Consumer medicine information

1. Why am I using NEUPOGEN?

NEUPOGEN contains the active ingredient filgrastim. NEUPOGEN is used to encourage your bone marrow to produce more neutrophils, a type of white blood cell. You may have been prescribed NEUPOGEN because you are receiving treatment for cancer, are receiving a bone marrow or stem cell transplant, are donating stem cells for another person, are suffering from severe chronic neutropenia or are receiving medicines for HIV infection.
For more information, see Section 1. Why am I using NEUPOGEN? in the full CMI.

2. What should I know before I use NEUPOGEN?

Do not use if you have ever had an allergic reaction to NEUPOGEN, any of the ingredients listed at the end of the CMI, or to any medicines or products that are produced using the bacteria E. coli.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use NEUPOGEN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NEUPOGEN and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use NEUPOGEN?

NEUPOGEN is injected under the skin (subcutaneous). More instructions can be found in Section 4. How do I use NEUPOGEN? in the full CMI.

5. What should I know while using NEUPOGEN?

6. Are there any side effects?

Common side effects include bone, back, muscle, joint, mouth or throat pain; swelling or stiffness of joints; muscle spasms; abdominal discomfort; diarrhoea; constipation; nausea; vomiting; severe nose bleeds; reddish or purplish bumps or blotches, mouth ulcers; numbness; tingling in the hands and feet; injection site reactions; cough; hair loss; headache; looking pale; loss of appetite; unusual weakness; difficulty sleeping. Serious side effects include rash, itching or hives; shortness of breath, wheezing, difficulty, or rapid breathing; tiredness, fever; easy bruising or bleeding; coughing up blood; swelling; faintness; rapid pulse or sweating; painful skin lesions; chest pain; left shoulder pain; pain in the upper left side of the stomach; swelling of your stomach-area; reduced urination; blood in the urine.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Neupogen is the Amgen Inc. trademark for filgrastim (rbe), a recombinant methionyl human granulocyte colony stimulating factor.

2 Qualitative and Quantitative Composition

Neupogen is available in single use prefilled syringes and vials. The single use prefilled syringes contain either 300 microgram or 480 microgram filgrastim at a fill volume of 0.5 mL. The single use vials contain either 300 microgram or 480 microgram filgrastim at a fill volume of 1.0 mL or 1.6 mL, respectively.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Neupogen is a sterile, clear, colourless, preservative-free liquid for parenteral administration.

4 Clinical Particulars

4.9 Overdose

The maximum tolerated dose of Neupogen has not been determined. Twenty seven patients have been treated at Neupogen doses of ≥ 69 microgram/kg/day. Of those, 6 patients have been treated at 115 microgram/kg/day with no toxic effects attributable to Neupogen. Efficacy has been demonstrated using much lower doses (doses of 4 to 8 microgram/kg/day showed efficacy in the phase 3 study). Doses of Neupogen which increase the ANC beyond 10 x 10⁹/L may not result in any additional clinical benefit.
In clinical trials of Neupogen in cancer patients receiving myelosuppressive chemotherapy, WBC counts > 100 x 10⁹/L have been reported in less than 5% of patients, but were not associated with any reported adverse clinical effects.
It is recommended, to avoid the potential risks of excessive leukocytosis, that Neupogen therapy should be discontinued if the ANC surpasses 10 x 10⁹/L after the chemotherapy-induced ANC nadir has occurred.
In cancer patients receiving myelosuppressive chemotherapy, discontinuation of Neupogen therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to pretreatment levels in 1 to 7 days.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Cell proliferation potential. As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells. G-CSF can promote growth of myeloid cells, including malignant cells, in vitro, and similar effects may be seen on some non-myeloid cells in vitro.
Genotoxicity. In either the presence or absence of a drug enzyme metabolising system, Neupogen failed to induce chromosomal aberrations (in Chinese hamster lung cells in vitro) or bacterial gene mutations. Neupogen was negative in an in vivo mouse micronuclear test. Neupogen failed to induce bacterial gene mutations in either the presence or absence of a drug metabolising enzyme system.
Carcinogenicity. The carcinogenic potential of Neupogen has not been studied.
Teratogenicity. The administration of Neupogen to pregnant rabbits during the period of organogenesis at doses of 20 microgram/kg/day IV or greater was associated with an increased incidence of embryonic loss, urogenital bleeding and decreased food consumption. External abnormalities were not observed in the fetuses of treated does, but there was a significant increase in the incidence of fusion of sternebrae at an 80 microgram/kg/day dose. The administration of Neupogen to pregnant rabbits at a dose of 5 microgram/kg/day IV was not associated with observable adverse effects to the doe or fetus (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Neupogen (filgrastim) is a 175 amino acid protein manufactured by recombinant DNA technology. Neupogen is produced by Escherichia coli bacteria into which has been inserted the human granulocyte colony stimulating factor (G-CSF) gene. It has a molecular weight of 18,800 daltons. Neupogen is unglycosylated and contains an N-terminal methionine necessary for expression in E. coli.
The specific activity of Neupogen by in vitro proliferative cell assay is 1 x 10⁸ IU/mg when assayed against the WHO international standard for granulocyte colony stimulating factor, 88/502. The clinical significance of this in vitro potency assignment is unknown.

7 Medicine Schedule (Poisons Standard)

S4 Prescription medicine.

Summary Table of Changes

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