| SARGRAMOSTIM (GM-CSF)
Classifications: blood former; hematological agent; hematopoietic growth factor; granulocyte macropahge colony stimulating factor (gm-csf); Therapeutic: hematpoietic growth factor; gm-csf
Pregnancy Category: C
250 mcg, 500 mcg injection
Recombinant human granulocyte macrophage colony stimulating factor (GM-CSF) is produced by recombinant DNA technology in
yeast. GM-CSF is a hematopoietic growth factor that stimulates proliferation and differentiation of hematopoietic progenitor
cells in the granulocyte-macrophage pathways.
Effectiveness is measured by an increase in the number of mature white blood cells (i.e., neutrophil count).
Myeloid reconstitution after autologous bone marrow transplantation for patients with non-Hodgkin's lymphoma (NHL), acute
lymphoblastic leukemia (ALL), and Hodgkin's disease; mobilization of peripheral blood stem cells (PBSCs) for autologous
To increase WBC counts in AIDS patients; to decrease leukopenia secondary to myelosuppressive chemotherapy; to correct neutropenia
in aplastic anemia and in liver and kidney transplantations.
Hypersensitivity to GM-CSF, yeast-derived products, benzyl alcohol; excessive leukemic myeloid blasts in bone marrow or
blood; within 24 h of chemotherapy or radiation treatment; pregnancy (category C); lactation; neonates.
History of cardiac arrhythmias, preexisting cardiac disease, renal or hepatic dysfunction, CHF, hypoxia, myelodysplastic
syndromes; pulmonary infiltrates; fluid retention; kidney and liver dysfunction.
Route & Dosage
|Autologous Bone Marrow Transplant
Adult: IV 250 mcg/m2/d infused over 2 h for 21 d, begin 24 h after bone marrow transfusion and not less than 24 h after last dose of chemotherapy
or 12 h after last radiation therapy
Neutropenia Following Chemotherapy
Adult: IV 250 mcg/m2/d infused over 4 h starting day 11
- Note: Do not give within 24 h preceding or following chemotherapy or within 12 h preceding or following radiotherapy.
- Reconstitute each 250 mcg vial with 1 mL of sterile water for injection (without preservative). Direct sterile water against
side of vial and swirl gently. Avoid excessive or vigorous agitation. Do not shake. Use without further dilution for SC injection.
- Note: Verify correct IV concentration and rate of infusion administration in infants and children with physician.
PREPARE: IV Infusion: Reconstitute as for SC, then further dilute reconstituted solution with NS. If the final concentration is <1 mcg/mL, add
albumin (human) to NS before addition of sargramostim. Use 1 mg albumin per 1 mL of NS to give a final concentration of 0.1%
albumin. Administer as soon as possible and within 6 h of reconstitution or dilution for IV infusion. Discard after 6 h.
Sargramostim vials are single-dose vials, do not reenter or reuse. Discard unused portion.
ADMINISTER: IV Infusion: Give over 2 h. Do not use an in-line membrane filter.
INCOMPATIBILITIES Y-site: Acyclovir, amphotericin B, ampicillin, ampicillin/sulbactam, amsacrine, cefonicid, cefoperazone, ceftazidime, chlorpromazine, ganciclovir, haloperidol, hydrocortisone, hydromorphone, hydroxyzine, imipenem/cilastatin, lorazepam, methylprednisolone, mitomycin, morphine, nalbuphine, ondansetron, piperacillin, sodium bicarbonate, tobramycin.
- Interrupt administration and reduce the dose by 50% if absolute neutrophil count exceeds 20,000/mm3 or if platelet count exceeds 500,000/mm3. Notify physician.
- Reduce the IV rate 50% if patient experiences dyspnea during administration. Discontinue infusion if respiratory symptoms
worsen. Notify physician.
- Refrigerate the sterile powder, the reconstituted solution, and store diluted solution at 2°8° C (36°46°
F). Do not freeze or shake.
Adverse Effects (≥1%)CNS:
Lethargy, malaise, headache, fatigue
Abnormal ST segment depression
, supraventricular arrhythmias, edema, hypotension, tachycardia, pericardial effusion,
Anemia, thrombocytopenia. GI:
Nausea, vomiting, diarrhea, anorexia. Body as a Whole: Bone pain, myalgia, arthralgias,
weight gain, hyperuricemia, fever. Respiratory:
Pleural effusion. Skin: Rash, pruritus. Other: First-dose reaction
(some or all of the following symptoms: hypotension, tachycardia, fever, rigors, flushing, nausea, vomiting, diaphoresis,
back pain, leg spasms, and dyspnea).
should be used with caution because it may potentiate the myeloproliferative effects.
Readily from SC site. Onset:
36 h. Peak:
12 h. Duration:
510 d SC. Elimination:
Probably in urine. Half-Life:
Assessment & Drug Effects
- Lab tests: Obtain a CBC and platelet count prior to initiation of therapy. Monitor biweekly CBC with differential during
therapy. Monitor kidney and liver function biweekly in patients with established kidney or liver dysfunction.
- Discontinue treatment if WBC 50,000/mm3. Notify the physician.
- Occasional transient supraventricular arrhythmias have occurred during administration, particularly in those with a history
of cardiac arrhythmias. Arrhythmias are reversed with discontinuation of drug.
- Give special attention to respiratory symptoms (dyspnea) during and immediately following infusion, especially in patients
with preexisting pulmonary disease.
- Use drug with caution in patients with preexisting fluid retention, pulmonary infiltrates, or CHF. Peripheral edema, pleural
or pericardial effusion has occurred after administration. It is reversible with dose reduction.
- Notify physician of any severe adverse reaction immediately.
- Discontinue therapy and notify physician if disease progression is detected. Potentially, drug can act as a growth factor
for myeloid malignancies.
Patient & Family Education
- Notify nurse or physician immediately of any adverse effect (e.g., dyspnea, palpitations, peripheral edema, bone or muscle
pain) during or after drug administration.