Acute myeloid leukemia following induction chemotherapy

Active Ingredient: Sargramostim

Indication for Sargramostim

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Sargramostim is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).

For this indication, competent medicine agencies globally authorize below treatments:

250 ug/m²/day over a 4-hour period for 3 consecutive days until ANC >1500 cells/mm³

For:

Dosage regimens

Intravenous, 250 micrograms sargramostim per square meter of body surface, once daily, over the duration of 3 to 42 days.

Detailed description

The recommended dose is 250 mcg/m²/day administered intravenously over a 4-hour period starting approximately on day 11 or four days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts. If a second cycle of induction chemotherapy is necessary, administer sargramostim approximately four days after the completion of chemotherapy if the bone marrow is hypoplastic with less than 5% blasts. Continue sargramostim until an absolute neutrophil count (ANC) greater than 1500 cells/mm³ for 3 consecutive days or a maximum of 42 days. Do not administer sargramostim within 24 hours preceding or following receipt of chemotherapy or radiotherapy.

Dose Modifications

Obtain a CBC with differential twice per week during sargramostim therapy and modify the dose for the following:

  • Leukemic regrowth: Discontinue sargramostim immediately
  • Grade 3 or 4 adverse reactions: Reduce the dose of sargramostim by 50% or interrupt dosing until the reaction abates
  • ANC greater than 20,000 cells/mm³: Interrupt sargramostim treatment or reduce the dose by 50%

Active ingredient

Sargramostim

Sargramostim is a recombinant human GM-CSF. The binding to GM-CSF receptors expressed on the surface of target cells (haematopoietic progenitors and mature immune cells), initiates an intracellular signalling cascade which induces the cellular responses (i.e., division, maturation, activation). GM-CSF is a multilineage factor and, in addition to dose-dependent effects on the myelomonocytic lineage, it can promote the proliferation and maturation of megakaryocytic and erythroid progenitors.

Read more about Sargramostim

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