Paclitaxel Ebewe injection is used to treat advanced cancer of the ovaries, breast, non-small cell lung cancer, and Kaposi sarcoma. Kaposi sarcoma is a cancer of the skin and mucous membranes that is commonly found in patients with acquired immunodeficiency syndrome (AIDS).
Paclitaxel Ebewe belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected, other unwanted 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 Ebewe, you and your doctor should talk about the good this medicine will do as well as the risks of using it.
This medicine is to be administered only by or under the immediate supervision of your doctor.
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 Ebewe is used in certain patients with the following medical conditions:
Cancer of the bladder.
Cancer of the cervix.
Cancer of the endometrium.
Cancer of the esophagus.
Cancer of the fallopian tube or lining of the abdomen (spreading from the ovary).
Cancers of the head and neck.
Cancer of the prostate.
Cancer of the stomach
Cancer of the testes.
Cancer of unknown primary site.
Small cell lung cancer (a certain type found in the tissues of the lungs).
Paclitaxel Ebewe indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
As 1st-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As 1st-line therapy, Paclitaxel Ebewe is indicated in combination with cisplatin. In noncomparative trials, continuous infusion of Paclitaxel Ebewe 110-300 mg/m2 over 3-96 hrs every 3-4 weeks produced complete or partial response in 16-48% of patients with ovarian cancer and 25-61.5% of patients with metastatic breast cancer, many of whom were refractory to treatment with cisplatin or doxorubicin. About 23-100% of patients with ovarian cancer achieved complete or partial response with Paclitaxel Ebewe in combination with cisplatin, carboplatin, cyclophosphamide, altretamine and/or doxorubicin. Similarly, response rates of 30-100% were observed with Paclitaxel Ebewe plus doxorubicin, cisplatin, mitoxantrone and/or cyclophosphamide in patients with metastatic breast cancer. In several comparative trials, treatment with Paclitaxel Ebewe in patients with advanced ovarian cancer produced greater response rates than hydroxyurea (71% vs 0%) or cyclophosphamide (when both agents were combined with cisplatin; 79% vs 63%).
Adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial of Paclitaxel Ebewe, there was an overall favourable effect on disease-free and overall survival in the total population of patients with receptor-positive and -negative tumors, but the benefit has been specifically demonstrated only in patients with estrogen and progesterone receptor-negative tumours.
Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Paclitaxel Ebewe therapy in combination with cisplatin is indicated for the 1st-line treatment of advanced nonsmall cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
Paclitaxel Ebewe is also indicated as a 2nd-line treatment of AIDS-related Kaposi's sarcoma.
Paclitaxel Ebewe is also found to be effective in patients with head and neck cancer, germ cell cancer, urothelial cancer, oesophageal cancer and non-Hodgkin's lymphoma.
How should I use Paclitaxel Ebewe?
Use Paclitaxel Ebewe as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Paclitaxel Ebewe. Talk to your pharmacist if you have questions about this information.
Paclitaxel Ebewe is usually given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
If nausea, vomiting, diarrhea, or loss of appetite occurs, do not discontinue your medicine. Ask your doctor or pharmacist for ways to lessen these effects.
You should receive certain other medicines, such as corticosteroids (eg, prednisone), diphenhydramine, and H blocker (eg, famotidine), before each treatment with Paclitaxel Ebewe to decrease the chance of an allergic reaction. Discuss any questions with your doctor.
Wear gloves while handling Paclitaxel Ebewe.
If you get Paclitaxel Ebewe on your skin, rinse the area thoroughly with soap and water. If you get Paclitaxel Ebewe in your eyes, nose, or mouth, flush the area thoroughly with water.
If you miss a dose of Paclitaxel Ebewe, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Paclitaxel Ebewe.
Uses of Paclitaxel Ebewe in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Paclitaxel Ebewe is used to treat various types of cancer. It is a cancer chemotherapy drug that works by slowing or stopping cancer cell growth.
How to use Paclitaxel Ebewe intravenous
Read the Patient Information Leaflet available from your pharmacist before you start using Paclitaxel Ebewe. If you have any questions, consult your doctor or pharmacist.
This medication is given by injection into a vein by a health care professional. It is given on a schedule as directed by your doctor. Dosage is based on your medical condition, body size, and response to treatment.
