Paclitaxel Injection 100mg/16.7ml, 1vial/Box

• Dosage Form: Injection
• Dossier: Ready
• Transport Package: Carton
• Specification: 100mg/16.7ml
• Trademark: Sinolead
• Origin: China

Product Description

Basic Info.

 

Generic Name	Paclitaxel Injection 100mg/16.7ml
Strength	100mg/16.7ml
Packing	1vial/box
Origin	China

Component:
Paclitaxel.

Character:

This product is colorless or yellowish viscous liquid.

Indications:

First-line and subsequent treatment of advanced ovarian cancer.

Adjuvant therapy after standard doxorubicin-containing chemotherapy in patients with lymph node positive breast cancer.

Patients with metastatic breast cancer who have failed combination chemotherapy or have recurred within six months of adjuvant chemotherapy.

First-line treatment for patients with non-small cell lung cancer.

Second-line treatment of AIDS-associated karnosarcoma.

 

Usage and dosage:

Note: Contact of undiluted concentrated liquid with polyvinyl chloride (PVC) containers for the preparation of infusion solutions is not recommended. To reduce patient exposure to DEHP plastic substances [2- (2-ethylhexyl)phthalate, di-(2-Ethy -lhexy)phthalate) that may be released from polyvinyl chloride drip bags or other devices, diluted beta-acetylene solutions should be stored in glass bottles, polypropylene bottles, or (polypropylene, polyolefin) plastic bags. A polyethylene lined drug delivery device is used for instillation.

Prophylactic drugs:

To prevent severe allergic reactions, all patients receiving Tylasol should be given prophylactic medication beforehand, with dexamethasone 20mg orally, usually given 12 to 6 hours before Tylasol, diphenhydramine (or its equivalent) 50mg by intravenous injection 30 to 60 minutes before Tylasol. As well as intravenous cimetidine (300mg) or ranitidine (50mg) 30 to 60 minutes prior to the injection of taxol.

Dose:

For patients with ovarian cancer, the following treatments are recommended:

1) For patients with untreated, severe ovarian cancer, the following therapies are recommended every three weeks.

A. Intravenous injection of Tylenol 175mg, injection time greater than 3 hours, and given cisplatin 75mg, or

b. Intravenous injection of taxol 135mg, injection time of more than 24 hours, and cisplatin 75mg.

2) The patient has undergone chemotherapy for ovarian cancer, and several doses and regimens have been used for Tylenol, but the optimal dose regimen is not yet known. The recommended treatment regimen is: intravenous injection of 135mg or 175mg every three weeks for more than 3 hours.

For breast cancer patients, the following treatments are recommended:

1) Adjuvant treatment for lymph node positive breast cancer is: intravenous injection of tyxin once every three weeks for more than 3 hours at a dose of 175mg, combined with doxorubicin chemotherapy.

2) For patients with metastasis or recurrence within 6 months after initial chemotherapy failure, the adjuvant treatment regimen is as follows: intravenous injection of 175mg every three weeks for more than 3 hours, which has proved effective.

The recommended protocol for patients with non-small cell lung cancer is:

Every three weeks, 175mg was given intravenously for more than 3 hours.

The recommended treatment for AIDS-associated sarcoma is:

Once every three weeks, 135mg/ m2 was given intravenously for more than 3 hours, or once every two weeks, 100mg/ m2 was given intravenously for more than 3 hours (dose intensity 45-50mg/ m2 /week). Intravenous administration of taxol 135mg every three weeks, injection time of more than 3 hours is more toxic than the latter. In addition, all patients receiving the latter (intravenous administration of 100mg/ m2 every two weeks, injection time greater than 3 hours) had lower efficacy.

