Anzatax solution 150mg/25ml pfizer treat ovarian cancer, breast cancer (25ml)

Dosage form Box x 25ml
Specifications Paclitaxel
Ingredient 3M Healthcare., Ltd

Ingredient

Composition informationContent
Paclitaxel150mg

Uses

Indications

Ovarian cancer:

The first chemotherapy for ovarian cancer, Paclitaxel is indicated for treatment for patients with progressive or malignant cell storage (> 1cm) after the initial surgical procedure, combined with Cisplatin.

In the replacement chemotherapy of ovarian cancer, Paclitaxel is indicated for the treatment of ovarian cancer after the treatment regimen fails.

Breast cancer:

In supportive treatment, Paclitaxel is indicated for treatment of positive breast cancer patients after treatment with anthracycline and cyclophosphamide (AC). Paclitaxel support treatment should be considered an alternative for extended AC therapy.

Paclitaxel is indicated for initial treatment for local or metastatic breast cancer, combined with anthracycline in patients suitable for Anthracycline treatment, or in combination with trastuzumab, in patients with 2-epidermal growth factor in humans (Her-2) in Level 3+ is determined by immunominalization and inappropriate with Anthracycline.

As a single treatment agent, indicated for metastatic breast cancer treatment in patients who do not respond to Anthracycline ice standard or not suitable for Anthracycline treatment.

Progressive non -cell lung cancer (NSCLC):

Paclitaxel, combined with cisplatin, is indicated for treatment of non -small cell lung cancer in patients who are unable to interfere with surgical intervention and/or radiation.

Sarcoma Kaposi (KS) related to AIDS: Paclitaxel is indicated for treatment of patients with Sarcoma Kaposi related to Tien Trien ATDS that has failed in the previous Anthracycline liposome.

There are little data on this indication support effect; Summary of relevant studies shown in section 5.1.

Pharmacokology

Paclitaxel is an anti -micro -pipe agent by stimulating the DIME Tubulin overlapping process to form microscopic and stabilize the virus due to inhibition of coincidence. This stability inhibits the normal reorganization of the microscopic network that is very important in the time of the cell division decreasing and the cell division function of the cell. In addition, Paclitaxel stimulates abnormal patches or bundles throughout the cell cycle and many micro -stars during the cell division.

Effective and clinical safety:

Please see more information about the drug in the instruction sheet of the drug attached.

Dynamic pharmacokinetics

Absorb: After being used by intravenous lines, Paclitaxel concentration in plasma decreases with 2 -phase graphs.

Paclitaxel pharmacokinetics are determined after 3 hours of infusion and 24 hours of 135 and 175 mg/m2 doses. The average selling time is between 3.0 hours and 52.7 hours and the non -zoning value for the entire clearance between 11.6 and 24.0 l/h/m2. The whole clearance seems to decrease when the plasma medication concentration is higher. The integral distribution in the average stable state between 198 and 688 l/m2, showing wide and/or tissue -linked external distributions. The increase in dosage related to infusion in 3 hours leads to non -linear pharmacokinetics. When increased by 30% from 135 mg/m2 to 175 mg/m2, the maximum plasma concentration (mmax) increased by 75% and the area under the time curve of plasma concentrations (AUCₒ) increased by 81%.

The level of change of the whole Paclitaxel concentration in the same patient is not significant. There is no sign of accumulated effects for Paclitaxel associated with many treatments.

Distribution: In vitro research on serum protein bonds shows 89-98% Paclitaxel linked to protein. No cimetidine, ranitidine, dexethasone or diphenhydramine affects paclitaxel protein bonds.

