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 1500 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 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 .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Mitotic Inhibitor
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 paclitaxel protein-bound will do as well as the risks of using it.
paclitaxel protein-bound 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:
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 paclitaxel protein-bound, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to paclitaxel protein-bound 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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paclitaxel protein-bound in the elderly.
|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.|
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.
Using paclitaxel protein-bound 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.
Using paclitaxel protein-bound 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.
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.
The presence of other medical problems may affect the use of paclitaxel protein-bound. Make sure you tell your doctor if you have any other medical problems, especially:
You will receive paclitaxel protein-bound while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you paclitaxel protein-bound. paclitaxel protein-bound is given through a needle placed in one of your veins.
It is very important that your doctor check your progress at regular visits to make sure paclitaxel protein-bound is working properly. Blood tests may be needed to check for unwanted effects.
Using paclitaxel protein-bound 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:
paclitaxel protein-bound 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 paclitaxel protein-bound 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.
paclitaxel protein-bound may cause some people to become drowsy, tired, weak, or less alert than they are normally. Make sure you know how you react to paclitaxel protein-bound 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.
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
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
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.
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