Abraxane (paclitaxel) for Breast Cancer: Side Effects & Warnings


What is Abraxane, and how does it work?

Abraxane is a prescription medicine used to treat:

It is not known if
Abraxane is safe or effective in children.

What are the side effects of Abraxane?

Abraxane may cause serious side effects, including:

  • severe decreased blood cell counts.
    Abraxane can cause a severe decrease in neutrophils, a type of white blood cell which helps fight infections, and blood cells called platelets which help to clot blood. Your healthcare provider will check your blood cell count during your treatment with
    Abraxane.
  • severe nerve problems (neuropathy). Tell your healthcare provider if you have numbness, tingling, pain, or weakness in your hands or feet.
  • severe infection (sepsis). If you receive
    Abraxane in combination with gemcitabine, infections can be severe and lead to death. Tell your healthcare provider right away if you have a fever (temperature greater than 100.4° F) or develop signs of infection.
  • lung or breathing problems. If you receive
    Abraxane in combination with gemcitabine, lung or breathing problems may be severe and can lead to death. Tell your healthcare provider right away if you suddenly get a dry cough that will not go away or shortness of breath.
  • severe allergic reactions. Severe allergic reactions are medical emergencies that can happen in people who receive
    Abraxane and can lead to death. You may have an increased risk of having an allergic reaction to
    Abraxane if you are allergic to other taxane medicines. Your healthcare provider will monitor you closely for allergic reactions during your infusion of
    Abraxane. Tell your healthcare provider right away if you get any of these signs of a serious allergic reaction: trouble breathing, sudden swelling of your face, lips, tongue, throat, or trouble swallowing, hives (raised bumps), rash, or redness all over your body.

The most common side effects of
Abraxane in people with breast cancer include:

The most common side effects of
Abraxane in people with non-small cell lung cancer include:

  • low red blood cell count (anemia)
  • decreased platelet cell count
  • numbness, tingling, pain, or weakness in the hands or feet
  • tiredness
  • decreased white blood cell count
  • hair loss
  • nausea

The most common side effects of
Abraxane in people with pancreatic cancer include:

  • decreased white blood cell count
  • numbness, tingling, pain, or weakness in the hands or feet
  • hair loss
  • diarrhea
  • vomiting
  • rash
  • tiredness
  • nausea
  • swelling in the hands or feet
  • fever
  • decreased appetite
  • signs of dehydration including thirst, dry mouth, dark yellow urine, decreased urine, headache, or muscle cramps Tell your healthcare provider if you have vomiting, diarrhea, or signs of dehydration that does not go away.
    Abraxane may cause fertility problems in males and females, which may affect your ability to have a child.

Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of
Abraxane. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Abraxane?

Important Administration Instructions

  • DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS. Abraxane has different dosage and administration instructions from other paclitaxel products.
  • Closely monitor the infusion site for extravasation or drug infiltration during
    administration. Limiting the infusion of Abraxane to 30 minutes may reduce the
    risk of infusion-related reactions.
  • Consider premedication in patients who
    have had prior hypersensitivity reactions to Abraxane. Do not re-challenge
    patients who experience a severe hypersensitivity reaction to Abraxane.

Recommended Dosage For Metastatic Breast Cancer

  • After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for
    Abraxane is 260 mg/m² administered intravenously over 30 minutes every 3 weeks.

Recommended Dosage For Non-Small Cell Lung Cancer

  • The recommended dose of Abraxane is 100 mg/m² administered as an intravenous
    infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle.
  • Administer
    carboplatin on Day 1 of each 21-day cycle immediately after Abraxane.

Recommended Dosage For Adenocarcinoma Of The Pancreas

  • The recommended dose of Abraxane is 125 mg/m² administered as an intravenous
    infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.
  • Administer gemcitabine immediately after Abraxane on Days 1, 8, and 15 of each
    28-day cycle.

Dosage Modifications For Hepatic Impairment

  • For patients with moderate or severe hepatic impairment, reduce the starting dose of
    Abraxane as shown in Table 1.

Table 1: Recommendations for Starting Dose in Patients with Moderate and Severe Hepatic Impairment

AST Levels Bilirubin Levels Abraxane Dosea
MBC NSCLC c Adenocarcinoma of Pancreasc
Moderate <10xULN AND > 1.5 to ≤ 3 x ULN 200 mg/m² b 80 mg/m² b not recommended
Severe <10x ULN AND > 3 to ≤ 5 x ULN 200 mg/m² b 80 mg/m² b not recommended
>10x ULN OR > 5 x ULN not recommended not recommended not recommended
AST = Aspartate Aminotransferase; MBC = Metastatic Breast Cancer; NSCLC = Non-Small Cell Lung Cancer; ULN = Upper limit of normal.
a Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance.
b A dose increase to 260 mg/m² for patients with metastatic breast cancer or 100 mg/m² for patients with non-small cell lung cancer in subsequent courses should be considered if the patient tolerates the reduced dose for two cycles.
c Patients with bilirubin levels above the upper limit of normal were excluded from clinical trials for pancreatic or lung cancer.

