Neulasta – Product Information
|Condition:||Neutropenia Associated with Chemotherapy, Neutropenia|
|Class:||Colony stimulating factors, Hematopoietic stem cell mobilizer|
|Form:||Subcutaneous (SC), Skin patch (transdermal)|
|Ingredients:||pegfilgrastim, acetate, polysorbate 20, sodium, sorbitol in water for Injection|
Indications and usage
Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14)].
Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Dosage and administration
The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
Neulasta is administered subcutaneously via a single prefilled syringe for manual use or for use with the On-body Injector for Neulasta which is co-packaged with a single prefilled syringe.
For manual use or On-body Injector for Neulasta use, visually inspect parenteral drug products (prefilled syringe) for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Neulasta if discoloration or particulates are observed.
The needle cap on the prefilled syringes contains dry natural rubber (derived from latex); persons with latex allergies should not administer these products.
Special Healthcare Provider Instructions for the On-body Injector for Neulasta
A healthcare provider must fill the On-body Injector with Neulasta using the prefilled syringe and then apply the on-body Injector for Neulasta to the patient’s skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the On-body Injector for Neulasta. Approximately 27 hours after the On-body Injector for Neulasta is applied to the patient’s skin, Neulasta will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the On-body Injector for Neulasta on the same day as the administration of cytotoxic chemotherapy, as long as the On-body Injector for Neulasta delivers Neulasta no less than 24 hours after administration of cytotoxic chemotherapy.
The prefilled syringe co-packaged in the Neulasta Delivery Kit must only be used with the On-body Injector for Neulasta. The prefilled syringe contains additional solution to compensate for liquid loss during delivery through the On-body Injector for Neulasta. If the prefilled syringe co-packaged in the Neulasta Delivery Kit is used for manual subcutaneous injection, the patient will receive an overdose. If the single use prefilled syringe for manual use is used with the On-body Injector for Neulasta, the patient may receive less than the recommended dose.
Do not use the On-body Injector for Neulasta to deliver any other drug product except the Neulasta prefilled syringe co-packaged with the On-body Injector for Neulasta.
The On-body Injector for Neulasta should be applied to intact, non-irritated skin on the arm or abdomen.
A missed dose could occur due to an On-body Injector for Neulasta failure or leakage. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use, as soon as possible after detection.
Refer to the Healthcare Provider Instructions for Use for the On-body Injector for Neulasta for full administration information.
Advice to Give to Patients Regarding Administration via the On-body Injector for Neulasta
Advise patients to avoid activities such as traveling, driving, or operating heavy machinery during hours 26-29 following application of the On-body Injector for Neulasta (this includes the 45-minute delivery period plus an hour post-delivery). Patients should have a caregiver nearby for the first use.
Refer the patient to the dose delivery information written on the Patient Instructions for Use. Provide training to patients to ensure they understand when the dose delivery of Neulasta will begin and how to monitor the On-body Injector for Neulasta for completed delivery. Ensure patients understand how to identify signs of malfunction of On- body Injector for Neulasta. [see Warnings and Precautions (5.3) and Patient Counseling Information (17)].
Dosage forms and strengths
- Injection: 6 mg/0.6 mL solution in a single use prefilled syringe for manual use only.
- Injection: 6 mg/0.6 mL solution in a single use prefilled syringe co-packaged with the On-body Injector for Neulasta (Neulasta Delivery Kit).
- Splenic Rupture [See Warnings and Precautions (5.1)]
- Acute Respiratory Distress Syndrome [See Warnings and Precautions (5.2)]
- Serious Allergic Reactions [See Warnings and Precautions (5.3)]
- Use in Patients with Sickle Cell Disorders [See Warnings and Precautions (5.5)]
- Potential for Tumor Growth Stimulatory Effects on Malignant Cells [See Warnings and Precautions (5.6)]
- Neulasta for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes.
- On-body Injector for Neulasta is supplied with a prefilled syringe containing 0.64 mL of Neulasta in solution that delivers 0.6 mL of Neulasta in solution when used with the On-body Injector for Neulasta.
- Splenic rupture
- Acute Respiratory Distress Syndrome
- Serious allergic reactions
- Sickle cell crisis
- Left upper quadrant or shoulder pain
- Shortness of breath
- Signs or symptoms of sickle cell crisis
- Signs or symptoms of infection
- Flushing, dizziness, or rash
- Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient.
- Refer the patient to the dose delivery information written on the Patient Instructions for Use.
- Tell the patient when their dose delivery of Neulasta will begin and when their dose delivery should be completed.
- Advise the patient that serious allergic reactions can happen with Neulasta. Patients should have a caregiver nearby for the first use. Patients should plan to be in a place where they can appropriately monitor the On-body Injector for Neulasta during the approximately 45 minute Neulasta delivery and for an hour after the delivery. Advise the patient to avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the On-body Injector for Neulasta.
- If the On-body Injector for Neulasta is placed on the back of the arm, remind the patient that a caregiver must be available to monitor the On-body Injector for Neulasta.
