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Sargramostim

Medically reviewed by Drugs.com. Last updated on Oct 14, 2020.

Pronunciation

(sar GRAM oh stim)

Index Terms

  • GM-CSF
  • GMCSF
  • Granulocyte-Macrophage Colony Stimulating Factor
  • Prokine
  • Recombinant Granulocyte-Macrophage Colony Stimulating Factor
  • rhuGM-CSF

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection [preservative free]:

Leukine: 250 mcg (1 ea)

Brand Names: U.S.

  • Leukine

Pharmacologic Category

  • Colony Stimulating Factor
  • Hematopoietic Agent

Pharmacology

Sargramostim is a colony stimulating growth factor which stimulates proliferation, differentiation, and functional activity of neutrophils, eosinophils, monocytes, and macrophages.

Distribution

IV: 96.8 L

Onset of Action

Increase in WBC in 7 to 14 days

Time to Peak

Serum: IV: During or immediately after infusion; SubQ: 2.4 to 4 hours

Duration of Action

WBCs return to baseline within 1 to 2 weeks of discontinuing drug

Half-Life Elimination

Children 6 months to 15 years: IV: Median: 1.6 hours; range: 0.9 to 2.5 hours; SubQ: Median: 2.3 hours (0.3 to 3.8 hours) (Stute 1995)

Adults: IV: 3.84 hours; SubQ: 1.4 hours

Use: Labeled Indications

Acute myeloid leukemia (following induction chemotherapy): To shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adults 55 years of age and older with acute myeloid leukemia (AML).

Allogeneic bone marrow transplantation (myeloid reconstitution): Acceleration of myeloid reconstitution in pediatric patients 2 years of age and older and adults undergoing allogeneic bone marrow transplantation from HLA-matched related donors.

Allogeneic or autologous bone marrow transplantation (treatment of delayed neutrophil recovery or graft failure): Treatment of delayed or failed neutrophil recovery in pediatric patients 2 years of age and older and adults who have undergone allogeneic or autologous bone marrow transplantation.

Autologous peripheral blood progenitor cell mobilization and collection: Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis in adults with cancer undergoing autologous hematopoietic stem cell transplantation.

Autologous peripheral blood progenitor cell and bone marrow transplantation: To accelerate myeloid reconstitution following autologous peripheral blood progenitor cell transplantation or bone marrow transplantation in pediatric patients 2 years of age and older and adults with acute lymphoblastic leukemia (ALL), Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL).

Hematopoietic radiation injury syndrome (acute): Treatment to increase survival due to acute exposure to myelosuppressive radiation doses (hematopoietic syndrome of acute radiation syndrome [H-ARS]) in infants, children, adolescents, and adults.

Off Label Uses

Primary prophylaxis of neutropenia in patients receiving chemotherapy (outside transplant and AML) or who are at high risk for neutropenic fever

Based on the ASCO Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline, sargramostim given for primary prophylaxis of neutropenia in patients receiving chemotherapy (outside transplant and AML) or who are at high risk for neutropenic fever is effective and recommended in the management of this condition.

Contraindications

Hypersensitivity (history of serious allergic reaction, including anaphylaxis) to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the formulation.

Dosing: Adult

Note: May round the dose to the nearest vial size (ASCO [Ozer 2000]).

Acute myeloid leukemia (following induction chemotherapy): Adults ≥55 years: IV: 250 mcg/m2/day (infused over 4 hours) starting approximately on day 11 or 4 days following the completion of induction chemotherapy (if day 10 bone marrow is hypoplastic with <5% blasts), continue until ANC >1,500/mm3 for 3 consecutive days or a maximum of 42 days. If ANC >20,000/mm3, interrupt treatment or reduce the dose by 50%. Do not administer within 24 hours before or after chemotherapy or radiation therapy.

If a second cycle of chemotherapy is necessary, administer ~4 days after the completion of chemotherapy if the bone marrow is hypoplastic with <5% blasts

Discontinue sargramostim immediately if leukemic regrowth occurs. If grade 3 or 4 adverse reactions occur, reduce the dose by 50% or temporarily interrupt therapy until the reaction abates.

