Sargramostim

Sargramostim is a leukocyte growth factor indicated:

• To shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML)
• In adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis
• For the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL)
• For the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors
• For the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed
• To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS])

Sargramostim is available under the following different brand names: gmcsf, Leukine

Common side effects of Sargramostim include:

• ache or pain in the bones and muscles
• joint pain
• chills
• headache
• nausea
• vomiting
• stomach pain
• diarrhea
• loss of appetite
• tired feeling
• hair loss
• weight loss
• skin rash or itching
• injection site reactions (redness, swelling, itching, lumps, irritation, or bruising)

Serious side effects of Sargramostim include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness
• nausea
• sweating
• light-headedness
• shortness of breath
• chest tightness
• fast heartbeats
• stuffy or runny nose
• thirst
• decreased urination
• sudden swelling or weight gain
• pain while breathing
• shortness of breath when lying down
• chest pain or pressure
• fast or slow heartbeats
• pain or burning while urinating
• severe headache
• blurred vision
• pounding in the neck or ears
• anxiety
• nosebleed
• loss of appetite
• stomach pain (upper right side)
• tiredness
• itching
• dark urine
• clay-colored stools
• yellowing of the skin or eyes (jaundice)
• easy bruising
• unusual bleeding
• purple or red spots under the skin

Rare side effects of Sargramostim include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 500 mcg/mL

Injection, lyophilized powder for reconstitution

• 250 mcg/vial

Acute myeloid leukemia following induction chemotherapy

Adult dosage

• 250 mcg/m2/day IV over 4 hours starting approximately day 11 or 4 days following completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts
• If a second cycle of induction chemotherapy is necessary, administer approximately 4 days after completion of chemotherapy if the bone marrow is hypoplastic with less than 5% blasts
• Continue until an absolute neutrophil count (ANC) of more than 1500 cells/mm3 for 3 consecutive days (not to exceed 42 days); do not administer sargramostim within 24 hours preceding or following receipt of chemotherapy or radiotherapy

Autologous peripheral blood progenitor cell mobilization and collection

Adult dosage

• 250 mcg/m2/day IV over 24 hours or SC once a day; continue at the same dose through peripheral blood progenitor cell collection

Autologous peripheral blood progenitor cell and bone marrow transplantation

Adult dosage

• Autologous peripheral blood progenitor cell transplantation
• 250 mcg/m2/day IV over 24 hours or SC once a day beginning immediately following the infusion of progenitor cells and continuing until an ANC of more than 1500 cells/mm3 for 3 consecutive days is attained
• Autologous bone marrow transplantation
• 250 mcg/m2/day IV over a 2-hour period beginning 2-4 hours after bone marrow infusion and not below 24 hours after the last dose of chemotherapy or radiotherapy

Pediatric dosage

Autologous peripheral blood progenitor cell transplantation

• Children aged 2 years and younger: Safety and efficacy not established
• Children older than 2 years
• 250 mcg/m2/day IV over 24 hours or SC once a day beginning immediately following the infusion of progenitor cells and continuing until an ANC of more than 1500 cells/mm3 for 3 consecutive days is attained

Autologous bone marrow transplantation

• Children aged 2 years and younger: Safety and efficacy not established
• Children older than 2 years
• 250 mcg/m2/day IV over 2 hours beginning 2-4 hours after bone marrow infusion and not less than 24 hours after the last dose of chemotherapy or radiotherapy

Allogeneic bone marrow transplantation

Adult dosage

• 250 mcg/m2/day IV over 2 hours beginning 2-4 hours after bone marrow infusion and not less than 24 hours after the last dose of chemotherapy or radiotherapy
• Treatment of delayed neutrophil recovery or graft failure

Adult dosage

• 250 mcg/m2/day IV over 2 hours for 14 days
• If neutrophil recovery has not occurred, the dose can be repeated after 7 days; if neutrophil recovery still has not occurred, a third course of 500 mcg/m2/day for 14 days may be tried after another 7 days off therapy

Acute radiation syndrome

Adult dosage

• 7 mcg/kg SC once a day
• Administer as soon as possible after suspected or confirmed exposure to radiation doses above 2 gray (Gy)
• H-ARS monitoring and dose duration
• Obtain baseline CBC with differential and then serial CBCs above every 3 days until the ANC remains above 1000/mm³ for 3 consecutive CBCs
• Do not delay administration if a CBC is not readily available
• Continue administration until the ANC remains above 1000/mm³ for 3 consecutive CBCs or exceeds 10,000/mm³ after a radiation-induced nadir

