Anzatax solution 30mg/5ml Pfizer treat ovarian cancer, breast cancer (5ml)

Dosage form Box x 5ml
Specifications Paclitaxel
Ingredient Hospira

Ingredient

Composition information	Content
Paclitaxel	30mg

Uses

Indications

concentrated solution mixed with anzatax infusion solution 30mg/5ml indicated treatment in the following cases:

Ovarian cancer

The first chemotherapy for ovarian cancer, Paclitaxel is indicated for treatment for patients from progression 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 is failed.

Breast cancer

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

Paclitaxel is indicated for the 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 factors in humans (Her-2) in Level 3+ are determined by immunominalization and inappropriate with anthracycline.

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

Advanced 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 progressive AIDS that failed in the previous Anthracycline liposome.

Pharmacology

Clinical pharmacological group: Anti -cancer drugs of Taxane group

ATC: L01C D01

Active mechanism

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

Clinical efficiency and safety

In the first treatment for ovarian cancer, the safety and effectiveness of Paclitaxel are assessed in two major random control trials (compared to Cyclophosphamide 750 mg/m2+ cisplatin 75 mg/m²).

In the inter-group test (BMS CA 139-209), more than 650 patients with primary ovarian cancer II-III or IV have been used up to 9 paclitaxel treatments (175 mg/m for 3 hours) then Cispiatin (75 mg/m) or control treatment. In another major study (GOG 111/B-MS CA139-022), maximum of 6 paclitaxel treatments are used (135 mg/m, through 24-hour infusion in combination with Cisplatin (75 mg/m2) or control treatment; The test involves more than 400 patients with primary ovarian cancer stage III or IV with a residual tumor> 1 cm after surgery, or metastases far away. Although two different doses are not directly compared, in both testing patients using Paclitaxel and Cisplatin has a significant higher response rate, a slower output and longer life than patients treated with standard.

Increased nerve toxicity, joint pain/muscle pain but decreased marrow failure has been observed in patients with advanced ovarian cancer for using paclitaxel cisplatin via injection in 3 hours when compared to patients using cyclophosphamide/cisplatin.

Pharmacokinetics

absorption

After being used by intravenous lines, the concentration of paclitaxel 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 -partition metabolic value for the entire clearance between 11.6 and 24.0 1/hour/m2. The whole clearance seems to decrease when the plasma medication concentration is higher. The volume of distribution in the average stability between 198 and 688 l/m2, shows wide and/or grave distribution. The increase in dosage related to infusion in 3 hours leads to non -linear pharmacokinetics. When the dose increased by 30% from 135 mg/m2 to 175 mg/m2, the maximum plasma concentration (mmax) increased by 75% and the area under the curve of the time concentration in plasma (AUC0-∞.) 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.

There is no cimetidine, ranitidine, dexethasone or diphenhydramine, which affects paclitaxel protein bonds.

Biological metabolism and elimination

The distribution and metabolism of Paclitaxel in humans has 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 pregnancy bar 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 with radiation eliminated in feces in the form of 6α-hydroxypaclitaxel, 2% in the form of 3'P-dihydroxypaclitaxel and 6% as 6α-3'P-dihydroxypaclitaxel. 6α-hydroxypaclitaxel is formed by the effect of CYP2C8, 3'P-Hydroxypaclitaxel by CYP3A4 and 60-3’P-dihydroxypaclitaxel by CYP2C8 and CYP3A4.

Effects of kidney failure or liver failure on excretion of paclitaxel 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 Paclitaxel through the infusion in 3 hours.

After intravenous infusion of 100 mg/m2 Paclitaxel for 3 hours in 19 patients KS, the average cmax is 1,530 ng/ml (about 761 - 2,860 ng/ml) and AUC on average 5,619 ng.VL/mL (about 2,609 - 9,428 ng.He/ml).

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 summary of the product characteristics of Cisplatin, Doxorubicin or Trastuzumab for information about the use of these drugs.

Before taking Anzatax solution 30mg/5ml Pfizer treat ovarian cancer, breast cancer (5ml)

How to use

must be cautious before manipulating or infusion.

The concentrated solution of 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 low -receptor antagonists before using Paclitaxel, to prevent serious hypersensitivity reactions. The medications that need to be taken before chemotherapy may include:

The process of drugs to be used before chemotherapy:

drugs needed dose Intravenous infusion: 30 - 60 minutes

diphenhydramine ***

50 mg IV

30 to 60 minutes

**: Injected with circuits

***: Or an antihistamine like 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 ≤ 0.22 microns.

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.

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 is 75 mg/m2 Cisplatin and the next treatment is repeated after 3 weeks, or 135 mg/m2 Paclitaxel intravenous injection in the next 24 -hour period of 75 mg/m2 Cisplatin week.

Alternative treatment for ovarian cancer: The recommended dose 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 batches, 3 obeys a 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 dose for Paclitaxel is 220 mg/batch of intravenous injection for 3 hours, with a distance of 3 weeks between batches.

