Understanding Safety Information About ABRAXANE^®

The following side effects were reported in ABRAXANE clinical trials. Provided here is a description of these side effects and some helpful information.

Hair loss (alopecia)

Loss of eyebrows, eyelashes, pubic hair, and scalp hair may occur 14 to 21 days after you begin treatment. Your hair will grow back once the ABRAXANE treatment has ended.

• Be gentle to your hair and scalp
• Use low heat when using a hair dryer
• Cut your hair short
• Protect your scalp from the sun

Infections due to low white blood cell count (neutropenia)

White blood cells are among the body’s defenses against bacterial infections. ABRAXANE usually causes a brief drop in white blood cells, and you may be more susceptible to infection and fever. Between your treatment cycles, you will have blood tests to check your white blood cell counts.

• Call your doctor if you experience a fever over 100.4°F
• Wash your hands often
• Avoid crowds and people with colds
• Immediately clean and protect cuts
• Check with your doctor before getting immunization shots
• Take a bath or shower daily using mild soap
• Use lotion to prevent your skin from cracking

Numbness, tingling, or burning of hands and feet (sensory neuropathy)

These side effects, known as sensory neuropathy, occur often and usually improve without medication within a month of completing treatment (average 22 days for severe side effects). It may be necessary to interrupt treatment with ABRAXANE until these symptoms improve, after which time treatment can be restarted at a lower dose.

• Immediately tell your doctor about these side effects—your doctor may find it necessary to adjust the dose
• Massage your hands and feet to stimulate nerves
• Apply moisturizing cream/lotion to your hands and feet
• Keep your body warm
• Avoid activities in extreme weather
• Avoid wearing tight footwear
• Avoid standing for long periods of time and walk only short distances
• Take extra precaution near fires, hot water, or other sources of heat
• Avoid using an ice pack on any part of your body

Fatigue and weakness (asthenia)

Tiredness and weakness after treatment are known as asthenia. They often disappear without interrupting or modifying treatment.

• Get proper rest
• Take part in activities that relax you
• Eat a well-balanced diet
• Drink plenty of fluids
• Perform light exercise daily

Joint and muscle pain

Soreness of the joints and muscles may occur shortly after treatment begins, but usually disappears within a few days.

• Tell your doctor if you are experiencing any severe joint or muscle pain
• Perform light exercise

Low red blood cell count (anemia)

Anemia occurs when there are not enough red blood cells in your blood. It may make you feel tired, appear pale, and experience shortness of breath. Contact your doctor if you experience any of these symptoms.

• Talk to your doctor about medications that may increase your red blood cell count
• Conserve energy by doing only the things that are most important to you
• Take short naps throughout the day instead of one long nap
• Perform light exercise
• Get up slowly from lying or sitting positions to reduce dizziness
• Eat small meals frequently throughout the day
• Drink plenty of fluids

Mouth or lip sores (mucositis)

Mouth or lip sores may occur a few days after starting treatment. This side effect usually disappears within 1 week.

• Use lip balm or another lip moisturizer
• Use a soft toothbrush and brush your teeth after eating
• Use mouthwash that does not contain alcohol
• Frequently rinse your mouth with warm salt water
• Avoid foods that might irritate your mouth, such as spicy foods, orange juice, and pretzels

Upset stomach and diarrhea

Nausea, vomiting, and/or diarrhea may occur following treatment. If you experience nausea or stomach upset, tell your doctor, because medicines can be given to reduce or eliminate these symptoms. Diarrhea will usually disappear without treatment; however, tell your doctor right away if you experience severe abdominal or stomach area pain and/or severe diarrhea.

• Drink plenty of fluids slowly and frequently
• Avoid drinking coffee, tea, and alcohol
• Avoid sweets as well as fried, greasy, or spicy foods
• Eat low-fiber foods such as eggs, potatoes, white bread, or creamed cereals
• Avoid dairy products such as milk, cheese, or ice cream

Irritation at the injection site

You may experience discomfort, redness, swelling, inflammation, or a deep sore or break in the skin at the site of the injection.

• Inform your doctor if you experience any irritation at the injection site

Low heart rate (bradycardia)

It is possible to experience a drop in your heart rate, but patients do not usually notice this change, which usually does not require treatment. You should tell your doctor if you have a history of heart disease.

Low blood pressure (hypotension)

If you experience dizziness, fainting, or shortness of breath, talk to your doctor.

• Have your doctor check your blood pressure
• Drink plenty of water
• Exercise moderately to increase blood flow
• Avoid heavy lifting
• Elevate the head of your bed to improve blood circulation
• Eat small meals frequently
• Rest after meals to minimize dizziness
• Avoid hot showers and baths
• Rise slowly from sitting or lying positions