Biological metabolism and elimination: Paclitaxel distribution and metabolism in humans have not been fully studied. Paclitaxel's accumulated excretion in the urine in the middle between 1.3% and 12.6% of the average dose, showing that the exterior clearance is wide. Metabolic in the liver and clearance in bile can be the main mechanism for eliminating Paclitaxel. Paclitaxel is mainly metabolized by CYP450 enzyme. On average, 26% of Paclitaxel dose is marked by radiation eliminated in feces in the form of 6ɑ-hydroxypaclitaxel, 2% under 3'P-dihydroxypaclitaxel and 6% in the form of 6ɑ-3'P-dihydroxypitaxel. 6ɑ-Hydroxypaclitaxel is formed by the effect of CYP2C8, 3P-Hydroxypaclitaxel by CYP3A4 and 6ɑ-3'P-Dihydroxypaclitaxel by CYP2C8 and CYP3A4. Effects of renal failure or liver failure on paclitaxel excretion after infusion in 3 hours have not been studied. The pharmacokinetic parameters of an artificial dialysis patient have the same values ​​as in patients without dialysis when the rate of drug use is 135 mg/m2 Pactaxel through the infusion in 3 hours.

After infusion of 100 mg/m2 Paclitaxel for 3 hours in 19 KS patients, the average cmax is 1,530 ng/ml (about 761 - 2,860 ng/ml) and the average AUC 5.619 ng. The clearance is 20.6 l/h/m2 (about 11-38) and the distribution volume is 291 l/m2 (about 121 - 638). The average disposal time is 23.7 hours (about 12 - 33).

In clinical trials that Paclitaxel and Doxorubicin are simultaneously used, the distribution and elimination of doxorubicin and metabolites of doxorubicin are prolonged. The total serum concentration of doxorubicin is 30% higher when using Paclitaxel immediately after Doxorubicin compared to when there is a 24 -hour gap between 2 drugs. For the use of Paclitaxel in combination with other therapies, please refer to the product summary of Cisplatin, Doxorubicin or Trastuzumab for information about the use of these drugs.

Before taking Anzatax solution 150mg/25ml pfizer treat ovarian cancer, breast cancer (25ml)

How to use

must be cautious before manipulating or infusion.

The concentrated solution mixed with the infusion solution must be diluted before use and only used by intravenously.

Dosage

Medicines needed before chemotherapy: All patients must be given drugs including corticosteroids, antihistamine drugs and H2 receptor antagonists before using Paclitaxel, to prevent serious hypersensitivity reactions. The medications that need to be taken before chemotherapy may include:

Table 1: The process of drugs to be used before chemotherapy

Medicines need to be used Dosage Usage time before using Palitaxel 12 and 6 hours

Intravenous infusion: 30 to 60 minutes

diphendramine *** 50 mg IV 30 to 60 minutes

50 mg IV

30 to 60 minutes

** Intravenous infusion

*** or an antihistamine is equivalent to chlorpheniramine 10 mg intravenous injection 30 to 60 minutes before using Paclitaxel.

Paclitaxel should be given through the filter in the line with micro -membrane

Due to the ability to exit the medication, it is advisable to closely monitor the infusion position to see if there is the ability to escape during the transmission.

First treatment for ovarian cancer: Despite the replacement drug regimen for Paclitaxel, which is currently being studied, Paclitaxel and Cisplatin combining therapy is recommended to use.

Depending on the time of infusion, two different doses are recommended for Paclitaxel treatment: 175 mg/m2 Paclitaxel intravenous injection for three hours later 75 mg/m2 cisplatin and the next treatment is repeated after 3 weeks, or 135 mg/m2 Paclitaxel intravenous injection in the next 24 hours of 75 mg/m2 Cisplatin (see section 5.1).

Alternative treatment for ovarian cancer: The dose of promotion for Paclitaxel is 175 mg/m2 for 3 hours, with a 3 -week distance between batches.

Chemotherapy supports breast cancer: The recommended dosage for Paclitaxel is 175 mg/m2 for 3 hours in 4 times, 3 weeks per batch, after AC therapy.

First chemotherapy for breast cancer: When used in combination with doxorubicin (50 mg/m2), Paclitaxel should be used 24 hours after using Doxorubicin. The recommended dosage for Paclitaxel is 220 mg/m2 of intravenous injection for 3 hours, with a 3 -week distance between phases.

