What Is Neulasta Used For

Neulasta Side Effects Center

What Is Neulasta?

Neulasta (pegfilgrastim) is a colony-stimulating factor, a human-made form of a protein that stimulates the growth of white blood cells, used to decrease the incidence of infection, by treating neutropenia, a lack of certain white blood cells acquired by receiving cancer chemotherapy.

What Are Side Effects of Neulasta?

Mutual side effects of Neulasta include:

bone pain,
pain in your arms or legs, or
injection site reactions (bruising, swelling, pain, redness, or a hard lump).

Get medical help correct away if you take rare but very serious side furnishings of Neulasta including:

animate problems (e.g., trouble breathing, shortness of breath, fast breathing).

Dosage for Neulasta

The recommended dosage of Neulasta is a single subcutaneous (nether the skin) injection of 6 mg administered in one case per chemotherapy cycle.

What Drugs, Substances, or Supplements Interact with Neulasta?

Neulasta may interact with lithium (Eskalith, Lithobid, and others). There may exist other drugs that can interact with Neulasta.

Neulasta During Pregnancy and Breastfeeding

Tell your dr. about all prescription and over-the-counter medications and supplements you use. Neulasta should be used simply when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Data

Our Neulasta (pegfilgrastim) Side Effects Drug Center provides a comprehensive view of bachelor drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice well-nigh side effects. You lot may report side furnishings to FDA at i-800-FDA-1088.

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Neulasta Consumer Information

Get emergency medical help if you take signs of an allergic reaction: hives, skin rash, sweating, warmth or tingly feeling; dizziness, fast heartbeats; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Capillary leak syndrome is a rare only serious side effect of pegfilgrastim. Call your md correct abroad if yous take signs of this condition, which may include: decreased urination, tiredness, dizziness or dizzy feeling, trouble breathing, and sudden swelling, puffiness, or feeling of fullness.

Call your doc at once if you take:

sudden or severe pain in your left upper stomach spreading up to your shoulder;
sudden and severe pain in your chest, stomach, or back;
severe or ongoing pain anywhere in your torso;
fever, tiredness;
shortness of breath, rapid breathing;
pale skin, easy bruising, unusual bleeding;
bruising, swelling, or a hard lump where the medicine was injected; or
kidney problems--little or no urination, pinkish or nighttime urine, swelling in your confront or lower legs.

Your cancer treatments may exist delayed or permanently discontinued if y'all have certain side effects.

Mutual side effects may include:

os pain; or
pain in your arms or legs.

This is non a complete list of side furnishings and others may occur. Call your doctor for medical advice most side furnishings. You may written report side effects to FDA at i-800-FDA-1088.

Read the unabridged detailed patient monograph for Neulasta (Pegfilgrastim)

Neulasta Professional Information

SIDE EFFECTS

The following clinically pregnant agin reactions are discussed in greater item in other sections of the labeling:

Splenic Rupture [see WARNINGS AND PRECAUTIONS]
Astute Respiratory Distress Syndrome [see WARNINGS AND PRECAUTIONS]
Serious Allergic Reactions [see WARNINGS AND PRECAUTIONS]
Allergies to Acrylics [see WARNINGS AND PRECAUTIONS]
Use in Patients with Sickle Prison cell Disorders [see WARNINGS AND PRECAUTIONS]
Glomerulonephritis [run across WARNINGS AND PRECAUTIONS]
Leukocytosis [see WARNINGS AND PRECAUTIONS]
Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
Capillary Leak Syndrome [see WARNINGS AND PRECAUTIONS]
Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see WARNINGS AND PRECAUTIONS]
Myelodysplastic syndrome [see WARNINGS AND PRECAUTIONS]
Acute myeloid leukemia [see WARNINGS AND PRECAUTIONS]
Aortitis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying atmospheric condition, agin reaction rates observed in the clinical trials of a drug cannot be straight compared with rates in the clinical trials of another drug and may non reflect the rates observed in clinical practise.

Neulasta clinical trials safe 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 person. The ethnicity was 75% Caucasian, xviii% Hispanic, v% Blackness, and i% Asian. Patients with breast (northward = 823), lung and thoracic tumors (northward = 53) and lymphoma (due north = 56) received Neulasta subsequently nonmyeloablative cytotoxic chemotherapy. Most patients received a unmarried 100 mcg/kg (due north = 259) or a unmarried 6 mg (n = 546) dose per chemotherapy bike over 4 cycles.

The following adverse reaction data in Tabular array 2 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 (Report 3). A total of 928 patients were randomized to receive either half-dozen 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.

The nearly common adverse reactions occurring in ≥ 5% of patients and with a betwixt-group difference of ≥ v% higher in the pegfilgrastim arm in placebo-controlled clinical trials are os hurting and pain in extremity.

Table 2: Adverse Reactions with ≥ five% College Incidence in Neulasta Patients Compared to Placebo in Study 3

Trunk System Adverse Reaction	Placebo (N = 461)	Neulasta half dozen mg SC on Day two (N = 467)
Musculoskeletal and connective tissue disorders
Bone pain	26%	31%
Hurting in extremity	4%	nine%

Leukocytosis

In clinical studies, leukocytosis (WBC counts > 100 10 ten⁹/L) was observed in less than i% of 932 patients with not-myeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies.

Immunogenicity

Every bit with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an analysis may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying illness. For these reasons, comparison of the incidence of antibodies to pegfilgrastim in the studies described beneath with the incidence of antibodies in other studies or to other products may be misleading.

Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing bounden 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.

Postmarketing Experience

The following agin reactions have been identified during post approval utilise of Neulasta. Considering these reactions are reported voluntarily from a population of uncertain size, it is not ever possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Splenic rupture and splenomegaly (enlarged spleen) [see WARNINGS AND PRECAUTIONS]
Acute respiratory distress syndrome (ARDS) [meet WARNINGS AND PRECAUTIONS]
Allergic reactions/hypersensitivity, including anaphylaxis, pare rash, urticaria, generalized erythema, and flushing [meet WARNINGS AND PRECAUTIONS]
Sickle cell crisis [see WARNINGS AND PRECAUTIONS]
Glomerulonephritis [run into WARNINGS AND PRECAUTIONS]
Leukocytosis [see WARNINGS AND PRECAUTIONS]
Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
Capillary Leak Syndrome [encounter WARNINGS AND PRECAUTIONS]
Injection site reactions
Sweet'southward syndrome (astute febrile neutrophilic dermatosis), cutaneous vasculitis
Awarding site reactions (including events such every bit application site hemorrhage, application site pain, awarding site discomfort, application site trample, and application site erythema) have been reported with the use of the on-body injector for Neulasta.
Contact dermatitis and local pare reactions such equally rash, pruritus, and urticaria have been reported with the use of the on-body injector for Neulasta, possibly indicating a hypersensitivity reaction to the adhesive.
Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy [meet WARNINGS AND PRECAUTIONS]
Aortitis [run into WARNINGS AND PRECAUTIONS]
hemorrhage

Read the entire FDA prescribing information for Neulasta (Pegfilgrastim)

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