Everolimus

Is Everolimus Safe? Breast Cancer, TSC & Transplant Risks Exposed!

Advanced Breast Cancer:

  • HR-positive/HER2-negative metastatic disease post-nonsteroidal aromatase inhibitor failure (e.g., letrozole/anastrozole).

  • Combined with exemestane, doubling progression-free survival (median PFS: 7.8 vs. 3.2 months

  • Neuroendocrine Tumors (NETs):

    • Pancreatic, gastric, intestinal, or lung NETs that are unresectable, progressive, or metastatic.

  • Tuberous Sclerosis Complex (TSC)-Related Tumors:

    • Renal angiomyolipomas (non-surgical candidates).

    • Subependymal giant cell astrocytoma (SEGA) and partial-onset seizures (adjunctive therapy).

  • Transplant Rejection:

    • Kidney or liver transplants (with tacrolimus/cyclosporine).

  • Mechanism: Inhibits mTOR kinase, disrupting cell proliferation, angiogenesis, and nutrient signaling

Dosing & Administration

Indication Dosing Key Instructions
Advanced Cancers & TSC 10 mg once daily Take consistently with/without food; swallow whole. Avoid crushing. Continue until progression or toxicity.
Transplant Rejection (Kidney) 0.75 mg twice daily Start post-transplant with cyclosporine.
Transplant Rejection (Liver) 1 mg twice daily Initiate 4 weeks post-transplant with tacrolimus.
Missed Dose Skip if >6 hours late; resume next dose Never double-dose

 

Special Populations:

  • Pediatrics: Approved for SEGA (≥1 year) and seizures (≥2 years)

Pregnancy & Lactation

  • Pregnancy (Category D):
    Risk of fetal harm. Use only if benefits outweigh risks. Contraception required during treatment + 8 weeks after (women) / 4 weeks (men).

  • Breastfeeding:
    Not recommended; potential transfer into milk.

Essential Precautions

  • Monitor Regularly:

    • Blood glucose/lipids (↑ diabetes/hypercholesterolemia risk).

    • Renal/hepatic function.

    • Wound healing (stop 1 week pre-surgery; resume after 2 weeks).

  • Infection Control:
    Avoid crowds/live vaccines; report fever >100.5°F.

  • Sun Protection:
    ↑ Skin cancer risk; use SPF 30+ and protective clothing.

Patient Counseling Points

  1. Consistency: Take same time daily, with or without food—but not with grapefruit.

  2. Mouth Care: Use alcohol-free mouthwash to prevent/treat stomatitis.

  3. Toxicity Signs: Report breathing difficulties, unexplained bleeding, or severe rashes immediately.

  4. Drug Interactions: Disclose all medications (including OTC/herbals).

Conclusion

Everolimus (Xevirol) is a versatile but complex medication requiring strict adherence to dosing, frequent monitoring, and proactive side-effect management. Consult your oncologist or transplant specialist to determine if it aligns with your clinical profile and to navigate potential risks. For full prescribing details, refer to the Afinitor Medication Guide or Xevirol product information