Is treatment with Caplyta (lumateperone) contraindicated in a patient with laryngeal cancer?

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Is Caplyta Contraindicated in Laryngeal Cancer?

No, treatment with Caplyta (lumateperone) is not contraindicated in patients with laryngeal cancer. The only contraindication for Caplyta is a history of hypersensitivity reaction to lumateperone, including pruritus, rash, or urticaria 1.

FDA-Approved Contraindications

The FDA prescribing information for Caplyta lists only one contraindication 1:

  • Hypersensitivity reactions to lumateperone (manifesting as pruritus, allergic dermatitis, papular rash, generalized rash, or urticaria)

Cancer, including laryngeal cancer, is not listed as a contraindication in the FDA label 1.

Clinical Context and Considerations

Caplyta's Approved Indications

Caplyta is FDA-approved for 1:

  • Schizophrenia in adults
  • Depressive episodes associated with bipolar I or II disorder in adults (as monotherapy or adjunctive therapy with lithium or valproate)

Relevant Warnings for Cancer Patients

While laryngeal cancer itself is not a contraindication, clinicians should be aware of specific warnings 1:

  • Elderly patients with dementia-related psychosis have increased mortality risk with antipsychotic drugs (1.6-1.7 times higher than placebo), though Caplyta is not approved for this indication 1
  • Cerebrovascular adverse reactions including stroke have been observed in elderly dementia patients treated with antipsychotics 1

Laryngeal Cancer Treatment Does Not Preclude Caplyta Use

Standard laryngeal cancer treatment involves 2, 3:

  • Concurrent cisplatin-based chemoradiation for advanced disease
  • Surgical approaches (endoscopic resection, partial or total laryngectomy) for early-stage disease
  • TPF induction chemotherapy for larynx preservation in select cases

None of these oncologic treatments create a contraindication to Caplyta if the patient requires treatment for schizophrenia or bipolar depression 1.

Practical Clinical Approach

If a patient with laryngeal cancer requires antipsychotic or mood stabilization therapy:

  • Verify no history of hypersensitivity to lumateperone before prescribing 1
  • Assess for drug interactions with CYP3A4 inhibitors, as cisplatin-based chemotherapy regimens may involve concurrent medications; dose adjustment to 21 mg or 10.5 mg daily may be needed with moderate or strong CYP3A4 inhibitors 1
  • Monitor for suicidal thoughts in patients being treated for bipolar depression, particularly in those under age 25 1
  • Consider hepatic function, as patients with moderate-to-severe hepatic impairment require dose reduction to 21 mg daily 1

The decision to use Caplyta should be based on psychiatric indication and the absence of hypersensitivity, not on the presence of laryngeal cancer.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Treatment of Laryngeal Cancer

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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