Paclitaxel Ebewe Novartis medicine for ovarian cancer, breast cancer (16.7ml)

Dosage form Box
Specifications Paclitaxel

Ingredient

Composition information	Content
Paclitaxel	6mg

Uses

indications

Paclitaxel "eBewe" indications for treatment in the following cases:

Ovarian cancer

In the first chemotherapy of ovarian cancer, Paclitaxel in combination with cisplatin is indicated for treatment for advanced ovarian cancer patients or residual tumors (> 1cm), after surgery.

The second chemotherapy of the ovarian metastatic carcinoma after using standard platinum.

Breast cancer

In the treatment of breast cancer support, Paclitaxel is indicated for treatment of metastatic carbohydration in breasts with positive lymphadenopathy after anthracyclin and cyclophosphamide (AC). Paclitaxel support treatment therapy should be considered an option to expand anthracyclin treatment regimen. Paclitaxel is indicated in the initial treatment for metastatic breast cancer or local progression in coordination with an Anthracyclin for patients in accordance with Anthracyclin therapy or in combination with trastuzumab for patients with excessive HER-2 at 3+ levels determined by immune tissue chemicals and patients who are not suitable for Anthracyclin therapy.

In single therapy, Paclitaxel is indicated in the treatment of metastatic carcinoma in the breast for patients who have failed or not suitable for anthracyclin therapy.

Non -small cell lung cancer (NSCLC)

Paclitaxel in combination with cisplatin is indicated in the treatment of non -small cell lung carcinoma in patients who cannot surgery and/or no rays.

u Sarcom Kaposi in AIDS patients (KS)

Paclitaxel is indicated for treatment for AIDS patients with a defeated Sarcom Kaposi tumor in the previous liposom anthracyclin therapy.

Pharmacokology

pharmacological group - ATC code treatment: L01CD01.

Paclitaxel is a new anti -micro -pipe drug, gathering micro -tubes from binary tubes and stabilizing the microscopic pipes due to blocking the process of coincidence. This stability inhibits the normal reorganization of the micro mesh, which is essential for the vacation (time) of the decreased cell division and the activity of the mitochondria. Moreover, Paclitaxel also promotes the formation of abnormal structures of microchip bundles throughout the cell cycle, and countless stars of the microscopic duct in the period of cockroaching.

In chemotherapy for ovarian cancer treatment, the effectiveness and safety of Paclitaxel are assessed in two main tests, controlled, randomly (compared to cyclophosphamide 750 mg/m2, Cisplatin 75 mg/m2). In the test between groups (B-MS CA 139-209), over 650 patients with primary ovarian cancer IIB-C, III or IV are treated up to 9 paclitaxel batches (175 mg/m2 for 3 hours) and then use Cisplatin (75 mg/m2) or placebo.

The 2nd main test (GOG-111/BMS CA139-022) has evaluated on a maximum of 6 paclitaxel treatments (135 mg/m2 for 24 hours) then Cisplatin (75 mg/m2) or placebo on more than 400 primary ovarian cancer patients III/IV, with tumor size> 1cm after abdominal surgery or metastasis. While two different ways of using Paclitaxel are not directly compared to each other, in both tests patients with Paclitaxel treatment in combination with cisplatin have a significant response rate, the time for the disease to progress longer, the survival time is longer when compared to the standard therapy. In patients with advanced ovarian cancer, Paclitaxel intravenous infusion for 3 hours later is cisplatin showing an increase in neurotoxicity, muscle aches/joint pain but reducing marrow failure compared to patients treated with cyclophosphamide/cisplatin.

In the treatment of breast cancer support, 3121 patients with positive lymph nodes are treated with Paclitaxel or non-chemotherapy after 4 doxorubicin and cyclophosphamide treatments (CALGB 9344, BMS CA 139-223). The average tracking time is 69 months. In general, patients treated with Paclitaxel significantly reduced 18% of the risk of recurrence (P = 0.0014) and significantly reduced 19% of the risk of death (P = 0.0044) compared to patients with single AC treatment. Rescue analysis shows benefits for all patient groups.

Patients with unknown tumors or no hormone receptors, the risk of recurrence of the disease decreased by 28% (95% CI: 0.59-0.86). In the group of patients with hormone receptors, the risk of recurrence decreased by 9% (95% CI: 0.78-1.07). However, the research design does not investigate the effect of AC therapy expanding more than 4 treatments. It is impossible to exclude the possibility of observation effects that may be partly due to the difference in the chemotherapy period between 2 groups (AC 4 treatments; AC + Paclitaxel 8 batches). Therefore, supportive treatment with Paclitaxel should be considered an option for extended AC therapy.

