From the Guidelines
Tacrolimus is not recommended for use in 15-week-old infants due to the potential for serious side effects and the lack of sufficient safety data in this age group. The medication is a potent immunosuppressant that can increase the risk of infections, kidney problems, high blood pressure, and neurological effects 1. According to the conjunctivitis preferred practice pattern, tacrolimus is typically used for patients 2 years old or older, and its use in younger infants is not supported by strong evidence 1.
Key Considerations
- The use of tacrolimus in infants requires careful consideration of the potential risks and benefits, and alternative treatments should be thoroughly discussed with specialists before proceeding with tacrolimus in an infant this young.
- If treatment is deemed necessary, dosing must be individualized based on the infant's weight, condition, and drug levels in the blood, and regular blood tests are mandatory to monitor drug levels and organ function.
- Parents should be aware of the potential side effects of tacrolimus, including increased risk of infections, kidney problems, high blood pressure, and neurological effects.
- The medication requires careful administration, typically twice daily, and consistent timing relative to feedings.
Evidence Summary
The evidence from the conjunctivitis preferred practice pattern suggests that tacrolimus is typically used for patients 2 years old or older, and its use in younger infants is not supported by strong evidence 1. Additionally, the joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients recommend tacrolimus 0.1% for off-label use, but the level of evidence is II-III, indicating that the recommendation is based on limited data 1.
Clinical Implications
In clinical practice, the use of tacrolimus in 15-week-old infants should be approached with caution, and alternative treatments should be considered first. If tacrolimus is deemed necessary, close monitoring of the infant's condition and regular blood tests are essential to minimize the risk of side effects. Pediatric specialists, such as transplant physicians, dermatologists, or immunologists, should be involved in the care of the infant to ensure that the medication is used safely and effectively.
From the FDA Drug Label
Safety and effectiveness have been established in pediatric liver transplant patients Liver Transplantation Safety and efficacy using tacrolimus in pediatric de novo liver transplant patients less than 16 years of age are based on evidence from active controlled studies that included 56 pediatric patients, 31 of which received tacrolimus, and supported by two pharmacokinetic and safety studies in 151 children who received tacrolimus
The safety of tacrolimus in a 15-week-old patient is not directly addressed in the provided drug label. However, it is established that tacrolimus is safe and effective in pediatric liver transplant patients less than 16 years of age.
- Pediatric use: The label mentions that pediatric patients generally required higher doses of tacrolimus to maintain blood trough concentrations similar to adult patients.
- Dose adjustments: Dose adjustments were made in the pharmacokinetic studies based on clinical status and whole blood concentrations. Since the patient is 15 weeks old, which is less than 1 year old, and the label only provides information on pediatric patients less than 16 years of age, caution should be exercised when considering the use of tacrolimus in this patient population. 2
From the Research
Safety of Tacrolimus in 15-Week-Old Patients
There are no research papers to assist in answering this question as the provided studies do not mention the safety of tacrolimus in 15-week-old patients.
Available Information on Tacrolimus
- The studies provided compare the efficacy and safety of tacrolimus with other immunosuppressants, such as cyclosporine and sirolimus, in adult patients undergoing organ transplantation 3, 4, 5, 6, 7.
- These studies suggest that tacrolimus is effective in preventing acute rejection and improving graft survival, but may be associated with side effects such as diabetes, neurological and gastrointestinal symptoms 6, 7.
- However, the safety and efficacy of tacrolimus in pediatric patients, particularly those as young as 15 weeks old, are not addressed in the provided studies.
Limitations of Available Data
- The available studies are limited to adult patients, and there is a lack of data on the safety and efficacy of tacrolimus in pediatric patients.
- Further research is needed to determine the safety and efficacy of tacrolimus in pediatric patients, including those as young as 15 weeks old.