Adult Dosing
Neutrophil Recovery Following Chemotherapy in Acute Myelogenous Leukemia
- 250 mcg/m2/day IV over 4 hrs
- Start on day 11 or 4 days following the completion of induction chemotherapy, if day 10 bone marrow is hypoplastic with <5% blasts
- Continue until absolute neutrophil count (ANC) >1500 cells/mm3 for 3 consecutive days; Max: 42 days
Mobilization of Peripheral Blood Progenitor Cells
- 250 mcg/m2/day IV over 24 hrs or SC q24 hrs, continue at the same dose through the period of PBPC collection
- If WBC > 50,000 cells/mm3 reduce dose by 50%
Post Peripheral Blood Progenitor Cell Transplantation
- 250 mcg/m2/day IV over 24 hrs or SC q24 hrs, start immediately following infusion of progenitor cells and continuing until an ANC >1,500 for 3 consecutive days is attained
Myeloid Reconstitution After Autologous or Allogeneic Bone Marrow Transplantation
- 250 mcg/m2/day IV over 24 hrs, start 2-4 hrs after bone marrow infusion, and not less than 24 hrs after the last dose of chemotherapy or radiotherapy
- Continue until an ANC >1,500 for 3 consecutive days is attained
- If the ANC >20,000 cells/mm3 reduce dose by 50%
Bone Marrow Transplantation Failure or Engraftment Delay
- 250 mcg/m2/day IV over 2 hr x 14 days, May repeat after 7 days off if no engraftment
- Repeat third course of 500 mcg/m2/day IV x 14 days after 7 days off period, if engraftment still has not occurred
Pediatric Dosing
- Safety and effectiveness in pediatric patients has not been established
[Outline]
- Sargramostim injection contains benzyl alcohol, which has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Hence do not administer to neonates
- Sargramostim administration can cause, capillary leak syndrome, pleural or pericardial effusion or may aggravate preexisting pleural and pericardial effusions, however these conditions has been reversible after interruption or dose reduction of sargramostim. Use cautiously in patients with preexisting fluid retention, pulmonary infiltrates or congestive heart failure
- Sequestration of granulocytes in the pulmonary circulation and dyspnea has been reported following sargramostim infusion. Monitor respiratory symptoms during or immediately following infusion, especially in patients with preexisting lung disease. If dyspnea occurs reduce the rate of infusion by half and discontinue if dyspnea still further worsen despite reducing infusion rate. Administer subsequent IV infusions following the standard dose schedule with careful monitoring. Use cautiously in patients with hypoxia
- Transient supraventricular arrhythmia has been reported occasionally, especially in patients with previous history of cardiac arrhythmia. However these arrhythmias have been reversible after discontinuation, use cautiously in patients with preexisting cardiac disease
- Elevation of serum creatinine or bilirubin and hepatic enzymes has been reported in patients with preexisting renal or hepatic dysfunction, receiving sargramostim. Monitor renal and hepatic function at least every other week during the therapy
- Serious allergic or anaphylactic reactions have been reported following sargramostim administration, discontinue the treatment immediately if any such reactions observed
- A syndrome characterized by respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia has been reported following the first administration sargramostim in a particular cycle, which resolves with symptomatic treatment and usually do not recur with subsequent doses in the same cycle of treatment
- Stimulation of marrow precursors resulting in a rapid rise in WBC count has been reported with sargramostim. Based on the clinical condition of the patient, withhold the therapy or reduce the dose by half, if ANC exceeds 20,000 cells/mm3 or if the platelet count exceeds 500,000/mm3
- Monitor CBC with differential twice weekly to preclude development of excessive counts
- Administer with caution in patients with myeloid malignancies, as sargramostim can act as a growth factor for any tumor type, particularly myeloid malignancies. Discontinue the therapy if disease progression is detected
- The effect of sargramostim on myeloid reconstitution may be limited, in patients who before autologous BMT, have received extensive radiotherapy to hematopoietic sites or have been exposed to multiple myelotoxic agents
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Pericardial effusion
- Pleural effusion
- CHF
- Arrhythmias
- Myeloid malignancies
- Preexisting lung disease
Pregnancy Category:C
Breastfeeding: It is not known whether sargramostim is excreted in human milk. As many drugs are excreted in human milk, manufacturer advises to administer sargramostim to a nursing woman only if clearly needed.
55 yrs patients with acute myelogenous leukemia (AML)
