Sargramo

 Indications Myeloid reconstitution after autologous bone marrow transplantation and after bone marrow transplantation failure or graft failure; promotion of early engraftment or engraftment delay; treatment of neutropenia associated bone marrow transplant; induction chemotherapy in acute myelogenous leukemia (AML); mobilization and following transplantation of autologous PBPC; and myeloid reconstitution after allogeneic BMT.

Increase WBC counts in patients with myelodysplastic syndromes and in AIDS patients receiving zidovudine; decrease nadir of leukopenia secondary to myelosuppressive chemotherapy; decrease myelosuppression in preleukemic patients; correct neutropenia in aplastic anemia patients; decrease transplantation-associated organ system damage.

 

 Contraindications Excessive leukemic myeloid blasts in bone marrow or peripheral blood; hypersensitivity to granulocyte-macrophage colony-stimulating factor, yeast-derived products, or any component of product; simultaneous administration with cytotoxic chemotherapy or radiotherapy, or administration 24 hrs preceding or following chemotherapy or radiotherapy.

 

 Route/Dosage

Bone Marrow Transplant Failure or Engraftment Delay

ADULTS: IV 250 mcg/m²/day for 14 days.

Myeloid Reconstitution After Bone Marrow Transplantation

ADULTS: IV 250 mcg/m²/day for 21 days (first dose given 2 to 4 hr after transplant).

Neutrophil Recovery Following Chemotherapy in AML

ADULTS: IV 250 mcg/m²/day over a 4-hr period starting around day 11 or 4 days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts.

Mobilization of PBPC

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily. Continue at the same dose through the period of PBPC collection.

Post Peripheral Blood Progenitor Cell Transplantation

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily beginning immediately following infusion of progenitor cells and continuing until an ANC of more than 1500 for 3 consecutive days is attained.

 

 Interactions

Antineoplastics: Do not use concomitantly.

Corticosteroids or Lithium: May potentiate myeloproliferative effects of sargramostim.

 

 Lab Test Interferences None well documented.

 

 Adverse Reactions

CARDIOVASCULAR: Tachycardia. CNS: Anxiety. DERMATOLOGIC: Pruritus. EENT: Eye hemorrhage. GI: Abdominal pain; hematemesis; dysphagia. GU: Bilirubinemia. METABOLIC: Metabolic disorder; weight gain. RESPIRATORY: Pharyngitis. OTHER: Bone pain; arthralgia; malaise; chest pain.

 

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. However, available data indicate that sargramostim does not exhibit any greater toxicity in children than in adults. Benzyl Alcohol: Benzyl alcohol as a preservative has been associated with fatal “gasping syndrome” in premature infants. Concomitant Chemotherapy and Radiotherapy: Since rapidly dividing cells are particularly sensitive to cytotoxic chemotherapy and radiotherapy, sargramostim should not be given within 24 hr of chemotherapy or within 12 hr of radiotherapy. Growth Factor Potential: Administer with caution in patients with myeloid malignancies. Hypersensitivity: Reactions are infrequent and have ranged from serious allergic or anaphylactic reactions to transient rashes and local injection site reactions. Renal Hepatic and Cardiac Patients: Monitor patients closely and use with caution. Respiratory Symptoms: It may be necessary to decrease rate of infusion by 50% if dyspnea occurs during administration.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Reconstitute with 1 mL Sterile Water for Injection (without preservative); do not re-enter vial. Discard any unused portion.
• During reconstitution, direct sterile water at side of vial and gently swirl contents to prevent foaming during dissolution. Avoid excessive or vigorous agitation; do not shake.
• Dilute in 0.9% Sodium Chloride Injection to prepare IV infusion. If final concentration is less than 10 mcg/mL, add human albumin to make final concentration of 0.1% to saline before adding sargramostim to prevent absorption to drug delivery system. For final concentration of 0.1% albumin, add 1 mg human albumin/1 mL 0.9% saline injection. Give within 6 hr after reconstitution. Discard any unused portion after 6 hr.
• Administer each dose over 2 hr as IV infusion.
• Do not use in-line membrane filter for IV infusion.
• Do not add other medications to IV solution.
• Administer 2 to 4 hr after autologous bone marrow infusion, not less than 24 hr after last dose of antineoplastics, and 12 hr after last dose of radiotherapy, bone marrow transplantation failure or engraftment delay.
• Refrigerate sterile powder, reconstituted solution, and diluted solution for injection. Do not freeze or shake.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor CBC and differential biweekly during therapy. If ANC is more than 20,000/mm³ or platelet count is more than 500,000 cells/mm³, discontinue or reduce dose by one half. Leukocytosis may occur.
• Monitor renal and hepatic studies before treatment, including BUN, creatinine, urinalysis, AST, ALT, alkaline phosphatase, and monitor biweekly during therapy if renal or hepatic disease is present.
• Observe for hypersensitivity reactions, including rashes and local injection site reactions, which are usually transient.
• Monitor I&O, hydration status and weight. Observe for fluid retention or edema; pleural and pericardial effusions have occurred.
• Monitor vital signs during therapy; supraventricular arrhythmias have occurred in patients with cardiac disease. Hypotension with flushing and syncope has rarely occurred with first dose.
• Monitor for respiratory symptoms during and immediately following infusion, especially in patients with history of pulmonary disease. If dyspnea occurs during infusion, reduce rate by one half. If symptoms worsen, notify health care provider and discontinue infusion.