Pediatric dosage

• Children weighing below 15 kg: 12 mcg/kg SC once a day 
• Children weighing between 15 to 40 kg:10 mcg/kg SC once a day 
• Children weighing above 40 kg:7 mcg/kg SC once a day
• Administer as soon as possible after suspected or confirmed exposure to radiation doses above 2 Gy
• H-ARS monitoring and dose duration
• Obtain a baseline CBC with differential and then serial CBCs approximately every 3 days until the ANC remains above 1000/mm3 for three consecutive CBCs
• Do not delay administration if a CBC is not readily available
• Continue administration until the ANC remains more than 1000/mm3 for three consecutive CBCs or exceeds 10,000/mm3 after a radiation-induced nadir

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Sargramostim has severe interactions with no other drugs.
• Sargramostim has serious interactions with no other drugs.
• Sargramostim has moderate interactions with the following drug:
  • ifosfamide
• Sargramostim has minor interactions with the following drugs:
  • budesonide
  • cortisone
  • dexamethasone
  • fludrocortisone
  • hydrocortisone
  • lithium
  • methylprednisolone
  • prednisolone
  • prednisone
  • triamcinolone acetonide injectable suspension

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious allergic reactions (eg, anaphylaxis to human granulocyte colony-stimulating factors [such as sargramostim], yeast-derived products, or any component of the product)
• More than 10% leukemic myeloid blasts in bone marrow or peripheral blood
• Do not administer within 24 hours preceding or following chemotherapy or radiotherapy

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Sargramostim?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Sargramostim?"

Cautions

• Caution in fluid retention, pulmonary infiltrates, congestive heart failure, lung disease, cardiac disease, hypoxia, and hepatic/renal impairment; conditions may worsen
• Solution should NOT be administered to neonates owing to the presence of benzyl alcohol in the formulation and its association with "gasping syndrome"
• Discontinue immediately if blast cells appear or disease progression occurs
• Reformulated liquid devoid of sodium ethylenediaminetetraacetic acid is now available
• Treatment may induce neutralizing antidrug antibodies; incidence of anti-sargramostim neutralizing antibodies may be related to the duration of exposure
• A first-dose effect characterized by respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia may occur with the first dose of the cycle and resolve with appropriate symptomatic treatment; symptoms do not usually occur with subsequent doses within that cycle
• Edema, capillary leak syndrome, and pleural and/or pericardial effusion; fluid retention shown to be reversible with dosage reduction or discontinuation with or without concomitant use of diuretics
• If there is a rapid increase in blood counts (ANC of 20,000/mm3 and more, WBC more than 50,000/mm3, platelets of more than 500,000/mm3), decrease dose by 50% or discontinue therapy; excessive blood counts should fall to normal within 3-7 days after discontinuation of therapy; monitor with differential twice weekly during treatment
• Sequestration of granulocytes in the pulmonary circulation and dyspnea reported; monitor respiratory symptoms during and following IV infusions; decrease infusion rate by 50% if dyspnea occurs; discontinue infusion if dyspnea persists despite the reduction in the rate of administration; subsequent doses may be administered at the standard rate with careful monitoring
• Supraventricular arrhythmia reported in uncontrolled studies during administration, particularly in patients with a previous history of cardiac arrhythmia
• Serious hypersensitivity reactions, including anaphylactic reactions reported
• May cause infusion-related reactions
• Owing to the possibility of tumor growth potentiation, exercise caution when using this drug in any malignancy with myeloid characteristic
• Avoid concomitant use of sargramostim and products that induce myeloproliferative (eg, lithium, corticosteroids)

Pregnancy and Lactation

• Limited available data on use in pregnant women are insufficient to inform the drug-associated risk for adverse developmental outcomes
• Based on animal studies, sargramostim may cause embryofetal harm; administration to pregnant rabbits during organogenesis resulted in adverse developmental outcomes including increased spontaneous abortion at systemic exposures more than 1.3 times the human exposure expected at the recommended human dose
• Advise pregnant women of the potential risk to a fetus
• Lactation
  • No information regarding the presence of drugs in human milk, the effects on the breastfed child, or milk production
  • Administration of sargramostim to rabbits during lactation resulted in a reduction in postnatal offspring survival; advise a lactating woman not to breastfeed during treatment and for at least 2 weeks after the last dose