IMPORTANT SAFETY INFORMATION
The use of ABRAXANE has not been studied in patients
with renal dysfunction.
Dose adjustment is recommended for patients with
moderate to severe hepatic impairment. Further dose
adjustments in subsequent courses should be based on
individual tolerance.
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.
Men should be advised to not father a child while
receiving ABRAXANE.
It is recommended that nursing be discontinued when
receiving ABRAXANE therapy.
ABRAXANE contains albumin, a derivative of human blood.
Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.
ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline
neutrophil counts of less than 1,500 cells/mm3. It is
recommended that frequent peripheral blood cell counts
be performed on all patients receiving ABRAXANE.
Patients should not be retreated with ABRAXANE until
neutrophils recover to a level >1,500 cells/mm3 and
platelets recover to >100,000 cells/mm3
In the case of severe neutropenia (<500 cells/mm3 for 7
days or more), a dose reduction for subsequent courses is
recommended.
Sensory neuropathy occurs frequently with ABRAXANE.
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.
Severe cardiovascular events possibly related to singleagent
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. During
postmarketing surveillance rare reports of congestive
heart failure and left ventricular dysfunction were
observed, primarily among individuals with underlying
cardiac history or prior exposure to cardiotoxic drugs.
In the randomized metastatic breast cancer study, the
most important adverse events included alopecia (90%),
neutropenia (all cases 80%; severe 9%), sensory
neuropathy (any symptoms 71%; severe 10%), asthenia
(any 47%; severe 8%), myalgia/arthralgia (any 44%;
severe 8%), anemia (all 33%; severe 1%), infections
(24%), nausea (any 30%; severe 3%), vomiting (any 18%;
severe 4%), diarrhea (any 27%; severe <1%) and
mucositis (any 7%; severe <1%).
Other adverse reactions have included ocular/visual
disturbances (any 13%; severe 1%), fluid retention (any
10%; severe 0%), hepatic dysfunction (elevations in
bilirubin 7%, alkaline phosphatase 36%, AST [SGOT]
39%), 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%). In clinical
trials and during postmarketing surveillance, dehydration
was common and pyrexia was very common. Rare
occurrences of severe hypersensitivity reactions have
also been reported during postmarketing surveillance
Adverse events such as fatigue, lethargy and malaisemay
affect the ability to drive and use machines.