OVERDOSAGE: SIGNS & SYMPTOMS   Dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache and chills, increases in WBC no more than 200,000 cells/mm3

 

 Patient/Family Education

• Reassure patient that hypotension with flushing and syncope has rarely occurred with first dose.
• Stress importance of follow-up for laboratory tests.
• Instruct patient to inform health care provider if any of the following symptoms occur: dyspnea, malaise, nausea, fever, rash, rapid heart rate, headache, chills.

Indications for Drugs ::

(sar-GRUH-moe-STIM)

Leukine

Powder for injection, lyophilized

250 mcg

Powder for injection, lyophilized

500 mcg

Liquid

500 mcg/mL

Class: Colony-stimulating factor

 

 Action Supports survival, proliferation, and differentiation of hematopoietic progenitor cells; induces partially committed progenitor cells to divide and differentiate in granulocyte-macrophage pathways; activates mature granulocytes and macrophages; promotes proliferation of megakaryocytic and erythroid progenitors.

 

 Indications Myeloid reconstitution after autologous bone marrow transplantation and after bone marrow transplantation failure or graft failure; promotion of early engraftment or engraftment delay; treatment of neutropenia associated bone marrow transplant; induction chemotherapy in acute myelogenous leukemia (AML); mobilization and following transplantation of autologous PBPC; and myeloid reconstitution after allogeneic BMT.

Increase WBC counts in patients with myelodysplastic syndromes and in AIDS patients receiving zidovudine; decrease nadir of leukopenia secondary to myelosuppressive chemotherapy; decrease myelosuppression in preleukemic patients; correct neutropenia in aplastic anemia patients; decrease transplantation-associated organ system damage.

 

 Contraindications Excessive leukemic myeloid blasts in bone marrow or peripheral blood; hypersensitivity to granulocyte-macrophage colony-stimulating factor, yeast-derived products, or any component of product; simultaneous administration with cytotoxic chemotherapy or radiotherapy, or administration 24 hrs preceding or following chemotherapy or radiotherapy.

 

 Route/Dosage

Bone Marrow Transplant Failure or Engraftment Delay

ADULTS: IV 250 mcg/m²/day for 14 days.

Myeloid Reconstitution After Bone Marrow Transplantation

ADULTS: IV 250 mcg/m²/day for 21 days (first dose given 2 to 4 hr after transplant).

Neutrophil Recovery Following Chemotherapy in AML

ADULTS: IV 250 mcg/m²/day over a 4-hr period starting around day 11 or 4 days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts.

Mobilization of PBPC

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily. Continue at the same dose through the period of PBPC collection.

Post Peripheral Blood Progenitor Cell Transplantation

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily beginning immediately following infusion of progenitor cells and continuing until an ANC of more than 1500 for 3 consecutive days is attained.

 

 Interactions

Antineoplastics: Do not use concomitantly.

Corticosteroids or Lithium: May potentiate myeloproliferative effects of sargramostim.

 

 Lab Test Interferences None well documented.

 

 Adverse Reactions

CARDIOVASCULAR: Tachycardia. CNS: Anxiety. DERMATOLOGIC: Pruritus. EENT: Eye hemorrhage. GI: Abdominal pain; hematemesis; dysphagia. GU: Bilirubinemia. METABOLIC: Metabolic disorder; weight gain. RESPIRATORY: Pharyngitis. OTHER: Bone pain; arthralgia; malaise; chest pain.

 