When used in combination with trastuzumab, the recommended dose for Paclitaxel is 175 mg/m2 intravenous injection for 3 hours, with a 3 -week distance between batches. Paclitaxel infusion may start the next day after the first dose of trastuzumab or immediately after the next dose of trastuzumab if the previous dose of trastuzumab is well tolerated.

Chemotherapy instead of breast cancer: The recommended dose for Paclitaxel is 175 mg/m2 for 3 hours, with a 3 -week distance between batches.

Aara non -cell lung cancer: The recommended dosage for Paclitaxel is 175 mg/m2 for 3 hours later, 80 mg/m2 Cisplatin, with a 3 -week distance between batches.

KS treatment related to AIDS: The recommended dose for Paclitaxel is 100 mg/m2 of intravenous injection for 3 hours every two weeks.

Dosage adjustment: The next dose of Paclitaxel should be used according to the ability of each patient to tolerate. Do not continue to use Paclitaxel until the number of neutral leukocytes is> = 1.5 x 10ꝰ/1 x (> = 1 x 10ꝰ/1 for KS patients) and the number of platelets is> = 100 x 10ꝰ/1 (> = 75 x 10ꝰ/1 for KS patient).

Patients with severe neutropenia (Number of neutrophils Patients with liver failure: There is no sufficient research on the adjustment of the dose in mild and medium liver failure patients. Paclitaxel should not be used for severe liver failure.

Used in children: It is not recommended to use Paclitaxel in children under 18 years old because there is not enough data for safety and efficiency.

What to do when using overdose?

In case of overdose, patients need to be closely monitored. Treatment should be directed to the expected toxic toxicity, which includes bone marrow inhibition, peripheral nerve toxicity and mucositis.

Overdose in children can accompany acute ethanol poisoning.

What to do when forgetting a dose?

Side Effects

Unless otherwise noted, the following discussion refers to the overall safety database of 812 patients with solid tumors treated with single Paclitaxel in clinical studies. Because the group of KS patients is very specific, the report is based on a clinical study with 107 KS patients presented at the end of this section.

The frequency and severity of unwanted effects, except for the case, is generally similar among patients who are taking Paclitaxel to treat ovarian cancer, breast cancer, or non -small cell lung cancer. No toxicity is clearly affected by age.

The most unwanted unwanted effect is the bone marrow inhibitor . Serious neutropenia ( = 7 days, platelets are reported in 11% of patients. Three percent of patients with the lowest number of platelets

Neurotoxicity , mainly peripheral neuropathy , often appears more and more serious at a dose of 175 mg/m2 injected in 3 hours (85% of neurotoxins, 15% serious) compared to the dose of 135 mg/m2 infusion in 24 hours (25% of peripheral neuropathy, 3% serious) when Paclitaxel is combined with Cisplate. In patients with non -cell lung cancer and in patients with ovarian cancer, Paclitaxel treated for 3 hours later is Cisplatin, which has significantly increased the proportion of serious nerve toxicity. Peripheral neuropathy can occur after the first treatment and may be more serious when increasing Paclitaxel levels. Peripheral neuropathy is a cause of paclitaxel treatment in some cases. Sensory symptoms are often improved or resolved within a few months after paclitaxel stops. The previous neuralgia, the result of previous therapies, is not a contraindication to Paclitaxel treatment.

joint pain or muscle pain affect 60% of patients and seriously in 13% of patients.

A significant hypersensitivity reaction can be fatal (defined as hypotension that needs treatment, angioedema, difficulty respiratory need to be treated with bronchodilators, or body urticaria) occurs in two (

thirty -quarter percent of patients (17% of all treatments) have mild hypersensitivity reactions. These mild reactions, mainly blushing and rash, do not need treatment intervention and do not prevent continued treatment with Paclitaxel.