Allogeneic bone marrow transplantation (myeloid reconstitution): IV: 250 mcg/m2/day (infused over 2 hours), begin 2 to 4 hours after the marrow infusion and at least 24 hours after chemotherapy or radiotherapy, do not initiate until the post marrow infusion ANC is <500/mm3, and continue until ANC >1,500/mm3 for 3 consecutive days. If WBC >50,000/mm3 or ANC >20,000/mm3, interrupt treatment or reduce the dose by 50%.

If grade 3 or 4 adverse reactions occur, reduce dose by 50% or temporarily discontinue the dose until the reaction abates.

If blast cells appear or progression of the underlying disease occurs, discontinue treatment.

Allogeneic or autologous bone marrow transplantation (treatment of delayed neutrophil recovery or graft failure): IV: 250 mcg/m2/day (infused over 2 hours) for 14 days; If engraftment has not occurred after 7 days off sargramostim, may repeat. If neutrophil recovery still has not occurred after 7 days off sargramostim, a third course of 500 mcg/m2/day for 14 days may be attempted. If there is still no improvement, it is unlikely that further dose escalation will be of benefit.

If grade 3 or 4 adverse reactions occur, reduce the dose by 50% or temporarily discontinue the dose until the reaction abates.

If blast cells appear or disease progression occurs, discontinue treatment immediately.

If WBC >50,000/mm3 or ANC >20,000/mm3, interrupt treatment or reduce the dose by 50%.

Autologous peripheral blood progenitor cell mobilization and collection: IV, SubQ: 250 mcg/m2/day IV (infused over 24 hours) or SubQ once daily; continue the same dose throughout peripheral blood progenitor cell collection period. If WBC >50,000/mm3, reduce the dose by 50%.

Note: The optimal schedule for peripheral blood progenitor cell collection has not been established (usually begun 5 days after sargramostim and performed daily until protocol specified targets are achieved). If adequate numbers of progenitor cells are not collected, consider other mobilization therapy.

Autologous peripheral blood progenitor cell transplantation (myeloid reconstitution): IV, SubQ: 250 mcg/m2/day IV (infused over 24 hours) or SubQ once daily beginning immediately following infusion of progenitor cells; continue until ANC is >1,500/mm3 for 3 consecutive days. Do not administer within 24 hours before or after chemotherapy or radiation therapy.

Autologous bone marrow transplantation (myeloid reconstitution): IV: 250 mcg/m2/day (infused over 2 hours), begin 2 to 4 hours after the marrow infusion and at least 24 hours after chemotherapy or radiotherapy, do not initiate until the post marrow infusion ANC is <500/mm3, and continue until ANC >1,500/mm3 for 3 consecutive days. Do not administer within 24 hours before or after chemotherapy or radiation therapy.

Hematopoietic radiation injury syndrome (acute): SubQ: Adults >40 kg: 7 mcg/kg once daily; begin as soon as possible after suspected or confirmed exposure to radiation doses >2 (gray) Gy; do not delay sargramostim if CBC is not readily available; continue sargramostim until ANC remains >1,000/mm3 for 3 consecutive CBCs (obtain CBCs approximately every 3 days) or ANC exceeds 10,000/mm3 after radiation-induced nadir.

Off-label dosing: SubQ: 250 mcg/m2/day; continue until ANC >1,000/mm3 (Waselenko 2004). ASCO guidelines recommend initiating within 24 hours of exposure of a dose ≥2 gray (Gy) and/or significant decrease in absolute lymphocyte count, or for anticipated neutropenia <500/mm3 for ≥7 days (ASCO [Smith 2015]).

Primary prophylaxis of neutropenia in patients receiving chemotherapy (outside transplant and AML) or who are at high risk for neutropenic fever (off-label use):

Note: WBC growth factors are generally recommended to reduce the risk of neutropenic fever when the anticipated risk of neutropenic fever for a chemotherapy regimen is approximately ≥20% (ASCO [Smith 2015]). However, to minimize possible emergency care needs during the COVID-19 pandemic, it may be reasonable to provide prophylactic WBC growth factors to patients at a lower anticipated neutropenic fever risk (eg, >10%). Telemedicine may be a reasonable option to evaluate if the febrile patient requires a clinic or emergency care environment. Follow standard guidelines for acute care in patients with known neutropenic fever, regardless of COVID-19 status (ASCO 2020).