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 use Paclitaxel until the number of neutral leukocytes is ≥1.5 x 109/l (≥1 x 109/l for KS patients) and the number of platelets is ≥100 x 109/l (≥75 x 109/l for KS patients).

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.

Instructions for use, manipulation and elimination

If Paclitaxel solution is exposed to the skin, wash the skin immediately and carefully with soap and water. After exposure to the skin, events include itching, burning, and redness. If Paclitaxel is exposed to the mucosa, you should wash the mucosa with water. When inhaled, there was a report that had difficulty breathing, chest pain, throat burning, and nausea.

Prepare to use intravenous injections: During the dilution of a concentrated solution for mixing the infusion solution, blending needle or similar devices with spikes should not be used with Paclitaxel vials because they can damage the node causing aseptic loss of the solution.

Before infusion, Paclitaxel must be diluted into a ready -to -use solution for infusion (0.3 to 1.2 mg/ml) using a sterile technique with one of the following solutions:

Sodium chloride solution 9 mg/ml (0.9%) for infusion.

Glucose solution 50 mg/ml (5%) for infusion.

The infusion solution is ready for use, so it is checked by the eye to see if there is a matter of matter and discoloration.

After preparation, the solution may be opaque, due to the means of formation, and not removed by filtering.

However, the opaque does not affect the effectiveness of the product. The infusion solution must be used through the filter in the line with a micro -membrane not greater than 0.22 micron. There is no significant reduction after the transmission of the intravenous solution containing the filter in the lines (0.22 micron).

There have been a number of reports on precipitate during Paclitaxel infusion, with precipitate that usually takes place at the end of the 24 -hour infusion phase. To reduce the risk of precipitation, Paclitaxel should be used as soon as possible after dilution and should not shake or stir excess. The infusion solution must be checked regularly during the infusion process and should stop infusion if the precipitate occurs.

To minimize the situation of patients in contact with Dehp that may be infected from the transmission bag, flexible PVC lines, or other medical tools, diluted Paclitaxel solution should be stored in non -PVC bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and use the polyethylene lining. Use filter equipment combined with short and//or plastic ping outputs that have been significantly contaminated with Dehp.

Disage: All items used for preparation, use, infusion, or contact and paclitaxel should be put in the appropriate safety container and remove according to manipulation instructions with cytotoxic drugs.

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 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.

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

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 effect on bonus is the bone marrow inhibition. Serious neutropenia (

Neurometrium, mainly peripheral neuropathy, often appears more and more serious at a dose of 175 mg/m2 injected in 3 hours (85% of nerve toxicity, 15% serious) compared to the dose of 135 mg/m2 injected in 24 hours (25% of the peripheral neuropathy, 3% serious) when Paclitaxel is combined with Cisplatin.

In patients with non -cell lung cancer and in ovarian cancer patients treated with Paclitaxel for 3 hours later, Cisplatin, which significantly increases the proportion of serious neurotoxicity. 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 in

Warnings

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

Contraindicated

concentrated solution mixed with anzatax infusion solution 30mg/5ml contraindicated in the following cases:

Contraindicated to use Paclitaxel in patients with serious 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 the heavy hypersensitivity reactions, it is available, so the appropriate support devices are 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

In case of serious hypersensitivity reactions, Paclitaxel infusion must be immediately stopped, symptomatic treatment must be started and not allowed for patients to use Paclitaxel.

macrogolglycerol ricinoleate (polyoxyl castor oil), is an excipient in the drug that can cause these reactions.

Bone marrow inhibition, mainly reduces the provincial media leukocytes, is the toxicity of the dose limit. Should be rewarded through blood recipe. Do not re -treat until the number of neutral leukocytes ≥1.5 × 109/l (≥1x 109/l for patients KS) and the amount of platelets recovered ≥ 100 x 109/l (≥75 × 109/l for KS patients).

In KS clinical research, most patients are used in granulocytes (G-CSF).

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 paclitaxel after cisplatin treatment leads to more severe marrow failure and reducing about 20% of Paclitaxel clearance. Patients treated with Paclitaxel and Cisplatin may have an increase in the risk of renal failure compared to when using 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.

The drugs are metabolized in the liver: Paclitaxel metabolism is catalyzed, partially, by the isoenzyme cytochrome P450 CYP2C8 and CYP3A4. Therefore, when there is no study of pharmacokinetics interactive drugs, it is careful to use Paclitaxel simultaneously with known drugs as CYP2C8 orC3A4 inhibitors (such as ketoconazole and other imidazol fungicides, erythromycin, Fluoxetine, Gemfibrozil, Clopidogrel, Cimetidine, Ritonavir, Ritonavir, Ritonavir, Ritonavir, Ritonavir, Ritonavir Saquinavir, Indinavir, and Nelfinavir) because Paclitaxel's toxicity may increase due to higher Paclitaxel levels. 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 showing the whole bar of Paclitaxel 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.

Storage

Store at a temperature not exceeding 30 ° C, avoiding light.

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