- If a patient calls the healthcare provider regarding any On-body Injector for Neulasta problems, the healthcare provider is advised to call Amgen at 1-800-772-6436.
- Advise the patient:
- to call their healthcare provider immediately if the status light on the On-body Injector for Neulasta is flashing red (see the Patient Instructions for Use).
- to inform their healthcare provider if the adhesive on the On-body Injector for Neulasta becomes saturated with fluid, or there is dripping, as this may be evidence of significant product leakage, resulting in inadequate or missed dose (see the Patient Instructions for Use).
- to keep the On-body Injector for Neulasta dry for approximately the last 3 hours prior to the dose delivery start to better enable potential leak detection.
- that the On-body Injector for Neulasta should only be exposed to temperatures between 41°F and 104°F (5°C-40°C)
- to keep the On-body Injector for Neulasta at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the On-body Injector for Neulasta at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta.
- that if the needle is exposed after On-body Injector for Neulasta removal, place the used On-body Injector for Neulasta in a sharps disposal container to avoid accidental needle stick and call their healthcare provider immediately.
- to remove the On-body Injector for Neulasta after the green light shines continuously and to place the used On-body Injector for Neulasta in a sharps disposal container (see the Patient Instructions for Use).
- Advise the patient:
- do not reapply the On-body Injector for Neulasta if the On-body Injector for Neulasta comes off before full dose is delivered and instead call their healthcare provider immediately.
- avoid bumping the On-body Injector for Neulasta or knocking the On-body Injector for Neulasta off the body.
- do not expose the On-body Injector for Neulasta to medical imaging studies, e.g. X-ray scan, MRI, CT scan, ultrasound and oxygen rich environments such as hyperbaric chambers to avoid On-body Injector for Neulasta damage and patient injury.
- Advise the patient to avoid:
- airport X-ray scans and request a manual pat down instead; remind patients who elect to request a manual pat down to exercise care to avoid having the On-body Injector for Neulasta dislodged during the pat down process.
- sleeping on the On-body Injector for Neulasta or applying pressure on the On-body Injector for Neulasta as this may affect On-body Injector for Neulasta performance.
- getting body lotions, creams, oils and cleaning agents near the On-body Injector for Neulasta as these products may loosen the adhesive.
- using hot tubs, whirlpools, or saunas and avoid exposing the On-body Injector for Neulasta to direct sunlight as these may affect the drug.
- peeling off or disturbing the On-body Injector for Neulasta adhesive before delivery of full dose is complete.
Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
Warnings and precautions
Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.
Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta, for ARDS. Discontinue Neulasta in patients with ARDS.
Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions. Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
Allergies to Acrylics
The On-body Injector for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.
Use in Patients With Sickle Cell Disorders
Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
The granulocyte-colony stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
The most common adverse reactions occurring in ≥5% of patients and with a between-group difference of ≥5% higher in the pegfilgrastim arm in placebo controlled clinical trials are bone pain and pain in extremity.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Neulasta clinical trials safety data are based upon 932 patients receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received Neulasta after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.
The following adverse reaction data in Table 1 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m² every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and <1% Asian, Native American or other.
Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients.
Table 1. Adverse Reactions With ≥5% Higher Incidence in Neulasta Patients Compared to Placebo in Study 3
|System Organ Class
| Neulasta 6 mg SC on Day
|Musculoskeletal and connective tissue disorders||Bone pain||26%||31%|
|Pain in extremity||4%||9%|
In clinical studies, leukocytosis (WBC counts >100×109/L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies.
As with all therapeutic proteins, there is a potential for immunogenicity. Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Neulasta with the incidence of antibodies to other products may be misleading.
The following adverse reactions have been identified during post approval use of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) reported frequency of the reaction, or (3) strength of causal relationship to Neulasta.
Gastro-intestinal disorders: Splenic rupture [see Warnings and Precautions (5.1)]
Blood and lymphatic system disorder: Sickle cell crisis [see Warnings and Precautions (5.5)]
Hypersensitivity reactions: Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, and urticaria, generalized erythema and flushing [see Warnings and Precautions (5.3)]
Respiratory, thoracic, and mediastinal disorder: ARDS [see Warnings and Precautions (5.2)] General disorders and administration site conditions: Injection site reactions
Skin and subcutaneous tissue disorders: Sweet’s syndrome, Cutaneous vasculitis
No formal drug interaction studies between Neulasta and other drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may result in transiently positive bone-imaging changes. Consider these findings when interpreting bone-imaging results.
Use in specific populations
Pregnancy Category C2
There are no adequate and well-controlled studies in pregnant women. Pegfilgrastim was embryotoxic and increased pregnancy loss in pregnant rabbits that received cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. Neulasta should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
In animal reproduction studies, when pregnant rabbits received pegfilgrastim at cumulative doses approximately 4 times the recommended human dose (based on body surface area), increased embryolethality and spontaneous abortions occurred. Signs of maternal toxicity (reductions in body weight gain/food consumption) and decreased fetal weights occurred at maternal doses approximately equivalent to the recommended human dose (based on body surface area). There were no structural anomalies observed in rabbit offspring at any dose tested. No evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area) [see Nonclinical Toxicology (13.3)].
