Paclitaxelum Accord 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).
Paclitaxelum Accord 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 Paclitaxelum Accord, you and your doctor should talk about the good Paclitaxelum Accord will do as well as the risks of using it.
Paclitaxelum Accord 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, Paclitaxelum Accord 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).
Paclitaxelum Accord 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.
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As 1st-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As 1st-line therapy, Paclitaxelum Accord is indicated in combination with cisplatin. In noncomparative trials, continuous infusion of Paclitaxelum Accord 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 Paclitaxelum Accord in combination with cisplatin, carboplatin, cyclophosphamide, altretamine and/or doxorubicin. Similarly, response rates of 30-100% were observed with Paclitaxelum Accord plus doxorubicin, cisplatin, mitoxantrone and/or cyclophosphamide in patients with metastatic breast cancer. In several comparative trials, treatment with Paclitaxelum Accord 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 Paclitaxelum Accord, 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.
Paclitaxelum Accord 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.
Paclitaxelum Accord is also indicated as a 2nd-line treatment of AIDS-related Kaposi's sarcoma.
Paclitaxelum Accord 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 Paclitaxelum Accord?
Use Paclitaxelum Accord as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Paclitaxelum Accord. Talk to your pharmacist if you have questions about this information.
Paclitaxelum Accord 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 Paclitaxelum Accord to decrease the chance of an allergic reaction. Discuss any questions with your doctor.
Wear gloves while handling Paclitaxelum Accord.
If you get Paclitaxelum Accord on your skin, rinse the area thoroughly with soap and water. If you get Paclitaxelum Accord in your eyes, nose, or mouth, flush the area thoroughly with water.
If you miss a dose of Paclitaxelum Accord, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Paclitaxelum Accord.
Uses of Paclitaxelum Accord 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.
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This medication is used to treat certain cancers (including breast, lung, and pancreatic cancer). Paclitaxelum Accord belongs to a class of drugs known as chemotherapy drugs. It works by slowing or stopping the growth of cancer cells.
How to use Paclitaxelum Accord intravenous
Read the Patient Information Leaflet available from your pharmacist before you start using Paclitaxelum Accord. 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.
Paclitaxelum Accord description
Paclitaxelum Accord Injection Concentrate is a sterile solution containing 6 mg/mL Paclitaxelum Accord, 2 mg/mL Anhydrous Citric Acid BP, 527 mg/mL PEG 35 Castor Oil and Ethanol BP.
Paclitaxelum Accord is extremely hydrophobic, and is therefore formulated in PEG 35 castor oil and ethanol.
Paclitaxelum Accord 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 Paclitaxelum Accord is 33069-62-4.
Paclitaxelum Accord Injection Concentrate must be diluted prior to intravenous infusion.
Paclitaxelum Accord 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.
Paclitaxelum Accord Injection Concentrate has a pH of 6 to 7.
Paclitaxelum Accord dosage
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All patients should be premedicated prior to Paclitaxelum Accord administration in order to minimize severe hypersensitivity reaction. Such premedication may consist of dexamethasone 20 mg orally approximately 12 and 6 hrs before Paclitaxelum Accord, dipenhydramine (or its equivalent) 50 mg IV 30-60 min prior to Paclitaxelum Accord, and cimetidine 300 mg or ranitidine 50 mg IV 30-60 min before Paclitaxelum Accord.
Ovarian Carcinoma: Paclitaxelum Accord 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. Paclitaxelum Accord should be administered before cisplatin.
Paclitaxelum Accord 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: Paclitaxelum Accord 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 Paclitaxelum Accord, 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 Paclitaxelum Accord is 175 mg/m2 administered IV over a period of 3 hrs with a 3-week interval between courses. Paclitaxelum Accord 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: Paclitaxelum Accord 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: Paclitaxelum Accord 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 Paclitaxelum Accord 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 Paclitaxelum Accord therapy should have the dosage reduced by 20% for subsequent courses of Paclitaxelum Accord.
Administration: Paclitaxelum Accord for injection must be diluted prior to infusion. Paclitaxelum Accord 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 Paclitaxelum Accord treatment leads to greater myelosuppression than that seen when Paclitaxelum Accord is given prior to cisplatin. In patients receiving cisplatin prior to Paclitaxelum Accord, there is about a 33% decrease in Paclitaxelum Accord clearance.
Ketoconazole: As ketoconazole may inhibit the metabolism of Paclitaxelum Accord, patients receiving Paclitaxelum Accord 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 Paclitaxelum Accord and doxorubicin when Paclitaxelum Accord was administered before doxorubicin and using longer than recommended infusion times (Paclitaxelum Accord administered over 24 hours; doxorubicin over 48 hours). Plasma levels of doxorubicin (and its active metabolite doxorubicinol) may be increased when Paclitaxelum Accord and doxorubicin are used in combination. However, data from a trial using bolus doxorubicin and 3 hour Paclitaxelum Accord 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 Paclitaxelum Accord. The metabolism of Paclitaxelum Accord is catalysed by cytochrome P450 isoenzymes CYP2C8 and CYP3A4. In the absence of formal clinical drug interaction studies caution should be exercised when administering Paclitaxelum Accord Injection Concentrate concomitantly with known substrates or inhibitors of these isoenzymes. In the clinical trial of Paclitaxelum Accord 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 Paclitaxelum Accord appear to be of a higher incidence in patients being treated concurrently with filgrastim (granulocyte colony stimulating factor; G-CSF).
