What is Pataxel?
Pataxel 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).
Pataxel 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 Pataxel, you and your doctor should talk about the good Pataxel will do as well as the risks of using it.
Pataxel 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, Pataxel 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).
Pataxel indications
As 1st-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As 1st-line therapy, Pataxel is indicated in combination with cisplatin. In noncomparative trials, continuous infusion of Pataxel 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 Pataxel in combination with cisplatin, carboplatin, cyclophosphamide, altretamine and/or doxorubicin. Similarly, response rates of 30-100% were observed with Pataxel plus doxorubicin, cisplatin, mitoxantrone and/or cyclophosphamide in patients with metastatic breast cancer. In several comparative trials, treatment with Pataxel 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 Pataxel, 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.
Pataxel 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.
Pataxel is also indicated as a 2nd-line treatment of AIDS-related Kaposi's sarcoma.
Pataxel 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 Pataxel?
Use Pataxel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Pataxel. Talk to your pharmacist if you have questions about this information.
- Pataxel 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 Pataxel to decrease the chance of an allergic reaction. Discuss any questions with your doctor.
- Wear gloves while handling Pataxel.
- If you get Pataxel on your skin, rinse the area thoroughly with soap and water. If you get Pataxel in your eyes, nose, or mouth, flush the area thoroughly with water.
- If you miss a dose of Pataxel, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Pataxel.
Uses of Pataxel in details
This medication is used to treat certain cancers (including breast, lung, and pancreatic cancer). Pataxel belongs to a class of drugs known as chemotherapy drugs. It works by slowing or stopping the growth of cancer cells.
How to use Pataxel intravenous
Read the Patient Information Leaflet available from your pharmacist before you start using Pataxel. 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, laboratory tests, and response to treatment.
Pataxel description
Pataxel Injection Concentrate is a sterile solution containing 6 mg/mL Pataxel, 2 mg/mL Anhydrous Citric Acid BP, 527 mg/mL PEG 35 Castor Oil and Ethanol BP.
Pataxel is extremely hydrophobic, and is therefore formulated in PEG 35 castor oil and ethanol.
Pataxel 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 Pataxel is 33069-62-4.
Pataxel Injection Concentrate must be diluted prior to intravenous infusion.
Pataxel 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.
Pataxel Injection Concentrate has a pH of 6 to 7.
Pataxel dosage
Premed all patients w/ oral dexamethasone (20 mg) approx 12 & 6 hr before Pataxel administration, IV diphenhydramine or its equiv (50 mg) 30-60 min before Pataxel & either IV cimetidine (300 mg) or IV ranitidine (50 mg) 30-60 min before Pataxel. Patient w/ HIV infection may follow the same premed regimen w/ the exception of a reduced dose of oral dexamethasone (10 mg). Ovarian cancer: Previously untreated ovarian cancer patient Pataxel 175 mg/m2 IV over 3 hr followed by cisplatin 75 mg/m2; may be given every 3 wk OR Pataxel 135 mg/m2 IV over 24 hr followed by cisplatin 75 mg/m2; may be given every 3 wk. Previously chemotherapy-treated ovarian cancer patient Pataxel 135 or 175 mg/m2 IV over 3 hr; given every 3 wk. Breast cancer: Adjuvant treatment of node +ve breast cancer Pataxel 175 mg/m2 IV over 3 hr given every 3 wk for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. After failure of initial chemotherapy for metastatic disease or relapse w/in 6 mth of adjuvant chemotherapy Pataxel 175 mg/m2 IV over 3 hr given every 3 wk. HER-2 overexpressing breast cancer Pataxel 175 mg/m2 IV over 3 hr; given every 3 wk for 6 cycles. Administer trastuzumab 2 mg/kg IV once a wk until progression of disease after an initial loading dose of 4 mg/kg body wt. NSCLC Pataxel 135 mg/m2 IV over 24 hr followed by cisplatin 75 mg/m2; given every 3 wk OR Pataxel 175 mg/m2 IV over 3 hr followed by cisplatin 80 mg/m2; given every 3 wk. AIDS-related Kaposi's sarcoma Pataxel 135 mg/m2 IV over 3 hr given every 3 wk OR Pataxel 100 mg/m2 IV over 3 hr given every 2 wk (dose intensity 45-50 mg/m2/wk).
Pataxel interactions
See also:
What other drugs will affect Pataxel?
Cisplatin: Administration of cisplatin prior to Pataxel treatment leads to greater myelosuppression than that seen when Pataxel is given prior to cisplatin. In patients receiving cisplatin prior to Pataxel, there is about a 33% decrease in Pataxel clearance.
