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Drug Interactions between Erleada and Malarone Pediatric

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

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Interactions between your drugs

Moderate

proguanil apalutamide

Applies to: Malarone Pediatric (atovaquone / proguanil) and Erleada (apalutamide)

MONITOR: Coadministration with apalutamide may decrease the plasma concentrations of drugs that are substrates of the metabolic enzymes CYP450 3A4, CYP450 2C19, CYP450 2C9, and uridine diphosphate glucuronosyltransferase (UGT), as well as substrates of the membrane transporters organic anion transporting polypeptide (OATP) 1B1, P-glycoprotein (P-gp), and breast cancer resistance protein (BCRP). According to the prescribing information, coadministration of apalutamide with single oral doses of sensitive CYP450 substrates resulted in a 92% decrease in the systemic exposure (AUC) of midazolam, a CYP450 3A4 substrate; 85% decrease in the AUC of omeprazole, a CYP450 2C19 substrate; and 46% decrease in the AUC of S(-) warfarin, a CYP450 2C9 substrate. These results indicate strong induction of CYP450 3A4 and 2C19 by apalutamide, and weak induction of CYP450 2C9. Coadministration of apalutamide with single oral doses of transporter substrates resulted in a 30% decrease in the AUC of fexofenadine, a P-gp substrate, and 41% decrease in the AUC of rosuvastatin, a BCRP/OATP1B1 substrate. These results suggest that apalutamide is a weak inducer of membrane transporters. Apalutamide may also induce UGT according to the prescribing information; however, no pharmacokinetic data from studies with UGT substrates are available.

MANAGEMENT: Caution is advised when apalutamide is used concomitantly with drugs that are substrates of CYP450 3A4, CYP450 2C19, CYP450 2C9, UGT, OATP1B1, P-gp and/or BCRP, particularly sensitive substrates or those with a narrow therapeutic range. Substitution for these medications is recommended when possible, or monitor for potential loss of therapeutic efficacy if coadministration is required. The prescribing information for concomitant medications should be consulted to assess the benefits versus risks of coadministration of a CYP450 inducer like apalutamide and for any dosage adjustments that may be required.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2018) "Product Information. Erleada (apalutamide)." Janssen Biotech, Inc.

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Drug and food interactions

Moderate

atovaquone food

Applies to: Malarone Pediatric (atovaquone / proguanil)

ADJUST DOSING INTERVAL: Food, particularly high-fat food, significantly enhances the oral absorption and bioavailability of atovaquone. In 16 healthy volunteers, administration of a single 750 mg dose of atovaquone suspension following a standard breakfast (23 g fat: 610 kCal) resulted in an approximately 3.4-fold increase in the mean peak plasma concentration (Cmax) and a 2.5-fold increase in the mean area under the plasma concentration-time curve (AUC) of atovaquone compared to administration following an overnight fast. In a study consisting of 19 HIV-infected volunteers receiving atovaquone suspension 500 mg/day, Cmax and AUC of atovaquone increased by 72% and 66%, respectively, in the fed state relative to the fasting state.

MANAGEMENT: To ensure maximal oral absorption, atovaquone products (suspension, tablet, or in combination with proguanil) should be administered with a meal or milky drink, or enteral nutrition at the same time(s) each day. Because plasma atovaquone concentrations have been shown to correlate with the likelihood of successful treatment and in some cases, survival, alternative therapies may be appropriate for patients who have difficulty taking atovaquone with food.

References

  1. (2001) "Product Information. Mepron (atovaquone)." Glaxo Wellcome
  2. (2001) "Product Information. Malarone (atovaquone-proguanil)." Glaxo Wellcome
  3. Wohlt PD, Zheng L, Gunderson S, Balzar SA, Johnson BD, Fish JT (2009) "Recommendations for the use of medications with continuous enteral nutrition." Am J Health Syst Pharm, 66, p. 1438-67

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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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