Paclitaxel Ebewe description
Paclitaxel Ebewe Injection Concentrate is a sterile solution containing 6 mg/mL Paclitaxel Ebewe, 2 mg/mL Anhydrous Citric Acid BP, 527 mg/mL PEG 35 Castor Oil and Ethanol BP.
Paclitaxel Ebewe is extremely hydrophobic, and is therefore formulated in PEG 35 castor oil and ethanol.
Paclitaxel Ebewe is an anticancer agent from the taxane class of drugs. It is a white powder with a molecular weight (MW) of 853.9. The CAS number for Paclitaxel Ebewe is 33069-62-4.
Paclitaxel Ebewe Injection Concentrate must be diluted prior to intravenous infusion.
Paclitaxel Ebewe is described chemically as (2 S,5 R,7 S,10 R,13 S)-10,20-bis(acetoxy)-2-benzoyloxy-1,7- dihydroxy-9-oxo-5,20- epoxytax-11-en-13-yl (3 S)-3-benzoylamino-3-phenyl-D-lactate.
Paclitaxel Ebewe Injection Concentrate has a pH of 6 to 7.
Paclitaxel Ebewe dosage
All patients should be premedicated prior to Paclitaxel Ebewe administration in order to minimize severe hypersensitivity reaction. Such premedication may consist of dexamethasone 20 mg orally approximately 12 and 6 hrs before Paclitaxel Ebewe, dipenhydramine (or its equivalent) 50 mg IV 30-60 min prior to Paclitaxel Ebewe, and cimetidine 300 mg or ranitidine 50 mg IV 30-60 min before Paclitaxel Ebewe.
Ovarian Carcinoma: Paclitaxel Ebewe administered IV over 3 hrs at a dose of 175 mg/m2 followed by cisplatin at a dose of 75 mg/m2, every 3 weeks. Paclitaxel Ebewe should be administered before cisplatin.
Paclitaxel Ebewe at a dose of 175 mg/m2 administered IV over 3 hrs every 3 weeks has been shown to be effective in patients with metastatic carcinoma of the ovary who have failed standard therapy.
Breast Carcinoma: Paclitaxel Ebewe at a dose of 175 mg/m2 administered IV over 3 hrs every 3 weeks has been shown to be effective in patients with metastatic carcinoma of the breast who have failed standard therapy.
For the adjuvant treatment of node-positive breast cancer, the recommended regimen is Paclitaxel Ebewe, at a dose of 175 mg/m2 IV over 3 hrs every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy.
When used in combination with trastuzumab, the recommended dose of Paclitaxel Ebewe is 175 mg/m2 administered IV over a period of 3 hrs with a 3-week interval between courses. Paclitaxel Ebewe may be started the day following the 1st dose of trastuzumab or immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Lung Carcinoma: Paclitaxel Ebewe administered IV over 3 hrs at a dose of 175 mg/m2 followed by cisplatin at a dose of 80 mg/m2, every 3 weeks.
Gastric Carcinoma: Paclitaxel Ebewe administered IV over 3 hrs at a dose of 175-210 mg/m2, and then it should be taken a rest at least 3 weeks. Determination of dosage should be considered by the age and symptoms. Single courses of Paclitaxel Ebewe should not be repeated until the neutrophil count is at least 1500 cell/mm3 and the platelet count is at least 100,000 cells/mm3. Patients who experience severe neutropenia (neutrophile <500 cells/mm3, for 7 days) or severe peripheral neuropathy during Paclitaxel Ebewe therapy should have the dosage reduced by 20% for subsequent courses of Paclitaxel Ebewe.
Administration: Paclitaxel Ebewe for injection must be diluted prior to infusion. Paclitaxel Ebewe should be diluted in 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, or 5% dextrose in ringer's injection to a final concentration of 0.3-1.2 mg/mL. The solutions are physically and chemically stable for up to 27 hrs at ambient temperature (15-30°C). Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle. No significant loss in potency has been noted following simulated delivery of the solution through IV tubing containing an in-line (0.22 micron) filter.
Interactions with Other Medicines: Cisplatin: Administration of cisplatin prior to Paclitaxel Ebewe treatment leads to greater myelosuppression than that seen when Paclitaxel Ebewe is given prior to cisplatin. In patients receiving cisplatin prior to Paclitaxel Ebewe, there is about a 33% decrease in Paclitaxel Ebewe clearance.
