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What is Pacliteva?
Pacliteva 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).
Pacliteva 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 Pacliteva, you and your doctor should talk about the good Pacliteva will do as well as the risks of using it.
Pacliteva 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, Pacliteva 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).
As 1st-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As 1st-line therapy, Pacliteva is indicated in combination with cisplatin. In noncomparative trials, continuous infusion of Pacliteva 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 Pacliteva in combination with cisplatin, carboplatin, cyclophosphamide, altretamine and/or doxorubicin. Similarly, response rates of 30-100% were observed with Pacliteva plus doxorubicin, cisplatin, mitoxantrone and/or cyclophosphamide in patients with metastatic breast cancer. In several comparative trials, treatment with Pacliteva 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 Pacliteva, 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.
Pacliteva 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.
Pacliteva is also indicated as a 2nd-line treatment of AIDS-related Kaposi's sarcoma.
Pacliteva 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 Pacliteva?
Use Pacliteva as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Pacliteva. Talk to your pharmacist if you have questions about this information.
- Pacliteva 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 Pacliteva to decrease the chance of an allergic reaction. Discuss any questions with your doctor.
- Wear gloves while handling Pacliteva.
- If you get Pacliteva on your skin, rinse the area thoroughly with soap and water. If you get Pacliteva in your eyes, nose, or mouth, flush the area thoroughly with water.
- If you miss a dose of Pacliteva, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Pacliteva.
Uses of Pacliteva in details
This medication is used to treat certain cancers (including breast, lung, and pancreatic cancer). Pacliteva belongs to a class of drugs known as chemotherapy drugs. It works by slowing or stopping the growth of cancer cells.
How to use Pacliteva intravenous
Read the Patient Information Leaflet available from your pharmacist before you start using Pacliteva. 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.
Pacliteva Injection Concentrate is a sterile solution containing 6 mg/mL Pacliteva, 2 mg/mL Anhydrous Citric Acid BP, 527 mg/mL PEG 35 Castor Oil and Ethanol BP.
Pacliteva is extremely hydrophobic, and is therefore formulated in PEG 35 castor oil and ethanol.
Pacliteva 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 Pacliteva is 33069-62-4.
Pacliteva Injection Concentrate must be diluted prior to intravenous infusion.
Pacliteva 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.
Pacliteva Injection Concentrate has a pH of 6 to 7.
All patients should be premedicated prior to Pacliteva administration in order to minimize severe hypersensitivity reaction. Such premedication may consist of dexamethasone 20 mg orally approximately 12 and 6 hrs before Pacliteva, dipenhydramine (or its equivalent) 50 mg IV 30-60 min prior to Pacliteva, and cimetidine 300 mg or ranitidine 50 mg IV 30-60 min before Pacliteva.
Ovarian Carcinoma: Pacliteva 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. Pacliteva should be administered before cisplatin.
Pacliteva 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: Pacliteva 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 Pacliteva, 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 Pacliteva is 175 mg/m2 administered IV over a period of 3 hrs with a 3-week interval between courses. Pacliteva 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: Pacliteva 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: Pacliteva 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 Pacliteva 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 Pacliteva therapy should have the dosage reduced by 20% for subsequent courses of Pacliteva.
Administration: Pacliteva for injection must be diluted prior to infusion. Pacliteva 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 Pacliteva treatment leads to greater myelosuppression than that seen when Pacliteva is given prior to cisplatin. In patients receiving cisplatin prior to Pacliteva, there is about a 33% decrease in Pacliteva clearance.
Ketoconazole: As ketoconazole may inhibit the metabolism of Pacliteva, patients receiving Pacliteva 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 Pacliteva and doxorubicin when Pacliteva was administered before doxorubicin and using longer than recommended infusion times (Pacliteva administered over 24 hours; doxorubicin over 48 hours). Plasma levels of doxorubicin (and its active metabolite doxorubicinol) may be increased when Pacliteva and doxorubicin are used in combination. However, data from a trial using bolus doxorubicin and 3 hour Pacliteva infusion found no sequence effects on the pattern of toxicity.