The reaction at the injection site while intravenous injection can lead to local edema, pain, erythema, and hard bottle; Sometimes, exit can lead to cellular inflammation. Peeling and/or skin peeling have been reported, sometimes related to vascular exit. There may also be skin discoloration. The reactions on the skin recur at the previous escape circuit after using Paclitaxel in another place, in other words being "recalled", rarely reported.

There is no special treatment for vascular escape reactions at this time.

In some cases, the response to the injection site occurs during prolonged infusion or then from one week to 10 days.

Disseminated intravascular coagulation (DIC), often accompany blood infections or multiple organ failures, have been reported.

Hair loss: Observe hair loss in 87% of patients and suddenly onset. Significant hair loss> = 50% is expected for most patients with hair loss.

The following table lists unwanted effects regardless of the severity of the use of Paclitaxel for three hours to treat metastases (812 patients treated in clinical research) and according to Paclitaxel's post -circulating monitoring report.

The frequency of unwanted effects listed below is defined according to the following convention:

Very common (> = 1/10); Common (> = 1/100, = 1/1,000, = 1/10,000, Infection and parasitic infection: is very common: infections (mainly urinary tract infections and upper respiratory tract infections), reports on death cases. Blood bacteria. Fever.

Unknown: Disseminated internal blood clotting (DIC).

] Abdominal, headache, sweating, and high blood pressure). Nursing: Rare*: Dehydration. Mix. intestines and hypotension), large epilepsy, convulsions, brain disease, dizziness, headache, loss of air conditioning. Clear*: Phu Hoang Diem, dizziness, lens floating seeds. Slowly. > vascular disorders: is very common: reducing blood pressure. > Respiratory disorders, chest and mediastinum: Rare*: Difficulty breathing, pleural effusion, interstitial pneumonia, pulmonary fibrosis, pulmonary embolism, respiratory failure. flow. Meet*: Hepatic necrosis, liver disease (both have reports on death). Ban, Red Ban.

Nails (patients who are being treated should wear sunscreen for hands and feet)

musculoskeletal and connective tissue disorders: very common: joint pain, muscle pain. Meeting: Mucus inflammation. Experiment: Common: sharply increasing aminotransferase (AST & ALT) (glutamic oxaloacetic transaminase in serum (SGOT)), sharply increasing alkaline phosphatase. Blood. However, the frequency of these events is suitable for the use of alone Paclitaxel, as reported above.

combined treatment

The following discussion refers to the two major trials of the first chemotherapy for ovarian cancer (Paclitaxel + Cisplatin: more than 1050 patients); Two stage III trials in the first treatment for metastatic breast cancer: A study combined with doxorubicin (Paclitaxel + Doxorubicin: 267 patients), and a study used in combination with trastuzumab (expected group analysis, Paclitaxel - Trastuzumab: 188 patients) and two stage III testing tests for small cell cancer treatment (Paclitaxel + Cisplatin: more than 360 patients).

When used through three hours of infusion for first chemotherapy for ovarian cancer, neuromuscular, joint pain/muscle pain, and fertilizer is reported as more frequently and seriously in patients treated with Paclitaxel, then cisplatin than patients treated with cyclophosphamide, then cisplatin. The marrow failure seems to be less often and less serious when injecting Paclitaxel in three hours later, Cisplatin compared to using cyclophosphamide then cisplatin.

For first chemotherapy for metastatic breast cancer, neutropenia, anemia, peripheral neuropathy, joint pain/muscle pain, weakness, fever, and diarrhea have been reported more often and at a more serious degree when Paclitaxel (220 mg/m2) is used through infusion in 3 hours 24 hours after Doxorubicin (50 mg/m2) doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2). Nausea and vomiting seem to be less often and less serious with the Paclitaxel regimen (220 mg/m2)/Doxorubicin (50 mg/m2) compared to the standard FAC regimen. Using corticosteroids may have contributed to the lower frequency and severity of nausea and vomiting when using Paclitaxel/Doxorubicin.