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 Paclitaxelum Accord 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 Paclitaxelum Accord 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 Paclitaxelum Accord 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 Paclitaxelum Accord are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common adverse reactions resulting in dose reduction of Paclitaxelum Accord are neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common adverse reactions leading to withholding or delay in Paclitaxelum Accord dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%).
In a randomized open-label trial of Paclitaxelum Accord in combination with gemcitabine for pancreatic adenocarcinoma, the most common ( ≥ 20%) selected (with a ≥ 5% higher incidence) adverse reactions of Paclitaxelum Accord are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. The most common serious adverse reactions of Paclitaxelum Accord (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 Paclitaxelum Accord are peripheral neuropathy (8%), fatigue (4%) and thrombocytopenia (2%). The most common adverse reactions resulting in dose reduction of Paclitaxelum Accord are neutropenia (10%) and peripheral neuropathy (6%). The most common adverse reactions leading to withholding or delay in Paclitaxelum Accord 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 Paclitaxelum Accord or Paclitaxelum Accord 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)
Paclitaxelum Accord 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 Paclitaxelum Accord/gemcitabine included:
Grade 3 peripheral neuropathy occurred in 17% of patients who received Paclitaxelum Accord/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 Paclitaxelum Accord arm was 140 days. Upon suspension of Paclitaxelum Accord dosing, the median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days. Of Paclitaxelum Accord-treated patients with Grade 3 peripheral neuropathy, 44% resumed Paclitaxelum Accord at a reduced dose.
Sepsis
Sepsis occurred in 5% of patients who received Paclitaxelum Accord/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 Paclitaxelum Accord/gemcitabine compared to 1% of patients who received gemcitabine alone. Two of 17 patients in the Paclitaxelum Accord arm with pneumonitis died.
Postmarketing Experience With Paclitaxelum Accord And Other Paclitaxelum Accord Formulations
Unless otherwise noted, the following discussion refers to the adverse reactions that have been identified during post-approval use of Paclitaxelum Accord. 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 Paclitaxelum Accord injection may be expected to occur with Paclitaxelum Accord.
Hypersensitivity Reactions
Severe and sometimes fatal hypersensitivity reactions have been reported with Paclitaxelum Accord. The use of Paclitaxelum Accord in patients previously exhibiting hypersensitivity to Paclitaxelum Accord injection or human albumin has not been studied.
Cardiovascular
There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with Paclitaxelum Accord. 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 Paclitaxelum Accord and reports of radiation pneumonitis in patients receiving concurrent radiotherapy. Reports of lung fibrosis have been received as part of the continuing surveillance of Paclitaxelum Accord injection safety and may also be observed with Paclitaxelum Accord.
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 Paclitaxelum Accord injection suggest persistent optic nerve damage. These may also be observed with Paclitaxelum Accord.
Reduced visual acuity due to cystoid macular edema (CME) has been reported during treatment with Paclitaxelum Accord 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 Paclitaxelum Accord injection safety and may occur following Paclitaxelum Accord treatment.
Gastrointestinal (GI)
There have been reports of intestinal obstruction, intestinal perforation, pancreatitis, and ischemic colitis following Paclitaxelum Accord treatment. There have been reports of neutropenic enterocolitis (typhlitis), despite the coadministration of G-CSF, occurring in patients treated with Paclitaxelum Accord injection alone and in combination with other chemotherapeutic agents.
Injection Site Reaction
There have been reports of extravasation of Paclitaxelum Accord. Given the possibility of extravasation, it is advisable to monitor closely the Paclitaxelum Accord 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 Paclitaxelum Accord injection safety. In some cases the onset of the injection site reaction in Paclitaxelum Accord 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 Paclitaxelum Accord 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 Paclitaxelum Accord. 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 Paclitaxelum Accord injection.
Accidental Exposure
No reports of accidental exposure to Paclitaxelum Accord have been received. However, upon inhalation of Paclitaxelum Accord, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported. Following topical exposure, events have included tingling, burning, and redness.
Do not use Paclitaxelum Accord protein-bound if you are pregnant. It could harm the unborn baby.
Use birth control to prevent pregnancy while you are receiving Paclitaxelum Accord protein-bound, whether you are a man or a woman. Paclitaxelum Accord protein-bound use by either parent may cause birth defects.
You should not use Paclitaxelum Accord 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 Paclitaxelum Accord:
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 Paclitaxelum Accord 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 Paclitaxelum Accord. 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.
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