Drugs Metabolised 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 Pacliteva. The metabolism of Pacliteva is catalysed by cytochrome P450 isoenzymes CYP2C8 and CYP3A4. In the absence of formal clinical drug interaction studies caution should be exercised when administering Pacliteva Injection Concentrate concomitantly with known substrates or inhibitors of these isoenzymes. In the clinical trial of Pacliteva 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 Pacliteva appear to be of a higher incidence in patients being treated concurrently with filgrastim (granulocyte colony stimulating factor; G-CSF).
Pacliteva side effects
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 Pacliteva 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 Pacliteva 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 Pacliteva 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 Pacliteva are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common adverse reactions resulting in dose reduction of Pacliteva are neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common adverse reactions leading to withholding or delay in Pacliteva dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%).
In a randomized open-label trial of Pacliteva in combination with gemcitabine for pancreatic adenocarcinoma, the most common ( ≥ 20%) selected (with a ≥ 5% higher incidence) adverse reactions of Pacliteva are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. The most common serious adverse reactions of Pacliteva (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 Pacliteva are peripheral neuropathy (8%), fatigue (4%) and thrombocytopenia (2%). The most common adverse reactions resulting in dose reduction of Pacliteva are neutropenia (10%) and peripheral neuropathy (6%). The most common adverse reactions leading to withholding or delay in Pacliteva 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 Pacliteva or Pacliteva 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 |
|Pacliteva 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 Pacliteva/gemcitabine included:
Infections & infestations: oral candidiasis, pneumonia
Vascular disorders: hypertension
Cardiac disorders: tachycardia, congestive cardiac failure
Eye disorders: cystoid macular edema
Grade 3 peripheral neuropathy occurred in 17% of patients who received Pacliteva/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 Pacliteva arm was 140 days. Upon suspension of Pacliteva dosing, the median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days. Of Pacliteva-treated patients with Grade 3 peripheral neuropathy, 44% resumed Pacliteva at a reduced dose.
Sepsis occurred in 5% of patients who received Pacliteva/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 occurred in 4% of patients who received Pacliteva/gemcitabine compared to 1% of patients who received gemcitabine alone. Two of 17 patients in the Pacliteva arm with pneumonitis died.
Postmarketing Experience With Pacliteva And Other Pacliteva Formulations
Unless otherwise noted, the following discussion refers to the adverse reactions that have been identified during post-approval use of Pacliteva. 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 Pacliteva injection may be expected to occur with Pacliteva.
Severe and sometimes fatal hypersensitivity reactions have been reported with Pacliteva. The use of Pacliteva in patients previously exhibiting hypersensitivity to Pacliteva injection or human albumin has not been studied.
There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with Pacliteva. Most of the individuals were previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac history.
There have been reports of pneumonitis, interstitial pneumonia and pulmonary embolism in patients receiving Pacliteva and reports of radiation pneumonitis in patients receiving concurrent radiotherapy. Reports of lung fibrosis have been received as part of the continuing surveillance of Pacliteva injection safety and may also be observed with Pacliteva.
Cranial nerve palsies and vocal cord paresis have been reported, as well as autonomic neuropathy resulting in paralytic ileus.
Reports in the literature of abnormal visual evoked potentials in patients treated with Pacliteva injection suggest persistent optic nerve damage. These may also be observed with Pacliteva.
Reduced visual acuity due to cystoid macular edema (CME) has been reported during treatment with Pacliteva as well as with other taxanes. After cessation of treatment, CME improves and visual acuity may return to baseline.
Reports of hepatic necrosis and hepatic encephalopathy leading to death have been received as part of the continuing surveillance of Pacliteva injection safety and may occur following Pacliteva treatment.
There have been reports of intestinal obstruction, intestinal perforation, pancreatitis, and ischemic colitis following Pacliteva treatment. There have been reports of neutropenic enterocolitis (typhlitis), despite the coadministration of G-CSF, occurring in patients treated with Pacliteva injection alone and in combination with other chemotherapeutic agents.
Injection Site Reaction
There have been reports of extravasation of Pacliteva. Given the possibility of extravasation, it is advisable to monitor closely the Pacliteva 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 Pacliteva injection safety. In some cases the onset of the injection site reaction in Pacliteva 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 Pacliteva 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 Pacliteva. 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 Pacliteva injection.