Ketoconazole: As ketoconazole may inhibit the metabolism of Paclitaxel Ebewe, patients receiving Paclitaxel Ebewe and ketoconazole should be closely monitored or the combination of these drugs should be avoided.
Doxorubicin: Sequence effects characterised by more profound neutropenic and stomatitis episodes have been observed with combination use of Paclitaxel Ebewe and doxorubicin when Paclitaxel Ebewe was administered before doxorubicin and using longer than recommended infusion times (Paclitaxel Ebewe administered over 24 hours; doxorubicin over 48 hours). Plasma levels of doxorubicin (and its active metabolite doxorubicinol) may be increased when Paclitaxel Ebewe and doxorubicin are used in combination. However, data from a trial using bolus doxorubicin and 3 hour Paclitaxel Ebewe infusion found no sequence effects on the pattern of toxicity.
DrugsMetabolised in the Liver: Caution should be exercised during concurrent administration of drugs which are metabolised in the liver (e.g. erythromycin) as such drugs may inhibit the metabolism of Paclitaxel Ebewe. The metabolism of Paclitaxel Ebewe is catalysed by cytochrome P450 isoenzymes CYP2C8 and CYP3A4. In the absence of formal clinical drug interaction studies caution should be exercised when administering Paclitaxel Ebewe Injection Concentrate concomitantly with known substrates or inhibitors of these isoenzymes. In the clinical trial of Paclitaxel Ebewe in combination with trastuzumab (Herceptin), mean serum trough concentrations of trastuzumab were consistently elevated 1.5 fold as compared with serum concentrations of trastuzumab in combination with anthracycline plus cyclophosphamide (AC). Arthralgia or myalgia adverse events of Paclitaxel Ebewe appear to be of a higher incidence in patients being treated concurrently with filgrastim (granulocyte colony stimulating factor; G-CSF).
Hematologic: Bone marrow suppression was the major dose-limiting toxicity of Paclitaxel Ebewe. Neutropenia, the most important hematologic toxicity, was dose- and schedule-dependent and was generally rapidly reversible. Among patients treated in phase 3 second-line ovarian study with a 3-hr infusion, neutrophil counts declined <500 cells/mm3 in 14% of patients treated with a dose of 135 mg/m2 compared to 27% at a dose of 175 mg/m2 (p=0.05). In the same study, severe neutropenia (<500 cells/mm3) was more frequent with the 24-hr than with the 3-hr infusion; infusion duration had a greater impact in myelosuppression than dose. Neutropenia did not appear to increase with cumulative exposure and did not appear to be more frequent; not more severe for patients previously treated with radiation therapy. When Paclitaxel Ebewe followed by cisplatin was administered to patients with advanced NSCLC in the ECOG study, the incidences of grade IV neutropenia were 74% (Paclitaxel Ebewe 135 mg/m2/24 hrs followed by cisplatin) and 65% (Paclitaxel Ebewe 250 mg/m2/24 hrs followed by cisplatin and G-CSF) compared with 55% in patients who received cisplatin/etoposide.
Hypersensitivity Reactions: Hypersensitivity reactions were observed in 20% of all courses and in 41% of all patients. These reactions were severe in <2% of the patients and 1% of the courses. No severe reactions were observed after course 3 and severe symptoms occurred generally within the 1st hour of Paclitaxel Ebewe infusion. The most frequent symptoms observed during these severe reactions were dyspnea, flushing, chest pain and tachycardia. The minor hypersensitivity reactions consisted mostly of flushing (28%), rash (12%), hypotension (4%), dyspnea (2%), tachycardia (2%) and hypertension (1%). The frequency of hypersensitivity reactions remained relatively stable during the entire treatment period. Rare reports of chills and back pain in association with hypersensitivity reactions have been received as part of the continuing surveillance of Paclitaxel Ebewe safety.