SubQ: 250 mcg/m2/day beginning at least 24 hours after chemotherapy administration; continue until ANC >1,500/mm3 for 3 consecutive days (ASCO [Smith 2015]). May round dose to the nearest vial size [ASCO (Ozer 2000)].

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Neutrophil recovery (myeloid reconstitution):

Allogeneic bone marrow transplantation:

Infants ≥5 months and Children <2 years: Limited data available: IV: 250 mcg/m2/day infused over 4 hours once daily; begin on day 0 of the BMT and administer first dose after marrow infusion completed and continue for 21 days; discontinue if ANC >20,000/mm3 (Trigg 2000)

Children ≥2 years and Adolescents: IV: 250 mcg/m2/day infused over 2 hours; begin 2 to 4 hours after the marrow infusion and at least 24 hours after chemotherapy or radiotherapy; do not initiate until the post marrow infusion ANC is <500/mm3 and continue until ANC >1,500/mm3 for 3 consecutive days

If WBC >50,000/mm3 or ANC >20,000/mm3, interrupt treatment or reduce the dose by 50%.

If grade 3 or 4 adverse reactions occur, reduce dose by 50% or temporarily discontinue the dose until the reaction abates.

If blast cells appear or progression of the underlying disease occurs, discontinue treatment.

Autologous bone marrow transplantation:

Children ≥2 years and Adolescents: IV: 250 mcg/m2/day infused over 2 hours; begin 2 to 4 hours after the marrow infusion and at least 24 hours after chemotherapy or radiotherapy; do not initiate until the post marrow infusion ANC is <500/mm3 and continue until ANC >1,500/mm3 for 3 consecutive days. Do not administer within 24 hours before or after chemotherapy or radiation therapy.

Delayed neutrophil recovery or graft failure (allogeneic or autologous bone marrow transplantation): Children ≥2 years and Adolescents: IV: 250 mcg/m2/day infused over 2 hours for 14 days; may repeat 14-day course if engraftment has not occurred after 7 days off sargramostim. If neutrophil recovery still has not occurred after 7 days off sargramostim, a third course of 500 mcg/m2/day for 14 days may be attempted. If there is still no improvement, it is unlikely that further dose escalation will be of benefit.

If WBC >50,000/mm3 or ANC >20,000/mm3, interrupt treatment or reduce the dose by 50%.

If grade 3 or 4 adverse reactions occur, reduce the dose by 50% or temporarily discontinue the dose until the reaction abates.

If blast cells appear or disease progression occurs, discontinue treatment immediately.

Hematopoietic radiation injury syndrome, acute:

Weight-directed dosing: Infants, Children, and Adolescents: Begin as soon as possible after suspected or confirmed exposure to radiation doses >2 gray (Gy); do not delay sargramostim if CBC is not readily available; continue sargramostim until ANC remains >1,000/mm3 for 3 consecutive CBCs (obtain CBCs approximately every 3 days) or ANC exceeds 10,000/mm3 after radiation-induced nadir.

<15 kg: SubQ: 12 mcg/kg once daily

15 to 40 kg: SubQ: 10 mcg/kg once daily

>40 kg: SubQ: 7 mcg/kg once daily

BSA-directed dosing: Limited data available: Children and Adolescents: SubQ: 250 mcg/m2/day; continue until ANC >1,000/mm3 (Waselenko 2004). Note: ASCO guidelines recommend initiating within 24 hours of exposure of a dose ≥2 Gy and/or significant decrease in absolute lymphocyte count, or for anticipated neutropenia <500/mm3 for ≥7 days (ASCO [Smith 2015]).

