Brand Names:

• Abraxane

Dosage Forms:

• Powder for Suspension

Warnings:

Paclitaxel protein-bound particles for injectable suspension should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Paclitaxel protein-bound particles therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm(3). In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving paclitaxel protein-bound particles.

Note: 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 .

Paclitaxel protein-bound particles therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 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—

No information is available 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 geriatrics-specific problems that would limit the usefulness of paclitaxel protein-bound in the elderly .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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—

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

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 .

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

Proper Use of This Medicine:

Paclitaxel protein-bound will be administered only by or under the direct supervision of your doctor .

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects .

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 .

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.

Because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that would not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

Check with your doctor 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 chest

troubled breathing with exertion

ulcers, sores, or white spots in mouth

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

white patches in mouth and/or on tongue

Less common

Abnormal electrocardiogram (ECG)

anxiety

bleeding

bleeding gums

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

painful or difficult urination

palpitations

pinpoint red spots on 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 arms or legs

sudden, unexplained shortness of breath

sweating

swelling of 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 arms, legs, or facial muscles

inability to speak

numbness or tingling in face, arms, or legs

severe pain in 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 joints

swelling

vomiting

Less common

Bleeding, blistering, burning, coldness, discoloration of 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.