In a second largest clinical study in supporting the treatment of positive breast cancer with a similar design, 3060 patients were randomly selected for treatment with 4 AC treatments (NSABP B-28, BMS CA139-270) and then Paclitaxel treatment at a higher dosage of 225 mg/m2. The average monitoring time is 64 months, patients with additional treatment of Paclitaxel supplements decrease significantly 17% of the risk of recurrence from the patient group only treated with AC (P = 0.006); Paclitaxel supplemented patients, which reduced the risk of death to 7% (95% CI: 0.78-1.12). All analysis are favored to benefit patients using Paclitaxel. In this study, patients with tumors with hormone receptors reduce the risk of recurrence to 23% (95% CI: 0.6-0.92); In the division of patients with tumors without hormone receptor recurrence, the disease is reduced by 10% (95% CI: 0.7-1.11).

In the initial treatment of metastatic breast cancer, the efficiency and safety of Paclitaxel are evaluated in two key trials with control, random, phase III.

In the first study (BMS CA139-278), the quick coordination regimen of Doxorubicin injection (50mg/m2) 24 hours from and continued Paclitaxel (220 mg/m2 intravenous infusion in 3 hours) (AT), compared to the standard Fac (5-FU 500 mg/m2, Doxorubicin 50 mg/mg, cyclophamid 500 mg) are applied every 3 weeks for 8 treatments. In this random trial, 267 patients with metastatic breast cancer without chemotherapy before or only Anthracyclin in the additional therapy were involved in the study. The results show that the difference is significant about the progressive disease time of patients treated at AT compared to patients with FAC treatment (8.2 compared to 6.2 months; p = 0.029). The average life time is more about the paclitaxel/doxorubicin group compared to the FAC group (23.0 compared to 18.3 months; p = 0.004). 44% of patients in AT and 48% of FAC patients have a second, 7% chemotherapy for them (AT group) and 50% (FAC) are treated with Taxan. The general response rate is significantly higher in the AT group compared to the FAC group (68% compared to 55%). The general response rate is 19% of patients in Paclitaxel/Doxorubicin group compared to 8% of the FAC group. All results of the effectiveness of the drug were later confirmed in an independent and blind assessment.

In the second main study, the effectiveness and safety of Paclitaxel when combined with trastuzumab are determined while separating the groups of the research of Ho648G (metastatic breast cancer patients with anthracycline support). The effect of trastuzumab in coordinating with Paclitaxel in untreated patients with anthracyclin support has not been proven. The combination of trastuzumab (4 mg/kg of the first dose then 2 mg/kg per week) and Paclitaxel (175 mg/m2) intravenously for 3 hours, every 3 weeks compared to the single paclitaxel (175 mg/m2) of intravenous infusion for 3 hours, every 3 weeks on 188 patients with metastatic breast cancer patients expression expression Her2 (2+ or 3+ Determined by exempted mchiculi) anthracyclin. Paclitaxel is treated every 3 weeks for at least 6 treatments while Trastuzumab is weekly intravenously until the disease progresses. Research shows the obvious benefits of the combination of Paclitaxel/Trastuzumab in terms of progressive disease (6.9 compared to 3.0 months), response rates (41% compared to 17%), and response time (10.5 compared to 4.5 months) when compared to single -therapy Paclitaxel. The most significant toxicity observed from the combination of Paclitaxel/Trastuzumab is the heart dysfunction.

In the treatment of progressive NSCLC, the dose of Paclitaxel 175 mg/m2 then Cisplatin 80 mg/m2 was assessed in two phase III tests (367 patients treated with Paclitaxel). Both tests are randomly, one comparison with cisplatin treatment 100 mg/m2, one uses teniposid 100 mg/m2 then Cisplatin 80 mg/m2 with the control substance (367 comparative group patients).

