neulasta
Pharmaranks rates Neulasta 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Neulasta (Pegfilgrastim) is a leukocyte growth factor used to treat Neutropenia.
Pegfilgrastim · by Amgen Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Pegfilgrastim
- Drug class
- Leukocyte Growth Factor
- Form
- Injectable, Solution, Kit
- Strength
- Pegfilgrastim 6MG/0.6ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- neutropenia
- Manufacturer
- Amgen Inc
- FDA application
- BLA125031
What is Neulasta?
From the FDA label: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 (pegfilgrastim) is a sterile, clear, colorless, preservative-free solution with a pH of 4.0, supplied in single-dose prefilled syringes for manual use or for use with the on-body injector (OBI) for Neulasta, which is co-packaged with a single-dose prefilled syringe, or in single-dose vials. Prefilled Syringe for Manual Use or for Use with OBI Neulasta for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL). On-body injector (OBI) 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 OBI for Neulasta. The syringe does…
How to use
Neulasta is sold in more than one form (Injectable, Solution and Kit), and each is dosed differently. The instructions below come from the FDA label for application BLA125031 — follow the label that came with the product you were actually prescribed.
Patients with cancer receiving myelosuppressive chemotherapy For adult patients of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is 6 mg subcutaneously once per chemotherapy cycle. ( 2.1 ) For pediatric patients weighing less than 45 kg, use weight-based dosing; refer to Table 1 ( 2.1 ) Do not administer between 14 days before and 24 hours after administration of chemotherapy. ( 2.1 ) Patients acutely exposed to myelosuppressive doses of radiation For adults of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is two doses, 6 mg each, subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after. ( 2.2 ) For pediatric patients weighing less than 45 kg, use weight-based dosing; refer to Table 1. ( 2.1 ) 2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy The recommended dosage of Neulasta for adults of any weight and pediatric patients weighing at least 45 kg with cancer receiving myelosuppressive chemotherapy is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administer Neulasta between 14 days before and 24 hours after administration of chemotherapy.…
Side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Allergies to Acrylics [see Warnings and Precautions (5.4) ] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions (5.5) ] Glomerulonephritis [see Warnings and Precautions (5.6) ] Leukocytosis [see Warnings and Precautions (5.7) ] Thrombocytopenia [see Warnings and Precautions (5.8) ] Capillary Leak Syndrome [see Warnings and Precautions (5.9) ] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.10) ] Myelodysplastic syndrome [see Warnings and Precautions (5.11) ] Acute myeloid leukemia [see Warnings and Precautions (5.11) ] Aortitis [see Warnings and Precautions (5.13) ] Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a…
Warnings
Important safety information
Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. ( 5.1 ) Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Neulasta in patients with ARDS. ( 5.2 ) Serious hypersensitivity reactions, including anaphylaxis: Permanently discontinue Neulasta in patients with serious hypersensitivity reactions. (5.3) 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. ( 5.4 ) Fatal sickle cell crises: Discontinue Neulasta if sickle cell crisis occurs. ( 5.5 ) Glomerulonephritis: Evaluate and consider dose-reduction or interruption of Neulasta if causality is likely. ( 5.6 ) Thrombocytopenia: Monitor platelet counts. ( 5.8 ) Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using Neulasta in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. ( 5.11 ) Potential device failures: Instruct patients to notify their healthcare provider if they suspect the on-body injector may not have performed as intended. ( 5.12 ) Aortitis: Discontinue Neulasta if aortitis is suspected. ( 5.13 ) 5.1 Splenic Rupture 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. 5.2 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. 5.3 Serious Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Hypersensitivity reactions, including anaphylaxis, can recur within days after the discontinuation of initial therapies to manage the reaction. Permanently discontinue Neulasta in patients with serious hypersensitivity reactions. Neulasta is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim or filgrastim. 5.4 Allergies to Acrylics The on-body injector (OBI) for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction. 5.5 Use in Patients with Sickle Cell Disorders Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Discontinue Neulasta if sickle cell crisis occurs. 5.6 Glomerulonephritis Glomerulonephritis has occurred in patients receiving Neulasta. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of Neulasta. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Neulasta. 5.7 Leukocytosis White blood cell (WBC) counts of 100 × 10 9 /L or greater have been observed in patients receiving Neulasta. Monitoring of complete blood count (CBC) during Neulasta therapy is recommended. 5.8 Thrombocytopenia Neulasta can cause thrombocytopenia. Monitor platelet counts during Neulasta therapy. 5.9 Capillary Leak Syndrome Capillary leak syndrome has been reported after G-CSF administration, including Neulasta, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care. 5.10 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 Neulasta acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded. 5.11 Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer MDS and AML have been associated with the use of Neulasta in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings. 5.12 Potential Device Failures Missed or partial doses have been reported in patients receiving Neulasta via the on-body injector (OBI) due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of Neulasta if they suspect that the device may not have performed as intended. 5.13 Aortitis Aortitis has been reported in patients receiving Neulasta. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta if aortitis is suspected. 5.14 Nuclear Imaging Increased hematopoietic activity of the bone marrow in response to growth factor therapy, including Neulasta, has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.
Who should not take Neulasta
Neulasta is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim or filgrastim. Reactions have included anaphylaxis [see Warnings and Precautions (5.3) ] . In patients with a history of serious hypersensitivity reaction to pegfilgrastim or filgrastim. ( 4 )
Overdose — what happens if you take too much
Overdosage of Neulasta may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered Neulasta on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6) ] . Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
May treat (source: NIH RxClass)
See how Neulasta ranks — best-rated leukocyte growth factor for:
Dosage forms
Injectable, Solution and Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Neulasta treat?
- Neulasta (Pegfilgrastim) may be used to treat neutropenia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Neulasta rated?
- pharmaranks gives Neulasta a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Neulasta?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Neulasta. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Neulasta?
- Neulasta is marketed by Amgen Inc. You can see Amgen Inc's full profile, rating, and other products on pharmaranks.
- Is Neulasta a brand-name or generic drug?
- Neulasta is a brand-name product with the active ingredient Pegfilgrastim.
- Is Neulasta available over the counter?
- No. Neulasta is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Neulasta come in?
- Neulasta is currently marketed as injectable, solution and kit, per the FDA's National Drug Code Directory.
- What class of drug is Neulasta?
- Neulasta is classified as leukocyte growth factor, per the FDA's Established Pharmacologic Class.
- Is Neulasta FDA-registered?
- Neulasta is on record with the U.S. FDA under application number BLA125031. You can verify this on its official FDA label.
- Has Neulasta been recalled by the FDA?
- Neulasta has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Neulasta safe?
- There's no single safe-or-not verdict. pharmaranks gives Neulasta a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Neulasta?
- Neulasta's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2) ] Serious Hypersensitivity Reactions [see Warnings a… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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neulasta
72/100