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. However, available data indicate that sargramostim does not exhibit any greater toxicity in children than in adults. Benzyl Alcohol: Benzyl alcohol as a preservative has been associated with fatal “gasping syndrome” in premature infants. Concomitant Chemotherapy and Radiotherapy: Since rapidly dividing cells are particularly sensitive to cytotoxic chemotherapy and radiotherapy, sargramostim should not be given within 24 hr of chemotherapy or within 12 hr of radiotherapy. Growth Factor Potential: Administer with caution in patients with myeloid malignancies. Hypersensitivity: Reactions are infrequent and have ranged from serious allergic or anaphylactic reactions to transient rashes and local injection site reactions. Renal Hepatic and Cardiac Patients: Monitor patients closely and use with caution. Respiratory Symptoms: It may be necessary to decrease rate of infusion by 50% if dyspnea occurs during administration.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Reconstitute with 1 mL Sterile Water for Injection (without preservative); do not re-enter vial. Discard any unused portion.
• During reconstitution, direct sterile water at side of vial and gently swirl contents to prevent foaming during dissolution. Avoid excessive or vigorous agitation; do not shake.
• Dilute in 0.9% Sodium Chloride Injection to prepare IV infusion. If final concentration is less than 10 mcg/mL, add human albumin to make final concentration of 0.1% to saline before adding sargramostim to prevent absorption to drug delivery system. For final concentration of 0.1% albumin, add 1 mg human albumin/1 mL 0.9% saline injection. Give within 6 hr after reconstitution. Discard any unused portion after 6 hr.
• Administer each dose over 2 hr as IV infusion.
• Do not use in-line membrane filter for IV infusion.
• Do not add other medications to IV solution.
• Administer 2 to 4 hr after autologous bone marrow infusion, not less than 24 hr after last dose of antineoplastics, and 12 hr after last dose of radiotherapy, bone marrow transplantation failure or engraftment delay.
• Refrigerate sterile powder, reconstituted solution, and diluted solution for injection. Do not freeze or shake.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor CBC and differential biweekly during therapy. If ANC is more than 20,000/mm³ or platelet count is more than 500,000 cells/mm³, discontinue or reduce dose by one half. Leukocytosis may occur.
• Monitor renal and hepatic studies before treatment, including BUN, creatinine, urinalysis, AST, ALT, alkaline phosphatase, and monitor biweekly during therapy if renal or hepatic disease is present.
• Observe for hypersensitivity reactions, including rashes and local injection site reactions, which are usually transient.
• Monitor I&O, hydration status and weight. Observe for fluid retention or edema; pleural and pericardial effusions have occurred.
• Monitor vital signs during therapy; supraventricular arrhythmias have occurred in patients with cardiac disease. Hypotension with flushing and syncope has rarely occurred with first dose.
• Monitor for respiratory symptoms during and immediately following infusion, especially in patients with history of pulmonary disease. If dyspnea occurs during infusion, reduce rate by one half. If symptoms worsen, notify health care provider and discontinue infusion.

OVERDOSAGE: SIGNS & SYMPTOMS   Dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache and chills, increases in WBC no more than 200,000 cells/mm3

 

 Patient/Family Education

• Reassure patient that hypotension with flushing and syncope has rarely occurred with first dose.
• Stress importance of follow-up for laboratory tests.
• Instruct patient to inform health care provider if any of the following symptoms occur: dyspnea, malaise, nausea, fever, rash, rapid heart rate, headache, chills.

Drug Dose ::

(sar-GRUH-moe-STIM)

Leukine

Powder for injection, lyophilized

250 mcg

Powder for injection, lyophilized

500 mcg

Liquid

500 mcg/mL

Class: Colony-stimulating factor

 

 Action Supports survival, proliferation, and differentiation of hematopoietic progenitor cells; induces partially committed progenitor cells to divide and differentiate in granulocyte-macrophage pathways; activates mature granulocytes and macrophages; promotes proliferation of megakaryocytic and erythroid progenitors.

 

 Indications Myeloid reconstitution after autologous bone marrow transplantation and after bone marrow transplantation failure or graft failure; promotion of early engraftment or engraftment delay; treatment of neutropenia associated bone marrow transplant; induction chemotherapy in acute myelogenous leukemia (AML); mobilization and following transplantation of autologous PBPC; and myeloid reconstitution after allogeneic BMT.

Increase WBC counts in patients with myelodysplastic syndromes and in AIDS patients receiving zidovudine; decrease nadir of leukopenia secondary to myelosuppressive chemotherapy; decrease myelosuppression in preleukemic patients; correct neutropenia in aplastic anemia patients; decrease transplantation-associated organ system damage.

 

 Contraindications Excessive leukemic myeloid blasts in bone marrow or peripheral blood; hypersensitivity to granulocyte-macrophage colony-stimulating factor, yeast-derived products, or any component of product; simultaneous administration with cytotoxic chemotherapy or radiotherapy, or administration 24 hrs preceding or following chemotherapy or radiotherapy.

 

 Route/Dosage

Bone Marrow Transplant Failure or Engraftment Delay

ADULTS: IV 250 mcg/m²/day for 14 days.

Myeloid Reconstitution After Bone Marrow Transplantation

ADULTS: IV 250 mcg/m²/day for 21 days (first dose given 2 to 4 hr after transplant).

Neutrophil Recovery Following Chemotherapy in AML

ADULTS: IV 250 mcg/m²/day over a 4-hr period starting around day 11 or 4 days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts.

Mobilization of PBPC

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily. Continue at the same dose through the period of PBPC collection.

