Maximum Dose of Basalog (Recombinant Human Growth Hormone)
The maximum recommended dose of Basalog is 0.05 mg/kg body weight per day, administered as a daily subcutaneous injection in the evening. 1
Standard Dosing Range
The established therapeutic dose is 0.045–0.05 mg/kg/day (equivalent to 28–30 IU/m²/week), given as daily subcutaneous injections. 1, 2
Higher doses provide no additional benefit: A study comparing 28 IU/m²/week to 56 IU/m²/week (equivalent to 0.09 mg/kg/day) demonstrated no significant difference in height gain or height velocity, establishing that doubling the dose offers no therapeutic advantage. 1, 2
Lower doses are less effective: Reducing the dose to 14 IU/m²/week (0.023 mg/kg/day) results in approximately 1.2 cm/year less height velocity compared to the standard 28 IU/m²/week dose. 1, 2
Dose Calculation Based on Body Weight
The dose must be calculated individually for each child based on current body weight, not as a fixed amount:
- For a 40 kg child: 40 kg × 0.045 mg/kg = 1.8 mg per day (minimum dose) 3
- For a 40 kg child: 40 kg × 0.05 mg/kg = 2.0 mg per day (maximum dose) 3
- For a 50 kg child: 50 kg × 0.05 mg/kg = 2.5 mg per day (maximum dose) 3
The dose should be adjusted every 3–6 months based on weight changes to maintain the appropriate mg/kg dosing. 1, 2
Special Population Considerations
Chronic Kidney Disease (CKD)
- The same maximum dose applies: 0.045–0.05 mg/kg/day for children with CKD stages 3–5 or on dialysis. 1
- A higher dose of up to 0.35 mg/kg/week (approximately 0.05 mg/kg/day) is FDA-approved for growth failure secondary to CKD, but this still translates to the same daily maximum. 4
Turner Syndrome
- Up to 0.375 mg/kg/week divided into 3–7 doses per week is FDA-approved, which equals approximately 0.054 mg/kg/day if given daily—slightly higher than the standard maximum. 4
Idiopathic Short Stature
- Maximum of 0.3 mg/kg/week (approximately 0.043 mg/kg/day) is recommended. 4
Small for Gestational Age (SGA)
- Doses of 35–70 µg/kg/day (0.035–0.07 mg/kg/day) have been studied, with higher doses reserved for children with very marked growth retardation requiring rapid catch-up growth. 5
Critical Safety Ceiling
Doses exceeding 0.05 mg/kg/day in standard growth hormone deficiency are not supported by evidence and do not improve outcomes. 1, 2
- Pharmacological doses up to 0.2 mg/kg/day have been used in metabolic conditions such as AIDS-associated wasting and severe burns, but these are entirely different indications with different risk-benefit profiles and are not applicable to pediatric growth disorders. 6
Administration Guidelines
- Timing: Administer in the evening before bedtime to mimic physiological nocturnal GH secretion. 1, 3, 2
- Route: Daily subcutaneous injection. 1, 4
- Site rotation: Rotate injection sites daily among thighs, abdomen, buttocks, and upper arms to prevent lipoatrophy. 3, 2, 4
When to Stop or Withhold Treatment
Growth hormone must be stopped in the following situations:
- Epiphyseal closure (no further growth potential). 1, 7
- Persistent severe secondary hyperparathyroidism (PTH >500 pg/mL); may resume when PTH returns to target range. 1, 7
- Intracranial hypertension (requires immediate discontinuation). 1, 7
- Slipped capital femoral epiphysis. 1, 7
- Inadequate response despite optimal metabolic control (height velocity <2 cm/year above baseline in first year). 1
- At time of renal transplantation (in CKD patients). 1
Common Pitfalls
- Do not use a fixed dose for all patients: The dose must be weight-based and recalculated regularly as the child grows. 3
- Do not exceed 0.05 mg/kg/day in standard indications: Higher doses do not improve outcomes and may increase adverse effects. 1, 2
- Monitor glucose metabolism closely in obese patients: GH increases insulin secretion and can worsen glucose intolerance. 1, 2, 7
- Ensure adequate treatment of CKD-MBD before starting GH: Untreated secondary hyperparathyroidism can worsen with GH therapy. 1