The results in each test are similar. Regarding the clinical main result of death, there is no significant difference between the treatment regime with Paclitaxel and the control substance (the average life time is 8.1 and 9.5 months for Paclitaxel treatment, 8.6 and 9.9 months for control substances). Similarly, about the time of life without progress, showing no difference between treatment groups. The better clinical response ratio on the group is treated with Paclitaxel. The results of improving the quality of life shows through anorexia also show the benefits of Paclitaxel treatment. Moreover, there are also clear evidence of Paclitaxel treatment for peripheral neuropathy (p

In the treatment of Kaposi Sarcoma in AIDS patients, the effectiveness and safety of Paclitaxel has been assessed in a non -comparative study in the advanced Kaposi Sarcoma patient who previously treated chemotherapy. Clinical assessment indicators are the response of the tumor after treatment. Of the 107 patients, 63 is considered to be resistant to liposom anthracyclin. This group is considered a central group to evaluate the effectiveness of treatment. The general success rate (full/local response) after 15 treatments is 57% (CI 44-70%) in patients resistant to anthracyclin liposom. Over 50% obviously responded after the first 3 treatments. In patients with Anthracycline liposom resistance, the response ratio can be comparable among patients who do not treat protease inhibitors (55.6%) than patients treated with protease inhibitors at least 2 months before Paclitaxel treatment (60.9%). The average time for the disease to progress in the central population group is 468 days (95% CI 257-NE). The average survival time has not been calculated but is 617 days at a lower rate of 95% of the central patient group.

Dynamic pharmacokinetics

When intravenous infusion, plasma concentration is proportional to the dose of intravenous transmission and decreased with 2 -phase graphs.

Paclitaxel's dynamics are determined in Mach static conditions with a period of 3 hours and 24 hours with 135 and 175 mg/m2 doses. The average selling time of the last phase is from 3.0-52.7 hours, while the average value of the body clearance does not depend on 11.6 to 24.0 liters/hour/m2 of the body clearance will decrease when the concentration of paclitaxel in plasma is high. The average distribution volume in a stable state is 198-688 liters/m2, proving that there is a wide distribution outside the blood vessels and/or strongly attached to the tissue. If 3 -hour transmission and increase the dose of Paclitaxel, the increased dose is not linearly related to the increase in pharmacokinetic parameters. If an increase of 30% of the dose, from 135 mg/m2 to 175 mg/m2, then CMAX will increase by 75% of the AUC0-fit value will increase 81%.

After an intravenous infusion of 100 mg/m2 in 3 hours on 19 patients with KS, the average cmax is 1530 ng/ml (about 761–2860 ng/ml variable range) and AC AUC on average 5619 ng/ml (about 2609 - 9428 ng/ml). The clearance is 20.6 l/h/m2 (variable 11-38) and the distribution volume is 291 l/m2 (about 121-638 variables). The average selling time for the last phase is 23.7 hours (variable 12-33 hours).

Very few changes among individuals in Paclitaxel distribution throughout the body. There is no evidence of Paclitaxel accumulation when using many treatments.

In vitro research shows that the drug is attached to 89-98% to protein-human serum. The presence of cimetidin, ranitidin, dexamethasone or diphenhydramin does not affect the cohesion of paclitaxel into the protein.

The distribution of paclitaxel in humans has not been clarified. The average value of the total amount of paclitaxel excretion in urine is only 1.3-12.6% of the dose, proving that there is significant removal without the kidneys. Metabolic through the liver and excretion through bile can be the main mechanism of the elimination of Paclitaxel. Paclitaxel metabolized mainly through the liver by catalysts of cytocrom P450 enzymes. When transmitting Paclitaxel marking, the average of the fertilizer markers are the following metabolites: 26% 6-alpha-hydroxy-paclitaxel, 2% is 3′-P-Dihydroxy-Paclitaxel, and 6% is 6-alpha-3′-P-dhydroxy Paclitaxel. The metabolism to produce these hydroxy metabolites is catalyzed by CYP2C8, CYP3A4 or by these two enzymes. The effect of liver and kidney failure has not been determined on the distribution of Paclitaxel when transmitted 3 hours. The pharmacokinetics parameters achieved from a patient through dialysis are transmitted 3 hours Paclitaxel 135 mg/m2 are in the range of specified parameters in patients without appraisal.

In clinical trials in which Paclitaxel and Doxorubicin treated simultaneously, the distribution and elimination of doxorubicin and the metabolites of the drug are prolonged. The total concentration of doxorubicin in plasma when treating Paclitaxel right after Doxorubicin is 30% higher than when 2 drugs are treated 24 hours apart.