Neuroblastoma, high-risk: Limited data available: Infants, Children, and Adolescents: SubQ or IV: 250 mcg/m2 once daily for 14 days during cycles 1, 3, and 5, beginning 3 days prior to administration of dinutuximab (each cycle is 28 days) as part of a multi-drug regimen that includes dinutuximab, isotretinoin, and aldesleukin (Gilman 2009; Yu 2010).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Reconstitution

Powder for injection: May be reconstituted with 1 mL of preservative free sterile water for injection (SWFI) or bacteriostatic water for injection. Direct the diluent toward the side of the vial and gently swirl to reconstitute; do not shake. Do not mix the contents of vials which have been reconstituted with different diluents.

SubQ: Administer without further dilution.

IV: Further dilution with NS is required. If the final sargramostim concentration is <10 mcg/mL, add albumin (human) to a final concentration of 0.1% or 1 mg of human albumin per 1 mL of NS (eg, add 1 mL of 5% human albumin per 50 mL of NS) to the NS prior to adding sargramostim to prevent adsorption to the drug delivery system.

Administration

Sargramostim is administered as a subcutaneous injection or intravenous infusion. Administer at approximately the same time each day.

IV: Infuse over 2 hours, 4 hours or 24 hours (indication specific). An in-line membrane filter should NOT be used for intravenous administration.

SubQ: Administer subcutaneously into the thigh, abdomen (avoiding waistline and avoiding within 2 inches of navel), or (if a caregiver administers) the outer upper arm; rotate injection sites (injection sites should be at least 1 inch apart from prior injection sites). Do not inject into areas that are tender, bruised, red, or hard; avoid areas with scars or stretch marks. Administer without further dilution.

Storage

Store intact vials at 2°C to 8°C (36°F to 46°F); do not freeze. Do not shake.

Solution for injection: May be stored for up to 20 days at 2°C to 8°C (36°F to 46°F) once the vial has been entered. Discard remaining solution after 20 days.

Powder for injection: Reconstituted solutions and solutions diluted for infusion should be administered as soon as possible, and discarded within 6 hours of reconstitution. The contents of vials reconstituted with different diluents should not be mixed together.

Drug Interactions

Belotecan: Granulocyte Colony-Stimulating Factors may enhance the neutropenic effect of Belotecan. Management: Do not administer granulocyte colony-stimulating factor (G-CSF) until at least 24 hours after completion of belotecan administration. Monitor neutrophil counts and signs/symptoms of neutropenic fever in patients receiving this combination. Consider therapy modification

Bleomycin: Granulocyte Colony-Stimulating Factors may enhance the adverse/toxic effect of Bleomycin. Specifically, the risk for pulmonary toxicity may be increased. Management: Avoid use of granulocyte colony-stimulating factors 24 hours before (14 days for pegfilgrastim) and 24 hours after the last dose of bleomycin. Consider therapy modification

Corticosteroids (Systemic): May enhance the therapeutic effect of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Monitor therapy

Cyclophosphamide: May enhance the adverse/toxic effect of Sargramostim. Specifically, the risk of pulmonary toxicity may be enhanced. Monitor therapy

Lithium: Sargramostim may enhance the adverse/toxic effect of Lithium. Specifically, the myeloproliferative effects may be increased. Monitor therapy

Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Monitor therapy

Tisagenlecleucel: Granulocyte Colony-Stimulating Factors may enhance the adverse/toxic effect of Tisagenlecleucel. Avoid combination

Topotecan: Granulocyte Colony-Stimulating Factors may enhance the adverse/toxic effect of Topotecan. Specifically, the risk for the development of interstitial lung disease may be increased. Granulocyte Colony-Stimulating Factors may enhance the myelosuppressive effect of Topotecan. Management: Avoid use of granulocyte colony-stimulating factors 24 hours before (14 days for pegfilgrastim) and 24 hours after the last dose of topotecan. Additionally, monitor patients closely for the development of interstitial lung disease with this combination. Consider therapy modification

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Hypertension (34%), edema (13% to 25%), pericardial effusion (4% to 25%), chest pain (15%), peripheral edema (11%), tachycardia (11%)

