Leukine
sargramostim (GM-CSF)
Pharmacologic class: Granulocytemacrophage colony stimulating factor
Therapeutic class: Hematopoietic agent
Pregnancy risk category C
Action
Stimulates proliferation and differentiation of hematopoietic cells that activate mature granulocytes and macrophages of target cells
Availability
Liquid: 500 mcg/ml
Powder for injection: 250 mcg
Indications and dosages
➣ Post peripheral blood progenitor cell (PBPC) transplantation
Adults: 250 mcg/m2/day I.V. over 24 hours or subcutaneously once daily, starting immediately after progenitor cell infusion
➣ Mobilization of PBPCs into peripheral blood for collection by leukapheresis
Adults: 250 mcg/m2/day I.V. over 24 hours or subcutaneously once daily, continued throughout harvesting
➣ Neutrophil recovery after chemotherapy in acute myelogenous leukemia Adults: 250 mcg/m2/day I.V. over 4 hours, starting 4 days after completion of chemotherapy induction
➣ Bone-marrow transplantation failure or engraftment delay
Adults: 250 mcg/m2/day as 2-hour I.V. infusion for 14 days. If engraftment doesn't occur, may repeat after 7 days of drug hiatus.
➣ Myeloid reconstitution after autologous or allogeneic bone-marrow transplantation
Adults: 250 mcg/m2/day as a 2-hour I.V. infusion, starting 2 to 4 hours after autologous bone marrow infusion and at least 24 hours after last chemotherapy or radiotherapy dose
Off-label uses
• Crohn's disease
• Melanoma
• Wound healing
• Mucositis
• Stomatitis
• Vaccine adjuvant
Contraindications
• Hypersensitivity to drug, its components, or yeast products
• Excessive leukemic myeloid blasts in bone marrow or peripheral blood (10% or more)
• Within 24 hours before or after chemotherapy or radiation therapy
Precautions
Use cautiously in:
• renal or hepatic insufficiency, fluid retention, pulmonary disorders, pulmonary infiltrates, heart failure, leukocytosis, transient supraventricular arrhythmias
• cancer patients undergoing sargramostim-mobilized PBPC collection
• patients receiving purged bone marrow or previously exposed to intensive chemotherapy or radiation therapy
• pregnant or breastfeeding patients
• children.
Administration
See Don't give within 24 hours of chemotherapy or radiation therapy.
• Add 1 ml of sterile water to powder for injection by directing water stream against side of vial and swirling vial gently to disperse contents.
• Avoid shaking or agitating solution.
• For a final drug concentration below 10 mcg/ml, add human albumin 0.1% to saline solution; then dilute drug in normal saline solution.
• Infuse as soon as possible after reconstitution, but no more than 6 hours after mixing.
• Don't add other drugs to infusion; don't use in-line filter.
Adverse reactions
CNS: malaise, asthenia
CV: peripheral edema, tachycardia, hypotension, transient supraventricular tachycardia, pericardial effusion
GI: nausea, vomiting, diarrhea, anorexia, stomatitis, GI hemorrhage
GU: urinary tract disorder, abnormal renal function
Hematologic: blood dyscrasias, hemorrhage
Hepatic: hepatic damage
Musculoskeletal: joint pain, myalgia, bone pain
Respiratory: dyspnea, lung disorder
Skin: rash, alopecia
Other: fever, chills, sepsis, edema, first-dose reaction (respiratory distress, hypoxia, syncope, tachycardia, hypotension, flushing)
Interactions
Drug-drug. Corticosteroids, lithium: potentiation of myeloproliferative effects
Vincristine: severe peripheral neuropathy
Patient monitoring
• Monitor for dyspnea. Halve dosage and contact prescriber if dyspnea occurs.
• Assess CBC with white cell differential. Check for presence of blast cells, and watch for signs and symptoms of blood dyscrasias.
• Closely monitor vital signs and fluid intake and output. Stay alert for signs and symptoms of fluid overload.
See Monitor liver function tests, and watch for evidence of hepatic damage and bleeding (especially GI hemorrhage).
Patient teaching
See Tell patient sargramostim is a powerful drug that can cause significant adverse reactions. Teach him to recognize and report serious reactions at once.
See Instruct patient to immediately report unusual bleeding or bruising or yellowing of skin or eyes.
• Tell patient drug may cause weakness and musculoskeletal pain.
• Inform patient that he'll undergo regular blood testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.
sargramostim
(sar-gram-oh-stim) sargramostim,Leukine
(trade name),rHu GM-CSF (recombinant human granulocyte/macrophage colony-stimulating factor)
(trade name)Classification
Therapeutic: colony stimulating factorsPharmacologic: biologic response modifiers
Indications
- Autologous bone marrow transplantation in patients with non-Hodgkin’s lymphoma, acute lymphoblastic leukemia, or Hodgkin’s disease;
- Allogenic bone marrow transplantation from HLA-matched donors.