Given that advanced HIV patients are immunosuppressed, improved protocols are recommended for these patients:

1) Reduce the dose of dexamethasone in the three premedications to 10mg orally (instead of 20mg);

2) Only when the neutrophil count is at least 1000 /mm3 should the first or second treatment be given with taxin;

3) For patients with neutropenia (less than 500 neutrophils /mm3), the dose of taxin is reduced by 20% in the subsequent course of treatment

4) G-CSF is recommended initially

For the treatment of patients with solid tumors (ovarian, breast, and non-small cell lung cancer), Tylenol should be used again only when neutrophils are at least 1500 /mm3 and platelets are at least 100,000 /mm3. Patients who have experienced severe neutropenia (less than 500 neutrophils /mm3 for more than a week or longer) or peripheral nerve disease during the course of treatment with taxin should receive a 20% reduction in the dose of taxin during subsequent treatment. The incidence of neurotoxicity and severe neutropenia increased with the increasing dose of taxin.

Patients with impaired liver function may be at increased risk for toxicity, especially for grade -IV myelosuppression. For 3-hour infusion and 24-hour infusion, the recommended dose regulation method for the first course of infusion is shown in Table 1. Whether to further reduce the dose in the subsequent course of infusion should be judged according to the individual's tolerance. Patients should be closely monitored for deep myelosuppression.

Table 1: Dosing recommendations for patients with impaired liver function based on clinical trial data a

Degree of liver function impairment

Aminotransferase level bilirubin level b Recommended dose of Taxitin c

24 hour infusion

< 2×ULN and ≤1.5mg/dl 135mg/m2

2-< 10 x ULN and ≤1.5mg/dl 100mg/m2

< 10×ULN and 1.6-7.5mg/dl 50mg/m2

≥10×ULN or > 7.5mg/dl should not be used

3 hour infusion

< 10 x ULN ≤1.25 x ULN 175mg/m2

< 10 x ULN and 1.26-2.0 x ULN 135mg/m2

< 10 x ULN and 2.01-5.0 x ULN 90mg/m2

≥10×ULN or > 5.0 x ULN is not suitable for use

a The above recommended dose is based on the dose for patients without liver function impairment (135mg/m2 with infusion duration greater than 24 hours or 175mg/m2 with infusion duration greater than 3 hours); There is no clinical data for other dose-adjusted regimens (e.g., AIDS-associated cartesian sarcoma)

The difference in bilirubin level standards for b3 and 24-hour infusion is due to differences in clinical trial design.

c This is the dosage recommendation for the first course of treatment: whether to reduce further in subsequent courses should be judged according to the individual's tolerance.

Matters needing attention:

Treatment should be preceded by adrenocortical hormones (such as dexamethasone), diphenhydramine, and H2 receptor antagonists (such as cimetidine or ranitidine) (see dosage and usage). Severe anaphylaxis characterized by dyspnea requiring treatment and hypotension, angioneurotic edema, and systemic urticaria occurred in 2% of patients treated with tasol. These reactions may be caused by the action of histamine. One lung cancer patient in the Phase I trial had an allergic reaction to one of these and died. The patient, who had not received prior prophylactic medication, had no accidents during the first course of Taxitin, which was administered with a single dose of Taxitin 190mg/ m2 for 3 hours. Within minutes of the second course of Taxitin, the patient developed a severe hypotensive reaction and died. People who have had a severe allergic reaction to Tylase should not use this drug.

Myelosuppression (mainly neutrophil deficiency) is a dose-limiting toxic reaction. The median low of neutrophil count was on day 11. Tylenol should not be used in patients with a neutrophil count of less than 1500 /mm3. During treatment with Tylenol, the blood count should be checked frequently until the neutrophil count reaches 1500 /mm3 and the platelet count reaches &gt. After 100,000 doses /mm3, another treatment course of Taxitin can be started.

Patients with severe conduction abnormalities during Taser therapy 1%, some patients need a pacemaker. If the patient develops significant conduction abnormalities during the Tylenol infusion, appropriate treatment should be given and the heart should be continuously monitored during subsequent Tylenol therapy.

Precautions for preparation:

Taxitin is a cytotoxic anticancer drug. Like other potentially toxic compounds, Taxitin must be prepared with care and gloves. If the skin comes into contact with the Taxitin solution, the skin should be washed immediately and thoroughly with soap and water, and once the taxitin comes into contact with the mucous membranes, rinse the skin thoroughly with water.