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Drug Interactions between bictegravir / emtricitabine / tenofovir alafenamide and Mi-Acid II

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

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Interactions between your drugs

Major

aluminum hydroxide bictegravir

Applies to: Mi-Acid II (aluminum hydroxide / magnesium hydroxide / simethicone) and bictegravir / emtricitabine / tenofovir alafenamide

ADJUST DOSING INTERVAL: Concurrent administration of medications or oral supplements containing polyvalent cations such as aluminum, calcium, iron, or magnesium may decrease the oral bioavailability of bictegravir. The mechanism of interaction has not been described.

Antacids - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 20 mL dose of maximum strength antacid (aluminum hydroxide-magnesium hydroxide-simethicone 80 mg-80 mg-8 mg/mL) under fasted conditions decreased mean bictegravir peak plasma concentration (Cmax) and systemic exposure (AUC) by approximately 80%, whereas simultaneous administration under fed conditions decreased mean bictegravir Cmax and AUC by approximately 50%. When the antacid was administered 2 hours before bictegravir under fasted conditions, mean Cmax and AUC of bictegravir decreased by 58% and 52%, respectively. However, when the antacid was administered 2 hours after bictegravir under fasted conditions, mean Cmax and AUC of bictegravir decreased by just 7% and 13%, respectively.

Calcium - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 1200 mg dose of calcium carbonate under fasted conditions decreased mean Cmax and AUC of bictegravir by 42% and 33%, respectively, while simultaneous administration under fed conditions had no significant effects on the Cmax and AUC of bictegravir.

Iron - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 324 mg dose of ferrous fumarate under fasted conditions decreased mean Cmax and AUC of bictegravir by 71% and 63%, respectively, while simultaneous administration under fed conditions decreased mean bictegravir Cmax and AUC by just 25% and 16%, respectively.

Sucralfate - Sucralfate contains the polyvalent cation aluminum. Concomitant administration with bictegravir is expected to lead to reduced plasma concentrations of bictegravir similar to that observed with antacids. However, data are not available.

MANAGEMENT: When used with antacids containing aluminum, magnesium or calcium, bictegravir may be taken under fasting conditions 2 hours before the antacids. Routine administration of bictegravir simultaneously with, or 2 hours after, antacids containing aluminum, magnesium or calcium is not recommended. When used with supplements containing calcium or iron, bictegravir and the supplements may be taken together with food. Routine administration of bictegravir under fasting conditions simultaneously with, or 2 hours after, supplements containing calcium or iron is not recommended.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Biktarvy (bictegravir/emtricitabine/tenofovir)." Gilead Sciences (2018):

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Major

magnesium hydroxide bictegravir

Applies to: Mi-Acid II (aluminum hydroxide / magnesium hydroxide / simethicone) and bictegravir / emtricitabine / tenofovir alafenamide

ADJUST DOSING INTERVAL: Concurrent administration of medications or oral supplements containing polyvalent cations such as aluminum, calcium, iron, or magnesium may decrease the oral bioavailability of bictegravir. The mechanism of interaction has not been described.

Antacids - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 20 mL dose of maximum strength antacid (aluminum hydroxide-magnesium hydroxide-simethicone 80 mg-80 mg-8 mg/mL) under fasted conditions decreased mean bictegravir peak plasma concentration (Cmax) and systemic exposure (AUC) by approximately 80%, whereas simultaneous administration under fed conditions decreased mean bictegravir Cmax and AUC by approximately 50%. When the antacid was administered 2 hours before bictegravir under fasted conditions, mean Cmax and AUC of bictegravir decreased by 58% and 52%, respectively. However, when the antacid was administered 2 hours after bictegravir under fasted conditions, mean Cmax and AUC of bictegravir decreased by just 7% and 13%, respectively.

Calcium - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 1200 mg dose of calcium carbonate under fasted conditions decreased mean Cmax and AUC of bictegravir by 42% and 33%, respectively, while simultaneous administration under fed conditions had no significant effects on the Cmax and AUC of bictegravir.