Cardiovascular: Hypotension, during the first 3 hrs of infusion, occurred in 12% of all patients and 3% of all courses administered. Bradycardia, during the first 3 hrs of infusion occurred in 3% of all patients and 1% of all courses. In the phase 3, second-line ovarian study, neither dose nor schedule had an effect on the frequency of hypotension and bradycardia. These vital sign changes most often caused no symptoms and required neither specific therapy nor treatment discontinuation. The frequency of hypotension and bradycardia were not influenced by prior anthracycline therapy. Significant cardiovascular events possibly related to single agent Paclitaxel Ebewe occurred in approximately 1% of all patients. These events included syncope, rhythm abnormalities, hypertension and venous thrombosis. One (1) of the patients with syncope treated with Paclitaxel Ebewe at 175 mg/m2 over 24 hrs had progressive hypotension and died. The arrhythmias included asymptomatic ventricular tachycardia, bigeminy and complete AV block requiring pacemaker placement. Electrocardiogram (ECG) abnormalities were common among patients at baseline. ECG abnormalities on study did not usually result in symptoms, were not dose-limiting and required no intervention. Congestive heart failure has been reported typically in patients who have received other chemotherapy, notably anthracyclines. Rare reports of atrial fibrillation and supraventricular tachycardia have been received as part of the continuing surveillance of Paclitaxel Ebewe safety.
Respiratory: Rare reports of interstitial pneumonia, lung fibrosis and pulmonary embolism have been received as part of the continuing surveillance of Paclitaxel Ebewe safety. Rare reports of radiation pneumonitis have been received in patients receiving concurrent radiotherapy.
Neurologic: Peripheral neuropathy was observed in 60% of all patients (3% severe) and in 52% (2% severe) of the patients without preexisting neuropathy. The frequency of peripheral neuropathy increased with cumulative dose. Peripheral neuropathy was the cause of Paclitaxel Ebewe discontinuation in 1% of all patients. Sensory symptoms have usually improved or resolved within several months of Paclitaxel Ebewe discontinuation. In patients with NSCLC, administration of Paclitaxel Ebewe followed by cisplatin resulted in a greater incidence of severe neurotoxicity compared to the incidence in patients with ovarian or breast cancer treated with single agent Paclitaxel Ebewe. Severe neurosensory symptoms were noted, in 13% of NSCLC patients receiving Paclitaxel Ebewe 135 mg/m2 by 24-hr infusion followed by cisplatin 75 mg/m2 and 8% of NSCLC patients receiving cisplatin/etoposide. Other than peripheral neuropathy, serious neurologic events following Paclitaxel Ebewe administration have been rare (<1%) and have included grand mal seizures, syncope, ataxia and neuroencephalopathy. Rare reports of autonomic neuropathy resulting in paralytic ileus have been received as part of the continuing surveillance of Paclitaxel Ebewe safety. Optic nerve and/or visual disturbances (scintillating scrotomata) have also been reported, particularly in patients who have received higher doses than those recommended. These effects generally have been reversible. However, rare reports in the literature of abnormal visual evoked potentials in patients have suggested persistent optic nerve damage.
Arthralgia/Myalgia: There was no consistent relationship between dose or schedule of Paclitaxel Ebewe and the frequency or severity of arthralgia/myalgia. Sixty (60) percent of all patients treated experienced arthralgia/myalgia; 8% experienced severe symptoms. The symptoms were usually transient, occurred 2 or 3 days after Paclitaxel Ebewe administration and resolved within a few days. The frequency and severity of musculoskeletal symptoms remained unchanged throughout the treatment period.
Hepatic: No relationship was observed between liver function abnormalities and either dose or schedule of Paclitaxel Ebewe administration. Among patients with normal baseline liver function 7%, 22% and 19% had elevations in bilirubin, alkaline phosphatase and AST (SGOT), respectively. Prolonged exposure to Paclitaxel Ebewe was not associated with cumulative hepatic toxicity. Rare reports of hepatic necrosis and encephalopathy leading to death have been received as part of the continuing surveillance of Paclitaxel Ebewe safety.
Renal: Among patients treated for Kaposi's sarcoma with Paclitaxel Ebewe, 5 patients had renal toxicity of grade III or IV severity. One (1) patient with suspected HIV nephropathy of grade IV severity had to discontinue therapy. The other 4 patients had renal insufficiency with reversible elevations of serum creatinine.
