Neulasta Side Effects

Generic Name: pegfilgrastim

Please note - some side effects for Neulasta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Neulasta - for the Consumer

Neulasta

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Neulasta:

Bone or joint pain; constipation; muscle pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Neulasta:

Severe allergic reactions (rash; hives; itching; difficulty breathing; dizziness; fast heartbeat; increased sweating; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); fast breathing; fever; left-sided shoulder tip pain; left-sided upper stomach pain; a lump, swelling, or bruising at the injection site; severe or persistent bone, chest, joint, or stomach pain; shortness of breath; swelling of the hands, feet, arms, or legs; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Neulasta Side Effects - for the Professional

Neulasta

The following serious 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 Allergic Reactions [See Warnings and Precautions (5.3)]
• Use in Patients with Sickle Cell Disorders [See Warnings and Precautions (5.4)]
• Potential for Tumor Growth Stimulatory Effects on Malignant Cells [See Warnings and Precautions (5.5)]

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 Preferred Term	Placebo (N= 461)	Neulasta 6 mg SC on Day 2 (N= 467)
Musculoskeletal and connective tissue disorders
Bone pain	26%	31%
Pain in extremity	4%	9%

Leukocytosis

In clinical studies, leukocytosis (WBC counts > 100 x 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.

Immunogenicity

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.

Postmarketing Experience

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 (5.4)]

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

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Side Effects by Body System - for Healthcare Professionals

Musculoskeletal

Musculoskeletal side effects associated with the administration of pegfilgrastim have included medullary bone pain, occurring in 26% of clinical trials patients.

Metabolic

Metabolic side effects associated with the administration of pegfilgrastim have included reversible elevations in LDH (19%), alkaline phosphatase (9%), and uric acid (8%). Treatment intervention was not necessary.

Hematologic

Hematologic side effects including splenic rupture have been reported rarely following the administration of filgrastim (the parent compound of pegfilgrastim) when used for peripheral blood progenitor cell mobilization in both healthy donors and patients with cancer. The administration of pegfilgrastim has been associated with asymptomatic leukocytosis (less than 1 %).

Pegfilgrastim should not be used for peripheral blood progenitor cell mobilization. Patients receiving pegfilgrastim who report left upper abdominal or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.

General

General side effects associated with the administration of pegfilgrastim have included many effects that have been associated with the chemotherapy that was given concomitantly. These have included nausea, fatigue, alopecia, diarrhea, vomiting, constipation, fever, anorexia, skeletal pain, headache, taste perversion, dyspepsia, myalgia, insomnia, abdominal pain, arthralgia, generalized weakness, peripheral edema, dizziness, granulocytopenia, stomatitis, mucositis, and neutropenic fever. Most of these effects have been attributed by the investigators to be the result of the underlying condition or the chemotherapy administered.

Respiratory

Respiratory side effects including adult respiratory distress syndrome (ARDS) has been reported with the use of filgrastim (the parent compound of pegfilgrastim).

Because adult respiratory distress syndrome (ARDS) has been reported with the use of filgrastim, patients receiving pegfilgrastim who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS.

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