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USP DI Vol. II - PACLITAXEL (Systemic)

PACLITAXEL (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Taxol

In Canada?

  • Taxol

Category

  • Antineoplastic

Description

Paclitaxel (PAK-li-tax-el)belongs to the group of medicines called antineoplastics.It is used to treat cancer of the ovaries, breast, certain types of lung cancer,and a cancer of the skin and mucous membranes more commonly found in patientswith acquired immunodeficiency syndrome (AIDS). It may also be used to treatother kinds of cancer, as determined by your doctor.

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

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

Paclitaxel is to be administered only by or under the immediate supervisionof your doctor. It is available in the following dosage form:

    Parenteral
  • Injection (U.S. and Canada)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to paclitaxel.

Pregnancy?Tell your doctor if you are pregnant or if you intendto become pregnant. Studies in rats and rabbits have shown that paclitaxelcauses miscarriages and deaths of the fetus, as well as problems in the mother.

Be sure that you have discussed this with your doctor before taking thismedicine. It is best to use some kind of birth control while you are receivingpaclitaxel. Tell your doctor right away if you think you have become pregnantwhile receiving paclitaxel.

Breast-feeding?It is not known whether paclitaxel passes intobreast milk. However, because this medicine may cause serious side effects,breast-feeding is generally not recommended while you are receiving it.

Children?There is no specific information comparing use ofpaclitaxel in children with use in other age groups.

Older adults?This medicine has been tested in a limited numberof patients and has not been shown to cause different side effects or problemsin older people than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are receivingpaclitaxel, it is especially important that your health care professionalknow if you are taking any of the following:

  • Amphotericin B by injection (e.g., Fungizone) or
  • Antithyroid agents (medicine for overactive thyroid) or
  • Azathioprine (e.g., Imuran) or
  • Chloramphenicol (e.g., Chloromycetin) or
  • Colchicine or
  • Flucytosine (e.g., Ancobon) or
  • Ganciclovir (e.g., Cytovene) or
  • Interferon (e.g., Intron A, Roferon-A) or
  • Plicamycin (e.g., Mithracin) or
  • Zidovudine (e.g., AZT, Retrovir) or
  • If you have ever been treated with x-rays or cancer medicines?Paclitaxelmay increase the effects of these medicines or radiation therapy on the blood

Other medical problems?The presence of other medicalproblems may affect the use of paclitaxel. Make sure you tell your doctorif you have any other medical problems, especially:

  • Chickenpox (including recent exposure) or
  • Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body
  • Heart rhythm problems?May be made worse by paclitaxel
  • Infection?Paclitaxel may decrease your body's ability to fightinfection

Proper Use of This Medicine

This medicineoften causes nausea and vomiting, which is usually mild. However, it is veryimportant that you continue to receive the medicine even if you begin to feelill. Ask your health care professional for ways to lessen these effects.

Dosing?The dose of paclitaxel will be different fordifferent patients. The dose that is used may depend on a number of things,including what the medicine is being used for, the patient's size, and whetheror not other medicines are also being taken. If you arereceiving paclitaxel at home, follow your doctor's orders or the directionson the label. If you have any questions about the proper dose of paclitaxel,ask 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 forunwanted effects.

While you are being treated with paclitaxel, and after you stop treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Paclitaxel may lower your body's resistanceand there is a chance you might get the infection the immunization is meantto prevent. In addition, other persons living in your household should nottake oral polio vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral polio vaccine withinthe last several months. Do not get close to them and do not stay in the sameroom with them for very long. If you cannot take these precautions, you shouldconsider wearing a protective face mask that covers the nose and mouth.

Paclitaxel can temporarily lower the number of white blood cells in yourblood, increasing the chance of getting an infection. It can also lower thenumber of platelets, which are necessary for proper blood clotting. If thisoccurs, there are certain precautions you can take, especially when your bloodcount is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor if you get a fever or chills, cough or hoarseness, lower back or side pain,or painful or difficult urination.
  • Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
  • Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injurycould occur.


Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Some side effects will have signsor symptoms that you can see or feel. Your doctor may watch for others bydoing certain tests.

Also, because of the way these medicines act on the body, there is a chancethat they might cause other unwanted effects that may not occur until monthsor years after the medicine is used. These delayed effects may include certaintypes of cancer. Discuss these possible effects with your doctor.

Check with your doctorimmediately if any of the following side effects occur:

    Less common

      Black, tarry stools; blood in urineor stools; pinpoint red spots on skin; unusual bleeding or bruising

    Rare

      Shortness of breath (severe); skin reaction(severe)

Check with your doctor as soon as possible if any of the followingside effects occur:

    More common

      Cough or hoarseness accompanied by fever or chills; fever or chills; flushing of face; lower back or side pain accompanied by fever or chills; painful or difficult urination accompanied by fever or chills; shortness of breath; skin rash or itching

    Rare

      Pain or redness at place of injection; sores in mouth and on lips (usually get better within 7 days after treatment)

This medicine may also cause the following side effects that your doctorwill watch out for:

    More common

      Anemia; low platelet count in blood; low white blood cell count

    Less common

      Effects on liver; low blood pressure; slow heartbeat

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. Also, your health careprofessional may be able to tell you about ways to prevent or reduce someof these side effects. Check with your health care professional if any ofthe following side effects continue or are bothersome or if you have any questionsabout them:

    More common

      Diarrhea; nausea and vomiting; numbness, burning, or tingling in hands or feet; pain in joints or muscles, especially in arms or legs (begins2 to 3 days after treatment and may last up to 5 days)

This medicine usually causes a temporary and total lossof hair (including eyebrows, eyelashes, and pubic hair) about 2 to 3 weeksafter treatment begins. After treatment with paclitaxel has ended, normalhair growth should return.

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.


Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, paclitaxel is used in certain patients with the following medicalconditions:

  • Cancer of the bladder
  • Cancer of the cervix
  • Cancer of the endometrium
  • Cancer of the fallopian tube or lining of the abdomen (spreadingfrom the ovary)
  • Cancer of the esophagus
  • Cancers of the head and neck
  • Small cell lung cancer (a certain type found in the tissues of thelungs)
  • Cancer of the stomach
  • Cancer of the prostate
  • Cancer of the testes
  • Cancer of unknown primary site

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.


Revised: 09/11/2003