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Drug Interactions between TheraCys and Yondelis

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

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Interactions between your drugs

Major

BCG trabectedin

Applies to: TheraCys (bcg) and Yondelis (trabectedin)

CONTRAINDICATED: Administration of intravesical BCG during immunosuppressant or intense antineoplastic therapy may be associated with a risk of disseminated infection due to enhanced replication of the BCG strain of Mycobacterium bovis in the presence of diminished immune competence. Deaths have been reported as a result of systemic BCG infection and sepsis. Patients may be immunosuppressed if they have recently received or are receiving alkylating agents, antimetabolites, radiation, some antirheumatic agents, high dosages of corticosteroids or adrenocorticotropic agents (e.g., greater than or equal to 2 mg/kg/day or 20 mg/day of prednisone or equivalent for 14 consecutive days or more), or long-term topical or inhaled corticosteroids. In addition, these patients may not develop an adequate immune response to BCG, which would reduce its anti-tumor efficacy.

MANAGEMENT: Use of intravesical BCG in immunosuppressed patients with congenital or acquired immune deficiencies, including those due to concurrent disease (e.g., AIDS, leukemia, lymphoma), cancer therapy (e.g., cytotoxic drugs, radiation) or immunosuppressive therapy (e.g., corticosteroids), is considered contraindicated. Clinicians should be aware that BCG may persist in the urinary tract for several months after BCG instillations, and delayed manifestations of disseminated BCG infection may develop months or years after BCG therapy. Patients who receive cancer or immunosuppressive therapy after BCG instillation may be at increased risk.

References

  1. Rawls WH, Lamm DL, Lowe BA, et al. (1990) "Fatal sepsis following intravesical bacillus Calmette-Guerin administration for bladder cancer." J Urol, 144, p. 1328-30
  2. Lamm DL, Stogdill VD, Stogdill BJ, Crispen RG (1986) "Complications of bacillus Calmette-Guerin immunotherapy in 1,278 patients with bladder cancer." J Urol, 135, p. 272-4
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."
  5. "Product Information. Tice BCG Live (for intravesical use) (BCG)." Organon Pharmaceuticals
  6. CDC Centers for Disease Control and Prevention (2019) General Best Practice Guidelines for Immunization: Altered Immunocompetence. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.pdf
View all 6 references

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Drug and food interactions

Moderate

trabectedin food

Applies to: Yondelis (trabectedin)

GENERALLY AVOID: Coadministration with grapefruit juice may increase the plasma concentrations of trabectedin. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit.

GENERALLY AVOID: Coadministration of trabectedin with other agents known to induce hepatotoxicity such as alcohol may potentiate the risk of liver injury. Reversible, acute increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have occurred frequently in patients treated with trabectedin alone or with pegylated liposomal doxorubicin in clinical trials. In one U.S. trial with 378 patients, grade 3 or 4 elevated liver function tests (defined as elevations in ALT, AST, total bilirubin, or alkaline phosphatase) were reported in 35% of patients receiving trabectedin. ALT or AST elevations greater than eight times the upper limit of normal (ULN) occurred in 18% of patients, and drug-induced liver injury (defined as concurrent elevations in ALT or AST more than three times ULN, alkaline phosphatase less than two times ULN, and total bilirubin at least two times ULN) occurred in 1.3% of patients.

MANAGEMENT: Consumption of grapefruit or grapefruit juice during treatment with trabectedin should be avoided. Excessive use of alcohol is also not recommended. Patients should be advised to seek medical attention if they experience potential signs and symptoms of hepatotoxicity such as fever, rash, itching, anorexia, nausea, vomiting, fatigue, malaise, right upper quadrant pain, dark urine, pale stools, and jaundice. Monitoring of alkaline phosphatase, bilirubin, AST, and ALT should occur regularly during trabectedin treatment in accordance with the product labeling, or as often as necessary when clinical symptoms develop. Trabectedin must not be used in patients with elevated bilirubin at the time of initiation of cycle. Elevated liver function tests should be managed with treatment interruption, dosage reduction, or permanent discontinuation depending on the severity and duration of abnormality.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2010) "Product Information. Yondelis (trabectedin)." Janssen Pharmaceuticals

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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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