When Paclitaxel coordinates treatment with other therapies, suggest summarizing the characteristics of cisplatin, doxorubicin or trastuzumab for information on how to use these drugs.

Before taking Paclitaxel Ebewe Novartis medicine for ovarian cancer, breast cancer (16.7ml)

How to use

Medicinal use

Like all other anti -cancer drugs, should be cautious when working with Paclitaxel. The drug is only mixed in aseptic condition because experienced medical staff and in specially designed area. Recommended use of protective gloves. Preventive measures should be taken to avoid exposure to skin and mucosa. If Paclitaxel is exposed to the skin, it is necessary to wash and thoroughly exposed to the drug with soap and water. Observed the skin after exposure to itching, burning and redness. If the mucosa is sticky with Paclitaxel, it is necessary to wash the exposed area with water. The phenomenon of shortness of breath, chest pain, burning throat, vomiting when inhaling the drug.

Do not use chemo-dispensing device or similar devices with spearhead due to being able to damage the rubber lid of the vial, leading to no sterile drugs.

Preparation of infusion

Before transmission, dilute Paclitaxel under sterile conditions with isothermic sodium chloride solution 0.9% or 5% glucose solution to the end concentration of 0.3 - 1.2mg Paclitaxel/ml for infusion.

The solution is prepared for transmission to be stable at room temperature within 27 hours. Users are responsible for time and storage conditions. Do not store diluted solution in the refrigerator.

After preparation, the solution may be slightly chiseled due to concentrated solvent; Can not filter. Paclitaxel infusion solution must be filtered through the foam film (in-line filter) with the size of the membrane

Despite rarely recorded the case of precipitation in Paclitaxel infusion, usually at the end of 24 hours of transmission. Although the cause of the precipitate is unclear, it is likely to be due to the level of surgery of the solution after dilution. To reduce the risk of precipitation, Paclitaxel should be used as soon as possible after diluting the solution to transmit, so avoid shaking the drug too strong. The cause n appears precipitate unclear, but it is assumed that this phenomenon is related to the level of overcoming saturation of the diluted solution.

The transmission must be washed carefully before use. During the transmission process, it is advisable to check the infusion regularly and if the precipitate appears, it should be stopped.

To limit the exposure patient with Dehp [BIS (2-AHYLHEXYL) Phthalate] infected from PVC bags containing infusion, the diluted solution of Paclitaxel must be stored in packaging (glass, polyethylen) without PVC or made of PVC and made of polyethylen wires. Filter tools (eg LVEX-2) with short inputs or outputs with PVC do not make the liberation meaning Dehp.

Drug treatment

Paclitaxel is not used and all the tools used to prepare and transmit Paclitaxel or have been in contact with Paclitaxel need to be processed under national/local guidelines for handling toxins.

Dosage

Before Paclitaxel treatment, all patients must use before corticosteroids, antihistamine, and H2 antagonists, etc.

Drugs dose minutes. Minutes

Paclitaxel should be transmitted through a diameter microplastic membrane ≤ 0.22μm.

Initial chemotherapy for ovarian cancer

Dosage dosage mode Paclitaxel and cisplatin is recommended to use. Over intravenously, there are 2 levels of Paclitaxel doses that are recommended: Paclitaxel 175 mg/m2 Injected in 3 hours, followed by Cisplatin 75 mg/m2 3 weeks or Paclitaxel 135 mg/m2 injected 24 hours, followed by Cisplatin 75 mg/m2 to treat about 3 weeks between 2 treatment phases. Other coordination is still researching.

The second chemotherapy for ovarian cancer

The recommended dose of Paclitaxel is 175 mg/m2 for 3 hours, with a period of 3 weeks between 2 phases.

Support treatment in breast cancer

The recommended dose of Paclitaxel is 175 mg/m2 for 3 hours, 3 weeks 1 batch in 4 phases after AC treatment.

Initial chemotherapy for breast cancer

When used in combination with doxorubicin (50 mg/m2), Paclitaxel is indicated for 24 hours after use doxorubicin. The recommended dose of Paclitaxel is 220 mg/m2 of intravenous infusion for 3 hours, about 3 weeks between the batches.

When used in combination with trastuzumab, the recommended dose of Paclitaxel is 175 mg/m2 intravenously for 3 hours, about 3 weeks between batches. Paclitaxel intravenous infusion may start right after taking the first dose trastuzumab or right after taking the next dose of trastuzumab if the previous dose of trastuzumab is well tolerated (to know the specific dose of trastuzumab see the characteristics of trastuzumab).

