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USP DI Vol. II - PACLITAXEL PROTEIN-BOUND (Systemic)

PACLITAXEL PROTEIN-BOUND (Systemic)?


Some commonly used brand names are:

In the U.S.?

  • Abraxane

? Not commercially available in Canada.


Category

  • Antineoplastic

Description

Paclitaxelprotein-bound (PAK-li-tax-el pro-teen bound) belongs to the group of medicines called antineoplastics. Itis used to treat cancer of the breast after other treatments have failed.

Paclitaxel interferes with the growth of cancer cells, which are eventuallydestroyed. Since the growth of normal body cells may also be affected by paclitaxelprotein bound, other effects will also occur. Some of these may be seriousand must be reported to your doctor. Other effects may not be serious butmay cause concern. Some effects may not occur until months or years afterthe medicine is used.

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

Paclitaxel protein-bound is to be administered only by or under the immediatesupervision of your doctor. It is available in the following dosage forms:

    Parenteral
  • Injection (U.S.)


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 protein-boundparticles, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to paclitaxel protein-bound. Also tell your doctor andpharmacist if you are allergic to any other substances, such as human albumin,foods, preservatives, or dyes.

Pregnancy?Tell your doctor if you are pregnant or if youintend to 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 you have discussed this with your doctor before taking this medicine.It is best to use some kind of birth control while you are receiving paclitaxelprotein-bound.

Breast-feeding?It is not known whether paclitaxel protein-boundpasses into breast milk. However, because this medicine may cause seriousside effects, breast-feeding is generally not recommended while you are receivingit.

Children?There is no specific information comparing useof paclitaxel protein-bound 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. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of paclitaxel protein-bound particles. Make sureyou tell your doctor if you have any other medical problems, especially:

  • Infection?Paclitaxel may decrease your body's ability to fightinfection.
  • Kidney problems or
  • Liver problems
  • Neuropathy, grade 3?May require a break in treatment or a decreasein the dose

Proper Use of This Medicine

Dosing?The dose of paclitaxel protein-bound will be different fordifferent patients. The dose that is used may depend on a number of things,including the patient's size, and whether or not other medicines are alsobeing taken. If you are receiving paclitaxel protein-boundat home, follow your doctor's orders or the directions on the label.If you have any questions about the proper dose of paclitaxel protein-bound,ask your doctor.

  • For parental dosage form:
    • For advanced breast cancer
      • Adults?260 milligrams per m2of body surface area, injected into the vein over 30 minutes once every 3weeks.
      • Children?Use and dose must be determined by your doctor.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits to make sure that this medicine is working properlyand to check for unwanted effects.

Men receiving paclitaxel protein-bound should not fathera child.

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 medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

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 may include certain types of cancer,such as leukemia or bladder cancer. Discuss these possible effects with yourdoctor.

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

      More common

        Black, tarry stools; blurred or doublevision; 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; troubled breathing with exertion; tightness in chest; ulcers, sores, orwhite 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 breathing; difficulty in swallowing; dizziness,faintness, or lightheadedness when getting up from a lying or sitting positionsuddenly; dizziness or lightheadedness; fainting; fast, pounding, or irregularheartbeat or pulse; no blood pressure or 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; slow or irregular heartbeat; slurred speech; stabbing pain; skin itching, rash, or redness; stopping of heart; sudden loss of coordination; sudden, severe weakness or numbness in arm or leg; sudden, unexplained shortness of breath; sweating; swelling of face, throat, or tongue; tenderness, pain, swelling, warmth, skin discoloration, and prominentsuperficial veins over affected area; unconsciousness; vision changes

      Rare

        Difficulty in speaking; headache; inability to move arms, legs, or facial muscles; inability to speak; numbness or tinglingin face, arms or legs; severe pain in chest; slow speech; sudden onset of severebreathing difficulty; trouble speaking, thinkingor walking

      Symptoms of Overdose

      Get emergency help immediately if any of the followingsymptoms of overdose occur

        Blurred or double vision; chest pain; chills; cough or hoarseness; cracked lips; diarrhea; difficulty in swallowing; fever; loss of taste; lowerback or side pain; painful or difficult urination; shortness of breath; sores, ulcers, or white spots on lips, tongue, or inside mouth; swollen glands; unusual bleeding orbruising; unusual tiredness or weakness

    Otherside effects may occur that usually do not need medical attention. These sideeffects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor are bothersome.

      More Common

        Cracked lips; diarrhea; difficulty in moving; difficulty inswallowing; 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 site of injection

      Rare

        Nail changes

      Observed during clinical trials

        Disturbed color perception; halos aroundlights; loss of vision; night blindness; overbright appearance of lights; tunnel vision

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.


Developed: 10/24/2005