) are advised if systemic antibiotics are indicated prior to, concurrently with, or after an ICI. Antibiotic use should be limited to clinically appropriate indications and durations. Clinicians should consult relevant literature, local and national treatment guidelines, and package labeling for further guidance.

Moderate

metroNIDAZOLE nivolumab

Applies to: Helidac (bismuth subsalicylate / metronidazole / tetracycline) and nivolumab

Consumer information for this interaction is not currently available.

MONITOR: Use of systemic antibiotics during or close to therapy with immune checkpoint inhibitors (ICIs) such as anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 monoclonal antibodies and/or inhibitors of programmed cell death-1 (PD-1)/programmed death ligand-1 (PD-L1) may result in reduced clinical efficacy of the ICI. The exact mechanism of this interaction has not been fully characterized, but may be related to alterations in the gut microbiota by the systemic antibiotic, potentially resulting in immune dysregulation and a decreased response to the ICI. A meta-analysis of 6 studies involving nivolumab for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) found that the median progression-free survival (PFS) and overall survival (OS) were reduced by 1.6 months and 8.8 months, respectively, in patients who were exposed to systemic antibiotics before, during, or after nivolumab therapy. Similarly, a single-site retrospective review of patients (n=291) with advanced cancer (melanoma, NSCLC, or renal cell carcinoma) treated with ICI(s) also revealed poorer clinical outcomes associated with the receipt of systemic antibiotics. This study divided patients into 3 groups: no antibiotics, single course of antibiotics, or cumulative courses of antibiotics (i.e., administration of concurrent or successive antibiotics for >7 days) during the 2 weeks prior to and 6 weeks after ICI treatment. The median PFS (6.3 months vs. 3.7 months vs. 2.8 months, respectively) and median OS (21.7 months vs. 17.7 months vs. 6.3 months, respectively) decreased as the antibiotic use increased, though the difference between no antibiotic use and cumulative courses of antibiotics was the only difference determined to be clinically significant. Additionally, a different retrospective analysis of patients (n=635) with advanced cancer treated with ICIs found that antibiotic use was associated with significantly shorter median OS (8 months vs. 23 months), median PFS (4 months vs. 7 months), as well as a reduction in tumor response (57% vs. 71%) when compared to patients who did not receive antibiotics. In contrast, a retrospective study of patients (n=302) with stage IV NSCLC treated with first-line chemo-immunotherapy combinations (i.e., ICI and cytotoxic chemotherapy) had similar OS, PFS, and objective response rate between those who did and did not receive antibiotics during the 30 days prior to initiating an ICI. The receipt of concurrent systemic antibiotics in this patient population was likewise not associated with changes in OS nor PFS.

MANAGEMENT: Until more information is available, caution and clinical monitoring for reduced efficacy of immune checkpoint inhibitors (ICIs) are advised if systemic antibiotics are indicated prior to, concurrently with, or after an ICI. Antibiotic use should be limited to clinically appropriate indications and durations. Clinicians should consult relevant literature, local and national treatment guidelines, and package labeling for further guidance.

Drug and food interactions

Major

metroNIDAZOLE food

Applies to: Helidac (bismuth subsalicylate / metronidazole / tetracycline)

Consumption of alcoholic beverages or products containing alcohol or propylene glycol during treatment with metroNIDAZOLE is not recommended. Doing so may occasionally trigger a reaction in some patients similar to the disulfiram reaction, which includes unpleasant effects such as flushing, throbbing in head and neck, throbbing headache, difficulty breathing, nausea, vomiting, sweating, thirst, chest pain, rapid heartbeat, palpitation, low blood pressure, dizziness, lightheadedness, blurred vision, and confusion. Rarely, more severe reactions may include abnormal heart rhythm, heart attack, heart failure, unconsciousness, convulsions, and even death. Patients treated with metroNIDAZOLE should continue to avoid using any products containing alcohol or propylene glycol for at least 3 days until after completion of therapy. Talk to your doctor or pharmacist if you have questions on how to take this or other medications you are prescribed. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Moderate

tetracycline food

Applies to: Helidac (bismuth subsalicylate / metronidazole / tetracycline)

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking tetracycline. These products can make tetracycline less effective in treating your infection. Do not take tetracycline with milk or other dairy products, unless your doctor has told you to. Dairy products can make it harder for your body to absorb the medication.

Moderate

tetracycline food

Applies to: Helidac (bismuth subsalicylate / metronidazole / tetracycline)

Iron can bind to tetracycline in the gastrointestinal tract, which may prevent their absorption into the bloodstream and possibly reduce their effectiveness. To avoid or minimize the interaction, iron-containing medications and tetracycline should preferably be taken at least three to four hours apart in most cases. Talk to your doctor if you have any questions or concerns, or if you have trouble separating the dosing times. Your doctor may be able to prescribe alternatives that do not interact. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.