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Neulasta

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Neulasta

Neulasta

Neulasta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Neulasta (pegfilgrastim) is used to decrease the incidence of infection, by treating neutropenia, a lack of certain white blood cells caused by receiving cancer chemotherapy. It is a colony-stimulating factor. It is a man-made form of a protein that stimulates the growth of white blood cells. Common side effects include bone pain.

The recommended dosage of Neulasta is a single subcutaneous (under the skin) injection of 6 mg administered once per chemotherapy cycle. Neulasta may interact with lithium (Eskalith, Lithobid, and others). There may be other drugs that can interact with Neulasta. Tell your doctor about all prescription and over-the-counter medications and supplements you use. Neulasta should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Neulasta (pegfilgrastim) Side Effects Drug Center provides a comprehensive view of available 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 about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Neulasta in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pegfilgrastim and call your doctor at once if you have a serious side effect such as:

  • sudden or severe pain in your left upper stomach spreading up to your shoulder;
  • severe dizziness, skin rash, or flushing (warmth, redness, or tingly feeling);
  • rapid breathing or feeling short of breath;
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness; or
  • bruising, swelling, pain, redness, or a hard lump where the injection was given.

Less serious side effects may include:

  • bone pain;
  • pain in your arms or legs; or
  • bruising, swelling, pain, redness, or a hard lump where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Neulasta (Pegfilgrastim) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Neulasta Overview - Patient Information: Side Effects

SIDE EFFECTS: Bone pain may occur. Taking a non-aspirin pain reliever such as acetaminophen may help with this pain. Ask your doctor or pharmacist for more details. Injection site reactions such as redness, swelling, itching, lumps, or bruising may also occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if any of these rare but very serious side effects occur: breathing problems (e.g., trouble breathing, shortness of breath, fast breathing).

Rarely, possibly fatal damage to the spleen may occur. Get medical help right away if you experience the following side effects: stomach/abdominal pain and/or shoulder pain.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, fast heartbeat, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Neulasta (Pegfilgrastim)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Neulasta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Splenic Rupture [See WARNINGS AND PRECAUTIONS]
  • Acute Respiratory Distress Syndrome [See WARNINGS AND PRECAUTIONS]
  • Serious Allergic Reactions [See WARNINGS AND PRECAUTIONS]
  • Use in Patients with Sickle Cell Disorders [See WARNINGS AND PRECAUTIONS]
  • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [See WARNINGS AND PRECAUTIONS]

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]

Blood and lymphatic system disorder: Sickle cell crisis [see WARNINGS AND PRECAUTIONS]

Hypersensitivity reactions: Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, and urticaria, generalized erythema and flushing [see WARNINGS AND PRECAUTIONS]

Respiratory, thoracic, and mediastinal disorder: ARDS [see WARNINGS AND PRECAUTIONS]

General disorders and administration site conditions: Injection site reactions

Skin and subcutaneous tissue disorders: Sweet's syndrome, Cutaneous vasculitis

Read the entire FDA prescribing information for Neulasta (Pegfilgrastim) »

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Neulasta - User Reviews

Neulasta User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Neulasta sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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