Post Peripheral Blood Progenitor Cell Transplantation

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily beginning immediately following infusion of progenitor cells and continuing until an ANC of more than 1500 for 3 consecutive days is attained.

 

 Interactions

Antineoplastics: Do not use concomitantly.

Corticosteroids or Lithium: May potentiate myeloproliferative effects of sargramostim.

 

 Lab Test Interferences None well documented.

 

 Adverse Reactions

CARDIOVASCULAR: Tachycardia. CNS: Anxiety. DERMATOLOGIC: Pruritus. EENT: Eye hemorrhage. GI: Abdominal pain; hematemesis; dysphagia. GU: Bilirubinemia. METABOLIC: Metabolic disorder; weight gain. RESPIRATORY: Pharyngitis. OTHER: Bone pain; arthralgia; malaise; chest pain.

 

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. However, available data indicate that sargramostim does not exhibit any greater toxicity in children than in adults. Benzyl Alcohol: Benzyl alcohol as a preservative has been associated with fatal “gasping syndrome” in premature infants. Concomitant Chemotherapy and Radiotherapy: Since rapidly dividing cells are particularly sensitive to cytotoxic chemotherapy and radiotherapy, sargramostim should not be given within 24 hr of chemotherapy or within 12 hr of radiotherapy. Growth Factor Potential: Administer with caution in patients with myeloid malignancies. Hypersensitivity: Reactions are infrequent and have ranged from serious allergic or anaphylactic reactions to transient rashes and local injection site reactions. Renal Hepatic and Cardiac Patients: Monitor patients closely and use with caution. Respiratory Symptoms: It may be necessary to decrease rate of infusion by 50% if dyspnea occurs during administration.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Reconstitute with 1 mL Sterile Water for Injection (without preservative); do not re-enter vial. Discard any unused portion.
• During reconstitution, direct sterile water at side of vial and gently swirl contents to prevent foaming during dissolution. Avoid excessive or vigorous agitation; do not shake.
• Dilute in 0.9% Sodium Chloride Injection to prepare IV infusion. If final concentration is less than 10 mcg/mL, add human albumin to make final concentration of 0.1% to saline before adding sargramostim to prevent absorption to drug delivery system. For final concentration of 0.1% albumin, add 1 mg human albumin/1 mL 0.9% saline injection. Give within 6 hr after reconstitution. Discard any unused portion after 6 hr.
• Administer each dose over 2 hr as IV infusion.
• Do not use in-line membrane filter for IV infusion.
• Do not add other medications to IV solution.
• Administer 2 to 4 hr after autologous bone marrow infusion, not less than 24 hr after last dose of antineoplastics, and 12 hr after last dose of radiotherapy, bone marrow transplantation failure or engraftment delay.
• Refrigerate sterile powder, reconstituted solution, and diluted solution for injection. Do not freeze or shake.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor CBC and differential biweekly during therapy. If ANC is more than 20,000/mm³ or platelet count is more than 500,000 cells/mm³, discontinue or reduce dose by one half. Leukocytosis may occur.
• Monitor renal and hepatic studies before treatment, including BUN, creatinine, urinalysis, AST, ALT, alkaline phosphatase, and monitor biweekly during therapy if renal or hepatic disease is present.
• Observe for hypersensitivity reactions, including rashes and local injection site reactions, which are usually transient.
• Monitor I&O, hydration status and weight. Observe for fluid retention or edema; pleural and pericardial effusions have occurred.
• Monitor vital signs during therapy; supraventricular arrhythmias have occurred in patients with cardiac disease. Hypotension with flushing and syncope has rarely occurred with first dose.
• Monitor for respiratory symptoms during and immediately following infusion, especially in patients with history of pulmonary disease. If dyspnea occurs during infusion, reduce rate by one half. If symptoms worsen, notify health care provider and discontinue infusion.

OVERDOSAGE: SIGNS & SYMPTOMS   Dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache and chills, increases in WBC no more than 200,000 cells/mm3

 

 Patient/Family Education

• Reassure patient that hypotension with flushing and syncope has rarely occurred with first dose.
• Stress importance of follow-up for laboratory tests.
• Instruct patient to inform health care provider if any of the following symptoms occur: dyspnea, malaise, nausea, fever, rash, rapid heart rate, headache, chills.

Contraindication ::

(sar-GRUH-moe-STIM)

Leukine

Powder for injection, lyophilized

250 mcg

Powder for injection, lyophilized

500 mcg

Liquid

500 mcg/mL

Class: Colony-stimulating factor

 

 Action Supports survival, proliferation, and differentiation of hematopoietic progenitor cells; induces partially committed progenitor cells to divide and differentiate in granulocyte-macrophage pathways; activates mature granulocytes and macrophages; promotes proliferation of megakaryocytic and erythroid progenitors.

