Usual Adult Dose for Neutropenia Associated with Chemotherapy

Initial dose: 5 mcg/kg ONCE a day via subcutaneous injection, short IV infusion (over 15 to 30 minutes) OR continuous IV infusion
Titration dose: Doses may be escalated in 5 mcg/kg doses in each chemotherapy cycle
Duration of therapy: Up to 2 weeks OR until the absolute neutrophil count (ANC) nadir reaches 10,000/mm3

Comments:

• Doses should be given at least 24 hours after cytotoxic chemotherapy.
• Transient increases in neutrophil counts are usually overserved 1 to 2 days after starting treatment.
• A CBC and platelet count should be obtained prior to and 2 times a week throughout treatment.

• Patients with cancer receiving myelosuppressive chemotherapy
• To decrease the incidence of infection, manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia and fever
• Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy
• Reducing the time to neutrophil recovery and the duration of fever, following induction/consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)

Usual Adult Dose for Bone Marrow Transplantation

Following Bone Marrow Transplantation (BMT):

• Initial dose: 10 mcg/kg via short IV infusion (over 15 to 30 minutes) OR continuous IV infusion
• Duration of therapy: Up to 24 hours

• ANC greater than 1000/mm3 for 3 consecutive days: 5 mcg/kg via short IV infusion (over 15 to 30 minutes) OR continuous IV infusion
• ANC greater than 1000/mm3 for an additional 3 or more consecutive days: Discontinue this drug.
• ANC less than 1000/mm3: 5 mcg/kg via short IV infusion (over 15 to 30 minutes) OR continuous IV infusion
• ANC less than 1000/mm3 while receiving 5 mcg/kg/day: 10 mcg/kg via short IV infusion (over 15 to 30 minutes) OR continuous IV infusion

• The first dose should be given at least 24 hours after cytotoxic chemotherapy AND at least 24 hours after bone marrow infusion.
• CBC and platelet levels should be monitored frequently.

• Patients with cancer undergoing bone marrow transplantation
• To reduce the duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation

Usual Adult Dose for Peripheral Progenitor Cell Transplantation

10 mcg/kg via subcutaneous injection once a day

Comments:

• This drug should be given at least 4 days prior to the first leukapheresis procedure.
• Administration of this drug for up to 7 days (on Days 5, 6, and 7) was shown to be safe and effective.
• Treatment should be discontinued if WBC counts exceed 100,000/mm3.

• Patients undergoing autologous peripheral blood progenitor cell collection and therapy
• Mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis

Usual Adult Dose for Neutropenia

Congenital Neutropenia:

• Initial dose: 3 mcg/kg via subcutaneous injection 2 times a day
• Maintenance dose: 6 mcg/kg via subcutaneous injection once a day
• Maximum dose: 100 mcg/kg/day or greater

• Initial dose: 5 mcg/kg via subcutaneous injection once a day
• Maintenance dose:
• Cyclic neutropenia: 2.1 mcg/kg via subcutaneous injection once a day
• Idiopathic neutropenia: 1.2 mcg/kg via subcutaneous injection once a day

• Severe chronic neutropenia (SCN) should be confirmed with serial CBC with differential and platelet counts, bone marrow morphology, and karyotype prior to starting treatment.
• Maintenance doses may be given once or 2 times a day.
• WBCs with differential and platelet counts should be monitored closely for the first 4 weeks of treatment and/or for the first 2 weeks after any dose adjustment. Patients who are clinically stable should receive monthly monitoring for the first year of treatment, with less frequent monitoring thereafter if the patient continues to be clinically stable.

• Patients with SCN
• Chronic administration to reduce the incidence of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia

Usual Adult Dose for Neutropenia Associated with Radiation

10 mcg/kg via subcutaneous injection once a day

Comments:

• Treatment should be started as soon as possible in patients exposed/suspected to be exposed to radiation doses greater than 2 gray (Gy).
• Absorbed radiation doses may be estimated based on biodosimetry, public health agencies, or clinical signs/symptoms (e.g., lymphocyte depletion kinetics, time to onset of vomiting).
• CBCs should be obtained at baseline and then every 3 days until the ANC remains greater than 1000/mm3 for 3 consecutive CBCs.
• Treatment should be continued until the ANC remains greater than 1000/mm3 for 3 consecutive CBCs OR ANC exceeds 10,000/mm3 after a radiation-induced nadir.

• Patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)
• To increase survival in patients acutely exposed to myelosuppressive doses of radiation

Usual Pediatric Dose for Neutropenia Associated with Chemotherapy

Initial dose: 5 mcg/kg ONCE a day via subcutaneous injection, short IV infusion (over 15 to 30 minutes) OR continuous IV infusion
Titration dose: Doses may be escalated in 5 mcg/kg doses in each chemotherapy cycle
Duration of therapy: Up to 2 weeks OR until the ANC nadir reaches 10,000/mm3

Comments:

• Doses should be given at least 24 hours after cytotoxic chemotherapy.
• Transient increases in neutrophil counts are usually overserved 1 to 2 days after starting treatment.
• A CBC and platelet count should be obtained prior to and 2 times a week throughout treatment.

• Patients with cancer receiving myelosuppressive chemotherapy
• To decrease the incidence of infection, manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia and fever
• Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy
• Reducing the time to neutrophil recovery and the duration of fever, following induction/consolidation chemotherapy treatment of patients with AML

Usual Pediatric Dose for Bone Marrow Transplantation

Following BMT:

• Initial dose: 10 mcg/kg via short IV infusion (over 15 to 30 minutes) OR continuous IV infusion
• Duration of therapy: Up to 24 hours

• ANC greater than 1000/mm3 for 3 consecutive days: 5 mcg/kg via short IV infusion (over 15 to 30 minutes) OR continuous IV infusion
• ANC greater than 1000/mm3 or 3 or more consecutive days: Discontinue this drug.
• ANC less than 1000/mm3: 5 mcg/kg via short IV infusion (over 15 to 30 minutes) OR continuous IV infusion
• ANC less than 1000/mm3 while receiving 5 mcg/kg/day: 10 mcg/kg via short IV infusion (over 15 to 30 minutes) OR continuous IV infusion

• The first dose should be given at least 24 hours after cytotoxic chemotherapy AND at least 24 hours after bone marrow infusion.
• CBC and platelet levels should be monitored frequently.

• Patients with cancer undergoing bone marrow transplantation
• To reduce the duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation

Usual Pediatric Dose for Peripheral Progenitor Cell Transplantation

10 mcg/kg via subcutaneous injection once a day

Comments:

• This drug should be given at least 4 days prior to the first leukapheresis procedure.
• Administration of this drug for up to 7 days (on Days 5, 6, and 7) was shown to be safe and effective.
• Treatment should be discontinued if WBC counts exceed 100,000/mm3.

• Patients undergoing autologous peripheral blood progenitor cell collection and therapy
• Mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis

Usual Pediatric Dose for Neutropenia

Congenital Neutropenia:

• Initial dose: 3 mcg/kg via subcutaneous injection 2 times a day
• Maintenance dose: 6 mcg/kg via subcutaneous injection once a day
• Maximum dose: 100 mcg/kg/day or greater

• Initial dose: 5 mcg/kg via subcutaneous injection once a day
• Maintenance dose:
• Cyclic neutropenia: 2.1 mcg/kg via subcutaneous injection once a day
• Idiopathic neutropenia: 1.2 mcg/kg via subcutaneous injection once a day

• SCN should be confirmed with serial CBC with differential and platelet counts, bone marrow morphology, and karyotype prior to starting treatment.
• Maintenance doses may be given once or 2 times a day.
• WBCs with differential and platelet counts should be monitored closely for the first 4 weeks of treatment and/or for the first 2 weeks after any dose adjustment. Patients who are clinically stable should receive monthly monitoring for the first year of treatment, with less frequent monitoring thereafter if the patient continues to be clinically stable.

• Patients with SCN
• Chronic administration to reduce the incidence of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia

Usual Pediatric Dose for Neutropenia Associated with Radiation

10 mcg/kg via subcutaneous injection once a day

Comments:

• Treatment should be started as soon as possible in patients exposed/suspected to be exposed to radiation doses greater than 2 Gy.
• Absorbed radiation doses may be estimated based on biodosimetry, public health agencies, or clinical signs/symptoms (e.g., lymphocyte depletion kinetics, time to onset of vomiting).
• CBCs should be obtained at baseline and then every 3 days until the ANC remains greater than 1000/mm3 for 3 consecutive CBCs.
• Treatment should be continued until the ANC remains greater than 1000/mm3 for 3 consecutive CBCs OR ANC exceeds 10,000/mm3 after a radiation-induced nadir.

• Patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)
• To increase survival in patients acutely exposed to myelosuppressive doses of radiation

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

Therapeutic drug monitoring/range: ANC greater than 10,0000/mm3: Treatment should be stopped.

Precautions

CONTRAINDICATIONS:

• Patients with a history of serious allergic reactions to the active component, pegfilgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients

Dialysis

Data not available

Other Comments

Administration advice:

• Prior to administration, allow the vial or prefilled syringe to reach room temperature (e.g., 25C) for a minimum of 30 minutes and a maximum of 24 hours.
• Subcutaneous injection: Inject into the abdomen, thighs, outer areas of the upper arms, or upper outer areas of the buttock.
• Vials/prefilled syringes left at room temperature longer than 24 hours, discolored solutions, and/or those containing precipitate should be discarded.

• Compatible: 5% dextrose; 5% glucose; 5% dextrose plus albumin (human); 5% glucose plus albumin (human)
• Incompatible: Saline

• Any unused drug after administration should be discarded.
• Some experts recommend: This drug should not be used to increase the dose of cytotoxic chemotherapy beyond established regimens.
• Single-dose vial formulations (compared to single-dose prefilled syringe formulations) may be more appropriate for patients requiring doses less than 180 mcg.

• HEMATOLOGIC: Complete blood counts (including platelet and hematocrit counts) at least every 2 weeks
• MUSCULOSKELETAL: Bone mineral density in patients with underlying osteoporotic bone diseases receiving treatment for greater than 6 months; bone marrow examinations every 12 months
• RENAL: Urinalysis

• Inform patients that this drug may cause dizziness, and they should avoid driving or operating machinery if these side effects occur.
• Patients who miss a dose should be instructed to contact their healthcare provider.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• How many biosimilars have been approved in the United States?
• What is the difference between Nivestym and Neupogen?