Ketoconazole: As ketoconazole may inhibit the metabolism of Pataxel, patients receiving Pataxel and ketoconazole should be closely monitored or the combination of these drugs should be avoided.
Doxorubicin: Sequence effects characterized by more profound neutropenic and stomatitis episodes have been observed with combination use of Pataxel and doxorubicin when Pataxel was administered before doxorubicin and using longer than recommended infusion times (Pataxel administered over 24 hrs; doxorubicin over 48 hrs). Plasma levels of doxorubicin (and its active metabolite doxorubicinol) may be increased when Pataxel and doxorubicin are used in combination. However, data from a trial using bolus doxorubicin and 3-hr Pataxel infusion found no sequence effects on the pattern of toxicity.
Drug Metabolized in the Liver: Caution should be exercised during concurrent administration of drugs which are metabolized in the liver (eg, erythromycin) as such drugs may inhibit the metabolism of Pataxel.
The metabolism of Pataxel is catalyzed by cytochrome P-450 isoenzymes CYP2C8 and CYP3A4. In the absence of formal clinical drug interaction studies caution should be exercised when administering Pataxel concomitantly with known substrates or inhibitors of these isoenzymes.
In the clinical trial of Pataxel 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 Pataxel appear to be of a higher incidence in patients being treated concurrently with filgrastim [granulocyte-colony stimulating factor (G-CSF)].
Pataxel side effects
See also:
What are the possible side effects of Pataxel?
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions ( ≥ 20%) with single-agent use of Pataxel in metastatic breast cancer are alopecia, neutropenia, sensory neuropathy, abnormal ECG, fatigue/asthenia, myalgia/arthralgia, AST elevation, alkaline phosphatase elevation, anemia, nausea, infections, and diarrhea.
The most common adverse reactions ( ≥ 20%) of Pataxel in combination with carboplatin for non-small cell lung cancer are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue. The most common serious adverse reactions of Pataxel in combination with carboplatin for non-small cell lung cancer are anemia (4%) and pneumonia (3%). The most common adverse reactions resulting in permanent discontinuation of Pataxel are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common adverse reactions resulting in dose reduction of Pataxel are neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common adverse reactions leading to withholding or delay in Pataxel dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%).
In a randomized open-label trial of Pataxel in combination with gemcitabine for pancreatic adenocarcinoma, the most common ( ≥ 20%) selected (with a ≥ 5% higher incidence) adverse reactions of Pataxel are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. The most common serious adverse reactions of Pataxel (with a ≥ 1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%) and vomiting (4%). The most common adverse reactions resulting in permanent discontinuation of Pataxel are peripheral neuropathy (8%), fatigue (4%) and thrombocytopenia (2%). The most common adverse reactions resulting in dose reduction of Pataxel are neutropenia (10%) and peripheral neuropathy (6%). The most common adverse reactions leading to withholding or delay in Pataxel dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%) and diarrhea (5%).
Clinical Trials Experience In Metastatic Breast Cancer
Table 6 shows the frequency of important adverse events in the randomized comparative trial for the patients who received either single-agent Pataxel or Pataxel injection for the treatment of metastatic breast cancer.
Table 6: Frequencya of Important Treatment Emergent Adverse Events in the Randomized Metastatic Breast Cancer Study on an Every-3-Weeks Schedule
| Percent of Patients | |
| ABRAXANE260 mg/m² over 30 min (n=229) | Pataxel Injection175 mg/m² over 3 h Urinary tract infections includes the preferred terms of: urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, and urinary tract infection enterococcal. |
Additional clinically relevant adverse reactions that were reported in < 10% of the patients with adenocarcinoma of the pancreas who received Pataxel/gemcitabine included:
Infections & infestations: oral candidiasis, pneumonia
Vascular disorders: hypertension
Cardiac disorders: tachycardia, congestive cardiac failure
Eye disorders: cystoid macular edema
Peripheral Neuropathy
Grade 3 peripheral neuropathy occurred in 17% of patients who received Pataxel/gemcitabine compared to 1% of patients who received gemcitabine only; no patients developed grade 4 peripheral neuropathy. The median time to first occurrence of Grade 3 peripheral neuropathy in the Pataxel arm was 140 days. Upon suspension of Pataxel dosing, the median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days. Of Pataxel-treated patients with Grade 3 peripheral neuropathy, 44% resumed Pataxel at a reduced dose.
