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:

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.

WARNING

NEUTROPENIA

Do not administer Abraxane therapy to patients who have baseline neutrophil counts of less than 1,500 cells/mm³. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving Abraxane.

Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

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 LevelsBilirubin Levels Abraxane Dosea
MBCNSCLC cAdenocarcinoma of Pancreasc
Moderate<10xULNAND> 1.5 to ≤ 3 x ULN200 mg/m² b80 mg/m² bnot recommended
Severe<10x ULNAND> 3 to ≤ 5 x ULN200 mg/m² b80 mg/m² bnot recommended
>10x ULNOR> 5 x ULNnot recommendednot recommendednot 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 ReactionOccurrenceWeekly Abraxane Dose (mg/m²)Every 3-Week Carboplatin Dose (AUC mg•min/mL)
Neutropenic Fever (ANC less than 500/mm³ with fever >38°C) ORFirst754.5
Delay of next cycle by more than 7 days for ANC less than 1500/mm³ ORSecond503
ANC less than 500/mm³ for more than 7 daysThirdDiscontinue Treatment
Platelet count less than 50,000/mm³First754.5
SecondDiscontinue Treatment
Severe sensory Neuropathy - Grade 3 or 4First754.5
Second503
ThirdDiscontinue 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 dose1251000
1st dose reduction100800
2nd dose reduction75600
If additional dose reduction requiredDiscontinueDiscontinue

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 DayANC (cells/mm³)Platelet count (cells/mm³) Abraxane / Gemcitabine
Day 1< 1500OR< 100,000Delay doses until recovery
Day 8500 to < 1000OR50,000 to < 75,000Reduce 1 dose level
< 500OR< 50,000Withhold doses
Day 15: If Day 8 doses were reduced or given without modification:
500 to < 1000OR50,000 to < 75,000Reduce 1 dose level from Day 8
< 500OR< 50,000Withhold doses
Day 15: If Day 8 doses were withheld:
≥ 1000OR≥ 75,000Reduce 1 dose level from Day 1
500 to < 1000OR50,000 to < 75,000Reduce 2 dose levels from Day 1
< 500OR< 50,000Withhold 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 AbraxaneGemcitabine
Febrile Neutropenia: Grade 3 or 4Withhold until fever resolves and ANC ≥ 1500; resume at next lower dose level
Peripheral Neuropathy: Grade 3 or 4Withhold until improves to ≤ Grade 1; resume at next lower dose levelNo dose reduction
Cutaneous Toxicity: Grade 2 or 3Reduce to next lower dose level; discontinue treatment if toxicity persists
Gastrointestinal Toxicity: Grade 3 mucositis or diarrheaWithhold until improves to ≤ Grade 1; resume at next lower dose level

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow

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.

Summary

Abraxane is a prescription medicine used to treat advanced breast cancer in people who have already received certain other medicines for their cancer, advanced non-small cell lung cancer (NSCLC), in combination with carboplatin in people who cannot be treated with surgery or radiation, and advanced pancreatic cancer, when used in combination with gemcitabine as the first medicine for advanced pancreatic cancer. Serious side effects of Abraxane include severe decreased blood cell counts, severe nerve problems (neuropathy), severe infection (sepsis), lung or breathing problems, and severe allergic reactions.

Treatment & Diagnosis

Medications & Supplements

QUESTION

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

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Medically Reviewed on 10/28/2020
References
All sections courtesy of the U.S. Food and Drug Administration