 

 Indications Myeloid reconstitution after autologous bone marrow transplantation and after bone marrow transplantation failure or graft failure; promotion of early engraftment or engraftment delay; treatment of neutropenia associated bone marrow transplant; induction chemotherapy in acute myelogenous leukemia (AML); mobilization and following transplantation of autologous PBPC; and myeloid reconstitution after allogeneic BMT.

Increase WBC counts in patients with myelodysplastic syndromes and in AIDS patients receiving zidovudine; decrease nadir of leukopenia secondary to myelosuppressive chemotherapy; decrease myelosuppression in preleukemic patients; correct neutropenia in aplastic anemia patients; decrease transplantation-associated organ system damage.

 

 Contraindications Excessive leukemic myeloid blasts in bone marrow or peripheral blood; hypersensitivity to granulocyte-macrophage colony-stimulating factor, yeast-derived products, or any component of product; simultaneous administration with cytotoxic chemotherapy or radiotherapy, or administration 24 hrs preceding or following chemotherapy or radiotherapy.

 

 Route/Dosage

Bone Marrow Transplant Failure or Engraftment Delay

ADULTS: IV 250 mcg/m²/day for 14 days.

Myeloid Reconstitution After Bone Marrow Transplantation

ADULTS: IV 250 mcg/m²/day for 21 days (first dose given 2 to 4 hr after transplant).

Neutrophil Recovery Following Chemotherapy in AML

ADULTS: IV 250 mcg/m²/day over a 4-hr period starting around day 11 or 4 days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts.

Mobilization of PBPC

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily. Continue at the same dose through the period of PBPC collection.

Post Peripheral Blood Progenitor Cell Transplantation

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily beginning immediately following infusion of progenitor cells and continuing until an ANC of more than 1500 for 3 consecutive days is attained.

 

 Interactions

Antineoplastics: Do not use concomitantly.

Corticosteroids or Lithium: May potentiate myeloproliferative effects of sargramostim.

 

 Lab Test Interferences None well documented.

 

 Adverse Reactions

CARDIOVASCULAR: Tachycardia. CNS: Anxiety. DERMATOLOGIC: Pruritus. EENT: Eye hemorrhage. GI: Abdominal pain; hematemesis; dysphagia. GU: Bilirubinemia. METABOLIC: Metabolic disorder; weight gain. RESPIRATORY: Pharyngitis. OTHER: Bone pain; arthralgia; malaise; chest pain.

 

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. However, available data indicate that sargramostim does not exhibit any greater toxicity in children than in adults. Benzyl Alcohol: Benzyl alcohol as a preservative has been associated with fatal “gasping syndrome” in premature infants. Concomitant Chemotherapy and Radiotherapy: Since rapidly dividing cells are particularly sensitive to cytotoxic chemotherapy and radiotherapy, sargramostim should not be given within 24 hr of chemotherapy or within 12 hr of radiotherapy. Growth Factor Potential: Administer with caution in patients with myeloid malignancies. Hypersensitivity: Reactions are infrequent and have ranged from serious allergic or anaphylactic reactions to transient rashes and local injection site reactions. Renal Hepatic and Cardiac Patients: Monitor patients closely and use with caution. Respiratory Symptoms: It may be necessary to decrease rate of infusion by 50% if dyspnea occurs during administration.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Reconstitute with 1 mL Sterile Water for Injection (without preservative); do not re-enter vial. Discard any unused portion.
• During reconstitution, direct sterile water at side of vial and gently swirl contents to prevent foaming during dissolution. Avoid excessive or vigorous agitation; do not shake.
• Dilute in 0.9% Sodium Chloride Injection to prepare IV infusion. If final concentration is less than 10 mcg/mL, add human albumin to make final concentration of 0.1% to saline before adding sargramostim to prevent absorption to drug delivery system. For final concentration of 0.1% albumin, add 1 mg human albumin/1 mL 0.9% saline injection. Give within 6 hr after reconstitution. Discard any unused portion after 6 hr.
• Administer each dose over 2 hr as IV infusion.
• Do not use in-line membrane filter for IV infusion.
• Do not add other medications to IV solution.
• Administer 2 to 4 hr after autologous bone marrow infusion, not less than 24 hr after last dose of antineoplastics, and 12 hr after last dose of radiotherapy, bone marrow transplantation failure or engraftment delay.
• Refrigerate sterile powder, reconstituted solution, and diluted solution for injection. Do not freeze or shake.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor CBC and differential biweekly during therapy. If ANC is more than 20,000/mm³ or platelet count is more than 500,000 cells/mm³, discontinue or reduce dose by one half. Leukocytosis may occur.
• Monitor renal and hepatic studies before treatment, including BUN, creatinine, urinalysis, AST, ALT, alkaline phosphatase, and monitor biweekly during therapy if renal or hepatic disease is present.
• Observe for hypersensitivity reactions, including rashes and local injection site reactions, which are usually transient.
• Monitor I&O, hydration status and weight. Observe for fluid retention or edema; pleural and pericardial effusions have occurred.
• Monitor vital signs during therapy; supraventricular arrhythmias have occurred in patients with cardiac disease. Hypotension with flushing and syncope has rarely occurred with first dose.
• Monitor for respiratory symptoms during and immediately following infusion, especially in patients with history of pulmonary disease. If dyspnea occurs during infusion, reduce rate by one half. If symptoms worsen, notify health care provider and discontinue infusion.