Sepsis
Sepsis occurred in 5% of patients who received Pataxel/gemcitabine compared to 2% of patients who received gemcitabine alone. Sepsis occurred both in patients with and without neutropenia. Risk factors for sepsis included biliary obstruction or presence of biliary stent.
Pneumonitis
Pneumonitis occurred in 4% of patients who received Pataxel/gemcitabine compared to 1% of patients who received gemcitabine alone. Two of 17 patients in the Pataxel arm with pneumonitis died.
Postmarketing Experience With Pataxel And Other Pataxel Formulations
Unless otherwise noted, the following discussion refers to the adverse reactions that have been identified during post-approval use of Pataxel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In some instances, severe events observed with Pataxel injection may be expected to occur with Pataxel.
Hypersensitivity Reactions
Severe and sometimes fatal hypersensitivity reactions have been reported with Pataxel. The use of Pataxel in patients previously exhibiting hypersensitivity to Pataxel injection or human albumin has not been studied.
Cardiovascular
There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with Pataxel. Most of the individuals were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history.
Respiratory
There have been reports of pneumonitis, interstitial pneumonia and pulmonary embolism in patients receiving Pataxel and reports of radiation pneumonitis in patients receiving concurrent radiotherapy. Reports of lung fibrosis have been received as part of the continuing surveillance of Pataxel injection safety and may also be observed with Pataxel.
Neurologic
Cranial nerve palsies and vocal cord paresis have been reported, as well as autonomic neuropathy resulting in paralytic ileus.
Vision Disorders
Reports in the literature of abnormal visual evoked potentials in patients treated with Pataxel injection suggest persistent optic nerve damage. These may also be observed with Pataxel.
Reduced visual acuity due to cystoid macular edema (CME) has been reported during treatment with Pataxel as well as with other taxanes. After cessation of treatment, CME improves and visual acuity may return to baseline.
Hepatic
Reports of hepatic necrosis and hepatic encephalopathy leading to death have been received as part of the continuing surveillance of Pataxel injection safety and may occur following Pataxel treatment.
Gastrointestinal (GI)
There have been reports of intestinal obstruction, intestinal perforation, pancreatitis, and ischemic colitis following Pataxel treatment. There have been reports of neutropenic enterocolitis (typhlitis), despite the coadministration of G-CSF, occurring in patients treated with Pataxel injection alone and in combination with other chemotherapeutic agents.
Injection Site Reaction
There have been reports of extravasation of Pataxel. Given the possibility of extravasation, it is advisable to monitor closely the Pataxel infusion site for possible infiltration during drug administration.
Severe events such as phlebitis, cellulitis, induration, necrosis, and fibrosis have been reported as part of the continuing surveillance of Pataxel injection safety. In some cases the onset of the injection site reaction in Pataxel injection patients either occurred during a prolonged infusion or was delayed by a week to ten days. Recurrence of skin reactions at a site of previous extravasation following administration of Pataxel injection at a different site, i.e., “recall”, has been reported.
Other Clinical Events
Skin reactions including generalized or maculopapular rash, erythema, and pruritus have been observed with Pataxel. There have been case reports of photosensitivity reactions, radiation recall phenomenon, and in some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysesthesia. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
There have been reports of conjunctivitis, cellulitis, and increased lacrimation with Pataxel injection.
Accidental Exposure
No reports of accidental exposure to Pataxel have been received. However, upon inhalation of Pataxel, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported. Following topical exposure, events have included tingling, burning, and redness.
Pataxel contraindications
See also:
What is the most important information I should know about Pataxel?
Do not use Pataxel protein-bound if you are pregnant. It could harm the unborn baby.
Use birth control to prevent pregnancy while you are receiving Pataxel protein-bound, whether you are a man or a woman. Pataxel protein-bound use by either parent may cause birth defects.
You should not use Pataxel protein-bound if you are allergic to it, or if you have a low white blood cell count.
Before you receive this medication, tell your doctor if you have kidney disease, liver disease, heart disease, or bone marrow suppression.
To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.
Call your doctor at once if you have a serious side effect such as fever, chills, flu symptoms, mouth sores, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, swelling or rapid weight gain, chest pain, sudden cough, rapid heart rate, or trouble breathing.