When Paclitaxel is used through 3 hours of injection when combined with trastuzumab to treat first treatment for metastatic breast cancer patients, the following events (regardless of the relationship with Paclitaxel or Trastuzumab) have been reported more frequently than Paclitaxel alone: ​​Heart failure (8% compared to 1%), infection (46% compared to 27%) 4%), fever (47% compared to 23%), cough (42% compared to 22%), rash (39% compared to 18%), joint pain (37% compared to 21%), fast heart rate (12% compared to 4%), diarrhea (45% compared to 30%), increased exotage (11% compared to 3%), nosebleeds (18% compared to 4%), acne compared to 3%) 3%), injury due to accidents (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 of these frequency differences may be due to the amount and treatment time when combining Paclitaxel/Trastuzumab compared to the single Paclitaxel. Serious events are reported at the same proportion for Paclitaxel/Trastuzumab and Paclitaxel alone.

When doxorubicin is used in combination with Paclitaxel in metastatic breast cancer, abnormal heart muscle spasm (> = 20% reduces left ventricular blood expenses) which are observed in 15% of patients compared to 10% with standard facing regimen. congestive heart failure has been observed at heart dysfunction compared to patients treated with solitary Paclitaxel (New York Heart Association (NYHA) Group I/II 10% compared to 0%; NYHA Group III/IV 2% compared to 1%) Turn off the product characteristics of trastuzumab). In all cases except for rare cases, patients respond to appropriate medical treatment.

Radiation pneumonia has been reported in patients with concurrent radiation.

Sarcoma Kaposi is related to AIDS

Except for unwanted effects on blood and liver (see below), the frequency and severity of the unwanted effects are generally similar between KS patients and patients treated with Paclitaxel monomers for other solid tumors, based on clinical research including 107 patients.

Blood disorders and lymphatic systems : Bone marrow inhibition is a significant dosage dependent toxicity. Neutral leukemia is the most significant toxicity on the blood. During the first treatment, severe neutropenia ( 7 days at 41% and for 30-35 days in 8% of patients. This condition is relieved within 35 days in all patients being monitored. The ratio of neutropenia level 4 extends> = 7 days is 22%.

Pacliraxel -related neutropenia is reported in 14% of patients and at 1.3% of the treatment cycle. There are 3 bacterial infections (2.8%) leading to death during the use of Paclitaxel.

Observed platelets have been observed in 50% of patients, and are serious (

Anemia (HB

Bile disorders: among patients (> 50% use protease inhibitors) with normal liver function initially, 28%, 43% and 44% respectively increase bilirubin, alkaline phosphatase and AST (SGOT). For each of these parameters, significantly increased in 1% of cases.

Report unexpected effects

Reporting unwanted effects after pharmaceuticals is very important. This allows to continue monitoring the benefits/risks of pharmaceuticals.

Warnings

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

Contraindicated

Contraindicated using Paclitaxel in patients with severe hypersensitivity reactions to Paclitaxel, Macrogolglycerol Ricinoleate (Polyoxyl castor oil) or any ingredients of the drug.

Paclitaxel is contraindicated in nursing women.

Do not use Paclitaxel in patients with initial neutropenia

Contraindicated Paclitaxel in Kaposi’s Sarcom patients and seriously and uncontrolled infection.

Patients with severe liver failure are not treated with Paclitaxel.

Caution when using

paclitaxel should be used under the supervision of medical staff who have experience in using cancer chemicals. Due to heavy hypersensitivity reactions, it is available, so the appropriate support equipment is available.

Due to the ability to exit the medication, it is advisable to closely monitor the infusion position to see if it is possible to escape the pulse while transmitting.

Patients must be used corticosteroids, antihistamine and H2 antagonists before treatment with paclitaxel.

Paclitaxel should be used before cisplatin when used combined.