Women who become pregnant during Neulasta treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.
It is not known whether pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman.
Safety and effectiveness of Neulasta in pediatric patients have not been established. The adverse reaction profile and pharmacokinetics of pegfilgrastim were studied in 37 pediatric patients with sarcoma. The mean (± standard deviation [SD]) systemic exposure (AUC0-inf) of pegfilgrastim after subcutaneous administration at 100 mcg/kg was 22.0 (± 13.1) mcg•hr/mL in the 6 to11 years age group (n = 10), 29.3 (± 23.2) mcg•hr/mL in the 12 to 21 years age group (n = 13), and 47.9 (± 22.5) mcg•hr/mL in the youngest age group (0 to5 years, n = 11). The terminal elimination half-lives of the corresponding age groups were 20.2 (± 11.3) hours, 21.2 (± 16.0) hours, and 30.1 (± 38.2) hours, respectively. The most common adverse reaction was bone pain.
Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.
In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. Therefore, pegfilgrastim dose adjustment in patients with renal dysfunction is not necessary [Clinical Pharmacology (12.3)].
The maximum amount of Neulasta that can be safely administered in single or multiple doses has not been determined. Single subcutaneous doses of 300 mcg/kg have been administered to 8 healthy volunteers and 3 patients with non-small cell lung cancer without serious adverse effects. These patients experienced a mean maximum absolute neutrophil count (ANC) of 55 × 109/L, with a corresponding mean maximum WBC of 67×109/L. The absolute maximum ANC observed was 96×109/L with a corresponding absolute maximum WBC observed of 120 ×109/L. The duration of leukocytosis ranged from 6 to 13 days. The effectiveness of leukapheresis in the management of symptomatic individuals with Neulasta-induced leukocytosis has not been studied.
Neulasta (pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.
Neulasta comes in two presentations:
The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection or the On-body Injector for Neulasta contains 6 mg pegfilgrastim (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP.
Mechanism of Action
Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
The pharmacokinetics of pegfilgrastim were studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim were nonlinear and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils. In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed. The half-life of Neulasta ranged from 15 to 80 hours after subcutaneous injection. In healthy volunteers, the pharmacokinetics of pegfilgrastim were comparable when delivered subcutaneously via a manual prefilled syringe versus via the On-body Injector for Neulasta.
No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥65 years of age) compared with younger patients (&il;65 years of age) [see Use in Specific Populations (8.5)]. The pharmacokinetics of pegfilgrastim were studied in pediatric patients with sarcoma [see Use in Specific Populations (8.4)]. Renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. [see Use in Specific Populations (8.6)]. The pharmacokinetic profile in patients with hepatic insufficiency has not been assessed.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim.
Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).
Reproductive and Developmental Toxicology
Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).
Neulasta was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active-controlled studies that employed doxorubicin 60 mg/m²and docetaxel 75 mg/m² administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of Neulasta. Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC &il;0.5×109/L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of Neulasta was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia.
In Study 1, 157 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of Neulasta (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle.
Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia of Neulasta-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy. The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the Neulasta arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI -0.2, 0.6)] and in Study 2 were 1.7 days in the Neulasta arm compared to 1.6 days in the Filgrastim arm [difference in means 0.1 (95% CI -0.2, 0.4)].
A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1.
Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m²administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥38.2°C and ANC ≤0.5×109/L) was lower for Neulasta-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p &il;0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the Neulasta-treated patients compared to the placebo-treated patients.
How supplied/storage and handling
Neulasta single use prefilled syringe for manual use
Neulasta is supplied in a prefilled single use syringe for manual use containing 6 mg pegfilgrastim, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard.
The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).
Neulasta is provided in a dispensing pack containing one sterile 6mg/0.6 mL prefilled syringe (NDC 55513-190-01).
Store refrigerated between 36° to 46°F (2° to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.
Neulasta Delivery Kit
The Neulasta Delivery Kit is provided in a carton containing one sterile prefilled syringe and one sterile On-body Injector for Neulasta (NDC 55513-192-01).
The single use prefilled syringe contains 0.64 mL of solution that delivers 6 mg/0.6 mL of pegfilgrastim when used with the On-body Injector for Neulasta. The prefilled syringe is supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard.
The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).
Store the Kit in the refrigerator at 36°F to 46°F (2°C to 8°C) until ready for use. Because the On-body Injector for Neulasta is at room temperature during the period of use, the Kit should not be held at room temperature longer than 12 hours prior to use. Discard the Kit if stored at room temperature for more than 12 hours.
Do not use the On-body Injector for Neulasta if its packaging has been previously opened.
Patient counceling information
Advise patients of the following risks for Neulasta:
Have patients immediately contact their healthcare provider and report:
Advise patients on the use of the On-body Injector for Neulasta: