Active Ingredient: Sargramostim
Sargramostim is indicated for treatment of patients of all ages acutely exposed to myelosuppressive doses of radiation with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS).
Sargramostim should be used in accordance with official radiological/nuclear emergency recommendations.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient weight is > 40 kg
Subcutaneous, 7 micrograms sargramostim per kilogram of body weight, once daily.
Regimen B, in case that patient weight is ≥ 15 kg and patient weight is < 40 kg
Subcutaneous, 10 micrograms sargramostim per kilogram of body weight, once daily.
Regimen C, in case that patient weight is < 15 kg
Subcutaneous, 12 micrograms sargramostim per kilogram of body weight, once daily.
Sargramostim should be administered once daily as a subcutaneous injection and dosing is based on body weight as follows:
See Treatment Response for guidance regarding sargramostim duration of treatment.
For grade 3 or 4 adverse reactions, sargramostim dose should be reduced to 50%, or interrupted until the adverse reaction abates and then resumed at 50% of the dose. Other measures to manage the adverse reaction should be instituted and continued as necessary. If a grade 3 or 4 adverse reaction persists or recurs following dose adjustment/resumption, sargramostim should be permanently discontinued.
For grade 1 or 2 adverse reactions, sargramostim should be continued with close patient monitoring and management of the adverse reaction.
A baseline CBC with differential and then serial CBCs should be obtained approximately every third day (when possible) until the absolute neutrophil count (ANC) remains greater than 1 000/mm³ for 3 consecutive CBCs. After the first achievement of ANC greater than 1 000/mm³, then serial CBCs should be collected daily (when possible) to avoid unnecessary treatment and minimise any risk of leucocytosis. The start or continuation of administration of sargramostim should not be delayed if a CBC is not available.
Administration of sargramostim should continue until the ANC remains greater than 1 000/mm³ for 3 consecutive CBCs or exceeds 10 000/mm³ after a radiation-induced nadir. If CBCs are not available or in absence of treatment response, sargramostim may be discontinued after 23 consecutive days of dosing.
Sargramostim should be administered subcutaneously in the abdomen, thigh, or upper arm.
For:
Subcutaneous, 7 micrograms sargramostim per kilogram of body weight, once daily.
Sargramostim should be administered once daily as a subcutaneous injection and the dose is 7 micrograms/kg.
See Treatment Response for guidance regarding sargramostim duration of treatment.
For grade 3 or 4 adverse reactions, sargramostim dose should be reduced to 50%, or interrupted until the adverse reaction abates and then resumed at 50% of the dose. Other measures to manage the adverse reaction should be instituted and continued as necessary. If a grade 3 or 4 adverse reaction persists or recurs following dose adjustment/resumption, sargramostim should be permanently discontinued.
For grade 1 or 2 adverse reactions, sargramostim should be continued with close patient monitoring and management of the adverse reaction.
A baseline CBC with differential and then serial CBCs should be obtained approximately every third day (when possible) until the absolute neutrophil count (ANC) remains greater than 1 000/mm³ for 3 consecutive CBCs. After the first achievement of ANC greater than 1 000/mm³, then serial CBCs should be collected daily (when possible) to avoid unnecessary treatment and minimise any risk of leucocytosis. The start or continuation of administration of sargramostim should not be delayed if a CBC is not available.
Administration of sargramostim should continue until the ANC remains greater than 1 000/mm³ for 3 consecutive CBCs or exceeds 10 000/mm³ after a radiation-induced nadir. If CBCs are not available or in absence of treatment response, sargramostim may be discontinued after 23 consecutive days of dosing.
Sargramostim should be administered subcutaneously in the abdomen, thigh, or upper arm.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.