Iron - In healthy volunteers, administration of a single 50 mg dose of bictegravir simultaneously with a 324 mg dose of ferrous fumarate under fasted conditions decreased mean Cmax and AUC of bictegravir by 71% and 63%, respectively, while simultaneous administration under fed conditions decreased mean bictegravir Cmax and AUC by just 25% and 16%, respectively.

Sucralfate - Sucralfate contains the polyvalent cation aluminum. Concomitant administration with bictegravir is expected to lead to reduced plasma concentrations of bictegravir similar to that observed with antacids. However, data are not available.

MANAGEMENT: When used with antacids containing aluminum, magnesium or calcium, bictegravir may be taken under fasting conditions 2 hours before the antacids. Routine administration of bictegravir simultaneously with, or 2 hours after, antacids containing aluminum, magnesium or calcium is not recommended. When used with supplements containing calcium or iron, bictegravir and the supplements may be taken together with food. Routine administration of bictegravir under fasting conditions simultaneously with, or 2 hours after, supplements containing calcium or iron is not recommended.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Biktarvy (bictegravir/emtricitabine/tenofovir)." Gilead Sciences (2018):

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Drug and food interactions

Major

aluminum hydroxide food

Applies to: Mi-Acid II (aluminum hydroxide / magnesium hydroxide / simethicone)

GENERALLY AVOID: The concomitant administration of aluminum-containing products (e.g., antacids and phosphate binders) and citrates may significantly increase serum aluminum concentrations, resulting in toxicity. Citrates or citric acid are contained in numerous soft drinks, citrus fruits, juices, and effervescent and dispersible drug formulations. Citrates enhance the gastrointestinal absorption of aluminum by an unknown mechanism, which may involve the formation of a soluble aluminum-citrate complex. Various studies have reported that citrate increases aluminum absorption by 4.6- to 50-fold in healthy subjects. Patients with renal insufficiency are particularly at risk of developing hyperaluminemia and encephalopathy. Fatalities have been reported. Patients with renal failure or on hemodialysis may also be at risk from soft drinks and effervescent and dispersible drug formulations that contain citrates or citric acid. It is unknown what effect citrus fruits or juices would have on aluminum absorption in healthy patients.

MANAGEMENT: The concomitant use of aluminum- and citrate-containing products and foods should be avoided by renally impaired patients. Hemodialysis patients should especially be cautioned about effervescent and dispersible over-the-counter remedies and soft drinks. Some experts also recommend that healthy patients should separate doses of aluminum-containing antacids and citrates by 2 to 3 hours.

ADJUST DOSING INTERVAL: The administration of aluminum-containing antacids with enteral nutrition may result in precipitation, formation of bezoars, and obstruction of feeding tubes. The proposed mechanism is the formation of an insoluble complex between the aluminum and the protein in the enteral feeding. Several cases of esophageal plugs and nasogastric tube obstructions have been reported in patients receiving high-protein liquids and an aluminum hydroxide-magnesium hydroxide antacid or an aluminum hydroxide antacid.

MANAGEMENT: Some experts recommend that antacids should not be mixed with or given after high protein formulations, that the antacid dose should be separated from the feeding by as much as possible, and that the tube should be thoroughly flushed before administration.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Wohlt PD, Zheng L, Gunderson S, Balzar SA, Johnson BD, Fish JT "Recommendations for the use of medications with continuous enteral nutrition." Am J Health Syst Pharm 66 (2009): 1438-67

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Minor

tenofovir food

Applies to: bictegravir / emtricitabine / tenofovir alafenamide

Food enhances the oral absorption and bioavailability of tenofovir, the active entity of tenofovir disoproxil fumarate. According to the product labeling, administration of the drug following a high-fat meal increased the mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of tenofovir by approximately 14% and 40%, respectively, compared to administration in the fasting state. However, administration with a light meal did not significantly affect the pharmacokinetics of tenofovir compared to administration in the fasting state. Food delays the time to reach tenofovir Cmax by approximately 1 hour. Tenofovir disoproxil fumarate may be administered without regard to meals.

References

  1. "Product Information. Viread (tenofovir)." Gilead Sciences (2001):

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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

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