Patients in different physiological states and health conditions need to pay special attention to their respective risks and precautions when using Icobet tablets (hydrochloride).

I. Precautions for patients with renal impairment

1. Enhanced monitoring required for moderate-to-severe impairment

For patients with moderate or severe renal impairment (estimated glomerular filtration rate below 60 mL/min), close monitoring by a physician is recommended during treatment to detect potential adverse reactions in a timely manner.

2. No dose adjustment needed for mild impairment

Drug exposure in patients with mild renal impairment is not significantly different from that in patients with normal renal function, so the usual dose can be given.

3. Route of drug elimination

(1) This drug is primarily excreted unchanged in faeces, with a very low proportion excreted in urine.

(2) Therefore, the impact of renal impairment on drug clearance is relatively manageable, but patients with moderate-to-severe impairment still require careful observation.

II. Guidance for patients in special life stages

1. Risks during pregnancy

(1) There are no adequate and well‑controlled studies in pregnant women; the effect on fetal development is unknown.

(2) In animal studies, at doses substantially higher than the human therapeutic dose, maternal weight loss and fetal rib fusion were observed.

(3) All pregnancies have a background risk of birth defects and miscarriage.

2. Recommendations during lactation

(1) It is unknown whether the drug is excreted in human milk.

(2) Animal studies have shown that the drug can be detected in the blood of nursing pups, suggesting that it is likely present in human milk.

(3) Before breastfeeding, the benefits of breastfeeding to the infant, the mother's need for the drug, and the potential risk to the infant should be considered comprehensively.

III. Key points for elderly and paediatric patients

1. No dose adjustment for elderly patients

The safety and efficacy of this drug in elderly patients (aged 65 years and older) are generally consistent with those in younger adults; no age‑based dose adjustment is needed.

2. Age and weight threshold for paediatric use

This drug is only indicated for adolescents aged 12 years and older with a body weight of at least 40 kg, for whom safety and efficacy have been established in clinical trials.

3. Use in younger children not established

(1) For children under 12 years of age or weighing less than 40 kg, safety and efficacy have not been established; use is not recommended at present.

(2) The pharmacokinetic profile in paediatric patients is not substantially different from that in adults.

4. Effect of hepatic impairment unclear

(1) As this drug is not metabolised by the liver, the effect of hepatic impairment on its disposition is unknown.

(2) Patients with severe hepatic impairment were not included in clinical studies; consult a physician before use.

5. Interruption during active infection

(1) If a clinically significant active infection occurs, treatment should be paused and resumed only after the infection has resolved.

(2) In patients with a history of chronic or recurrent infection, the risk‑benefit ratio should be assessed before starting therapy.

(3) During treatment, watch for signs of tuberculosis; patients with a history of tuberculosis may require prior anti‑tuberculosis therapy.

(4) Avoid administration of live‑attenuated vaccines during treatment.