Active ingredient matches for Pataxel:
Paclitaxel in Georgia, Greece, Serbia.
| Unit description / dosage (Manufacturer) | Price, USD |
| PATAXEL inj 30 mg x 5ml (VHB) | $ 21.47 |
| PATAXEL inj 100 mg x 16.67ml (VHB) | $ 59.64 |
| PATAXEL inj 150 mg x 25ml (VHB) | |
| PATAXEL inj 260 mg x 43.34ml (VHB) | |
| PATAXEL inj 300 mg x 50ml (VHB) | |
List of Pataxel substitutes (brand and generic names): | |
| Pastaxel (Vietnam) | |
| Pastaxel 6 mg x 1 Bottle | |
| Paxceed | |
| Paxec (Mexico) | |
| Paxel (Philippines, South Korea) | |
| Paxel / vial 30 mg/5 mL x 1's (Intas) | |
| Paxel 100 mg/16.7 mL x 1's (Intas) | |
| Paxel inj 100 mg/16.7 mL 1's (Intas) | |
| Paxel inj 30 mg/5 mL / vial 1's (Intas) | |
| Paxene (Czech Republic, Latvia, Spain) | |
| Injectable; Injection; Paclitaxel 6 mg / ml (Norton heathcare) | |
| Paxene liquid 6 mg (Norton heathcare) | |
| Paxene Paclitaxel (Greece) | |
| Paxital (Greece) | |
| Paxitas (South Africa) | |
| Paxol (Myanmar) | |
| Paxoll (Thailand) | |
| Paxoll 30 mg/5 mL x 1's (Venus Remedies) | |
| Paxoll 100 mg/16.7 mL x 1's (Venus Remedies) | |
| Paxoll 260 mg/43.4 mL x 1's (Venus Remedies) | |
| Paxoll 300 mg/50 mL x 1's (Venus Remedies) | |
| Paxoll inj 100 mg/16.7 mL 1's (Venus Remedies) | |
| Paxoll inj 260 mg/43.4 mL 1's (Venus Remedies) | |
| Paxoll inj 30 mg/5 mL 1's (Venus Remedies) | |
| Paxoll inj 300 mg/50 mL 1's (Venus Remedies) | |
| Paxomed (Indonesia) | |
| Paxoral (Brazil) | |
| PAXTAL (India) | |
| PAXTAL Injection / 30mg / 5ml units (SPPL) | $ 28.61 |
| 5ml (SPPL) | $ 28.61 |
| Paxtal Paclitaxel 6 mg, polyoxyl 35castor oil 527 mg, dehydratedalcohol 49.7 % v/v/1 mL. INJ / 5ml (SPPL) | $ 28.61 |
| PAXTAL 100MG INJECTION 1 vial / 20 ML injection each (SPPL) | $ 48.16 |
| PAXTAL 260MG INFUSION 1 bottle / 50 ML infusion each (SPPL) | $ 36.30 |
| PAXTAL 30MG INJECTION 1 vial / 5 ML injection each (SPPL) | $ 21.42 |
| PAXTAL inj 6 mg x 5ml (SPPL) | $ 28.61 |
| Paxtal Paclitaxel 6 mg, polyoxyl 35castor oil 527 mg, dehydratedalcohol 49.7 % v/v/1 mL. INJ / 5ml (SPPL) | $ 28.61 |
| Paxtal 100mg Injection (SPPL) | $ 2.41 |
| Paxtal 260mg Injection (SPPL) | $ 0.73 |
| Paxtal 30mg Injection (SPPL) | $ 4.28 |
| Paxuba (India) | |
| Paxuba 6mg x 1mL VIAL / 16.7ml (Glenmark (Onkos)) | $ 51.20 |
| Paxuba 6mg x 1mL VIAL / 43.3ml (Glenmark (Onkos)) | $ 112.05 |
| Paxuba 6mg x 1mL VIAL / 5ml (Glenmark (Onkos)) | $ 18.31 |
| PAXUBA 100MG INJECTION 1 vial / 1 injection each (Glenmark (Onkos)) | $ 51.20 |
| PAXUBA 260MG INJECTION 1 vial / 1 ML injection each (Glenmark (Onkos)) | $ 112.05 |
| PAXUBA 30MG INJECTION 1 vial / 5 ML injection each (Glenmark (Onkos)) | $ 18.31 |
| Paxuba 100mg Injection (Glenmark (Onkos)) | $ 51.20 |
| Paxuba 260mg Injection (Glenmark (Onkos)) | $ 112.05 |
See 1076 substitutes for Pataxel | |
References
- 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).
- PubChem. "paclitaxel". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "paclitaxel". http://www.drugbank.ca/drugs/DB01229 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Pataxel 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 Pataxel. 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.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yet2 consumers reported age
| Users | % | ||
|---|---|---|---|
| > 60 | 2 | 100.0% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
