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Drug Interactions between Afinitor Disperz and ombitasvir / paritaprevir / ritonavir

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

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Interactions between your drugs

Major

ritonavir everolimus

Applies to: ombitasvir / paritaprevir / ritonavir and Afinitor Disperz (everolimus)

GENERALLY AVOID: Coadministration with potent inhibitors of CYP450 3A4 and P-glycoprotein may significantly increase the plasma concentrations of everolimus following oral administration. Everolimus is a substrate of both the CYP450 3A4 isoenzyme and P-glycoprotein drug efflux transporter, thus their inhibition in the intestine can enhance the absorption of everolimus. The risk of side effects such as pneumonitis, stomatitis, infection, dyspnea, diarrhea, anemia, leucopenia, thrombocytopenia, hyperglycemia, and hyperlipidemia may be increased.

MANAGEMENT: Concomitant use of everolimus with potent inhibitors of CYP450 3A4 and P-glycoprotein should generally be avoided. Some authorities recommend avoiding concomitant use of everolimus during and for 2 weeks after treatment with itraconazole.

References

  1. "Product Information. Sporanox (itraconazole)." Janssen Pharmaceuticals PROD (2002):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals (2009):
  4. Homma S, Takahashi KI, Nihei S, Kato F, Sugihara S, Nunoda S "The successful management of respiratory complications with long-term, low-dose macrolide administration in pediatric heart transplant recipients." Int Heart J (2014):
View all 4 references

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Major

everolimus paritaprevir

Applies to: Afinitor Disperz (everolimus) and ombitasvir / paritaprevir / ritonavir

CONTRAINDICATED: Coadministration of ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, may significantly increase the blood concentrations of tacrolimus, sirolimus, and everolimus. The proposed mechanism involves ritonavir inhibition of intestinal and hepatic CYP450 3A4, the isoenzyme responsible for the metabolic clearance of these immunosuppressants. Enhanced oral bioavailability due to inhibition of intestinal P-glycoprotein (P-gp) efflux transporter by ritonavir, paritaprevir, and dasabuvir may also contribute. When a single dose of tacrolimus was administered with ombitasvir/paritaprevir/ritonavir in healthy study subjects, tacrolimus peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) increased by approximately 4.3-, 85.8- and 24.6-fold, respectively, compared to tacrolimus administered alone. Likewise, sirolimus Cmax, AUC and Cmin increased by approximately 6.4-, 38.0- and 19.6-fold, respectively, while everolimus Cmax, AUC and Cmin increased by approximately 4.7-, 27.1- and 16.1-fold, respectively, when coadministered with ombitasvir/paritaprevir/ritonavir plus dasabuvir. Single-dose tacrolimus Cmax, AUC and Cmin increased by approximately 4.0-, 57.1-fold and 16.6-fold when coadministered with ombitasvir/paritaprevir/ritonavir plus dasabuvir

MANAGEMENT: Concomitant use of tacrolimus, sirolimus, or everolimus in combination with ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, is considered contraindicated.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC (2022):
  3. "Product Information. Technivie (ombitasvir/paritaprevir/ritonavir)." AbbVie US LLC (2015):
  4. Badri P, Dutta S, Coakley E, et al. "Pharmacokinetics and dose recommendations for cyclosporine and tacrolimus when coadministered with ABT-450, ombitasvir, and dasabuvir." Am J Transplant 15 (2015): 1313-22
View all 4 references

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Drug and food interactions

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. "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical PROD (2001):

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Moderate

everolimus food

Applies to: Afinitor Disperz (everolimus)

GENERALLY AVOID: Grapefruit juice may significantly increase the plasma concentrations of orally administered everolimus. The mechanism is inhibition of CYP450 3A4 and P-glycoprotein activity in the gut wall by certain compounds present in grapefruit.

MANAGEMENT: Patients treated with everolimus should avoid consumption of grapefruit and grapefruit juice.

References

  1. "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals (2009):

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

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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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