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Drug Interactions between ombitasvir / paritaprevir / ritonavir and venetoclax

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

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Interactions between your drugs

Major

ritonavir venetoclax

Applies to: ombitasvir / paritaprevir / ritonavir and venetoclax

CONTRAINDICATED: Coadministration with potent inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of venetoclax, which is primarily metabolized by the isoenzyme. In 11 previously treated non-Hodgkin's lymphoma patients, venetoclax peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 2.3- and 6.4-fold, respectively, when coadministered with 400 mg once daily for 7 days of ketoconazole, a potent CYP450 3A4 inhibitor. Additionally, inhibition of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) efflux transporters by ketoconazole may contribute. Increased venetoclax exposure may potentiate the risk of tumor lysis syndrome, particularly at initiation of therapy and during the dosage ramp-up phase, as well as other adverse effects such as diarrhea, nausea, vomiting, neutropenia, anemia, and thrombocytopenia.

MANAGEMENT: Concomitant use of potent CYP450 3A4 inhibitors at initiation and during the dosage ramp-up phase of venetoclax is considered contraindicated. If a potent CYP450 3A4 inhibitor is required after the ramp-up phase, the manufacturer recommends that venetoclax dosage be reduced by at least 75%. The dosage used prior to initiating the CYP450 3A4 inhibitor may be resumed 2 to 3 days after discontinuation of the inhibitor.

References

  1. (2016) "Product Information. Venclexta (venetoclax)." AbbVie US LLC

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Major

paritaprevir venetoclax

Applies to: ombitasvir / paritaprevir / ritonavir and venetoclax

GENERALLY AVOID: Coadministration with P-glycoprotein (P-gp) inhibitors may increase the plasma concentrations of venetoclax, which is a substrate of this efflux transporter. Administration of venetoclax with a single dose of rifampin, a P-gp inhibitor when given acutely, increased venetoclax Cmax by 106% and AUC by 78%. Increased venetoclax exposure may potentiate the risk of tumor lysis syndrome, particularly at initiation of therapy and during the dosage ramp-up phase, as well as other adverse effects such as diarrhea, nausea, vomiting, neutropenia, anemia, and thrombocytopenia.

MANAGEMENT: Concomitant use of venetoclax with P-gp inhibitors should generally be avoided. If coadministration is required, the manufacturer recommends that venetoclax dosage be reduced by at least 50%. The dosage used prior to initiating the P-gp inhibitor may be resumed 2 to 3 days after discontinuation of the inhibitor.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2016) "Product Information. Venclexta (venetoclax)." AbbVie US LLC

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Moderate

ombitasvir venetoclax

Applies to: ombitasvir / paritaprevir / ritonavir and venetoclax

GENERALLY AVOID: Coadministration with venetoclax may increase the plasma concentrations of drugs that are substrates of P-glycoprotein (P-gp). The proposed mechanism is decreased clearance due to inhibition of P-glycoprotein-mediated drug efflux in the intestine, liver, and/or kidney by venetoclax. Data are available for the P-gp substrate digoxin. When a single 0.5 mg dose of digoxin was coadministered with a single 100 mg dose of venetoclax, digoxin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 35% and 9%, respectively.

MANAGEMENT: Caution is advised when venetoclax is prescribed with drugs that are P-gp substrates, particularly those with a narrow therapeutic range such as digoxin and dabigatran etexilate. Alternatives should be considered whenever possible. The manufacturer recommends that drugs sensitive to P-gp inhibition in the gastrointestinal tract be administered at least 6 hours before venetoclax. Dosage adjustments as well as clinical and laboratory monitoring may be appropriate following the initiation or discontinuation of venetoclax.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2016) "Product Information. Venclexta (venetoclax)." AbbVie US LLC

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Drug and food interactions

Major

venetoclax food

Applies to: venetoclax

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of venetoclax. Relative to fasting conditions, venetoclax systemic exposure (AUC) increased by approximately 3.4-fold when administered with a low-fat meal and by 5.1- to 5.3-fold when administered with a high-fat meal.

GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations of venetoclax. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Increased venetoclax exposure may potentiate the risk of tumor lysis syndrome, particularly at initiation of therapy and during the dosage ramp-up phase, as well as other adverse effects such as diarrhea, nausea, vomiting, neutropenia, anemia, and thrombocytopenia.

MANAGEMENT: Venetoclax should be administered with a meal and water at approximately the same time each day. Patients should avoid consumption of grapefruit products, Seville oranges, and starfruit during treatment with venetoclax.

References

  1. (2016) "Product Information. Venclexta (venetoclax)." AbbVie US LLC

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Moderate

ritonavir food

Applies to: ombitasvir / paritaprevir / ritonavir

ADJUST DOSING INTERVAL: Administration with food may modestly affect the bioavailability of ritonavir from the various available formulations. When the oral solution was given under nonfasting conditions, peak ritonavir concentrations decreased 23% and the extent of absorption decreased 7% relative to fasting conditions. Dilution of the oral solution (within one hour of dosing) with 240 mL of chocolate milk or a nutritional supplement (Advera or Ensure) did not significantly affect the extent and rate of ritonavir absorption. When a single 100 mg dose of the tablet was administered with a high-fat meal (907 kcal; 52% fat, 15% protein, 33% carbohydrates), approximately 20% decreases in mean peak concentration (Cmax) and systemic exposure (AUC) were observed relative to administration after fasting. Similar decreases in Cmax and AUC were reported when the tablet was administered with a moderate-fat meal. In contrast, the extent of absorption of ritonavir from the soft gelatin capsule formulation was 13% higher when administered with a meal (615 KCal; 14.5% fat, 9% protein, and 76% carbohydrate) relative to fasting.

MANAGEMENT: Ritonavir should be taken with meals to enhance gastrointestinal tolerability.

References

  1. (2001) "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical

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Moderate

paritaprevir food

Applies to: ombitasvir / paritaprevir / ritonavir

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of ombitasvir, paritaprevir, ritonavir, and dasabuvir. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a moderate-fat meal (approximately 600 Kcal; 20% to 30% calories from fat) increased the mean systemic exposure (AUC) by 82%, 211%, 49%, and 30%, respectively. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a high-fat meal (approximately 900 Kcal; with 60% calories from fat) increased the mean AUC by 76%, 180%, 44%, and 22%, respectively.

MANAGEMENT: Ombitasvir/paritaprevir/ritonavir plus dasabuvir should always be administered with a meal. The fat or calorie content does not matter.

References

  1. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC

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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.

See also

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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.

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