Central nervous system: Malaise (57%), headache (26%), chills (25%), anxiety (11%), insomnia (11%)

Dermatologic: Skin changes (77%), skin rash (44%), pruritus (23%)

Endocrine & metabolic: Elevated serum glucose (49%), weight loss (37%), decreased serum albumin (36%), hyperglycemia (25%), hypomagnesemia (15%)

Gastrointestinal: Diarrhea (81% to 89%), nausea (58% to 70%), vomiting (46% to 70%), abdominal pain (38%), anorexia (13%), hematemesis (13%), dysphagia (11%), gastrointestinal hemorrhage (11%)

Genitourinary: Urinary tract infection (14%)

Hepatic: Hyperbilirubinemia (30%)

Neuromuscular & skeletal: Asthenia (66%), ostealgia (21%), arthralgia (11% to 21%), myalgia (18%)

Ophthalmic: Retinal hemorrhage (11%)

Renal: Increased serum creatinine (15%)

Respiratory: Pharyngitis (23%), epistaxis (17%), dyspnea (15%)

Miscellaneous: Fever (81%), laboratory test abnormality (58%, metabolic)

1% to 10%:

Immunologic: Antibody development (2%)

Respiratory: Pleural effusion (1%)

<1%, postmarketing, and/or case reports: Anaphylaxis, bone marrow dysplasia, capillary leak syndrome, cardiac disease, decreased serum total protein, eosinophilia, erythema, flushing, hemorrhage (neurocortical events), hypersensitivity reaction, hypotension, hypoxia, increased monocytes, infusion related reaction, injection site reaction, leukocytosis, liver function impairment, pain, prolonged prothrombin time, respiratory distress, supraventricular cardiac arrhythmia, syncope, thromboembolic complications, urticaria, weight gain

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular effects: Supraventricular arrhythmia has been reported during sargramostim administration, particularly in patients with a prior history of cardiac arrhythmia. These arrhythmias have been reversible following sargramostim discontinuation. Use with caution in patients with preexisting cardiac disease.

• Effusions/capillary leak syndrome: Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported. Sargramostim may aggravate fluid retention in patients with preexisting pleural and pericardial effusions; however, fluid retention has been shown to be reversible with dosage reduction or discontinuation of sargramostim with or without concomitant use of diuretics. Use with caution in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure. Monitor body weight and hydration status carefully during sargramostim treatment.

• Hypersensitivity: Serious allergic and anaphylactic reactions have been reported; discontinue immediately and initiate appropriate therapy if a serious allergic or anaphylactic reaction occurs. Discontinue permanently for serious allergic reactions.

• Immunogenicity: Treatment with sargramostim may induce neutralizing anti-drug antibodies. Antibody formation may be related to duration of sargramostim exposure; use sargramostim for the shortest duration necessary.

• Infusion reactions: IV administration of sargramostim may be associated with infusion-related reactions; symptoms may include respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia following the initial IV infusion in a cycle. Infusion reactions have resolved with symptomatic treatment and generally do not recur with subsequent doses within the same treatment cycle. Observe closely for symptoms during infusion, particularly in patients with preexisting pulmonary disease. If dyspnea or other acute symptoms occur, reduce the infusion rate by 50%. If symptoms persist or worsen despite rate reduction, discontinue the sargramostim infusion. After an infusion reaction, subsequent IV infusions may be administered utilizing the standard dose schedule with careful monitoring.

• Leukocytosis: White blood cell counts ≥50,000/mm3 have observed with sargramostim. Monitor complete blood counts (CBC) with differential twice a week. The decision to reduce the dose or interrupt treatment should be based on the patient's clinical condition. Following cessation of therapy, excessive blood counts return to normal or baseline levels within 3 to 7 days. A rapid increase in blood counts (ANC >20,000/mm3 or platelets >500,000/mm3) may require dose reduction or discontinuation.

Concurrent drug therapy issues:

• Cytotoxic chemotherapy/radiotherapy: Do not administer simultaneously with or within 24 hours preceding/following cytotoxic chemotherapy or radiotherapy (due to the sensitivity of rapidly dividing hematopoietic progenitor cells).

