Parenteral Manual

Sargramostim (SPECIAL ACCESS PROGRAM), GM-CSF, NCI #613795

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Leukine(R) , Prokine(R)
Classification: 
Granulocyte Macrophage Colony Stimulating Factor
Original Date: 
August 2005
Revised Date: 
November 2019
Indications: 
  • As adjunctive immunotherapy for high-risk neuroblastoma
  • Accelerates myeloid recovery and engraftment in patients undergoing bone marrow transplant
  • Mobilization for peripheral blood stem cell harvest
  • Increase neutrophil recovery in patients receiving myelosuppressive chemotherapy
Reconstitution and Stability: 
  • Available as 250 mcg/vial lyophilized powder for injection.
  • Reconstitute lyophilized powder with 1 mL of SWFI for a final concentration of 250 mcg/mL.  Direct the diluent at the side of the vial to prevent foaming.  Gently swirl to dissolve.  DO NOT SHAKE.
  • Stable for 6 hours at room temperature once reconstituted or once diluted for IV infusion.
  • Do not shake. Protect from light.
  • Keep vials in refrigerator. Do not freeze.
Compatibility: 

- Solutions Compatible:  Albumin and NS only.

- Additives/above cassette Compatible: Do not mix with other drugs or IV solutions.

- Y-site Compatible: Do not run with other drugs or IV solution

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC

YES, PREFERRED (less toxicity)

Usual dilution: 250 mcg/mL
IM NO
IV Push

NO
IV Intermittent Infusion

YES, Do not use an in-line filter when infusing
Infusion time: 2 hours. If final concentration less than 10 mcg/mL, add albumin 1 mg/mL to prevent adsorption
IV Continuous Infusion

YES

If final concentration less than 10 mcg/mL, add albumin 1 mg/mL to prevent adsorption
Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

 

High-risk Neuroblastoma:

  • 250 mcg/m2/day subcutaneously x 14 days

Relapse Neuroblastoma:

  • 250 mcg/m2/day subcutaneously x 7 days or as per protocol

Chemotherapy Recovery:

  •  5 - 10 mcg/kg/day (max 30 mcg/kg/day) or 250 mcg/m2/day subcutaneously x 14 - 21 days

Bone Marrow Transplant:

  • 250 mcg/m2/day  subcutaneously x  21 days, beginning 2-4 hours post BMT

 

Potential hazards of parenteral administration: 
  • Flu-like Syndrome: fever, chills, headache, myalgia, bone pain, transient rash, malaise, abdominal cramps, anorexia, nausea
  • First Dose Reaction: respiratory distress, hypoxia, hypotension with flushing, syncope, tachycardia (can occur within 3 hours of first dose)
  • Urticaria, dyspnea, rigors
  • Local reaction
  • Anaphylaxis (rare)
  • Thromboembolic phenomena (rare)
  • Capillary leak syndrome (rare)
  • All side effects are worse with IV route

 

Notes: 
  • Do not administer within 24 hours following administration of chemotherapy or 12 hours prior or after radiotherapy
  • Hold if WBC greater than 50 x 10 9/L. Resume at 50% dose once WBC is less than 20 x 109/L
  • Monitor renal and liver function tests if pre-existing dysfunction
  • Concomitant therapy with sargramostim and vincristine in lymphoma patients has resulted in severe peripheral neuropathy, usually localized to the feet
  • Concomitant therapy with lithium and sargramostin should be undertaken with caution. Patients receiving lithium and sargramostin should have more frequent monitoring of neutrophil counts.

 

 

References: 

Federal Drug Association (FDA): Leukine Product Monograph. Accessed 22Nov2019.https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103362s5237lbl...

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