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.
Subcutaneous
  • 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
  • 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. 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

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