Special populations:

• Elderly patients: The American Society of Clinical Oncology (ASCO) Recommendations for the Use of WBC Growth Factors Clinical Practice Guideline Update recommend that prophylactic colony-stimulating factors be considered in patients ≥65 years with diffuse aggressive lymphoma treated with curative chemotherapy (eg, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), especially if patients have comorbid conditions (ASCO [Smith 2015]).

• Pediatric patients: Colony-stimulating factor (CSF) use in pediatric patients is typically directed by clinical pediatric protocols. The ASCO Recommendations for the Use of WBC Growth Factors Clinical Practice Guideline Update states that CSFs may be reasonable as primary prophylaxis in pediatric patients when chemotherapy regimens with a high likelihood of febrile neutropenia are employed. Likewise, secondary CSF prophylaxis should be limited to high-risk patients. In pediatric cancers in which dose-intense chemotherapy (with a survival benefit) is used, CSFs should be given to facilitate chemotherapy administration. CSFs should not be used in the pediatric population for non-relapsed acute lymphoblastic or myeloid leukemia when no infection is present (ASCO [Smith 2015]).

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Appropriate use: ASCO guidelines for the use of WBC growth factors state that the prophylactic use of WBC growth factors to reduce the risk of neutropenic fever is reasonable when the anticipated risk of neutropenic fever for the chemotherapy regimen is approximately ≥20% (ASCO [Smith 2015]). CSFs should not be routinely used in the treatment of established neutropenic fever. CSFs may be considered in cancer patients with febrile neutropenia who are at high risk for infection-associated complications or who have prognostic factors indicative of a poor clinical outcome (eg, prolonged and severe neutropenia, age >65 years, hypotension, pneumonia, sepsis syndrome, presence of invasive fungal infection, uncontrolled primary disease, hospitalization at the time of fever development) (ASCO [Smith 2006]; IDSA [Freifeld 2011]). CSFs should not be routinely used for patients with neutropenia who are afebrile. Dose-dense regimens that require CSFs should only be used within the context of a clinical trial or if supported by convincing evidence (ASCO [Smith 2015]).

• Tumor growth factor: May potentially act as a growth factor for any tumor type, particularly myeloid malignancies; caution should be exercised when using in any malignancy with myeloid characteristics. Discontinue use if disease progression occurs during treatment.

Monitoring Parameters

CBC with differential (twice weekly during treatment); when monitoring for hematopoietic radiation injury syndrome, obtain CBCs approximately every 3 days; vital signs; hydration status; weight; monitor for signs/symptoms of hypersensitivity or infusion-related reactions.

Pregnancy Considerations

Data regarding use in pregnant females is limited. Some dosage forms may contain benzyl alcohol (avoid in pregnant women due to association with gasping syndrome in premature infants); if use is necessary during pregnancy, lyophilized powder reconstituted with preservative-free sterile water for injection is recommended.

Patient Education

What is this drug used for?

• It is used to lower the chance of getting an infection in people with bone marrow problems caused by chemo.

• It is used to raise the number of white blood cells in certain patients.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Anxiety

• Nausea

• Vomiting

• Abdominal pain

• Bone pain

• Joint pain

• Mouth sores

• Mouth irritation

• Loss of strength and energy

• Diarrhea

• Sore throat

• Weight loss

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infusion reaction

• Low magnesium like mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit

• Capillary leak syndrome like abnormal heartbeat; chest pain; shortness of breath; weight gain; vomiting blood or vomit that looks like coffee grounds; black, tarry, or bloody stools; unable to pass urine or change in amount of urine passed; or blood in the urine

• Fast heartbeat

• Abnormal heartbeat

• Shortness of breath

• Excessive weight gain

• Swelling of arms or legs

• Dizziness

• Passing out

• Severe headache

• Flushing

• Chills

• Vomiting blood

• Black, tarry, or bloody stools

• Vision changes

• Skin irritation

• Unable to pass urine

• Change in amount of urine passed

• Chest pain

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.