Usual Adult Dose for Ovarian Cancer

For previously untreated patients with cancer of the ovary:
175 mg/m2 IV over 3 hours followed by cisplatin 75 mg/m2 IV every 3 weeks
OR
135 mg/m2 IV over 24 hours followed by cisplatin 75 mg/m2 IV every 3 weeks

For patients previously treated for cancer of the ovary (NOTE: This drug has been used at several doses and schedules; however, the optimal regimen is not yet clear):
135 mg/m2 IV over 3 hours every 3 weeks
OR
175 mg/m2 IV over 3 hours every 3 weeks

Comments:

• All patients should be premedicated to prevent severe hypersensitivity reactions.
• Consult the manufacturer product information or local protocol for premedication guidelines.

Uses: As subsequent therapy for the treatment of advanced carcinoma of the ovary; as first-line therapy in combination with cisplatin

Usual Adult Dose for Breast Cancer

After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy:
175 mg/m2 IV over 3 hours every 3 weeks

Comments:

• All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions.
• Consult the manufacturer product information or local protocol for premedication guidelines.

Use: For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; prior therapy should have included an anthracycline unless clinically contraindicated

Usual Adult Dose for Breast Cancer - Adjuvant

For adjuvant treatment of node-positive breast cancer:
175 mg/m2 IV over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing chemotherapy

Comments:

• All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions.
• Consult the manufacturer product information or local protocol for premedication guidelines.

Use: For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy

Usual Adult Dose for Non-Small Cell Lung Cancer

135 mg/m2 IV over 24 hours followed by cisplatin mg/m2 IV every 3 weeks

Comments:

• All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions.
• Consult the manufacturer product information or local protocol for premedication guidelines.

Use: For the first-line treatment of non-small cell lung cancer in combination with cisplatin in patients who are not candidates for potentially curative surgery and/or radiation therapy

Usual Adult Dose for Kaposi's Sarcoma

For patients with AIDS-Related Kaposi's Sarcoma:
135 mg/m2 IV over 3 hours every 3 weeks
OR
100 mg/m2 IV over 3 hours every 2 weeks

Note: In patients with advanced HIV disease:
1) Reduce the dose of dexamethasone as one of the premedication drugs (consult the manufacturer product information).
2) Initiate or repeat treatment with this drug only if the neutrophil count is at least 1000 cells/mm3.
3) Reduce the dose of subsequent courses of this drug by 20% for patients who experience severe neutropenia (a neutrophil count less than 500 cells/mm3 for a week or longer).
4) Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.

Comments:

• All patients should be premedicated prior to receiving this drug to prevent severe hypersensitivity reactions.
• Consult the manufacturer product information or local protocol for premedication guidelines.

Use: For the second-line treatment of AIDS-related Kaposi's sarcoma

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Dose adjustments for liver impairment:
24-HOUR INFUSION:

• Transaminase levels less than 2 x ULN and bilirubin levels less than or equal to 1.5 mg/dL: 135 mg/m2 IV
• Transaminase levels 2 to less than 10 x ULN and bilirubin levels less than or equal to 1.5 mg/dL: 100 mg/m2 IV
• Transaminase levels less than 10 x ULN and bilirubin levels 1.6 to 7.5 mg/dL: 50 mg/m2 IV
• Transaminase levels greater than or equal to 10 x ULN or bilirubin levels greater than 7.5 mg/dL: Not recommended.

3-HOUR INFUSION:

• Transaminase levels less than 10 x ULN and bilirubin levels less than or equal to 1.25 x ULN: 175 mg/m2 IV
• Transaminase levels less than 10 x ULN and bilirubin levels 1.26 to 2 x ULN: 135 mg/m2 IV
• Transaminase levels less than 10 x ULN and bilirubin levels 2.01 to 5 x ULN: 90 mg/m2 IV
• Transaminase levels greater than or equal to 10 x ULN or bilirubin levels greater than 5 x ULN: Not recommended.

Dose Adjustments

For patients with solid tumors (ovary, breast, and NSCLC): Courses should not be repeated until the neutrophil count is at least 1500 cells/mm3 and the platelet count is at least 100,000 cells/mm3.

This drug should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline or subsequent neutrophil count is less than 1000 cells/mm3.

Patients who experience severe neutropenia (neutrophil less than 500 cells/mm3 for a week or longer) or severe peripheral neuropathy during therapy should have the dosage reduced by 20% for subsequent courses.

The incidence of neurotoxicity and the severity of neutropenia increase with dose.

Precautions

US BOXED WARNINGS:

• This drug should only be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents in facilities appropriately equipped for management of complications.
• Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving this drug in clinical trials. Fatal reactions can occur despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. Patients who experience severe hypersensitivity reactions should not be rechallenged with the drug.
• This drug should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm3 and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1000 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving this drug.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Hypersensitivity to other drugs formulated in polyoxyl 35 castor oil
• In patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm3 or in patients with AIDS-related Kaposi's sarcoma with baseline neutrophil counts of less than 1000 cells/mm3

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be administered using an in-line filter with a microporous membrane of less than or equal to 0.22 microns.

Storage requirements:

• Consult the manufacturer product information.

Reconstitution/preparation techniques:

• Consult the manufacturer product information.

IV compatibility:

• Consult the manufacturer product information.

General:

• All patients should be premedicated with corticosteroids, antihistamines and H2-receptor antagonists prior to receiving this drug to prevent severe hypersensitivity reactions. Consult the manufacturer product information or local protocol for premedication guidelines.

Monitoring:

• Because of the possibility of extravasation, it is advisable to monitor the infusion site for possible infiltration during administration.
• Dose adjustments based on hepatic function may be necessary.

Frequently asked questions

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• What is Paxel called in the USA?