SARGRAMOSTIM (GM-CSF)
| SARGRAMOSTIM (GM-CSF) (sar-gra'mos-tim) Leukine Classifications: blood former; hematological agent; hematopoietic growth factor; granulocyte macropahge colony stimulating factor (gm-csf); Therapeutic: hematpoietic growth factor; gm-csf Prototype: Filgrastim Pregnancy Category: C |
Availability
250 mcg, 500 mcg injection
Action
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.
Therapeutic Effect
Effectiveness is measured by an increase in the number of mature white blood cells (i.e., neutrophil count).
Uses
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 transplantation.
Unlabeled Uses
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.
Contraindications
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.
Cautious Use
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 2–4 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 |
Administration
- 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.
Intravenous
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.
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- 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. CV: Abnormal ST segment depression, supraventricular arrhythmias, edema, hypotension, tachycardia, pericardial effusion, pericarditis. Hematologic: 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).Interactions
Drug: corticosteroids and lithium should be used with caution because it may potentiate the myeloproliferative effects.Pharmacokinetics
Absorption: Readily from SC site. Onset: 3–6 h. Peak: 1–2 h. Duration: 5–10 d SC. Elimination: Probably in urine. Half-Life: 80–150 min.Nursing Implications
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.
Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; 
Canadian drug name; 
Prototype drug