Serious hypersensitivity reactions, characterized by shortness of breath and hypotension that need treatment, angioedema, body urticaria has occurred in

Bone marrow inhibitor, mainly reduces neutropen blood cells, is the toxicity of the dose limit. Should regularly monitor blood recipe. Do not re -treat until the number of neutral leukemia> = 1.5 x 10ꝰ/1 (> = 1 x/10ꝰ/1 for patients KS) and the amount of platelet restoring is recovered> = 100 x 10ꝰ/1 (> = 75 x 10ꝰ/1 for KS patient). In KS clinical research, most patients are used to stimulate granulocytes (G-CSF).

Serious heart transmission abnormalities are rarely reported when using single -single Paclitaxel. If the patient generates significant transmission abnormalities while using Paclitaxel, appropriate treatment must be conducted and continuous heart monitoring in the next treatment with Paclitaxel.

Observed hypotension, hypertension and slow heart rate while using Paclitaxel; Patients often have no symptoms and no need to be treated. Should regularly monitor the signs of survival, especially in the first hour during Paclitaxel infusion. Serious cardiovascular events are observed more often in patients with non -cell lung cancer than people with breast cancer or ovarian cancer. A single case of heart failure is recorded related to Paclitaxel in AIDS-KK clinical research.

Pay attention to the heart function when Paclitaxel is used in combination with doxorubicin or trastuzumab to treat the initial treatment of metastatic breast cancer. When patients can be treated with Paclitaxel in combination with these drugs, they must be initially checked for heart, medical examination, electrocardiogram (ECG), echocardiography, and/or multi -port dye (MUGA). Heart function should be monitored further during treatment (for example every three months). This monitor may help detect patients with heart -functional disorders and treatment doctors should be cautious in the evaluation of accumulated dose (mg/m2) of anthracycline used when making decisions based on the frequency of ventricular function appraisal. When testing shows that the heart function decline, even without symptoms, the treating doctor should be careful to assess the clinical benefits of continuing treatment compared to the possibility of the heart, including lesions that may not recover. If continued treatment, the heart function must be monitored (for example 1-2 cycles). For more details, please refer to the product characteristics of trastuzumab or doxorubicin.

Peripheral neuropathy: often occurs peripheral neuropathy; Rarely develop serious symptoms. In serious cases, a 20% reduction should be reduced (25% for KS patients) for all the next Paclitaxel treatments. In patients with non -cell lung cancer, using Paclitaxel in combination with cisplatin leads to a higher rate of serious nerve toxicity than when using a single Paclitaxel. In patients with ovarian cancer, Paclitaxel is infected for 3 hours in combination with cisplatin, leading to a higher serious nerve poisoning rate than when used, combining cyclophosphamide and cisplatin.

Liver failure: Patients with liver failure may have a higher risk of toxicity, especially the medulla III-IV. There is no evidence that Paclitaxel's toxicity increases when the infusion in 3 hours in patients with abnormal liver function is mild. There is no research data in patients with severe stasis. When Paclitaxel is injected longer, it is possible to see an increase in marrow failure in patients with medium to severe liver failure. Patients should be closely monitored to see if the development of deep marrow failures. There is no sufficient research on adjusting the dose in patients with mild and medium liver failure. Paclitaxel should not be used for severe liver failure.

ethanol: This drug contains 49.7% ethanol (alcohol), meaning that up to 21 g per medium dose, equivalent to 740 ml of 3.5 degrees beer, 190 ml of 14 degrees of alcohol per dose. This can be harmful to patients with alcoholism. It is also necessary to consider this when considering using this drug in children and high -risk groups like people with liver or epilepsy. The amount of alcohol in this drug can change the effects of other drugs.

Internal artery: should be especially cautious to avoid the use of internal artery paclitaxel. In animal studies assessing local tolerance, serious tissue reactions occur after internal injection.

Palm colitis is also rarely reported, including cases where patients are not treated with antibiotics simultaneously. This reaction needs to be considered in the guessing of the case of severe or prolonged diarrhea that occurs during or immediately after Paclitaxel treatment.

Combining pulmonary radiation and Paclitaxel treatment (regardless of the order of treatment) can promote the development of interstitial pneumonia.

