\1. ### Special population

\2. ### Drug interactions

\3. ### Drug overdose

\1. ### Special population

Renal function impairment: Patients with mild renal function impairment do not need dose adjustment. There is limited experience in the treatment of moderate renal impairment. At present, it is not recommended to use this product in patients with severe renal function impairment, including patients with end-stage renal disease (see pharmacokinetics).

Liver function damage: the treatment experience in patients with liver function damage is limited, so this product is not recommended for light, medium and severe liver function damage

Patients (see pharmacokinetics).

Medication for pregnant and lactating women

gestation

At present, there is no sufficient data of this product for pregnant women.

Animal studies have shown that the product has reproductive toxicity (see preclinical safety data).

The potential risk of this product to humans is not clear. This product should not be used during pregnancy. Insulin is recommended. If the patient is planning to be pregnant or has been pregnant during the treatment, the treatment with this product should be stopped.

lactation

It is not clear whether or not Liraglutide is secreted in human milk. Animal studies have shown that the proportion of Liraglutide and its structurally closely related metabolites in milk is very low. Due to lack of relevant experience, this product should not be used in lactation.

Medication for children

Due to the lack of relevant data, this product is not recommended for children and adolescents under 18 years old.

Geriatric medication

Based on a pharmacokinetic study in healthy subjects and analysis of population pharmacokinetic data for patients (18-80 years old), age had no clinically relevant effect on the pharmacokinetics of Liraglutide. Therefore, there is no need to adjust the dose according to age. There is limited treatment experience in patients who must be 75 years old.

\2. ### Drug interactions

It has been confirmed in vitro that the possibility of pharmacokinetic interaction betweenLiraglutide and other active substances related to the binding of cytochrome P450 and plasma protein is very low.

A slight delay in gastric emptying byLiraglutide may affect the absorption of other drugs taken simultaneously. The interaction study did not show any clinically relevant delay in drug absorption. A few patients treated with this product reported at least one serious diarrhea event. diarrhea

It may affect the absorption of drugs taken orally at the same time.

Paracetamol

Rilalutide did not change the overall exposure after a single dose of 1000 mg of paracetamol. The peak concentration (Cmax) of paracetamol decreased by 31%, while the median time to peak (Tmax) was delayed by 15 minutes. There is no need for dose adjustment when combined with paracetamol.

Atorvastatin

There was no clinically significant change in the overall exposure to atorvastatin after a single dose of 40 mg. Therefore, dose adjustment is not necessary when atorvastatin is combined with this product. The peak concentration (Cmax) of atorvastatin decreased under the action of Liraglutide

38%, and the median peak time (Tmax) was increased from 1 hour to 3 hours.

Gray and yellow pigment

Rilalutide did not change the overall exposure to griseofulvin after a single dose of 500 mg. The peak concentration (Cmax) of griseofulvin increased by 37%, while the median time to peak (Tmax) did not change. There is no need to adjust the dosage of griseofulvin and other drugs with low solubility and high permeability.

Lisinopril and digoxin

The AUC of lisinopril and digoxin decreased by 15% and 16%, respectively, and the Cmax decreased by 27% and 31%, respectively. The median time to peak (Tmax) of lisinopril was increased from 6 hours to 8 hours, while that of digoxin was increased from 1 hour to 1.5 hours. According to the above results, there is no need to adjust the dose of lisinopril or digoxin.

Oral contraceptives
After a single oral contraceptive administration, the peak concentrations of ethinylestradiol and levonorgestrel (Cmax) were reduced by 12% and 13%, respectively. The peak time (Tmax) of both components was prolonged by 1.5 hours. Total of p-ethinylestradiol or levonorgestrel
Body exposure did not produce clinically significant effects. Therefore, the combination of lilalutide is not expected to affect the contraceptive effect of oral contraceptives.
warfarin
No drug interaction studies have been carried out. After warfarin treatment, more frequent INR monitoring is recommended.
Insulin

The combination of this product and insulin has not been evaluated.
Incompatibility
Substances added to this product may cause degradation ofLiraglutide。 This product shall not be mixed with other drugs without incompatibility study.

\3. ### Drug overdose

In a clinical study of this product, an overdose event of 17.4mg (10 times of the maximum recommended maintenance dose of 1.8mg) was found in a patient with type 2 diabetes mellitus. The overdose resulted in severe nausea and vomiting, but no hypoglycemia. The patient recovered without complications.

In case of drug overdose, appropriate supportive treatment should be taken according to the patient's clinical signs and symptoms.

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Chengdu Shengnuo Biotechnology Co., Ltd. has "Chengdu polypeptide drug engineering technology research center" in Chengdu, mainly engaged in polypeptide, polypeptide drug and beauty peptide research. Our zero defect has passed the FDA certification, and now it has become the first-class professional peptide drug and product development, technology transfer, technical service and peptide drug industry in the scale production and export of China's parks.