The second chemotherapy of breast cancer

The recommended dose of Paclitaxel is 175 mg/m2 of intravenous infusion for 3 hours with a distance of 3 weeks between batches.

Progressive NSCLC treatment

Paclitaxel 175 mg/m2 for 3 hours, followed by Cisplatin 80 mg/m2; There is a period of 3 weeks away from 2 times.

Sarcom Kaposi treatment in AIDS patients

The recommended dose of Paclitaxel is 100 mg/m2 intravenously in 3 hours, every 2 weeks.

The next dose of Paclitaxel should be indicated according to the ability to tolerate drugs of individuals.

Paclitaxel should not be reduced until neutral leukocytes ≥1,500/mm3 (≥1,000/mm3 for KS patients) and platelets> 100,000/mm3 (> 75,000/mm3 for KS patients). Patients have severe neutropenia (neutropenia Patients with liver failure

There is no adequate data on the change of dosage regime in patients with mild to moderate liver failure. Patients with severe liver failure should not be treated with Paclitaxel.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose?

In case of overdose, patients need to be closely monitored. Treatment should be directed at the predictable main toxic toxicity, which includes bone marrow inhibition, peripheral nerve and mucous inflammation.

Overdose in children can be related to ethanol's acute toxicity.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

Except for the case, the following discussions refer to the general safety database of about 812 patients with solid tumors for single -therapeutic Paclitaxel treatment in clinical studies. Because the group of KS patients is very special, a separate part is based on 100 research patients given at the end of this section.

The frequency and severity of unwanted effects are generally similar among patients using Paclitaxel for treating ovarian, breast cancer, or NSCLC cancer patients. There is no association between age and weight of side effects.

The most common side effect is bone marrow failure. The phenomenon of severe neutrophils ( 7 days. Platelet reduction appears over 11% of patients. 3% of patients have the lowest platelet number

Neurotoxicity, mainly peripheral neuropathy, seems to be more common and worse when injecting 175 mg/m2 Paclitaxel for 3 hours (85% of nerves, 15% severe) compared to 135 mg/m2 intravenous infusion for 24 hours (25% of peripheral neuropathy, 3% severe) in combination with cisplatin. In patients with NSCLC and ovarian cancer patients treat Paclitaxel for 3 hours then use cisplatin, the incidence of severe nerve toxicity increases significantly. Peripheral neuropathy can occur after the first treatment and may be worse when continuing to use Paclitaxel. Peripheral neuropathy is the cause of stopping using Paclitaxel in a few cases. Sensory symptoms are often improved and recovered within a few months after stopping Paclitaxel treatment. The previous neurological diseases due to previous therapies are not a contraindication of Paclitaxel treatment.

joint pain or muscle pain affects 60% of patients of which 13% of patients are severe.

Clear sensitivity reactions can lead to death (including hypotension that needs treatment, angioedema, respiratory disorders that need to be treated with bronchiectasis, or pervasive urticaria) occurs in 2 cases (

The response to the injection site while intravenous infusion can lead to local edema, pain, erythema, and hard; Moreover, vascular drainage can cause cellular inflammation. Peeling and/or skin peeling have been reported, sometimes related to vascular exit. Pigmentation disorders can also occur. The recurrence of skin reactions at a previous exit position after using Paclitaxel in another position in other words is called "recall" rarely encounter. Special treatment for vascular drainage reactions has not been clarified.

Unwanted effects regardless of the severity associated with the treatment of single -treatment Paclitaxel infusion in 3 hours in metastatic state (about 800 patients treated in clinical trials) and as reported during the monitoring after circulation of Paclitaxel.

The frequency of the side effects listed below uses the following convention:

Very common (≥1/10); Common (≥1/100 to

Infections and parasites

Very common: infection (mainly urinary tract infection and gastrointestinal tract), with some cases of death reports.

Very common: marrow failure, neutropenia, anemia, thrombocytopenia, leukopenia, bleeding

Very common: Mild sensitivity reactions (mainly flushed and rash). Ve.

Very rare: Anaphylaxis.

Very rare: Anorexia.

Mental disorders

Very rare: Confusion.

Nervous system disorders

Very common: neurotoxicity (usually peripheral neuropathy).

