Paclitaxel is a prescription medication used to treat cancer, including ovarian, breast, and lung cancer, and Kaposi's sarcoma. Paclitaxel belongs to a group of drugs called antimicrotubule agents or taxanes. It works by stopping the growth and spread of cancer cells.
This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider.
Common side effects of Paclitaxel include low blood cell count, hair loss, and joint or muscle pain.
Paclitaxel is a prescription medicine used to treat some forms of cancer including:
- ovarian cancer
- breast cancer
- lung cancer
- Kaposi’s sarcoma
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Paclitaxel can cause serious side effects including death.
Serious allergic reactions (anaphylaxis) can happen in people who receive paclitaxel. Anaphylaxis is a serious medical emergency that can lead to death and must be treated right away.
Tell your healthcare provider right away if you have any of these signs of an allergic reaction:
- trouble breathing
- sudden swelling of your face, lips, tongue, throat, or trouble swallowing
- hives (raised bumps) or rash
Your healthcare provider will give you medicines to lessen your chance of having an allergic reaction.
Tell your healthcare provider right away if you have:
- severe stomach pain
- severe diarrhea
The most common side effects of paclitaxel include:
- low red blood cell count (anemia) feeling weak or tired
- hair loss
- numbness, tingling, or burning in your hands or feet (neuropathy)
- joint and muscle pain
- nausea and vomiting
- hypersensitivity reaction - trouble breathing; sudden swelling of your face, lips, tongue, throat, or trouble swallowing; hives (raised bumps) or rash
- mouth or lip sores (mucositis)
- infections - if you have a fever (temperature above 100.4°F) or other sign of infection, tell your healthcare provider right away
- swelling of your hands, face, or feet
- bleeding events
- irritation at the injection site
- low blood pressure (hypotension)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of paclitaxel. For more information, ask your healthcare provider or pharmacist.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
Do not receive paclitaxel if:
- you are allergic to any of the ingredients in paclitaxel. See the end of this leaflet for a complete list of ingredients in paclitaxel.
- are allergic to medicines containing polyoxyl 35 castor oil, NF.
- you have low white blood cell counts.
Grapefruit and grapefruit juice may interact with paclitaxel and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Before receiving paclitaxel, tell your healthcare provider about all your medical conditions, including if you:
- have liver problems
- have heart problems
- are pregnant or plan to become pregnant. Paclitaxel can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if paclitaxel passes into your breast milk. You and your healthcare provider should decide if you will receive paclitaxel or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you are pregnant or plan to become pregnant. Paclitaxel can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if paclitaxel passes into your breast milk. You and your doctor should decide if you will receive paclitaxel or breastfeed.
Paclitaxel is injected into a vein (intravenous [IV] infusion) by your healthcare provider. It may be given once every 3 weeks. For the treatment of Kaposi's Sarcoma, paclitaxel may be given every 2 or 3 weeks.
Your healthcare provider will do certain tests while you receive paclitaxel.
The following paclitaxel regimens are recommended:
For patients with carcinoma of the ovary:
- For previously untreated patients with carcinoma of the ovary, one of the following recommended regimens may be given every 3 weeks. In selecting the appropriate regimen, differences in toxicities should be considered.
- Paclitaxel injection administered intravenously over 3 hours at a dose of 175 mg/m2 followed by cisplatin at a dose of 75 mg/m2; or
- Paclitaxel injection administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin at a dose of 75 mg/m2.
- In patients previously treated with chemotherapy for carcinoma of the ovary, paclitaxel injection has been used at several doses and schedules; however, the optimal regimen is not yet clear. The recommended regimen is paclitaxel injection 135 mg/m2 or 175 mg/m2 administered intravenously over 3 hours every 3 weeks.
For patients with carcinoma of the breast, the following regimens are recommended:
- For the adjuvant treatment of node-positive breast cancer, the recommended regimen is paclitaxel injection, at a dose of 175 mg/m2 intravenously over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. The clinical trial used 4 courses of doxorubicin and cyclophosphamide.
- After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, paclitaxel injection at a dose of 175 mg/m2administered intravenously over 3 hours every 3 weeks has been shown to be effective.
For patients with non-small cell lung carcinoma, the recommended regimen, given every 3 weeks, is paclitaxel injection administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin, 75 mg/m2.
For patients with AIDS-related Kaposi’s sarcoma, paclitaxel injection administered at a dose of 135 mg/m2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m2 given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45 to 50 mg/m2/week). In the 2 clinical trials evaluating these schedules, the former schedule (135 mg/m2 every 3 weeks) was more toxic than the latter. In addition, all patients with low performance status were treated with the latter schedule (100 mg/m2 every 2 weeks).
Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:
- Reduce the dose of dexamethasone as 1 of the 3 premedication drugs to 10 mg PO (instead of 20 mg PO);
- Initiate or repeat treatment with paclitaxel injection only if the neutrophil count is at least 1000 cells/mm3;
- Reduce the dose of subsequent courses of paclitaxel injection by 20% for patients who experience severe neutropenia (neutrophil < 500 cells/mm3 for a week or longer); and
- Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.
For the therapy of patients with solid tumors (ovary, breast, and NSCLC), courses of paclitaxel injection should not be repeated until the neutrophil count is at least 1500 cells/mm3 and the platelet count is at least 100,000 cells/mm3. Paclitaxel injection should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline or subsequent neutrophil count is less than 1000 cells/mm3. Patients who experience severe neutropenia (neutrophil < 500 cells/mm3 for a week or longer) or severe peripheral neuropathy during paclitaxel injection therapy should have dosage reduced by 20% for subsequent courses of paclitaxel injection. The incidence of neurotoxicity and the severity of neutropenia increase with dose.
Paclitaxel is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.
Paclitaxel injection is available as follows:
- multidose vial 30 mg/5 mL
- mulitdose vial 100 mg/16.7 mL
- multidose vial 150 mg/25 mL
- multidose vial 300 mg/50 mL
Active ingredient: paclitaxel, USP.
Inactive ingredients include: polyoxyl 35 castor oil, NF, anhydrous citric acid, USP and dehydrated alcohol, USP.
Ask your doctor or pharmacist if you have any questions about paclitaxel.
Paclitaxel 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.
Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.
Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1000 cells/mm3. 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.