Prescribing information

ARIMIDEX Tablets — Full Prescribing Information

FASLODEX^® (fulvestrant) Injection — Full Prescribing Information

ABRAXANE^® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) — Full Prescribing Information including Boxed Warning

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Important Information About ARIMIDEX

ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is also approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.

Important Safety Information About ARIMIDEX

Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should not be taken if you are pregnant because it may harm your unborn child.

In the early breast cancer clinical trial, the most common side effects seen with ARIMIDEX include hot flashes, joint symptoms, weakness, mood changes, pain, sore throat, nausea and vomiting, depression, high blood pressure, osteoporosis, swelling of arms/legs, and headache. Fractures (including fractures of the spine, hip, and wrist) occurred more frequently with ARIMIDEX than with tamoxifen (10% vs 7%).

In advanced breast cancer trials, the most common side effects seen with ARIMIDEX versus tamoxifen include hot flashes, nausea, decreased energy and weakness, pain, back pain, bone pain, and increased cough. Joint pain/stiffness has been reported in association with the use of ARIMIDEX.

ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies.

Please click here for full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Important Information About FASLODEX

FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women whose disease has returned or progressed following antiestrogen therapy.

Important Safety Information About FASLODEX

Only postmenopausal women should take FASLODEX. Do not take FASLODEX if you are pregnant and do not become pregnant while taking FASLODEX, because it may harm your unborn child. (See WARNINGS and CONTRAINDICATIONS sections of full Prescribing Information.)

Because FASLODEX is administered intramuscularly, it should not be used in patients with certain blood disorders or in patients receiving anticoagulants (sometimes called blood thinners, for example, warfarin).

In clinical studies, the most commonly reported side effects were nausea, vomiting, constipation, diarrhea, abdominal pain, headache, back pain, hot flashes, sore throat, and injection site reactions with mild, transient pain and inflammation.

Please see full Prescribing Information. For more information, see your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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

ABRAXANE 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.

You should receive ABRAXANE under the care of a doctor who is trained to use cancer drugs. Because you may have side effects from your treatment, you should get this medicine in a clinic or hospital with doctors, nurses, and pharmacists who are trained to give cancer drugs.

ABRAXANE therapy should not be given to patients with metastatic breast cancer who have low white blood cell counts, which may make you more likely to get an infection. Your doctor will schedule frequent blood tests for you in order to check for low blood counts.

Note: ABRAXANE is paclitaxel made with the human blood protein albumin. This makes it behave differently in the body than regular paclitaxel. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL DRUGS.

Important Safety Information About ABRAXANE

One of the more important side effects associated with chemotherapy is neutropenia, which is a decrease in the number of infection-fighting white blood cells (neutrophils). Normal levels range from approximately 1,500 cells/mm³ to 1,800 cells/mm³ (but vary according to several factors, such as age and race). If levels fall below 500 cells/mm³, your risk of developing an infection increases and treatment may be interrupted. To avoid the risk of serious infection and fever, your doctor will monitor your absolute neutrophil count (ANC) during therapy.

Women should avoid becoming pregnant while being treated with ABRAXANE. Tell your doctor if you are pregnant, if you become pregnant, or you plan to become pregnant while taking ABRAXANE. Discuss with your doctor how ABRAXANE may affect fertility. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in breast milk.

The most important adverse events included lower white and red blood cell counts, infections, tingling and numbness, nausea, vomiting, diarrhea, muscle and joint aches, and mouth sores. Other adverse reactions included weakness, visual disturbances, fluid retention, hair loss, and liver and kidney dysfunction. Low platelet counts, allergic reactions (which in rare cases were severe), cardiovascular reactions, and injection site reactions were uncommon.

Sensory neuropathy (numbness, tingling, or burning in the hands and feet) can occur with ABRAXANE and other paclitaxel medications. Severe sensory neuropathy can improve with proper management, as prescribed by your doctor. You should tell your nurse or doctor if you experience numbness, tingling, or burning in your hands or feet while taking ABRAXANE.

Please talk to your doctor or nurse if you have questions regarding the potential side effects of ABRAXANE therapy. You may want to review the Product Information, including Warnings, Precautions, and Contraindications.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

This site is intended for US consumers/patients. If you are a non-US consumer/patient, click here.

ARIMIDEX and FASLODEX 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.

All other registered trademarks are the property of their respective owners.

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