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Drug Interactions between denosumab and diroximel fumarate

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

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Interactions between your drugs

Moderate

denosumab diroximel fumarate

Applies to: denosumab and diroximel fumarate

MONITOR: Concomitant use of immunosuppressive or myelosuppressive agents with denosumab may increase the risk of serious infections. Denosumab binds to and inhibits the receptor activator of nuclear factor kappa-B ligand (RANKL), which is expressed on activated T and B lymphocytes and in lymph nodes. Thus, denosumab alone may increase the risk of infections. In a clinical trial of over 7800 women with postmenopausal osteoporosis, the incidence of nonfatal serious infections was 3.3% in the placebo group and 4.0% in the denosumab group. Specifically, hospitalizations due to skin infections including erysipelas and cellulitis (<0.1% placebo vs. 0.4% denosumab) and serious infections in the abdomen (0.7% placebo vs. 0.9% denosumab), urinary tract (0.5% placebo vs. 0.7% denosumab), and ear (0.0% placebo vs. 0.1% denosumab) were reported. Endocarditis was reported in no placebo patients and 3 denosumab-treated patients. There was no difference in the incidence of opportunistic infections or infections resulting in death between the placebo and denosumab groups. The overall incidence of infections was also similar between the two groups.

MANAGEMENT: Caution is advised if denosumab must be used in combination with immuno- or myelosuppressive agents. Patients should be advised to contact their physician if they develop signs and symptoms of infection such as fever, chills, diarrhea, sore throat, muscle aches, shortness of breath, blood in phlegm, weight loss, red or inflamed skin, body sores, and pain or burning during urination. The need for continued denosumab therapy should be assessed when serious infections occur during treatment.

References (1)
  1. (2010) "Product Information. Prolia (denosumab)." Amgen USA

Drug and food interactions

Moderate

diroximel fumarate food

Applies to: diroximel fumarate

GENERALLY AVOID: Food does not significantly affect the oral bioavailability of diroximel fumarate. Administration of diroximel fumarate with a high-fat, high-calorie (900 to 1000 calories; 50% from fat) meal did not affect the systemic exposure (AUC) of its active metabolite, monomethyl fumarate (MMF), but decreased its peak plasma concentration (Cmax) by 44% and prolonged the time to reach peak concentration (Tmax) from 2.5 to 7.0 hours relative to administration in the fasted state. In comparison, administration of diroximel fumarate with low-fat, low-calorie (350 to 400 calories; 10 to 15 g fat) and medium-fat, medium-calorie (650 to 700 calories; 25 to 30 g fat) meals decreased the MMF Cmax by approximately 12% and 25%, respectively, while also leaving the AUC unaffected.

GENERALLY AVOID: Coadministration of diroximel fumarate with ethanol may reduce the plasma concentrations of monomethyl fumarate (MMF). The mechanism has not been reported. Following coadministration with 240 mL of 5% v/v and 40% v/v ethanol, the mean Cmax of MMF was reduced by 9% and 21%, respectively, relative to coadministration with water. The AUC of MMF was not significantly altered, indicating that ethanol did not induce dose dumping.

MANAGEMENT: Diroximel fumarate may be taken with or without food; however, high-fat, high-calorie meals or snacks should be avoided. The manufacturer recommends meals or snacks containing no more than 700 calories and no more than 30 grams of fat. Taking diroximel fumarate with food may improve tolerability for patients experiencing flushing or gastrointestinal adverse reactions. The manufacturer also recommends avoiding concomitant use of diroximel fumarate with ethanol.

References (3)
  1. (2022) "Product Information. Vumerity (diroximel fumarate)." Biogen Australia Pty Ltd
  2. (2022) "Product Information. Vumerity (diroximel fumarate)." Biogen Idec Ltd
  3. (2023) "Product Information. Vumerity (diroximel fumarate)." Biogen Idec Inc, SUPPL-9

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.