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DOCEFREZ

Sun Pharma Global FZE

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DOCEFREZ safely and effectively. See full prescribing information for DOCEFREZ. DOCEFREZ (docetaxel) for Injection, Intravenous InfusionInitial U.S. Approval: 1996 RECENT MAJOR CHANGES Dosage and administration (2.9) 07/2012 BOXED WARNING 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) Should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle (8.6) Should not be given if neutrophil counts are


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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


The incidence of treatment-related mortality associated with docetaxel therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m2   [see Warnings and Precautions (5.1)].

DOCEFREZ should not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 x ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death. Bilirubin, AST or ALT, and alkaline phosphatase values should be obtained prior to each cycle of DOCEFREZ therapy [see Warnings and Precautions (5.2)].
 
DOCEFREZ therapy should not be given to patients with neutrophil counts of <1500 cells/mm3. In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood cell counts should be performed on all patients receiving DOCEFREZ [see Warnings and Precautions (5.3)].
 
Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received a 3-day dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the DOCEFREZ infusion and administration of appropriate therapy [see Warnings and Precautions (5.4)]. DOCEFREZ must not be given to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80 [see Contraindications (4)].
 
Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) [see Warnings and Precautions (5.5)].

1 INDICATIONS AND USAGE

1.1 Breast Cancer


1.2 Non-Small Cell Lung Cancer


1.3 Prostate Cancer


2 DOSAGE AND ADMINISTRATION


[see Dosage and Administration (2.7)].

2.1 Breast Cancer

  • For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of DOCEFREZ is 60 mg/m2 to 100 mg/m2 administered intravenously over 1 hour every 3 weeks.

2.2 Non-Small Cell Lung Cancer

  • For treatment after failure of prior platinum-based chemotherapy, docetaxel was evaluated as monotherapy, and the recommended dose is 75 mg/m2 administered intravenously over 1 hour every 3 weeks. A dose of 100 mg/m2 in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized, controlled trials [see Boxed Warning, Dosage and Administration (2.7), Warnings and Precautions (5), Clinical Studies (14)].

2.3 Prostate Cancer

  • For hormone-refractory metastatic prostate cancer, the recommended dose of DOCEFREZ is 75 mg/m2 every 3 weeks as a 1 hour intravenous infusion. Prednisone 5 mg orally twice daily is administered continuously [see Dosage and Administration (2.7)].

2.6 Premedication Regimen


[see Boxed Warning, Warnings and Precautions (5.4)]. 2

[see Warnings and Precautions (5.4)]

2.7 Dosage Adjustments During Treatment


Breast Cancer

2 3 2 22 2 2 3

Non-Small Cell Lung Cancer

Monotherapy with DOCEFREZ for NSCLC treatment after failure of prior platinum-based chemotherapy

23 2

Prostate Cancer

Combination therapy with DOCEFREZ  for hormone-refractory metastatic prostate cancer

33



[see Drug Interactions (7), Clinical Pharmacology (12.3)]

2.8 Administration Precautions


. [see How Supplied/ Storage and Handling (16.3)].





DOCEFREZ (Lyophilized Powder for Injection and Diluent)





Table 1- Reconstitution of DOCEFREZ (docetaxel) for Injection
Product Fill Range of the Diluent (35.4% w/w ethanol in polysorbate 80) Volume of Diluent to be added for the reconstitution Concentration of the reconstituted solution
Docetaxel 20 mg vial
 1.10 – 1.15 mL
 1 mL
 20 mg/0.8 mL
Docetaxel 80 mg vial
 4.13 – 4.29 mL
 4 mL
 24 mg/mL

2.9 Preparation and Administration


DOCEFREZ (Lyophilized Powder for Injection and Diluent)
  • DOCEFREZ vials should be stored between 2°C and 8°C (36°F and 46°F). Allow the appropriate number of vials of DOCEFREZ (docetaxel) for Injection and diluent (35.4% ethanol in polysorbate 80) vials to stand at room temperature for approximately 5 minutes.
  • a) For DOCEFREZ 20: Use 1 mL syringe with needle of 18- to 21-gauge, 1½-inch for withdrawing diluent for DOCEFREZ 20.
    b) For DOCEFREZ 80: Use 4 mL syringe with needle of 18- to 21-gauge, 1½-inch for withdrawing diluent for DOCEFREZ 80.
  • a) For DOCEFREZ 20: Aseptically withdraw 1 mL from the diluent vial into a syringe by partially inverting the vial, and transfer it to product vial of DOCEFREZ (docetaxel) for Injection.
    b) For DOCEFREZ 80:  Aseptically withdraw 4 mL from the diluent vial into a syringe by partially inverting the vial, and transfer it to product vial of DOCEFREZ (docetaxel) for Injection.
  • Shake the reconstituted vial well in order to completely dissolve the docetaxel powder present in the vial. For the 20 mg vial, the resultant concentration is 20 mg/0.8 mL. For the 80 mg vial, the resultant concentration is 24 mg/mL.




  • Aseptically withdraw the required amount of reconstituted DOCEFREZ solution with a calibrated syringe and inject into a 250 mL infusion bag or bottle of either 0.9% Sodium Chloride solution or 5% Dextrose solution to produce a final concentration of 0.3 to 0.74 mg/mL. If a dose greater than 200 mg of DOCEFREZ is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/mL docetaxel is not exceeded.
  • Thoroughly mix the infusion by manual rotation.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If the DOCEFREZ reconstituted solution or infusion solution is not clear or appears to have precipitation, these should be discarded.

