Paclitex Uses

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What is Paclitex?

Paclitex 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).

Paclitex 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 Paclitex, you and your doctor should talk about the good Paclitex will do as well as the risks of using it.

Paclitex 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, Paclitex is used in certain patients with the following medical conditions:

Paclitex 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, Paclitex is indicated in combination with cisplatin. In noncomparative trials, continuous infusion of Paclitex 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 Paclitex in combination with cisplatin, carboplatin, cyclophosphamide, altretamine and/or doxorubicin. Similarly, response rates of 30-100% were observed with Paclitex plus doxorubicin, cisplatin, mitoxantrone and/or cyclophosphamide in patients with metastatic breast cancer. In several comparative trials, treatment with Paclitex 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 Paclitex, 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.

Paclitex 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.

Paclitex is also indicated as a 2nd-line treatment of AIDS-related Kaposi's sarcoma.

Paclitex 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 Paclitex?

Use Paclitex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Paclitex.

Uses of Paclitex 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). Paclitex belongs to a class of drugs known as chemotherapy drugs. It works by slowing or stopping the growth of cancer cells.

How to use Paclitex intravenous

Read the Patient Information Leaflet available from your pharmacist before you start using Paclitex. 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.

Paclitex description

Paclitex Injection Concentrate is a sterile solution containing 6 mg/mL Paclitex, 2 mg/mL Anhydrous Citric Acid BP, 527 mg/mL PEG 35 Castor Oil and Ethanol BP.

Paclitex is extremely hydrophobic, and is therefore formulated in PEG 35 castor oil and ethanol.

Paclitex 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 Paclitex is 33069-62-4.

Paclitex Injection Concentrate must be diluted prior to intravenous infusion.

Paclitex 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.

Paclitex Injection Concentrate has a pH of 6 to 7.

Paclitex dosage

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All patients should be premedicated prior to Paclitex administration in order to minimize severe hypersensitivity reaction. Such premedication may consist of dexamethasone 20 mg orally approximately 12 and 6 hrs before Paclitex, dipenhydramine (or its equivalent) 50 mg IV 30-60 min prior to Paclitex, and cimetidine 300 mg or ranitidine 50 mg IV 30-60 min before Paclitex.

Ovarian Carcinoma: Paclitex 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. Paclitex should be administered before cisplatin.

Paclitex 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: Paclitex 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 Paclitex, 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 Paclitex is 175 mg/m2 administered IV over a period of 3 hrs with a 3-week interval between courses. Paclitex 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: Paclitex 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: Paclitex 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 Paclitex 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 Paclitex therapy should have the dosage reduced by 20% for subsequent courses of Paclitex.

Administration: Paclitex for injection must be diluted prior to infusion. Paclitex 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.

Paclitex interactions

See also:
What other drugs will affect Paclitex?

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Interactions with Other Medicines: Cisplatin: Administration of cisplatin prior to Paclitex treatment leads to greater myelosuppression than that seen when Paclitex is given prior to cisplatin. In patients receiving cisplatin prior to Paclitex, there is about a 33% decrease in Paclitex clearance.

Ketoconazole: As ketoconazole may inhibit the metabolism of Paclitex, patients receiving Paclitex 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 Paclitex and doxorubicin when Paclitex was administered before doxorubicin and using longer than recommended infusion times (Paclitex administered over 24 hours; doxorubicin over 48 hours). Plasma levels of doxorubicin (and its active metabolite doxorubicinol) may be increased when Paclitex and doxorubicin are used in combination. However, data from a trial using bolus doxorubicin and 3 hour Paclitex 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 Paclitex. The metabolism of Paclitex is catalysed by cytochrome P450 isoenzymes CYP2C8 and CYP3A4. In the absence of formal clinical drug interaction studies caution should be exercised when administering Paclitex Injection Concentrate concomitantly with known substrates or inhibitors of these isoenzymes. In the clinical trial of Paclitex 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 Paclitex appear to be of a higher incidence in patients being treated concurrently with filgrastim (granulocyte colony stimulating factor; G-CSF).

Paclitex side effects

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What are the possible side effects of Paclitex?