No reports of accidental exposure to Pacliteva have been received. However, upon inhalation of Pacliteva, 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 Pacliteva if you are pregnant. It could harm the unborn baby.
You should not receive this medication if you are allergic to Pacliteva, 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 Pacliteva, 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 Pacliteva. 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.
Pacliteva 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 Pacliteva:
Paclitaxel in Argentina, Bulgaria.
List of Pacliteva substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|PACLITOL 100MG INJECTION 1 vial / 1 ML injection each (Pharmanel)||$ 21.58|
|PACLITOL 260MG INJECTION 1 vial / 1 ML injection each (Pharmanel)||$ 158.71|
|PACLITOL 30MG INJECTION 1 vial / 5 ML injection each (Pharmanel)||$ 33.33|
|Paclitol 100mg Injection (Pharmanel)||$ 21.58|
|Paclitol 260mg Injection (Pharmanel)||$ 158.71|
|Paclitol 30mg Injection (Pharmanel)||$ 6.67|
|30 mg x 1's (Panacea)||$ 23.81|
|100 mg x 1's (Panacea)||$ 60.32|
|300 mg x 1's (Panacea)||$ 142.86|
|Paclitrust 30mg VIAL / 1 (Panacea)||$ 23.81|
|Paclitrust 100mg VIAL / 1 (Panacea)||$ 60.32|
|Paclitrust 300mg VIAL / 1 (Panacea)||$ 142.86|
|PACLITRUST 100MG INJECTION 1 vial / 1 ML injection each (Panacea)||$ 54.71|
|PACLITRUST 260MG INJECTION 1 vial / 1 ML injection each (Panacea)||$ 129.58|
|PACLITRUST 30MG INJECTION 1 vial / 5 ML injection each (Panacea)||$ 21.60|
|PACLITRUST inj 30 mg x 1's (Panacea)||$ 23.81|
|PACLITRUST inj 100 mg x 1's (Panacea)||$ 60.32|
|PACLITRUST inj 300 mg x 1's (Panacea)||$ 142.86|
|Paclitrust 30mg VIAL / 1 (Panacea)||$ 23.81|
|Paclitrust 100mg VIAL / 1 (Panacea)||$ 60.32|
|Paclitrust 300mg VIAL / 1 (Panacea)||$ 142.86|
|Paclitrust 100mg Injection (Panacea)||$ 54.71|
|Paclitrust 260mg Injection (Panacea)||$ 129.58|
|Paclitrust 30mg Injection (Panacea)||$ 4.32|
|PACLIZEN 260MG INJECTION 1 vial / 1 injection each (Unimark Remedies Ltd)||$ 141.72|
|Pacovary (Latvia, Lithuania)|
|Pactal / vial 6 mg/1 mL x 5 mL x 1's (PPC)|
|Pactal 6 mg/1 mL x 16.7 mL x 1's (PPC)|
|Pactal 6 mg/1 mL x 25 mL x 1's (PPC)|
|Pactal 6 mg/1 mL x 43.33 mL x 1's (PPC)|
|Pactal 6 mg/1 mL x 50 mL x 1's (PPC)|
|Pactal infusion conc 6 mg/mL / vial 5 mL x 1's (PPC)|
|Pactal infusion conc 6 mg/mL 16.7 mL x 1's (PPC)|
|Pactal infusion conc 6 mg/mL 25 mL x 1's (PPC)|
|Pactal infusion conc 6 mg/mL 43.33 mL x 1's (PPC)|
|Pactal infusion conc 6 mg/mL 50 mL x 1's (PPC)|
|Padexol (South Korea)|
|Padexol 6 mg/1 mL x 1 Bottle 5 mL|
|Padexol 6 mg/1 mL x 1 Bottle 16.67 mL|
- 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).
ReviewsThe results of a survey conducted on ndrugs.com for Pacliteva 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 Pacliteva. 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.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
Consumer reported time for resultsNo survey data has been collected yet
Consumer reported ageNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology