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Neupogen

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Neupogen

Neupogen

INDICATIONS

Cancer Patients Receiving Myelosuppressive Chemotherapy

NEUPOGEN® is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever (see Clinical Experience). A complete blood count (CBC) and platelet count should be obtained prior to chemotherapy‚ and twice per week (see Laboratory Monitoring) during NEUPOGEN® therapy to avoid leukocytosis and to monitor the neutrophil count. In phase 3 clinical studies‚ NEUPOGEN® therapy was discontinued when the ANC was ≥ 10‚000/mm³ after the expected chemotherapy-induced nadir.

Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy

NEUPOGEN® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML.

Cancer Patients Receiving Bone Marrow Transplant

NEUPOGEN® is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg‚ febrile neutropenia‚ in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation (see Clinical Experience). It is recommended that CBCs and platelet counts be obtained at a minimum of 3 times per week (see Laboratory Monitoring) following marrow infusion to monitor the recovery of marrow reconstitution.

Patients Undergoing Peripheral Blood Progenitor Cell Collection and Therapy

NEUPOGEN® is indicated for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Mobilization allows for the collection of increased numbers of progenitor cells capable of engraftment compared with collection by leukapheresis without mobilization or bone marrow harvest. After myeloablative chemotherapy‚ the transplantation of an increased number of progenitor cells can lead to more rapid engraftment‚ which may result in a decreased need for supportive care (see Clinical Experience).

Patients With Severe Chronic Neutropenia

NEUPOGEN® is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia (see Clinical Experience). It is essential that serial CBCs with differential and platelet counts‚ and an evaluation of bone marrow morphology and karyotype be performed prior to initiation of NEUPOGEN® therapy (see WARNINGS). The use of NEUPOGEN® prior to confirmation of SCN may impair diagnostic efforts and may thus impair or delay evaluation and treatment of an underlying condition‚ other than SCN‚ causing the neutropenia.

DOSAGE AND ADMINISTRATION

NEUPOGEN® is supplied in either vials or in prefilled syringes with UltraSafe® Needle Guards. Following administration of NEUPOGEN® from the prefilled syringe, the UltraSafe® Needle Guard should be activated to prevent accidental needle sticks. To activate the UltraSafe® Needle Guard, place your hands behind the needle, grasp the guard with one hand, and slide the guard forward until the needle is completely covered and the guard clicks into place. NOTE: If an audible click is not heard, the needle guard may not be completely activated. The prefilled syringe should be disposed of by placing the entire prefilled syringe with guard activated into an approved puncture-proof container.

Cancer Patients Receiving Myelosuppressive Chemotherapy

The recommended starting dose of NEUPOGEN® is 5 mcg/kg/day‚ administered as a single daily injection by SC bolus injection‚ by short IV infusion (15 to 30 minutes)‚ or by continuous SC or continuous IV infusion. A CBC and platelet count should be obtained before instituting NEUPOGEN® therapy‚ and monitored twice weekly during therapy. Doses may be increased in increments of 5 mcg/kg for each chemotherapy cycle‚ according to the duration and severity of the ANC nadir.

NEUPOGEN® should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. NEUPOGEN® should not be administered in the period 24 hours before the administration of chemotherapy (see PRECAUTIONS). NEUPOGEN® should be administered daily for up to 2 weeks‚ until the ANC has reached 10‚000/mm³ following the expected chemotherapy-induced neutrophil nadir. The duration of NEUPOGEN® therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed. NEUPOGEN® therapy should be discontinued if the ANC surpasses 10‚000/mm³ after the expected chemotherapy-induced neutrophil nadir (see PRECAUTIONS). In phase 3 trials‚ efficacy was observed at doses of 4 to 8 mcg/kg/day.

Cancer Patients Receiving Bone Marrow Transplant

The recommended dose of NEUPOGEN® following BMT is 10 mcg/kg/day given as an IV infusion of 4 or 24 hours‚ or as a continuous 24-hour SC infusion. For patients receiving BMT‚ the first dose of NEUPOGEN® should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.

During the period of neutrophil recovery‚ the daily dose of NEUPOGEN® should be titrated against the neutrophil response as follows:

Absolute Neutrophil Count NEUPOGEN® Dose Adjustment
When ANC > 1000/mm³ for 3 consecutive days Reduce to 5 mcg/kg/daya
then: If ANC remains > 1000/mm³ for 3 more consecutive days Discontinue NEUPOGEN®
then: If ANC decreases to < 1000/mm³ Resume at 5 mcg/kg/day
a If ANC decreases to < 1000/mm³ at any time during the 5 mcg/kg/day administration‚ NEUPOGEN® should be increased to 10 mcg/kg/day‚ and the above steps should then be followed.