OVERDOSAGE: SIGNS & SYMPTOMS   Dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache and chills, increases in WBC no more than 200,000 cells/mm3

 

 Patient/Family Education

• Reassure patient that hypotension with flushing and syncope has rarely occurred with first dose.
• Stress importance of follow-up for laboratory tests.
• Instruct patient to inform health care provider if any of the following symptoms occur: dyspnea, malaise, nausea, fever, rash, rapid heart rate, headache, chills.

Drug Precautions ::

(sar-GRUH-moe-STIM)

Leukine

Powder for injection, lyophilized

250 mcg

Powder for injection, lyophilized

500 mcg

Liquid

500 mcg/mL

Class: Colony-stimulating factor

 

 Action Supports survival, proliferation, and differentiation of hematopoietic progenitor cells; induces partially committed progenitor cells to divide and differentiate in granulocyte-macrophage pathways; activates mature granulocytes and macrophages; promotes proliferation of megakaryocytic and erythroid progenitors.

 

 Indications Myeloid reconstitution after autologous bone marrow transplantation and after bone marrow transplantation failure or graft failure; promotion of early engraftment or engraftment delay; treatment of neutropenia associated bone marrow transplant; induction chemotherapy in acute myelogenous leukemia (AML); mobilization and following transplantation of autologous PBPC; and myeloid reconstitution after allogeneic BMT.

Increase WBC counts in patients with myelodysplastic syndromes and in AIDS patients receiving zidovudine; decrease nadir of leukopenia secondary to myelosuppressive chemotherapy; decrease myelosuppression in preleukemic patients; correct neutropenia in aplastic anemia patients; decrease transplantation-associated organ system damage.

 

 Contraindications Excessive leukemic myeloid blasts in bone marrow or peripheral blood; hypersensitivity to granulocyte-macrophage colony-stimulating factor, yeast-derived products, or any component of product; simultaneous administration with cytotoxic chemotherapy or radiotherapy, or administration 24 hrs preceding or following chemotherapy or radiotherapy.

 

 Route/Dosage

Bone Marrow Transplant Failure or Engraftment Delay

ADULTS: IV 250 mcg/m²/day for 14 days.

Myeloid Reconstitution After Bone Marrow Transplantation

ADULTS: IV 250 mcg/m²/day for 21 days (first dose given 2 to 4 hr after transplant).

Neutrophil Recovery Following Chemotherapy in AML

ADULTS: IV 250 mcg/m²/day over a 4-hr period starting around day 11 or 4 days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts.

Mobilization of PBPC

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily. Continue at the same dose through the period of PBPC collection.

Post Peripheral Blood Progenitor Cell Transplantation

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily beginning immediately following infusion of progenitor cells and continuing until an ANC of more than 1500 for 3 consecutive days is attained.

 

 Interactions

Antineoplastics: Do not use concomitantly.

Corticosteroids or Lithium: May potentiate myeloproliferative effects of sargramostim.

 

 Lab Test Interferences None well documented.

 

 Adverse Reactions

CARDIOVASCULAR: Tachycardia. CNS: Anxiety. DERMATOLOGIC: Pruritus. EENT: Eye hemorrhage. GI: Abdominal pain; hematemesis; dysphagia. GU: Bilirubinemia. METABOLIC: Metabolic disorder; weight gain. RESPIRATORY: Pharyngitis. OTHER: Bone pain; arthralgia; malaise; chest pain.

 