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 Paclitex 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 Paclitex 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 Paclitex 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 Paclitex are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%). The most common adverse reactions resulting in dose reduction of Paclitex are neutropenia (24%), thrombocytopenia (13%), and anemia (6%). The most common adverse reactions leading to withholding or delay in Paclitex dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%).

In a randomized open-label trial of Paclitex in combination with gemcitabine for pancreatic adenocarcinoma, the most common ( ≥ 20%) selected (with a ≥ 5% higher incidence) adverse reactions of Paclitex are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration. The most common serious adverse reactions of Paclitex (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 Paclitex are peripheral neuropathy (8%), fatigue (4%) and thrombocytopenia (2%). The most common adverse reactions resulting in dose reduction of Paclitex are neutropenia (10%) and peripheral neuropathy (6%). The most common adverse reactions leading to withholding or delay in Paclitex 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 Paclitex or Paclitex 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)

Paclitex 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 Paclitex/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 Paclitex/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 Paclitex arm was 140 days. Upon suspension of Paclitex dosing, the median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days. Of Paclitex-treated patients with Grade 3 peripheral neuropathy, 44% resumed Paclitex at a reduced dose.

Sepsis

Sepsis occurred in 5% of patients who received Paclitex/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 Paclitex/gemcitabine compared to 1% of patients who received gemcitabine alone. Two of 17 patients in the Paclitex arm with pneumonitis died.

Postmarketing Experience With Paclitex And Other Paclitex Formulations

Unless otherwise noted, the following discussion refers to the adverse reactions that have been identified during post-approval use of Paclitex. 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 Paclitex injection may be expected to occur with Paclitex.

Hypersensitivity Reactions

Severe and sometimes fatal hypersensitivity reactions have been reported with Paclitex. The use of Paclitex in patients previously exhibiting hypersensitivity to Paclitex injection or human albumin has not been studied.

Cardiovascular

There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with Paclitex. 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 Paclitex and reports of radiation pneumonitis in patients receiving concurrent radiotherapy. Reports of lung fibrosis have been received as part of the continuing surveillance of Paclitex injection safety and may also be observed with Paclitex.

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 Paclitex injection suggest persistent optic nerve damage. These may also be observed with Paclitex.

Reduced visual acuity due to cystoid macular edema (CME) has been reported during treatment with Paclitex 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 Paclitex injection safety and may occur following Paclitex treatment.

Gastrointestinal (GI)

There have been reports of intestinal obstruction, intestinal perforation, pancreatitis, and ischemic colitis following Paclitex treatment. There have been reports of neutropenic enterocolitis (typhlitis), despite the coadministration of G-CSF, occurring in patients treated with Paclitex injection alone and in combination with other chemotherapeutic agents.

Injection Site Reaction

There have been reports of extravasation of Paclitex. Given the possibility of extravasation, it is advisable to monitor closely the Paclitex 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 Paclitex injection safety. In some cases the onset of the injection site reaction in Paclitex 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 Paclitex 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 Paclitex. 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 Paclitex injection.

Accidental Exposure

No reports of accidental exposure to Paclitex have been received. However, upon inhalation of Paclitex, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported. Following topical exposure, events have included tingling, burning, and redness.

Paclitex contraindications

See also:
What is the most important information I should know about Paclitex?

Do not use Paclitex protein-bound if you are pregnant. It could harm the unborn baby.

Use birth control to prevent pregnancy while you are receiving Paclitex protein-bound, whether you are a man or a woman. Paclitex protein-bound use by either parent may cause birth defects.

You should not use Paclitex 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 Paclitex:

Paclitaxel in Bangladesh.


List of Paclitex substitutes (brand and generic names)

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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
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 6 mg/1 mL x 1 Bottle 5 mL
Padexol 6 mg/1 mL x 1 Bottle 16.67 mL
Padexol 6 mg/1 mL x 1 Bottle 33.34 mL
Padexol 6 mg/1 mL x 1 Bottle 50 mL

References

  1. 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).
  2. PubChem. "paclitaxel". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "paclitaxel". http://www.drugbank.ca/drugs/DB01229 (accessed September 17, 2018).

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