docetaxel injection, USP 10 mg/ml VIAL Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION.

DOCETAXEL injection, for intravenous use

Initial U.S. Approval: 1996

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

See full prescribing information for complete boxed warning.

•
Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m2 (5.1)
•
Avoid use of Docetaxel Injection if bilirubin > ULN, or if AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle (5.2)
•
Do not administer Docetaxel Injection to patients with neutrophil counts <1500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia (4, 5.3)
•
Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of Docetaxel Injection and administration of appropriate therapy (5.5)
•
Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80 (4)
•
Severe fluid retention may occur despite dexamethasone (5.6)

INDICATIONS AND USAGE

Docetaxel Injection is a microtubule inhibitor indicated for:

•
Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1)
•
Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2)
•
Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3)
•
Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4)
•
Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5)

DOSAGE AND ADMINISTRATION

Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hour every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw Docetaxel Injection from the vial.

•
BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent (2.1)
•
BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (2.1)
•
NSCLC: after platinum therapy failure: 75 mg/m2 single agent (2.2)
•
NSCLC: chemotherapy-naïve: 75 mg/m2 followed by cisplatin 75 mg/m2 (2.2)
•
CRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously (2.3)
•
GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hour IV (days 1–5), starting at end of cisplatin infusion (2.4)
•
SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hour IV (days 1–5), starting at end of cisplatin infusion; for 4 cycles (2.5)
•
SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hour IV (days 1–4); for 3 cycles (2.5)

For all patients:

•
Premedicate with oral corticosteroids (2.6)
•
Adjust dose as needed (2.7)

DOSAGE FORMS AND STRENGTHS

•
20 mg/2 mL (10 mg/mL) single-dose vial (3)
•
80 mg/8 mL (10 mg/mL) multiple-dose vial (3)
•
160 mg/16 mL (10 mg/mL) multiple-dose vial (3)

CONTRAINDICATIONS

•
Hypersensitivity to docetaxel or polysorbate 80 (4)
•
Neutrophil counts of <1500 cells/mm3 (4)

WARNINGS AND PRECAUTIONS

•
Second primary malignancies: In patients treated with Docetaxel Injection-containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer. (5.7)
•
Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe cutaneous adverse reactions have been reported. Severe skin toxicity may require dose adjustment or permanent treatment discontinuation. (5.8)
•
Neurologic reactions: Reactions including paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent. (5.9)
•
Eye disorders: Cystoid macular edema (CME) has been reported and requires treatment discontinuation. (5.10)
•
Asthenia: Severe asthenia may occur and may require treatment discontinuation. (5.11)
•
Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (5.12, 8.1, 8.3)
•
Alcohol content: The alcohol content in a dose of Docetaxel Injection may affect the central nervous system. This may include impairment of a patient's ability to drive or use machines immediately after infusion. (5.13)
•
Tumor lysis syndrome: Tumor lysis syndrome has been reported. Patients at risk should be well hydrated and closely monitored during treatment. (5.14)

ADVERSE REACTIONS

Most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Cytochrome P450 3A4 inducers, inhibitors, or substrates: May alter docetaxel metabolism. (7)

USE IN SPECIFIC POPULATIONS

•
Lactation: Advise women not to breastfeed. (8.2)
•
Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of Docetaxel Injection. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 5/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION.

DOCETAXEL injection, for intravenous use

Initial U.S. Approval: 1996

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

See full prescribing information for complete boxed warning.

•
Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m2 (5.1)
•
Avoid use of Docetaxel Injection if bilirubin > ULN, or if AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle (5.2)
•
Do not administer Docetaxel Injection to patients with neutrophil counts <1500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia (4, 5.3)
•
Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of Docetaxel Injection and administration of appropriate therapy (5.5)
•
Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80 (4)
•
Severe fluid retention may occur despite dexamethasone (5.6)

INDICATIONS AND USAGE

Docetaxel Injection is a microtubule inhibitor indicated for:

•
Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1)
•
Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2)
•
Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3)
•
Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4)
•
Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5)

DOSAGE AND ADMINISTRATION

Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hour every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw Docetaxel Injection from the vial.

•
BC locally advanced or metastatic: 60 mg/m2 to 100 mg/m2 single agent (2.1)
•
BC adjuvant: 75 mg/m2 administered 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (2.1)
•
NSCLC: after platinum therapy failure: 75 mg/m2 single agent (2.2)
•
NSCLC: chemotherapy-naïve: 75 mg/m2 followed by cisplatin 75 mg/m2 (2.2)
•
CRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously (2.3)
•
GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 mg/m2 per day as a 24-hour IV (days 1–5), starting at end of cisplatin infusion (2.4)
•
SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hour IV (days 1–5), starting at end of cisplatin infusion; for 4 cycles (2.5)
•
SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hour IV (days 1–4); for 3 cycles (2.5)

For all patients:

•
Premedicate with oral corticosteroids (2.6)
•
Adjust dose as needed (2.7)

DOSAGE FORMS AND STRENGTHS

•
20 mg/2 mL (10 mg/mL) single-dose vial (3)
•
80 mg/8 mL (10 mg/mL) multiple-dose vial (3)
•
160 mg/16 mL (10 mg/mL) multiple-dose vial (3)

CONTRAINDICATIONS

•
Hypersensitivity to docetaxel or polysorbate 80 (4)
•
Neutrophil counts of <1500 cells/mm3 (4)

WARNINGS AND PRECAUTIONS

•
Second primary malignancies: In patients treated with Docetaxel Injection-containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer. (5.7)
•
Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe cutaneous adverse reactions have been reported. Severe skin toxicity may require dose adjustment or permanent treatment discontinuation. (5.8)
•
Neurologic reactions: Reactions including paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent. (5.9)
•
Eye disorders: Cystoid macular edema (CME) has been reported and requires treatment discontinuation. (5.10)
•
Asthenia: Severe asthenia may occur and may require treatment discontinuation. (5.11)
•
Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (5.12, 8.1, 8.3)
•
Alcohol content: The alcohol content in a dose of Docetaxel Injection may affect the central nervous system. This may include impairment of a patient's ability to drive or use machines immediately after infusion. (5.13)
•
Tumor lysis syndrome: Tumor lysis syndrome has been reported. Patients at risk should be well hydrated and closely monitored during treatment. (5.14)

ADVERSE REACTIONS

Most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Cytochrome P450 3A4 inducers, inhibitors, or substrates: May alter docetaxel metabolism. (7)

USE IN SPECIFIC POPULATIONS

•
Lactation: Advise women not to breastfeed. (8.2)
•
Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of Docetaxel Injection. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 5/2023
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