Clarifying the contraindications and special population principles for Zetuzumab is an important prerequisite to ensure treatment safety and avoid serious adverse events. The following details are elaborated in three aspects.
I. Absolute Contraindications
1. Severe Allergy History
(1) Patients allergic to any component of Zetuzumab (including active substances or excipients) are prohibited from use.
(2) Patients who have experienced severe infusion-related reactions (e.g., anaphylactic shock, laryngeal edema) with this drug in the past must not use it again.
(3) Patients with a documented history of severe allergy to other monoclonal antibody drugs should be highly vigilant; use is generally not recommended.
2. Specific Concomitant Medication Situations
(1) When using drugs that have clear interactions with this product and the regimen cannot be adjusted, careful evaluation is required.
(2) Specific contraindicated concomitant medications should be based on the latest drug label; a complete medication list must be provided before use.
3. Pregnancy
(1) Use of this product is prohibited during pregnancy unless the expected benefit clearly outweighs the potential risk to the fetus and no alternative is available.
(2) Women of childbearing potential must undergo pregnancy testing before treatment, and treatment can only begin after confirmation of a negative result.
II. Situations Requiring Cautious Use
1. Active Infection
(1) In the presence of uncontrolled severe infection (e.g., sepsis, severe pneumonia), use of this product should be postponed.
(2) For mild infection (e.g., upper respiratory tract infection), a physician should assess the risk before deciding whether to continue treatment.
(3) Treatment may be considered after the infection is controlled, with close monitoring of the patient's condition.
2. Significantly Abnormal Liver Function
(1) In patients with severe hepatic impairment before treatment, use of this product requires caution and possibly regimen adjustment.
(2) If a significant increase in transaminases or bilirubin occurs during treatment, dosing should be suspended and the cause investigated.
(3) Whether to restart the drug after liver injury recovery should be determined by a specialist physician.
3. History of Severe Infusion Reactions
(1) Patients who have had severe reactions to other infusion drugs (including other monoclonal antibodies) are at higher risk when using this product.
(2) If use is necessary, it should be done in a medical facility equipped with emergency resuscitation equipment, and premedication with antihistamines should be given.
(3) The infusion rate should be further slowed, and the patient should be closely monitored throughout.
4. History of Autoimmune Disease
(1) In patients with active autoimmune disease (e.g., systemic lupus erythematosus, inflammatory bowel disease), use of this product may exacerbate the underlying condition.
(2) A rheumatology consultation is required to evaluate the benefit-risk ratio before deciding on use.
III. Special Population Recommendations
1. Pediatric Population
This product is not indicated for children and adolescents under 18 years of age.
2. Elderly Population
No routine dose adjustment is required for elderly patients aged 65 years and older; they may follow the standard adult dosing regimen.
3. Pregnant and Breastfeeding Women
(1) Pregnancy: Contraindicated. Effective contraception should be used during treatment and for a period after the last dose.
(2) Breastfeeding: It is unknown whether this product is excreted in human milk. Given the potential risk, breastfeeding should be discontinued during treatment.
(3) Women of childbearing potential must confirm their pregnancy status before treatment, and continue contraception during and after treatment.
4. Patients with Hepatic or Renal Impairment
(1) Hepatic impairment: No dose adjustment is generally needed for mild abnormalities; caution is required for moderate to severe abnormalities, use under the guidance of a hepatologist, and shorten monitoring intervals.
(2) Renal impairment: There is currently no evidence to suggest routine dose adjustment, but patients with severe renal impairment should be monitored more closely after dosing.
5. Fertility and Contraception
(1) Women of childbearing potential should use effective contraception during treatment and for a period after treatment discontinuation.
(2) Male patients are also advised to use contraceptive measures during treatment to avoid potential genotoxic risks.
(3) If there is a plan for pregnancy, a full discussion with the physician should occur before starting treatment to assess the feasibility of fertility preservation.
