Can Keytruda (pembrolizumab) cause hypogonadism, specifically low testosterone, in women?

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Can Keytruda Cause Low Testosterone in Women?

Keytruda (pembrolizumab) can cause hypogonadism, including low testosterone in women, through immune-related hypophysitis that disrupts the hypothalamic-pituitary-gonadal axis. This is a recognized immune-related adverse event (irAE) of immune checkpoint inhibitors.

Mechanism and Clinical Presentation

  • Pembrolizumab and other immune checkpoint inhibitors can cause inflammation of the pituitary gland (hypophysitis), which leads to multiple endocrine deficiencies including hypogonadism 1
  • Hypophysitis presents with low testosterone or estradiol levels accompanied by low luteinizing hormone (LH) and follicle-stimulating hormone (FSH), indicating central (secondary) hypogonadism 1
  • In premenopausal women, this manifests as fatigue, loss of libido, mood changes, and menstrual irregularities 1

Diagnostic Workup

When hypophysitis is suspected in women on Keytruda, the following evaluation should be performed:

  • Measure LH, FSH, and estradiol levels in premenopausal females with fatigue, loss of libido, and mood changes 1
  • Check morning ACTH and cortisol levels, as adrenal insufficiency commonly coexists with hypophysitis 1
  • Evaluate TSH and free T4, since central hypothyroidism frequently accompanies pituitary dysfunction 1
  • Consider MRI of the brain with pituitary/sellar cuts in patients with multiple endocrine abnormalities, especially if new severe headaches or vision changes are present 1

Management Approach

The primary treatment is hormone replacement therapy, not corticosteroids alone:

  • Testosterone or estrogen therapy should be provided to affected women without contraindications 1
  • For mild symptoms (Grade 1), consider holding Keytruda until the patient is stabilized on replacement hormones 1
  • For moderate to severe symptoms (Grade 2-4), hold Keytruda until stabilization occurs 1
  • Endocrine consultation is essential for all grades of hypophysitis 1

Critical Pitfall

When multiple hormone deficiencies exist, always start corticosteroids several days before thyroid hormone replacement to prevent precipitating adrenal crisis 1. This is a life-threatening complication that occurs when thyroid hormone increases metabolic demand in the setting of untreated adrenal insufficiency.

Monitoring Considerations

  • Follow free T4 (not TSH) for thyroid hormone replacement titration, as TSH is unreliable in central hypothyroidism 1
  • All patients with adrenal insufficiency need education on stress dosing and should wear a medical alert bracelet 1
  • The hypogonadism from checkpoint inhibitor-induced hypophysitis is typically permanent and requires lifelong hormone replacement 1

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

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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