Very rare: optic nerve disorders and/or vision (flashing point) in patients treated higher than recommendations.

Very rare: Poison with hearing, bad hearing, tinnitus, dizziness.

Common: Slow heart rate.

Very common: Hypotension.

Rare: Difficulty breathing, overflowing embryos, interstitial pneumonia, pulmonary fibrosis, coordinated congestion, respiratory failure.

Very rare: Cough.

Very common: nausea, vomiting, diarrhea, mucositis

Very rare: liver necrosis, hepatic brain disease (both have death reports).

Skin and subcutaneous tissue disorders

Very common: hair loss. pins).

Very common: muscle pain, joint pain.

Common: The response to the injection site (including local edema, pain, erythema, hardness, exit leads to cellular inflammation, skin fibrosis and skin necrosis).

Common: High AST increases (SGOT), Alkalin Phosphatase increases. joints, anemia, infection, fever, nausea/vomiting and diarrhea than patients only treat AC. However, the frequency of these side effects is suitable for solitary Paclitaxel treatment, as mentioned above.

Coordination treatment

The following discussions refer to the clinical trials in the first treatment of ovarian cancer (Paclitaxel + Cisplatin: Over 1050 patients), 2 phase III tests in the initial treatment of metastatic breast cancer: A study of coordination with Doxorubicin (Paclitaxel + Doxorubicin: 267 patients), a research test of coordination with the distribution of group (Analysis Paclitaxel + Trastuzumab: 188 patients) and 2 phase III tests for progressive NSLC treatment (Paclitaxel + Cisplatin: Over 360 patients). When intravenous infusion for 3 hours for the initial treatment of ovarian cancer, neurotoxicity, muscle aches/joint pain, and sensitivity in patients with Paclitaxel treatment patients then use cisplatin with higher and worse frequency in patients with cyclophosphamide treatment and then cisplatin. The phenomenon of paclitaxel intravenous infusion for 3 hours after using cisplatin is less common and lighter than using cyclophosphamide and then using cisplatin.

In the first chemotherapy for metastatic breast cancer, neutropenia, anemia, peripheral neuropathy, muscle pain/joint pain, weakness, fever, and diarrhea reported to have a higher frequency and severe frequency when infusion of Paclitaxel (220 mg/m2) in 3 hours after 24 hours after Doxorubicin infusion (50 mg/m2) compared to 5-Facu 500 mg/m2 mg/m2 mg/m2 mg/m2 mg/m2 mg/m2 mg/m2 mg/m2 mg/m2 doxorubicin 50 mg/m2, cyclophosphamid 500 mg/m2). Nausea and vomiting in Paclitaxel mode (220 mg/m2)/doxorubicin (50 mg/m2) are less common and lighter than the standard facing FAC therapy. The use of corticosteroids can contribute to reducing the frequency and severity of vomiting and nausea of the Paclitaxel/Doxorubicin treatment.

When Paclitaxel intravenously in 3 hours in combination with Trastuzumab in the first treatment for patients with metastatic breast cancer, the following side effects (may be related to Paclitaxel or Trastuzumab) are reported more commonly than Paclitaxel Single Therapy: Heart failure (8% compared to 1%), infection (46% compared to 42%) (47% compared to 23%), cough (42% compared to 22%), rash (39% compared to 18%), joint pain (37% compared to 21%), fast heartbeat (12% compared to 4%), diarrhea (45% compared to 30%), increased tone (11% compared to 3%), nosebleeds (18% compared to 4%), folliculitis (11% compared to 3%). (13% compared to 3%), insomnia (25% compared to 13%), rhinitis (22% compared to 5%), sinusitis (21% compared to 7%), and in the injection site (7% compared to 1%). Some cases in these differences may be due to the number and periods of treatment for combination of Paclitaxel/Trastuzumab compared to single -treatment Paclitaxel. Some severe reactions are recorded in the same ratio in both groups of Paclitaxel/Trastuzumab and single -treatment Paclitaxel treatment.

When doxorubicin is used in combination with paclitaxel in metastatic breast cancer, observed abnormal heart muscle (reduced ≥ ≥ 20% of the rate of left ventricular blood) over 15% of patients compared to 10% of patients using standard facing regimens. Hemorrhagic heart failure is noticed in

irradiation pneumonia is reported in patients treated at the same time with radiation therapy.