Gastrointestinal (GI): Nausea/vomiting, diarrhea and mucositis were reported by 52%, 38% and 31% of all patients, respectively. These manifestations were usually mild to moderate. In the first-line phase 3 ovarian carcinoma studies, the incidence of nausea and vomiting when Paclitaxel Ebewe was administered in combination with cisplatin appeared to be greater compared with the database for single agent Paclitaxel Ebewe in ovarian and breast carcinoma. In addition, diarrhea of any grade was reported more frequently compared to the control arm, but there was no difference for severe diarrhea in these studies. Rare reports of intestinal obstruction, intestinal perforation, pancreatitis, ischemic colitis and dehydration have been received as part of the continuing surveillance of Paclitaxel Ebewe safety. Rare reports of neutropenic enterocolitis (typhlitis), despite the co-administration of G-CSF, were observed in patients treated with Paclitaxel Ebewe alone and in combination with other chemotherapeutic agents.
Injection Site Reactions: Injection site reactions, including reactions secondary to extravasation, were usually mild and consisted of erythema, tenderness, skin discoloration or swelling at the injection site. These reactions have been observed more frequently with the 24-hr infusion than with the 3-hr infusion. Recurrence of skin reactions at a site of previous extravasation following administration of Paclitaxel Ebewe at a different site has been reported rarely. Rare reports of more severe events eg, phlebitis, cellulitis, induration, skin exfoliation, necrosis and fibrosis have been received as part of the continuing surveillance of Paclitaxel Ebewe safety. In some cases, the onset of the injection site reaction either occurred during a prolonged infusion or was delayed by a week to 10 days. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.
Do not use Paclitaxel Ebewe if you are pregnant. It could harm the unborn baby.
You should not receive this medication if you are allergic to Paclitaxel Ebewe, or to other medications that contain an ingredient called Cremophor EL (polyoxyethylated castor oil). This includes cyclosporine (Gengraf, Neoral, Sandimmune) and teniposide (Vumon).
Before you receive Paclitaxel Ebewe, tell your doctor if you have HIV, AIDS, Kaposi's sarcoma, heart disease, high blood pressure, or liver disease.
There are many other medicines that can interact with Paclitaxel Ebewe. Tell your doctor about all other chemotherapy treatments you are receiving, and about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
Paclitaxel Ebewe can lower blood cells that help your body fight infections and help your blood to clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.
Call your doctor if you have a serious side effect such as fever, flu symptoms, mouth sores, pale skin, easy bruising or bleeding, chest pain, trouble breathing, numbness or tingling, jaundice (yellowing of the skin or eyes), severe headache, buzzing in your ears, confusion, slow or uneven heartbeats, seizure (convulsions), or severe irritation where the medicine was injected.
Active ingredient matches for Paclitaxel Ebewe:
Paclitaxel in Belgium, Bulgaria, Croatia (Hrvatska), Czech Republic, Estonia, Finland, France, Georgia, Hungary, Latvia, Lithuania, Netherlands, New Zealand, Poland, Romania, Serbia, Slovenia, Sweden, Thailand, United States, Vietnam.
Unit description / dosage (Manufacturer)
Paclitaxel Ebewe 6 mg/1 mL x 5 mL x 1 tube
Paclitaxel Ebewe 30 mg/5 mL x 1's
Paclitaxel Ebewe 100 mg/16.6 mL x 1's
Paclitaxel Ebewe 150 mg/25 mL x 1's
Paclitaxel Ebewe 210 mg/35 mL x 1's
Paclitaxel Ebewe 300 mg/50 mL x 1's
Paclitaxel Ebewe inj 100 mg/16.6 mL 1's (Sandoz)
Paclitaxel Ebewe inj 30 mg/5 mL 1's (Sandoz)
Paclitaxel Ebewe inj 300 mg/50 mL 1's (Sandoz)
List of Paclitaxel Ebewe substitutes (brand and generic names):
DailyMed. "PACLITAXEL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Paclitaxel Ebewe are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Paclitaxel Ebewe. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
1 consumer reported useful
Was the Paclitaxel Ebewe drug useful in terms of decreasing the symptom or the disease? According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Consumer reported price estimates
No survey data has been collected yet
Consumer reported time for results
No survey data has been collected yet
Consumer reported age
No survey data has been collected yet
There are no reviews yet. Be the first to write one!