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Important Information About ARIMIDEX Tablets

ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is indicated for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer.

ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with estrogen receptor-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.

Important Safety Information About ARIMIDEX

ARIMIDEX is only for postmenopausal women. ARIMIDEX can cause fetal harm when administered to a pregnant woman. Before starting treatment with ARIMIDEX, pregnancy must be excluded (see WARNINGS section of full Prescribing Information).

Common side effects seen with ARIMIDEX vs tamoxifen in the early breast cancer trial after 5 years of treatment include hot flashes (36% vs 41%), joint disorders (including arthritis, arthrosis, arthralgia) (36% vs 29%), asthenia (19% vs 18%), mood disturbances (19% vs 18%), pain (17% vs 16%), pharyngitis (14% vs 14%), nausea and vomiting (13% vs 12%), depression (13% vs 12%), hypertension (13% vs 11%), osteoporosis (11% vs 7%), peripheral edema (10% vs 11%), and headache (10% vs 8%). Fractures, including fractures of the spine, hip, and wrist, occurred more frequently with ARIMIDEX vs tamoxifen (10% vs 7%).

Compared to baseline, ARIMIDEX showed a mean decrease in both lumbar spine and total hip bone mineral density. Tamoxifen showed a mean increase in these measurements. Nine percent of patients receiving ARIMIDEX had an elevated serum cholesterol vs 3.5% of patients receiving tamoxifen.

The common side effects seen with ARIMIDEX in advanced breast cancer trials include hot flushes (26.5%), nausea (18.6%), asthenia (16.4%), pain (13.8%), back pain (11.9%), bone pain (10.7%), and increased cough (10.9%). Joint pain/stiffness has been reported in association with the use of ARIMIDEX.

Clinical and pharmacokinetic results suggest that tamoxifen should not be administered with ARIMIDEX. Estrogen-containing therapies should not be used with ARIMIDEX, as they may diminish its pharmacologic action.

Please click here for full Prescribing Information.

Important Information About FASLODEX^® (fulvestrant) Injection

FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Important Safety Information About FASLODEX

FASLODEX is indicated only for postmenopausal women. FASLODEX can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving FASLODEX (See WARNINGS and CONTRAINDICATIONS sections of full Prescribing Information).

Because FASLODEX is administered intramuscularly, it should not be used in patients with bleeding diatheses, thrombocytopenia, or in patients on anticoagulants. In clinical trials, the most commonly reported adverse effects seen with FASLODEX, regardless of the investigator’s assessment of causality, were gastrointestinal symptoms (nausea 26%, vomiting 13%, constipation 12.5%, diarrhea 12.3%, abdominal pain 11.8%), headache (15.4%), back pain (14.4%), hot flushes (17.7%), and pharyngitis (16.1%). Injection site reactions with mild, transient pain and inflammation were reported in 7% of patients (1% of treatments) given a single 5 mL injection and 27% of patients (4.6% of treatments) given 2 x 2.5 mL injections of FASLODEX.

Please click here for full Prescribing Information.

Important Information About ABRAXANE^® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)

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.

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.

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 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.

Please click here for full Prescribing Information.

Important Information About ZOLADEX (goserelin acetate implant) 3.6 mg Depot for Advanced Breast Cancer

ZOLADEX 3.6 mg depot is indicated for use in the palliative treatment of advanced breast cancer in premenopausal and perimenopausal women. The estrogen and progesterone receptor values may help predict whether therapy with ZOLADEX is likely to be of benefit.

Important Safety Information About ZOLADEX 3.6 mg Depot for Advanced Breast Cancer

ZOLADEX should not be prescribed if a patient is pregnant, breastfeeding, has undiagnosed abnormal vaginal bleeding, or is allergic to the components of ZOLADEX. Before starting treatment with ZOLADEX, pregnancy must be excluded. Pregnancy must be avoided by the use of nonhormonal methods of birth control during treatment with ZOLADEX, and for 12 weeks following the discontinuation of ZOLADEX or until the return of menses.

Because of the decreased estrogen levels, treatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment, some of which may not be reversible.

The most commonly reported side effects with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), malaise/fatigue/lethargy (5%), and vomiting (4%). Injection site reactions were reported in less than 1% of patients. Transient worsening of symptoms or the occurrence of additional signs and symptoms may occasionally develop during the first few weeks of treatment with ZOLADEX.

Please click here for full Prescribing Information for ZOLADEX 3.6 mg Depot.

ARIMIDEX, FASLODEX, and ZOLADEX are registered trademarks of the AstraZeneca group of companies. ABRAXANE is marketed under a co-promotion agreement between Abraxis BioScience, LLC. and AstraZeneca.

Abraxis Oncology is a division of Abraxis BioScience, LLC.

This product information is intended for US professionals only.
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