Sarcom Kaposi is related to AIDS

Except for the side effects on the liver and blood (see below), the frequency and extent of the side effects are similar between the group of KS patients and patients with Paclitaxel treatment for solid tumors, based on a clinical study including 107 patients.

Blood disorders and lymphatic systems: Bone marrow failure is a toxicity mainly depending on the dose. Neutral leukemia is the most important toxicity in the blood. During the first treatment, severe neutropenia ( 7 days over 41% and in 30-35 days over 8% of patients. It recovers within 35 days in all patients being monitored. The incidence of neutropenia reduction level 4 lasts ≥ 7 days is 22%.

Paclitaxel neutropenia fever is recorded over 14% of patients and in 1.3% of treatment. There are 3 cases of infection (2.8%) while using Paclitaxel related to death drugs.

Platelets are noticed more than 50% of patients, and severe (

Anemia (HB

Liver disorders: Among patients (> 50% have normal protease inhibitors) have normal liver function, 28%, 43% and 44% have bilirubin, alkalin phosphatase and AST (SGOT) respectively. For each of these parameters, the degree of severity is over 1% of patients.

Notify the physician with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Paclitaxel "eBewe" contraindicated in the following cases:

Contraindicated Paclitaxel in patients with a history of serious hypersensitivity reactions for the active ingredient or any other ingredient of the preparation, especially with Polyoxyl castor oil. KS).

Be cautious when used

Paclitaxel is only used under the close supervision of a specialist physician with experience in chemical anti -cancer therapy. Because it is possible to encounter hypersensitivity reactions, it is necessary to have appropriate support devices.

Due to the ability to escape vessels, the drug is recommended to closely monitor the infection that may occur at the transmission position.

Before using Paclitaxel, it is necessary to use for patients with corticosteroids, antihistamines, H2 antagonists, when combined with cisplatin, paclitaxel must be used before cisplatin.

Disclosure hypersensitivity reactions that have difficulty breathing, hypotension need to be treated, can be angiography and spreading urticaria, common in

Bone marrow failure (first of all neutropenia) has a toxicity depending on the dose. During Paclitaxel transmission time, always monitor blood formula. Patients must not use the drug until neutrophils reach ≥1,500/mm3 (≥1,000/mm3 for KS patients) and platelets reaching ≥100,000/mm3 (≥75,000/mm3 for KS patients). In KS clinical research, most patients use the elevation of endogenous granulocytes (G-CSF).

Patients with liver failure may have a higher risk of toxicity, especially 3-4. There is no evidence that Paclitaxel's toxicity increases when infusion for 3 hours for patients with mild liver dysfunction. When Paclitaxel has a longer intravenous transmission, the phenomenon of severe marrow failure can be seen in patients with medium to severe liver failure. It is necessary to strictly control the development of myeloma. There is no data on recommendations to change the dose in patients with medium to severe liver failure.

There is no data on patients with severe biliary stasis. Patients with severe liver failure should not use Paclitaxel.

Serious abnormalities in the rare heart transmission in Paclitaxel monitor, but if the patient is clearly abnormal on heart transmission during the period of using Paclitaxel, it is necessary to take appropriate treatment and always monitor the heart when continuing to use Paclitaxel. When using Paclitaxel, there is hypotension or hypertension, slow heart rate, often the patient has no symptoms and often does not require treatment. Need to regularly monitor the signs of life, especially serious during the first hour when transmitting Paclitaxel. The more serious cardiovascular phenomena in patients with NSCLC are for patients with breast or ovarian cancer. A case of heart failure related to Paclitaxel was discovered in a clinical study on AIDS-KK.

When using Paclitaxel combination with doxorubicin or trastuzumab in the initial chemotherapy, breast cancer is metastatic, should pay attention to the heart function. When patients are indicated for Paclitaxel treatment in these drug combinations, they need to be evaluated on cardiovascular basically including history, clinical examination, ECG, echocardiography and/or Muga scan. Heart function should be monitored more closely throughout the treatment process (for example every 3 months). The supervision can help identify patients with heart dysfunction and treatment doctor should have a thorough assessment of anthracyclin's accumulation of treatment (mg/m2) when making a decision on the frequency of ventricular function assessment. It is necessary to assess the decline of heart function, even if there are no symptoms, doctors should carefully assess the clinical benefits of treatments rather than the ability to cause heart damage including lesions that may not recover. If there are additional therapies, the control of the heart function should be conducted more often (for example after 1-2 treatments). For more information, to summarize the product characteristics of Herceptin® or Doxorubicin.