Paclitaxel has been proven to be a monster, toxic to embryo and mutations in some tests. Therefore, female and male patients of reproductive age need to have contraceptive measures for themselves and/or partners during treatment and at least 6 months after treatment. Male patients should seek advice on sperm storage before treatment because of the possibility of infertility indispensable due to Paclitaxel treatment.

In KS patients, rarely serious mucous inflammation. If serious reaction occurs, Paclitaxel dose should be reduced by 25%.

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

This drug contains alcohol, so it can reduce the ability to drive or operate machinery. It is rare to observe some unwanted effects on the nervous system, mental and eye disorders such as confusion, hearing loss, tinnitus, ... Therefore, be careful when driving and operating machinery.

Use drugs for women during pregnancy and lactation

Pregnant women:

Paclitaxel has been shown to be toxic to the embryo and toxic to pregnancy in the rabbit.

There is no adequate data from the use of Pacliraxel in pregnant women, but as for other cytotoxic drugs, Paclitaxel can be dangerous to pregnancy when used in pregnant women.

Do not use concentrated solution mixed with Paclitaxel 6 mg/mL infusion solution during pregnancy unless the clinical condition of the mother is needed to be treated with Paclitaxel.

Pregnant women who are using Paclitaxel should be recommended to avoid pregnancy and must notify the doctor immediately if pregnant. Female and male patients in the reproductive age, and/or their partners should use contraception for at least 6 months after treatment with Paclitaxel.

breastfeeding women:

It is not known whether Paclitaxel will excrete in milk. Paclitaxel is contraindicated in nursing women. Should stop breastfeeding during Paclitaxel treatment.

Reproduction:

Paclitaxel has been shown to reduce fertility in mice.

Male patients should seek sperm storage advice before treatment with Paclitaxel because of infertility.

Interactive drug

Paclitaxel's clearance is not affected by the drug used before cimetidine.

Cisplatin: Paclitaxel is recommended to be used before cisplatin. When used before cisplatin, Paclitaxel's safety data consistently with safe data reported when used alone. The use of paciitaxel after treatment with cisplatin leads to more severe marrow failure and reducing about 20% of Paclitaxel clearance. Patients treated with Paclitaxel and Cisplatin may have an increased risk of renal failure compared to only cisplatin in gynecological cancer.

doxorubicin: In the initial treatment for metastatic breast cancer, Paclitaxel should be used 24 hours after doxorubicin due to the elimination of doxorubicin and the active metabolites of doxorubicin can be reduced when using paclitaxel and doxorubicin at shorter time distance.

Metabolic drugs in the liver: Paclitaxel metabolism is catalyzed, partially, by the ISOENZE Cytochrome P450 CYP2C8 and CYP3A4. Therefore, when there is no study of pharmacokinetics-pharmacokinetics, should be cautious when using Paclitaxel simultaneously with known drugs as CYP2C8 or CYP3A4 inhibitors (such as ketoconazole and other imidazol fungicides, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, ritonaVir, ritonavir, ritonvir Saquinavir, Indinavir and Nelfinavir) because Paclitaxel's toxicity may increase due to higher Paclitaxel concentration. It is not recommended for the use of Paclitaxel in combination with known drugs as CYP2C8 or CYP3A4 activation (eg Rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) because the effect may be worse due to lower Paclitaxel levels.

Studies in KS patients are taking a variety of drugs and shows that Paclitaxel's total clearance is significantly lower when Nelfinavir and Ritonavir, but not so with Indinavir. There is no enough information about interacting with other protease inhibitors. Therefore, caution when using simultaneously Paclitaxel in patients taking protease inhibitors.

taboo

macrogolglycerol ricinoleeate can cause release of di- (2-elylhexyl) phthalate [DEHP] from the packaging containing polyvinyl chloride (PVC), the level of cessation of infection increases over time and concentration. Therefore, the process of preparation, storage, and use of paclitaxel in container does not have PVC such as water, polypropylene, or polyolefin.

Storage

Store at temperatures not more than 30 ° C, avoiding light.

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