Toripalimab (a PD-1 inhibitor) should be used in special populations strictly following the principle of individualization. Key populations include children, pregnant and lactating women, patients with hepatic and renal impairment, and elderly patients. Clinical evaluation and medical advice are required for specific administration.
1. Pediatric Use
The safety and efficacy of toripalimab in children and adolescents under 18 years of age have not been established.
Given the limited available data, it should be used cautiously after the potential benefits and risks are evaluated by a physician, with close monitoring for adverse reactions.
2. Pregnancy and Lactation
Pregnancy:
Animal studies have indicated that PD‑1/PD‑L1 pathway inhibitors may cause fetal harm.
Use of toripalimab should be avoided during pregnancy.
If pregnancy occurs during treatment, the physician must be informed immediately for risk assessment.
Lactation:
It is unknown whether toripalimab is excreted in human milk.
Breastfeeding is not recommended during treatment and for at least 4 weeks after the last dose to minimize infant exposure.
3. Patients with Hepatic and Renal Impairment
Hepatic impairment:
No dose adjustment is required in patients with mild hepatic impairment.
Data are limited in patients with moderate to severe hepatic impairment; use cautiously with enhanced monitoring.
Renal impairment:
No dose adjustment is required in patients with mild to moderate renal impairment.
Data are lacking in patients with severe renal impairment (eGFR < 30 mL/min); use only after a careful benefit‑risk assessment by a physician.
4. Geriatric Use
No dose adjustment is necessary for patients aged 65 years and older.
However, due to potential comorbidities and reduced physiological function, closer monitoring for immune‑related adverse reactions (such as pneumonitis, colitis, etc.) is recommended.
5. Other Special Populations
Patients with autoimmune diseases:
Toripalimab may exacerbate pre‑existing conditions and should only be used after thorough evaluation.
Organ transplant recipients:
Safety data are insufficient, and there is a risk of transplant rejection. Use is generally not recommended.
Important Precautions
Toripalimab is a prescription drug.
All dosing regimens must be evaluated by a physician based on the patient’s individual condition.
Regular follow‑up examinations, including hepatic and renal function, complete blood count, and other indicators, are required during treatment.
Seek immediate medical attention if severe adverse reactions occur, such as fever, dyspnea, diarrhea, etc.
