Tislelizumab (anti-PD-1 monoclonal antibody) should be individualized for patients in special populations, with key considerations for pregnant women, lactating women, pediatric patients, elderly patients, and those with hepatic or renal impairment. Use must be strictly under medical supervision, with benefits and risks assessed based on the patient’s health status.
1. Pregnant and Lactating Women
Pregnancy
There are no sufficient clinical data in humans. Animal studies suggest potential harm to the fetus. Use should be avoided during pregnancy. If use is unavoidable, the benefits and risks must be fully evaluated, and effective contraception should be used during treatment.
Lactation
The drug may be excreted in human milk. Breastfeeding is recommended to be discontinued during treatment and for at least 5 months after the last dose, or discontinuation of the drug may be considered as advised by a physician.
2. Pediatric and Adolescent Patients
Safety and efficacy in patients under 18 years of age have not been established. Use in this population is not recommended. If required, use should only be considered after evaluation by an oncologist.
3. Elderly Patients
Clinical trials included a number of elderly patients, and no significant age-related differences were observed. However, elderly patients often have comorbidities (e.g., cardiovascular and cerebrovascular diseases), so individualized dose adjustment and close monitoring for adverse reactions are recommended.
4. Patients with Hepatic or Renal Impairment
Hepatic impairment
No dose adjustment is required in patients with mild or moderate impairment. Data are limited in patients with severe impairment, so use with caution.
Renal impairment
No dose adjustment is required in patients with mild or moderate impairment. Use in patients with severe impairment or end-stage renal disease should be determined after medical evaluation.
5. Patients with Immune-Related Diseases or Organ Transplantation
Use is contraindicated in patients with active autoimmune diseases or a history of organ transplantation. Use in these patients may exacerbate pre-existing conditions or induce transplant rejection. Patients should disclose their full medical history to their physician before treatment.
All patients should be monitored regularly for immune-related adverse reactions (e.g., pneumonitis, hepatitis, colitis) during treatment. Seek immediate medical attention if any abnormal symptoms occur.
Tislelizumab is a prescription drug. Its specific administration, treatment duration, and dose adjustments must be prescribed by a physician. Do not discontinue or modify the regimen without medical advice.