Dosage Modifications For Adverse Reactions

Metastatic Breast Cancer
  • Patients who experience severe neutropenia (neutrophils less than 500 cells/mm³
    for a week or longer) or severe sensory neuropathy during Abraxane therapy
    should have dosage reduced to 220 mg/m² for subsequent courses of Abraxane.
  • For
    recurrence of severe neutropenia or severe sensory neuropathy, additional dose
    reduction should be made to 180 mg/m².
  • For Grade 3 sensory neuropathy hold
    treatment until resolution to Grade 1 or 2, followed by a dose reduction for all
    subsequent courses of Abraxane.
Non-Small Cell Lung Cancer
  • Do not administer Abraxane on Day 1 of a cycle until absolute neutrophil count
    (ANC) is at least 1500 cells/mm³ and platelet count is at least 100,000
    cells/mm³.
  • In patients who develop severe neutropenia or thrombocytopenia withhold treatment until counts recover to an absolute neutrophil count of at least 1500 cells/mm³ and platelet count of at least 100,000 cells/mm³ on Day 1 or to an absolute neutrophil count of at least 500 cells/mm³ and platelet count of at least 50,000 cells/mm³ on Days 8 or 15 of the cycle. Upon resumption of dosing, permanently reduce
    Abraxane and carboplatin doses as outlined in Table 2.
  • Withhold
    Abraxane for Grade 3-4 peripheral neuropathy. Resume Abraxane and
    carboplatin at reduced doses (see Table 2) when peripheral neuropathy improves
    to Grade 1 or completely resolves.

Table 2: Permanent Dose Reductions for Hematologic and Neurologic Adverse Reactions in NSCLC

Adverse Reaction Occurrence Weekly
Abraxane Dose (mg/m²)
Every 3-Week Carboplatin Dose (AUC mg•min/mL)
Neutropenic Fever (ANC less than 500/mm³ with fever >38°C) OR First 75 4.5
Delay of next cycle by more than 7 days for ANC less than 1500/mm³ OR Second 50 3
ANC less than 500/mm³ for more than 7 days Third Discontinue Treatment
Platelet count less than 50,000/mm³ First 75 4.5
Second Discontinue Treatment
Severe sensory Neuropathy – Grade 3 or 4 First 75 4.5
Second 50 3
Third Discontinue Treatment

Adenocarcinoma Of The Pancreas

Dose level reductions for patients with adenocarcinoma of the pancreas, as referenced in Tables 4 and 5, are provided in Table 3.

Table 3: Dose Level Reductions for Patients with Adenocarcinoma of the Pancreas

Dose Level Abraxane (mg/m²) Gemcitabine (mg/m²)
Full dose 125 1000
1st dose reduction 100 800
2nd dose reduction 75 600
If additional dose reduction required Discontinue Discontinue

Recommended dose modifications for neutropenia and thrombocytopenia for patients with adenocarcinoma of the pancreas are provided in Table 4.

Table 4: Dose Recommendation and Modifications for Neutropenia and/or Thrombocytopenia at the Start of a Cycle orwithin a Cycle for Patients with Adenocarcinoma of the Pancreas

Cycle Day ANC (cells/mm³) Platelet count (cells/mm³) Abraxane / Gemcitabine
Day 1 < 1500 OR < 100,000 Delay doses until recovery
Day 8 500 to < 1000 OR 50,000 to < 75,000 Reduce 1 dose level
< 500 OR < 50,000 Withhold doses
Day 15: If Day 8 doses were reduced or given without modification:
500 to < 1000 OR 50,000 to < 75,000 Reduce 1 dose level from Day 8
< 500 OR < 50,000 Withhold doses
Day 15: If Day 8 doses were withheld:
≥ 1000 OR ≥ 75,000 Reduce 1 dose level from Day 1
500 to < 1000 OR 50,000 to < 75,000 Reduce 2 dose levels from Day 1
< 500 OR < 50,000 Withhold doses
ANC = Absolute Neutrophil Count

Recommended dose modifications for other adverse reactions in patients with adenocarcinoma of the pancreas are provided in Table 5.

Table 5: Dose Modifications for Other Adverse Reactions in Patients with Adenocarcinoma of the Pancreas

Adverse Reaction Abraxane Gemcitabine
Febrile Neutropenia: Grade 3 or 4 Withhold until fever resolves and ANC ≥ 1500; resume at next lower dose level
Peripheral Neuropathy: Grade 3 or 4 Withhold until improves to ≤ Grade 1; resume at next lower dose level No dose reduction
Cutaneous Toxicity: Grade 2 or 3 Reduce to next lower dose level; discontinue treatment if toxicity persists
Gastrointestinal Toxicity: Grade 3 mucositis or diarrhea Withhold until improves to ≤ Grade 1; resume at next lower dose level




QUESTION


A lump in the breast is almost always cancer.
See Answer

What drugs interact with Abraxane?

  • The metabolism of paclitaxel is catalyzed by CYP2C8 and CYP3A4.
  • Caution should be exercised when administering Abraxane concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4.

Is Abraxane safe to use while pregnant or breastfeeding?

  • Based on its mechanism of action and findings in animals, Abraxane can cause fetal harm when administered to a pregnant woman.
  • There are no available human data on Abraxane use in pregnant women to inform the drug-associated risk.
  • There are no data on the presence of paclitaxel in human milk, or its effect on the breastfed child or on milk production.
  • In animal studies, paclitaxel and/or its metabolites were excreted into the milk of lactating rats.
  • Because of the potential for serious adverse reactions in a breastfed child from
    Abraxane, advise lactating women not to breastfeed during treatment with
    Abraxane and for two weeks after the last dose.

Medically Reviewed on 10/28/2020

References


All sections courtesy of the U.S. Food and Drug Administration



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