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (noted as effects on blood counts)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| Subcut, IV | rapid | unknown | 3–7 days |
Contraindications/Precautions
Adverse Reactions/Side Effects
Central nervous system
- headache (most frequent)
- malaise
- weakness
Respiratory
- dyspnea
Cardiovascular
- pericardial effusion
- peripheral edema
- transient supraventricular tachycardia
Gastrointestinal
- diarrhea
Dermatologic
- itching (most frequent)
- rash (most frequent)
Musculoskeletal
- arthralgia (most frequent)
- bone pain (most frequent)
- myalgia (most frequent)
Miscellaneous
- chills
- fever
- first-dose reaction
Interactions
Drug-Drug interaction
Lithium or corticosteroids may potentiate myeloproliferative effects of sargramostim (concurrent use should be undertaken cautiously).Route/Dosage
After Bone Marrow TransplantationAvailability
Nursing implications
Nursing assessment
- Monitor heart rate, BP, and respiratory status during and immediately after infusion. If dyspnea develops, slow infusion rate by half. Reassess; medication may need to be discontinued. Assess for peripheral edema daily throughout therapy. Capillary leak syndrome (swelling of feet or lower legs, sudden weight gain, dyspnea) and pleural or pericardial effusion may occur, usually at doses >32 mcg/kg/day.
- Monitor for first-dose reaction (flushing, hypotension, syncope, weakness). Does not recur with first dose of each course but may occur with first dose of more than 1 course.
- Assess for fever daily during therapy. Usually mild and dose-related and resolves with discontinuation or administration of antipyretics.
- Assess for arthralgias and myalgias, usually in lower extremities, which tend to occur when granulocyte counts are returning to normal. May also cause mild to moderate bone pain, possibly from bone marrow expansion. Usually occurs over 1–3 days before myeloid recovery and occurs in the sternum, spine, pelvis, and long bones. Treat with analgesics.
- Lab Test Considerations: Obtain a CBC with differential and platelet count before chemotherapy and twice weekly during therapy to avoid leukocytosis. Monitor ANC; may increase rapidly. If ANC >20,000/mm3 or 10,000/mm3 after the nadir has occurred or if platelet count >500,000/mm3, interrupt administration and reduce dose by half or discontinue. Excessive blood levels usually return to baseline 3–7 days after discontinuation of therapy. If blast cells appear, sargramostim should be discontinued.
- Monitor renal and hepatic function before and biweekly throughout therapy in patients with renal or hepatic dysfunction. May cause ↑ BUN, creatinine, and hepatic enzymes.
- May cause ↓ serum albumin concentrations.
Potential Nursing Diagnoses
Risk for infection (Indications)Implementation
- Administer 2–4 hr after bone marrow transplant and no earlier than 24 hr after cytotoxic chemotherapy or 12 hr after last dose of radiotherapy.
- Refrigerate but do not freeze powder, reconstituted solution, or diluted solution. Reconstitute with 1 mL of sterile water without preservatives injected toward side of vial. Swirl gently to avoid foaming. Do not shake. Solution should be clear and colorless. Discard if left at room temperature for >6 hr. Vial is for 1-time use only.
- Subcutaneous: Administer reconstituted solution without further dilution.
Intravenous Administration
- pH: 7.1–7.7.
- Intermittent Infusion: Diluent: Dilute in 0.9% NaCl.Concentration: If final concentration is <10 mcg/mL, add 1 mg human albumin per 1 mL of 0.9% NaCl before addition of sargramostim to prevent absorption of the components of the drug delivery system. Do not administer with an in-line filter.
- Rate: Usually infused over 2–4 hr. Has been administered over 30–60 min, over 5–12 hr, and as a continuous infusion over 24 hr.
- After bone marrow transplantation or failure of engraftment: Administer over 2 hr.
- Chemotherapy for AML: Administer over 4 hr.
- Mobilization of PBPCs or PBPC transplant: Administer as a continuous infusion over 24 hr.
- Y-Site Compatibility: amikacin, aminocaproic acid, aminophylline, aztreonam, bleomycin, butorphanol, calcium gluconate, carboplatin, carmustine, cefazolin, cefepime, cefotaxime, cefotetan, ceftriaxone, cefuroxime, cisplatin, clindamycin, cyclophosphamide, cyclosporine, cytarabine, dacarbazine, dactinomycin, dexamethasone sodium phosphate, diphenhydramine, dopamine, doxorubicin hydrochloride, doxycycline, droperidol, etoposide, famotidine, fentanyl, floxuridine, fluconazole, fluorouracil, furosemide, gentamicin, granisetron, heparin, idarubicin, ifosfamide, immune globulin, levofloxacin, magnesium sulfate, mannitol, mechlorethamine, meperidine, mesna, methotrexate, metoclopramide, metronidazole, mitoxantrone, pentostatin, piperacillin/tazobactam, potassium chloride, prochlorperazine, promethazine, ranitidine, rituximab, sodium acetate, teniposide, ticarcillin/clavulanate, trastuzumab, trimethoprim/sulfamethoxazole, vinblastine, vincristine, zidovudine
- Y-Site Incompatibility: acyclovir, ampicillin, ampicillin/sulbactam, cefoperazone, chlorpromazine, ganciclovir, haloperidol, hydrocortisone, hydromorphone, hydroxyzine, imipenem/cilastatin, lorazepam, methylprednisolone sodium succinate, mitomycin, morphine, nalbuphine, nesiritide, ondansetron, sodium bicarbonate, tobramycin
- Additive Incompatibility: Do not admix with other medications.
Patient/Family Teaching
- Explain purpose of sargramostim to patient.
- Instruct patient to notify health care professional if dyspnea or palpitations occur.
Evaluation/Desired Outcomes
- Acceleration of bone marrow recovery and decreased incidence of infection in patients after autologous and allogenic bone marrow transplantation, bone marrow transplant failure or engraftment delay, chemotherapy for AML, and PBPC transplantation.
Leukine®
Sargramostim Oncology A formulation of GM-CSF used for cell recovery in Pts with ↓ cell counts due to chemotherapy with Immunex. See GM-CSF.- dogma of the assumption
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