Brand Names:

• Abraxane

Dosage Forms:

• Powder for Suspension

Warnings:

Paclitaxel protein-bound particles therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1500 cells/mm(3). It is recommended that frequent peripheral blood cell counts be performed on all patients in order to monitor for the occurrence of bone marrow suppression. 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 .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

Paclitaxel protein-bound belongs to the group of medicines called antineoplastics. It is used to treat cancer of the breast after other treatments have failed.

Paclitaxel interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by paclitaxel protein-bound, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with paclitaxel protein-bound, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, paclitaxel protein-bound is used in certain patients with the following medical condition:

• Metastatic breast cancer, used alone for the treatment of breast cancer that has spread.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of paclitaxel protein-bound in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paclitaxel protein-bound in the elderly.

Pregnancy—

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ethinyl Estradiol
• Testosterone
• Tretinoin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—May decrease your body's ability to fight infection.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Neutropenia (low white blood cells)—Should not be used in patients with this condition.

• Sensory neuropathy, grade 3—Condition may cause a change to the treatment schedule or dose.

Proper Use of This Medicine:

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Men who receive paclitaxel protein-bound should not father a child.

Paclitaxel can temporarily lower the number of white blood cells in your blood, which will increase the chance of getting an infection. It can also lower the number of platelets in your blood, which are necessary for proper blood clotting. If this occurs, these are the precautions you can take to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection, or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in your urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor, fingernail clippers, or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Stop using this medicine and check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called sensory neuropathy.

Check with your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.

This medicine may cause some people to become drowsy, tired, weak, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

blurred or double vision

chest pain

chills

cough

fever

loss of taste

lower back or side pain

painful or difficult urination

pale skin

shortness of breath

sneezing

sore mouth or tongue

sore throat

tightness in the chest

troubled breathing with exertion

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

white patches in the mouth or on the tongue

Less common

Abnormal electrocardiogram (ECG)

anxiety

bleeding

bleeding gums

blood in the urine or stools

burning, tingling, numbness or pain in the hands, arms, feet, or legs

confusion

difficulty with breathing

difficulty with swallowing

dizziness or lightheadedness

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

fainting

fast, pounding, or irregular heartbeat or pulse

low blood pressure or slow pulse

pain in the chest, groin, or legs, especially the calves

palpitations

pinpoint red spots on the skin

sensation of pins and needles

severe, sudden headache

skin itching, rash, or redness

slow or irregular heartbeat

slurred speech

stabbing pain

sudden loss of coordination

sudden, severe weakness or numbness in the arms or legs

sudden, unexplained shortness of breath

sweating

swelling of the face, throat, or tongue

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

unconsciousness

vision changes

Rare

Difficulty with speaking

headache

inability to move the arms, legs, or facial muscles

inability to speak

numbness or tingling in the face, arms, or legs

severe pain in the chest

slow speech

sudden onset of severe breathing problems

trouble speaking, thinking, or walking

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Cracked lips

diarrhea

difficulty with moving

lack or loss of strength

loss of hair

muscle pain or stiffness

nausea

pain in the joints

swelling

vomiting

Less common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the site of injection

Rare

Nail changes

Observed during clinical trials

Disturbed color perception with your eyes

halos around lights

loss of vision

night blindness

overbright appearance of lights

tunnel vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.