Saizen Dosage/Direction for Use



PT. Merck Tbk
Full Prescribing Info
Dosage/Direction for Use
Saizen is intended for single-use. Saizen dosage should be individualised for each patient based on body surface area (BSA) or on body weight (BW). It is recommended that Saizen be administered at bedtime according to the following dosage: Growth Failure Due to Inadequate Endogenous Growth Hormone Secretion: 0.7-1 mg/m2 body surface area (BSA) daily or 0.025-0.035 mg/kg body weight (BW) daily by SC or IM administration.
Growth Failure in Girls Due to Gonadal Dysgenesis (Turner Syndrome): 1.4 mg/m2 BSA daily or 0.045-0.050 mg/kg BW daily by SC administration. Concomitant therapy with non-androgenic anabolic steroids in patients with Turner Syndrome can enhance the growth response.
Growth Failure in Children Born Small for their Gestational Age: The daily dose is 0.035-0.067 mg/kg BW (or 1-2 mg/m² daily) administered by SC injection.
Duration of Treatment in Children: The treatment is generally continued for several years. The duration of the treatment depends on the development of the patient's height and on the therapeutic target that is set. The treatment must be terminated when the patient has reached a satisfactory adult height or when the epiphyses are closed.
In the case of retarded growth in children born small for their gestational age, the treatment is generally continued until the child reaches final height. It must be stopped after the 1st year if the growth rate is <+1 SDS. It must also be stopped if final height is reached (growth rate <2 cm/year) and when confirmation proves necessary, if the bone age, based on the epiphyseal closures, is >14 years (girls) or >16 years (boys).
Growth Hormone Deficiency: Adults: At the start of the treatment with somatropin, it is recommended to start with low doses, 0.15-0.3 mg daily administered by SC injection. The dose should then be increased gradually. The dosage must be checked, taking into account the clinical reaction, the side effects that appear and the concentration of the IGF-1 in the serum. If necessary, the dosage may be increased once a month. The final dosage of growth hormone required is rarely >1 mg daily. Women may need higher dosages than men. Generally, the lowest effective dosage should be administered; the requirement may fall with increasing age or in patients who are overweight.
Duration of the Treatment in Adults: The duration of the treatment in adults is generally several years. The optimal duration of the treatment is not defined. It is recommended to check, in the course of annual specialist medical examinations, whether the treatment should be continued.
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