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Drug Interactions between ketoconazole and Photofrin

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

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Interactions between your drugs

Moderate

ketoconazole porfimer

Applies to: ketoconazole and Photofrin (porfimer)

GENERALLY AVOID: Patients exposed to photosensitizing agents at the same time as or in the 30 to 90 days following treatment with porfimer may be at an increased risk of a photosensitivity reaction (e.g., erythema, swelling, pruritus, burning sensations, feeling hot, and/or blisters). These agents have each been individually associated with photosensitivity reactions and may have additive effects if used together. Medicinal products with known phototoxic or photoallergic potential include, but are not limited to, hypericin-containing products (e.g., St. John's Wort), griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones, and tetracyclines. Photosensitivity with porfimer is due to residual drug being present in the skin. Porfimer is cleared from a variety of tissues over 40 to 72 hours after treatment, but organs of the reticuloendothelial system (e.g., liver, spleen), skin and the tumor itself retain the drug for a longer period. Patients treated with porfimer will be photosensitive for at least 30 days and possibly up to 90 days or more for patients with hepatic or severe renal dysfunction. In clinical studies of porfimer, photosensitivity reactions occurred in approximately 20% of cancer patients and 69% of high-grade dysplasia in Barrett's esophagus patients.

MANAGEMENT: Use of photosensitizing agents should be avoided for at least 30 days and maybe up to 90 days or longer after porfimer treatment depending on the patient's hepatic function, renal function, and/or ability to tolerate exposure to sunlight. Following treatment with porfimer, patients should follow measures outlined in the product labeling for light and sun exposure. It is important to counsel patients to expose their skin to ambient indoor light as it is not only safe but will help eliminate porfimer through the skin by a process called "photobleaching." Before exposing skin or eyes to direct sunlight or bright indoor light (e.g., examination lamps, dental lamps, operating room lamps, floodlights, halogen lamps, unshaded light bulbs at close proximity, etc.), patients should test for residual photosensitivity as described in porfimer's product labeling.

References

  1. Hoffman GA, Gradl G, Schulz M, Haidinger G, Tanew A, Weber B (2020) "The frequency of photosensitizing drug dispensings in Austria and Germany: A correlation with their photosensitizing potential based on published literature." J Eur Acad Dermatol Venereol, 34, p. 589-600
  2. Blakely KM, Drucker AM, Rosen CF (2019) "Drug-induced photosensitivity—an update: Culprit drugs, prevention and management." Drug Saf, 42, p. 827-47
  3. (2023) "Product Information. Photofrin (porfimer)." Pinnacle Biologicals, Inc.
  4. Concordia Laboratories Inc. (2023) Photofrin sterile porfimer sodium for injection for intravenous use antineoplastic photosensitizing agent. https://pdf.hres.ca/dpd_pm/00028148.PDF
  5. Pinnacle Biologics B.V. (2023) Annex I summary of product characteristics https://www.ema.europa.eu/en/documents/product-information/photobarr-epar-product-information_en.pdf
View all 5 references

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Drug and food interactions

Moderate

ketoconazole food

Applies to: ketoconazole

GENERALLY AVOID: Excessive use of alcohol or products containing alcohol together with ketoconazole or levoketoconazole may potentiate the risk of liver injury. Serious hepatotoxicity has been reported with levoketoconazole. Hepatotoxicity requiring liver transplantation has been reported with the use of oral ketoconazole, of which levoketoconazole is an enantiomer. Some patients had no obvious risk factors for liver disease. In addition, use of alcohol or products containing alcohol during ketoconazole or levoketoconazole therapy may result in a disulfiram-like reaction in some patients. Symptoms of disulfiram-like reaction include flushing, rash, peripheral edema, nausea, and headache.

GENERALLY AVOID: Coadministration with grapefruit juice may increase the plasma concentrations of ketoconazole or levoketoconazole. The mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits. Inhibition of hepatic CYP450 3A4 may also contribute. 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. Pharmacokinetic interactions involving grapefruit juice are also subject to a high degree of interpatient variability, thus the extent to which a given patient may be affected is difficult to predict.

When administered to healthy volunteers with a high-fat meal (875 calories; 62% fat), levoketoconazole systemic exposure (AUC) increased by 30% while peak plasma concentration (Cmax) did not change and the time to reach Cmax (Tmax) was delayed from 2 to 4 hours, compared to fasted conditions.

MANAGEMENT: Levoketoconazole may be administered with or without food. Excessive consumption of alcohol should generally be avoided during ketoconazole or levoketoconazole therapy. Patients should preferably avoid or limit consumption of grapefruit, grapefruit juice, or any supplement containing grapefruit extract during ketoconazole or levoketoconazole therapy. Patients receiving ketoconazole or levoketoconazole should be instructed to contact their doctor immediately if they experience swelling, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark colored urine, light colored stools, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage.

References

  1. (2019) "Product Information. Ketoconazole (ketoconazole)." Mylan Pharmaceuticals Inc
  2. (2022) "Product Information. Recorlev (levoketoconazole)." Xeris Pharmaceuticals Inc
  3. Auchus R, Pivonello R, Fleseriu M, et al. (2022) Levoketoconazole: a novel treatment for endogenous Cushing's syndrome. https://www.tandfonline.com/doi/pdf/10.1080/17446651.2021.1945440
  4. (2021) "Product Information. Ketoconazole (ketoconazole)." Burel Pharmaceuticals Inc
View all 4 references

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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.

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