Despite the common peripheral neuropathy, there is rarely serious symptoms. In severe cases, it is recommended to reduce 20% of the dose (25% for KS patients) in all the next use of Paclitaxel. For patients with NSCLC and patients with ovarian cancer initially treated, the coordination of Paclitaxel intravenous infusion for 3 hours with Cisplatin will increase the severity of the toxicity when compared to Paclitaxel alone and cyclophosphamide treatment after cisplatin.

Particularly be careful to avoid paclitaxel injection into the artery because in animal studies on local tolerance, heavy tissue reactions are noticeable after getting into the artery.

Paclitaxel in combination with lung irradiation, regardless of time sequence, can contribute to the development of interstitial pneumonia.

Rare fake conjunctivitis includes cases where patients are not treated in combination with antibiotics. This reaction should be considered while distinctive diagnosis of severe or prolonged diarrhea occurs during the process or a short time of Paclitaxel treatment.

In patients with rare mucous inflammation. If serious reactions occur, Paclitaxel dose should be reduced to 25%.

Because Paclitaxel contains ethanol (396 mg/ml), central nervous and other effects may be encountered.

The effect of the drug on the ability to drive and operate machinery

No proof of Paclitaxel's influence on this possibility. However, be careful because the product contains Alcohol.

Use drugs for women during pregnancy and lactation

Pregnant women:

There is no information on using Paclitaxel in pregnant people. Paclitaxel is indicated for embryo and teratogenicity in rabbits, and reduces mouse fertility.

As well as other cell poison, Paclitaxel can be harmful to the fetus when used in pregnant women. Therefore, Paclitaxel should not be used during pregnancy unless necessary. Women who are likely to get pregnant and have used Paclitaxel should be advised to avoid pregnancy and need to notify the doctor for treatment right after pregnancy.

Patients with men and women of reproductive age and/or their partners should use contraception at least 6 months after treatment with Paclitaxel.

Male patients should find advice on sperm reserve before treatment with Paclitaxel for infertility.

breastfeeding women:

Contraindicated using paclitaxel when breastfeeding. It is not clear whether Paclitaxel is excreted through breast milk. Should stop breastfeeding during treatment.

Drug interaction

Paclitaxel's clearance is not affected when using cimetidin earlier.

Paclitaxel's recommended dosage mode in the initial chemotherapy for ovarian cancer is for paclitaxel before cisplatin. When Paclitaxel is used before cisplatin, the safety properties of Paclitaxel are equivalent to the safety of solitary Paclitaxel. When Paclitaxel is used after cisplatin, the patient has a more severe marrow failure and reduces nearly 20% of the clearance. Patients treated with Paclitaxel and Cisplatin may be at higher risk of renal failure than using solitary cisplatin in gynecological cancer.

Due to the exhaust activity of doxorubicin and its active metabolites may be reduced when Paclitaxel and Doxorubicin are treated in the near future, so Paclitaxel used in the initial chemotherapy for metastatic breast cancer should be used 24 hours after using Doxorubicin.

Metabolism of Paclitaxel is partially catalyzed through Cytocrom P450 (isenzyme CYP2C8 and 3A4) (please read the pharmacokinetic section). Clinical research proves that Paclitaxel metabolizes through CYP2C8 to form 6-α-hydroxypaclitaxel, which is the main metabolism path in humans. When used in combination with ketoconazole, it is also a metabolic substance through CYP3A4, it does not inhibit the elimination of Paclitaxel in patients, so they can share these two drugs without adjusting the dose. Lack of data on the effect of drug interactions between Paclitaxel and other substrates or with CYP3A4 inhibitors. Therefore, it is necessary to be cautious when using Paclitaxel with the familiar substrates or inhibitors of CYP2C8 or 3A4 (such as erythromycin, fluoxetin, gemfibrozil) or touch (such as rifampicin, carbamazepin, phenytoin, phenobarbital, efavirenz, nevirapin).

Studies in patients with KS use a lot of drugs at the same time suggest that the body clearance of Paclitaxel is noticeably lower in Nelfinavir and Ritonavir, but not for Indinavir. There is no full information about interacting with other protease inhibitors. Therefore, Paclitaxel should be carefully indicated in patients treated simultaneously with protease inhibitors.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

Other drugs

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