Peripheral Blood Progenitor Cell Collection and Therapy in Cancer Patients

The recommended dose of NEUPOGEN® for the mobilization of PBPC is 10 mcg/kg/day SC‚ either as a bolus or a continuous infusion. It is recommended that NEUPOGEN® be given for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis. Although the optimal duration of NEUPOGEN® administration and leukapheresis schedule have not been established‚ administration of NEUPOGEN® for 6 to 7 days with leukaphereses on days 5‚ 6‚ and 7 was found to be safe and effective (see Clinical Experience for schedules used in clinical trials). Neutrophil counts should be monitored after 4 days of NEUPOGEN®‚ and NEUPOGEN® dose modification should be considered for those patients who develop a WBC count > 100‚000/mm³.

In all clinical trials of NEUPOGEN® for the mobilization of PBPC‚ NEUPOGEN® was also administered after reinfusion of the collected cells (see Clinical Experience).

Patients With Severe Chronic Neutropenia

NEUPOGEN® should be administered to those patients in whom a diagnosis of congenital‚ cyclic‚ or idiopathic neutropenia has been definitively confirmed. Other diseases associated with neutropenia should be ruled out.

Starting Dose

Congenital Neutropenia: The recommended daily starting dose is 6 mcg/kg BID SC every day.

Idiopathic or Cyclic Neutropenia: The recommended daily starting dose is 5 mcg/kg as a single injection SC every day.

Dose Adjustments

Chronic daily administration is required to maintain clinical benefit. Absolute neutrophil count should not be used as the sole indication of efficacy. The dose should be individually adjusted based on the patients' clinical course as well as ANC. In the SCN postmarketing surveillance study, the reported median daily doses of NEUPOGEN® were: 6.0 mcg/kg (congenital neutropenia), 2.1 mcg/kg (cyclic neutropenia), and 1.2 mcg/kg (idiopathic neutropenia). In rare instances, patients with congenital neutropenia have required doses of NEUPOGEN® ≥ 100 mcg/kg/day.

Dilution

If required‚ NEUPOGEN® may be diluted in 5% dextrose. NEUPOGEN® diluted to concentrations between 5 and 15 mcg/mL should be protected from adsorption to plastic materials by the addition of Albumin (Human) to a final concentration of 2 mg/mL. When diluted in 5% dextrose or 5% dextrose plus Albumin (Human)‚ NEUPOGEN® is compatible with glass bottles‚ PVC and polyolefin IV bags‚ and polypropylene syringes.

Dilution of NEUPOGEN® to a final concentration of less than 5 mcg/mL is not recommended at any time. Do not dilute with saline at any time; product may precipitate.

Storage

NEUPOGEN® should be stored in the refrigerator at 2° to 8°C (36° to 46°F). Avoid shaking. Prior to injection‚ NEUPOGEN® may be allowed to reach room temperature for a maximum of 24 hours. Any vial or prefilled syringe left at room temperature for greater than 24 hours should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration‚ whenever solution and container permit; if particulates or discoloration are observed‚ the container should not be used.

HOW SUPPLIED

NEUPOGEN®: Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.

Use only one dose per prefilled syringe. Discard unused portions. Do not save unused drug for later administration.

Vials

Single-dose‚ preservative-free vials containing 300 mcg (1 mL) of Filgrastim (300 mcg/mL). Dispensing packs of 10 (NDC 55513-530-10).

Single-dose‚ preservative-free vials containing 480 mcg (1.6 mL) of Filgrastim (300 mcg/mL). Dispensing packs of 10 (NDC 55513-546-10).

Prefilled Syringes (SingleJect®)

Single-dose‚ preservative-free, prefilled syringes with 27 gauge, ½ inch needles with an UltraSafe® Needle Guard, containing 300 mcg (0.5 mL) of Filgrastim (600 mcg/mL). Dispensing packs of 10 (NDC 55513-924-10).

Single-dose‚ preservative-free, prefilled syringes with 27 gauge, ½ inch needles with an UltraSafe® Needle Guard, containing 480 mcg (0.8 mL) of Filgrastim (600 mcg/mL). Dispensing packs of 10 (NDC 55513-209-10).

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex).

NEUPOGEN® should be stored at 2° to 8°C (36° to 46°F). Avoid shaking.

Manufactured by: Amgen Manufacturing, Limited, a subsidiary of Amgen Inc. One Amgen Center Drive, Thousand Oaks, California 91320-1799. Issue Date: 03/2010

Last reviewed on RxList: 6/4/2012
This monograph has been modified to include the generic and brand name in many instances.

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