Breast Cancer Treatment | Abraxis Oncology - Abraxane® for Injectable Suspension

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Deliver More With ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)

» Nearly double the overall response rate vs solvent-based paclitaxel
» Comparable safety with no solvent-related side effects
» Convenient administration vs solvent-based paclitaxel

ABRAXANE for Injectable Suspension is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

For the full prescribing information for ABRAXANE, including black box warning and important safety information, visit the Product Web site at www.ABRAXANE.com.

In a clinical study, ABRAXANE delivered nearly double the overall response rate (complete + partial responses) vs
solvent-based paclitaxel¹

*Reconciled TLRR in the randomized, open-label, phase III trial was the rigorous protocol-specific primary end point based on independent radiologic assessment of tumor responses reconciled with investigator responses (which also included clinical information) for the first 6 cycles of therapy. (Tumor response was assessed using Response Evaluation Criteria in Solid Tumor [RECIST].)
It is well established that reconciled TLRR are lower than investigator-reported response rates typically reported in the scientific literature.

ABRAXANE lets you deliver a 49% higher dose of tumor-fighting paclitaxel vs solvent-based paclitaxel¹

78% increase in the median total paclitaxel dose delivered with ABRAXANE in randomized, phase III clinical trial¹⁰
- 1560 mg/m² median cumulative ABRAXANE dose vs 875 mg/m² median cumulative solvent-based paclitaxel dose¹⁰

Deliver a 49% higher dose of paclitaxel than solvent-based paclitaxel without compromising safety¹

Frequency^a of Selected Treatment-emergent Side Effects¹


	ABRAXANE (n=229) 260 mg/m² 30-minute infusion time %	Solvent-based paclitaxel (n=225) 175 mg/m² 3-hour infusion time^b %



Bone marrow
Neutropenia
<2.0 x 10⁹/L	80	82
<0.5 x 10⁹/L	9	22



Hypersensitivity reactions^c*
All	4	12
Severe^d	0	2



Sensory neuropathy
Any symptoms	71	56
Severe symptoms^d	10	2



Myalgia/arthralgia
Any symptoms	44	49
Severe symptoms^d	8	4



Gastrointestinal
Nausea
Any symptoms	30	22
Severe symptoms^d	3	<1
Vomiting
Any symptoms	18	10
Severe symptoms^d	4	1
Diarrhea
Any symptoms	27	15
Severe symptoms^d	<1	1

^aBased on worst grade, ^bpaclitaxel injection; patients received premedication, ^cincludes treatment-related events related to hypersensitivity (eg, flushing, dyspnea, chest pain, hypotension) that began on a day of dosing, ^dsevere events are defined as at least grade 3 toxicity.
*>99% of patients treated with solvent-based paclitaxel received premedication vs 8%
of patients treated with ABRAXANE.¹⁷

Comparable safety vs solvent-based paclitaxel with no need to premedicate for solvent-based toxicities¹

No solvent-related hypersensitivity reactions¹
No increase in toxicity seen in elderly (≥65) vs younger patients treated with ABRAXANE¹

Give her a way to manage her therapy

58% (14/24) of ABRAXANE-treated patients who developed grade 3 neuropathy showed documented improvement after a median of 22 days, often allowing resumption of therapy at a reduced dose¹

Solvent-free ABRAXANE means added convenience for you and your patients

Eliminates need for premedication (eg, steroids, antihistamines) for solvent-based hypersensitivity reactions¹
No need for special intravenous (IV) tubing¹
Shortened, 30-minute infusion time vs up to 3 hrs with solvent-based paclitaxel¹

Abraxis Oncology is a division of Abraxis BioScience, LLC
All Abraxis BioScience, LLC corporate names (eg, ABRAXIS, ABRAXIS ONCOLOGY, ABRAXIS BIOSCIENCE, and their logos), names of services, and names of products (eg, ABRAXANE^® and the ABRAXANE logo) referred to herein are trade names, service marks and/or trademarks that are owned by or licensed to Abraxis BioScience, its divisions, or its affiliates, unless otherwise noted.

Important Safety Information & Boxed Warning

WARNING: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

ABRAXANE therapy should not be administered to patients with metastatic breast cancer 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.

Important Safety Information

In the randomized metastatic breast cancer study, the most important adverse events included neutropenia (all cases 80%; severe 9%), anemia (all 33%; severe 1%), infections (24%), sensory neuropathy (any symptoms 71%; severe 10%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 27%; severe <1%), myalgia/arthralgia (any 44%; severe 8%), and mucositis (any 7%; severe <1%). Other adverse reactions included asthenia (any 47%; severe 8%), ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), alopecia (90%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), and renal dysfunction (any 11%; severe 1%). Thrombocytopenia (any 2%; severe <1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (<1%) were uncommon. During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with ABRAXANE.

Warnings, Precautions, and Contraindications

The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.

ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.

Men should be advised to not father a child while receiving treatment with ABRAXANE.

ABRAXANE contains albumin (human), a derivative of human blood.

Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.

It is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm³ and platelets recover to a level >100,000 cells/mm³.

In the case of severe neutropenia (<500 cells/mm³ for 7 days or more) during a course of ABRAXANE therapy, a dose reduction for subsequent courses is recommended. Sensory neuropathy occurs frequently with ABRAXANE. The occurrence of grade 1 or 2 sensory neuropathy does not generally require dose modification. If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE.

It is recommended that nursing be discontinued when receiving ABRAXANE therapy.

Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary embolism, and hypertension.