Pronunciation:

pak-li-TAX-el PROE-teen - bownd

Brand Names:

• Abraxane

Dosage Forms:

• Powder for Suspension

Warnings:

Severe MyelosuppressionDo not administer paclitaxel protein-bound particles therapy to patients with baseline neutrophil counts less than 1500 cells/mm(3).Monitor for neutropenia, which may be severe and result in infection or sepsis.Perform frequent complete blood cell counts on all patients receiving paclitaxel protein-bound particles .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

Paclitaxel protein-bound injection is used to treat metastatic breast cancer (cancer that has already spread) after other treatments have failed. It is used together with carboplatin, a cancer medicine, to treat advanced or metastatic non-small cell lung cancer in patients who cannot receive radiation therapy or have surgery. Paclitaxel protein-bound is used together with gemcitabine, a cancer medicine, to treat metastatic pancreas cancer.

Paclitaxel belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by paclitaxel, other unwanted effects will also occur.

This medicine is to be given only by or under the direct supervision of a doctor.

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 injection 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 injection in the elderly. However, elderly patients are more likely to have unwanted effects which may require caution in patients receiving this medicine.

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.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster 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.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ethinyl Estradiol
• Idarubicin
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Testosterone
• Tretinoin
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

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 body's ability to fight infection.

• Liver disease, moderate to severe—Should not be used to treat pancreas cancer in patients with this condition.

• Neutropenia (low white blood cells) or
• Sensory neuropathy (tingling, numbness of arms, hands, legs, or feet)—Use with caution. May make these conditions worse.

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.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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 are receiving this medicine should not father a child. This medicine can harm the unborn baby of your partner.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

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. Although the risk is low, some people have received viruses from human blood products. Human donors and donated blood are both tested for viruses before the medicine is prepared. Talk with your doctor if this concerns you.

Check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called sensory neuropathy.

Lung or breathing problems may occur if you are receiving this medicine together with gemcitabine. Tell your doctor right away if you have shortness of breath, trouble breathing, or a persistent dry cough.

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

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred or double vision

chest pain

chills

cough

fever

loss of taste

lower back or side pain

painful or difficult urination

pale skin

rapid weight gain

sneezing

sore mouth, tongue, or throat

tightness in the chest

tingling of the hands or feet

troubled breathing with exertion

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual weight gain or loss

unusual tiredness or weakness

Less common

Anxiety

bleeding

blood in the urine or stools

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

confusion

difficulty with swallowing

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

fast, pounding, slow, or irregular heartbeat or pulse

general feeling of discomfort or illness

inability to move the arms, legs, or facial muscles

inability to speak

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

pinpoint red spots on the skin

rapid, shallow breathing

sensation of pins and needles

severe, sudden headache

skin itching, rash, or redness

slurred or slow 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

thickening of bronchial secretions

trouble 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

decreased appetite

diarrhea

difficulty with moving

headache

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, a 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

Rare

Nail changes

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.