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. However, available data indicate that sargramostim does not exhibit any greater toxicity in children than in adults. Benzyl Alcohol: Benzyl alcohol as a preservative has been associated with fatal “gasping syndrome” in premature infants. Concomitant Chemotherapy and Radiotherapy: Since rapidly dividing cells are particularly sensitive to cytotoxic chemotherapy and radiotherapy, sargramostim should not be given within 24 hr of chemotherapy or within 12 hr of radiotherapy. Growth Factor Potential: Administer with caution in patients with myeloid malignancies. Hypersensitivity: Reactions are infrequent and have ranged from serious allergic or anaphylactic reactions to transient rashes and local injection site reactions. Renal Hepatic and Cardiac Patients: Monitor patients closely and use with caution. Respiratory Symptoms: It may be necessary to decrease rate of infusion by 50% if dyspnea occurs during administration.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Reconstitute with 1 mL Sterile Water for Injection (without preservative); do not re-enter vial. Discard any unused portion.
• During reconstitution, direct sterile water at side of vial and gently swirl contents to prevent foaming during dissolution. Avoid excessive or vigorous agitation; do not shake.
• Dilute in 0.9% Sodium Chloride Injection to prepare IV infusion. If final concentration is less than 10 mcg/mL, add human albumin to make final concentration of 0.1% to saline before adding sargramostim to prevent absorption to drug delivery system. For final concentration of 0.1% albumin, add 1 mg human albumin/1 mL 0.9% saline injection. Give within 6 hr after reconstitution. Discard any unused portion after 6 hr.
• Administer each dose over 2 hr as IV infusion.
• Do not use in-line membrane filter for IV infusion.
• Do not add other medications to IV solution.
• Administer 2 to 4 hr after autologous bone marrow infusion, not less than 24 hr after last dose of antineoplastics, and 12 hr after last dose of radiotherapy, bone marrow transplantation failure or engraftment delay.
• Refrigerate sterile powder, reconstituted solution, and diluted solution for injection. Do not freeze or shake.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor CBC and differential biweekly during therapy. If ANC is more than 20,000/mm³ or platelet count is more than 500,000 cells/mm³, discontinue or reduce dose by one half. Leukocytosis may occur.
• Monitor renal and hepatic studies before treatment, including BUN, creatinine, urinalysis, AST, ALT, alkaline phosphatase, and monitor biweekly during therapy if renal or hepatic disease is present.
• Observe for hypersensitivity reactions, including rashes and local injection site reactions, which are usually transient.
• Monitor I&O, hydration status and weight. Observe for fluid retention or edema; pleural and pericardial effusions have occurred.
• Monitor vital signs during therapy; supraventricular arrhythmias have occurred in patients with cardiac disease. Hypotension with flushing and syncope has rarely occurred with first dose.
• Monitor for respiratory symptoms during and immediately following infusion, especially in patients with history of pulmonary disease. If dyspnea occurs during infusion, reduce rate by one half. If symptoms worsen, notify health care provider and discontinue infusion.

OVERDOSAGE: SIGNS & SYMPTOMS   Dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache and chills, increases in WBC no more than 200,000 cells/mm3

 

 Patient/Family Education

• Reassure patient that hypotension with flushing and syncope has rarely occurred with first dose.
• Stress importance of follow-up for laboratory tests.
• Instruct patient to inform health care provider if any of the following symptoms occur: dyspnea, malaise, nausea, fever, rash, rapid heart rate, headache, chills.

Drug Side Effects ::

(sar-GRUH-moe-STIM)

Leukine

Powder for injection, lyophilized

250 mcg

Powder for injection, lyophilized

500 mcg

Liquid

500 mcg/mL

Class: Colony-stimulating factor

 

 Action Supports survival, proliferation, and differentiation of hematopoietic progenitor cells; induces partially committed progenitor cells to divide and differentiate in granulocyte-macrophage pathways; activates mature granulocytes and macrophages; promotes proliferation of megakaryocytic and erythroid progenitors.

 

 Indications Myeloid reconstitution after autologous bone marrow transplantation and after bone marrow transplantation failure or graft failure; promotion of early engraftment or engraftment delay; treatment of neutropenia associated bone marrow transplant; induction chemotherapy in acute myelogenous leukemia (AML); mobilization and following transplantation of autologous PBPC; and myeloid reconstitution after allogeneic BMT.

Increase WBC counts in patients with myelodysplastic syndromes and in AIDS patients receiving zidovudine; decrease nadir of leukopenia secondary to myelosuppressive chemotherapy; decrease myelosuppression in preleukemic patients; correct neutropenia in aplastic anemia patients; decrease transplantation-associated organ system damage.

 

 Contraindications Excessive leukemic myeloid blasts in bone marrow or peripheral blood; hypersensitivity to granulocyte-macrophage colony-stimulating factor, yeast-derived products, or any component of product; simultaneous administration with cytotoxic chemotherapy or radiotherapy, or administration 24 hrs preceding or following chemotherapy or radiotherapy.

 

 Route/Dosage

Bone Marrow Transplant Failure or Engraftment Delay

ADULTS: IV 250 mcg/m²/day for 14 days.

Myeloid Reconstitution After Bone Marrow Transplantation

ADULTS: IV 250 mcg/m²/day for 21 days (first dose given 2 to 4 hr after transplant).

Neutrophil Recovery Following Chemotherapy in AML

ADULTS: IV 250 mcg/m²/day over a 4-hr period starting around day 11 or 4 days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts.

Mobilization of PBPC

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily. Continue at the same dose through the period of PBPC collection.

Post Peripheral Blood Progenitor Cell Transplantation

ADULTS: IV 250 mcg/m²/day over 24 hr or SC once daily beginning immediately following infusion of progenitor cells and continuing until an ANC of more than 1500 for 3 consecutive days is attained.

 

 Interactions

Antineoplastics: Do not use concomitantly.

Corticosteroids or Lithium: May potentiate myeloproliferative effects of sargramostim.

 

 Lab Test Interferences None well documented.

 

 Adverse Reactions

CARDIOVASCULAR: Tachycardia. CNS: Anxiety. DERMATOLOGIC: Pruritus. EENT: Eye hemorrhage. GI: Abdominal pain; hematemesis; dysphagia. GU: Bilirubinemia. METABOLIC: Metabolic disorder; weight gain. RESPIRATORY: Pharyngitis. OTHER: Bone pain; arthralgia; malaise; chest pain.

 

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. However, available data indicate that sargramostim does not exhibit any greater toxicity in children than in adults. Benzyl Alcohol: Benzyl alcohol as a preservative has been associated with fatal “gasping syndrome” in premature infants. Concomitant Chemotherapy and Radiotherapy: Since rapidly dividing cells are particularly sensitive to cytotoxic chemotherapy and radiotherapy, sargramostim should not be given within 24 hr of chemotherapy or within 12 hr of radiotherapy. Growth Factor Potential: Administer with caution in patients with myeloid malignancies. Hypersensitivity: Reactions are infrequent and have ranged from serious allergic or anaphylactic reactions to transient rashes and local injection site reactions. Renal Hepatic and Cardiac Patients: Monitor patients closely and use with caution. Respiratory Symptoms: It may be necessary to decrease rate of infusion by 50% if dyspnea occurs during administration.

PATIENT CARE CONSIDERATIONS

 

 Administration/Storage

• Reconstitute with 1 mL Sterile Water for Injection (without preservative); do not re-enter vial. Discard any unused portion.
• During reconstitution, direct sterile water at side of vial and gently swirl contents to prevent foaming during dissolution. Avoid excessive or vigorous agitation; do not shake.
• Dilute in 0.9% Sodium Chloride Injection to prepare IV infusion. If final concentration is less than 10 mcg/mL, add human albumin to make final concentration of 0.1% to saline before adding sargramostim to prevent absorption to drug delivery system. For final concentration of 0.1% albumin, add 1 mg human albumin/1 mL 0.9% saline injection. Give within 6 hr after reconstitution. Discard any unused portion after 6 hr.
• Administer each dose over 2 hr as IV infusion.
• Do not use in-line membrane filter for IV infusion.
• Do not add other medications to IV solution.
• Administer 2 to 4 hr after autologous bone marrow infusion, not less than 24 hr after last dose of antineoplastics, and 12 hr after last dose of radiotherapy, bone marrow transplantation failure or engraftment delay.
• Refrigerate sterile powder, reconstituted solution, and diluted solution for injection. Do not freeze or shake.

 

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Monitor CBC and differential biweekly during therapy. If ANC is more than 20,000/mm³ or platelet count is more than 500,000 cells/mm³, discontinue or reduce dose by one half. Leukocytosis may occur.
• Monitor renal and hepatic studies before treatment, including BUN, creatinine, urinalysis, AST, ALT, alkaline phosphatase, and monitor biweekly during therapy if renal or hepatic disease is present.
• Observe for hypersensitivity reactions, including rashes and local injection site reactions, which are usually transient.
• Monitor I&O, hydration status and weight. Observe for fluid retention or edema; pleural and pericardial effusions have occurred.
• Monitor vital signs during therapy; supraventricular arrhythmias have occurred in patients with cardiac disease. Hypotension with flushing and syncope has rarely occurred with first dose.
• Monitor for respiratory symptoms during and immediately following infusion, especially in patients with history of pulmonary disease. If dyspnea occurs during infusion, reduce rate by one half. If symptoms worsen, notify health care provider and discontinue infusion.

OVERDOSAGE: SIGNS & SYMPTOMS   Dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache and chills, increases in WBC no more than 200,000 cells/mm3

 

 Patient/Family Education

• Reassure patient that hypotension with flushing and syncope has rarely occurred with first dose.
• Stress importance of follow-up for laboratory tests.
• Instruct patient to inform health care provider if any of the following symptoms occur: dyspnea, malaise, nausea, fever, rash, rapid heart rate, headache, chills.

Drug Mode of Action ::  

(sar-GRUH-moe-STIM)

Leukine

Powder for injection, lyophilized

250 mcg

Powder for injection, lyophilized

500 mcg

Liquid

500 mcg/mL

Class: Colony-stimulating factor

 

 Action Supports survival, proliferation, and differentiation of hematopoietic progenitor cells; induces partially committed progenitor cells to divide and differentiate in granulocyte-macrophage pathways; activates mature granulocytes and macrophages; promotes proliferation of megakaryocytic and erythroid progenitors.