The final DOCEFREZ infusion solution should be administered intravenously as a 1-hour infusion under ambient room temperature and lighting conditions.

2.10 Stability


3 DOSAGE FORMS AND STRENGTHS


DOCEFREZ (Lyophilized Powder for Injection and Diluent)

DOCEFREZ 80 mg


 
DOCEFREZ 20 mg

4 CONTRAINDICATIONS

  • DOCEFREZ is contraindicated in patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred [see Warnings and Precautions (5.4)]. 
  • DOCEFREZ should not be used in patients with neutrophil counts of <1500 cells/mm3.

5 WARNINGS AND PRECAUTIONS

5.1 Toxic Deaths


Breast Cancer

2 2

Non-Small Cell Lung Cancer

222[see Dosage and Administration (2.2), Clinical Studies (14)].

5.2 Hepatic Impairment


[see Boxed Warning, Use in Specific Populations (8.6), Clinical studies (14)].

5.3 Hematologic Effects


33

3[see Dosage and Administration (2.7)].

3223223

22[see Adverse Reactions (6.1), Clinical Studies (14)].

[see Dosage and Administration (2.7), Adverse Reactions (6)]

5.4 Hypersensitivity Reactions




[see Dosage and Administration (2.6)].

5.5 Fluid Retention


[see Dosage and Administration (2.6)]



22

e.g

5.6 Acute Myeloid Leukemia


5.7 Cutaneous Reactions


[see Dosage and Administration (2.7)]

5.8 Neurologic Reactions


e.g[see Dosage and Administration (2.7)].

5.9 Asthenia


5.10 Use in Pregnancy




[see Use in Specific Populations (8.1)]

6 ADVERSE REACTIONS


  • Toxic Deaths [see Boxed Warning, Warnings and Precautions (5.1)]
  • Hepatotoxicity [see Boxed Warning, Warnings and Precautions (5.2)]
  • Neutropenia [see Boxed Warning, Warnings and Precautions (5.3)]
  • Hypersensitivity [see Boxed Warning, Warnings and Precautions (5.4)]
  • Fluid Retention [see Boxed Warning, Warnings and Precautions (5.5)]




6.1 Clinical Trials Experience


Breast Cancer

Monotherapy with docetaxel for locally advanced or metastatic breast cancer after failure of prior chemotherapy

22 
Table 2 - Summary of Adverse Reactions in Patients Receiving Docetaxel at 100 mg/m2
Adverse Reaction All Tumor Types Normal LFTsNormal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
n=2045
%		 All Tumor Types Elevated LFTsElevated Baseline LFTs: AST and/or ALT >1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN
n=61
%		 Breast Cancer Normal LFTsNormal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
n=965
%
Hematologic
Neutropenia
<2000 cells/mm3
96
 96
 99
<500 cells/mm3
75
 88
 86
Leukopenia
<4000 cells/mm3
96
 98
 99
<1000 cells/mm3
32
 47
 44
Thrombocytopenia
<100,000 cells/mm3
8
 25
 9
Anemia
<11 g/dL
 90
 92
 94
<8 g/dL
 9
 31
 8
Febrile NeutropeniaFebrile Neutropenia: ANC grade 4 with fever >38oC with intravenous antibiotics and/or hospitalization
11
 26
 12
Septic Death
2
 5
 1
Non-Septic Death
1
 7
 1
Infections
Any
 22
 33
 22
Severe
 6
 16
 6
Fever in Absence of Infection
Any
 31
 41
 35
Severe
 2
 8
 2
Hypersensitivity Reactions
Regardless of Premedication
Any
 21
 20
 18
Severe
 4
 10
 3
With 3-day Premedication
 n=92
 n=3
 n=92
Any
 15
 33
 15
Severe
 2
 0
 2
Fluid Retention
Regardless of Premedication
Any
 47
 39
 60
Severe
 7
 8
 9
With 3-day Premedication
 n=92
 n=3
 n=92
Any
 64
 67
 64
Severe
 7
 33
 7
Neurosensory
Any
 49
 34
 58
Severe
 4
 0
 6
Cutaneous
Any
 48
 54
 47
Severe
 5
 10
 5
Nail Changes
Any
 31
 23
 41
Severe
 3
 5
 4
Gastrointestinal
Nausea
 39
 38
 42
Vomiting
 22
 23
 23
Diarrhea
 39
 33
 43
Severe
 5
 5
 6
Stomatitis
Any
 42
 49
 52
Severe
 6
 13
 7
Alopecia
76
 62
 74
Asthenia
Any
 62
 53
 66
Severe
 13
 25
 15
Myalgia
Any
 19
 16
 21
Severe
 2
 2
 2
Arthralgia
9
 7
 8
Infusion Site Reactions
4
 3
 4
Hematologic Reactions

[see Warnings and Precautions (5.3)]. 3

3



3

Hypersensitivity Reactions

[see Boxed Warning, Warnings and Precautions (5.4)]

Fluid Retention

[see Boxed Warning, Dosage and Administration (2.6), Warnings and Precautions (5.5)]

Cutaneous Reactions

[see Warnings and Precautions (5.7)].



Neurologic Reactions

[ see Warnings and Precautions (5.8)].

Gastrointestinal Reactions





Cardiovascular Reactions

2

Infusion Site Reactions



Hepatic Reactions



Hematologic and Other Toxicity: Relation to dose and baseline liver chemistry abnormalities

22

Table 3 - Hematologic Adverse Reactions in Breast Cancer Patients Previously Treated with Chemotherapy Treated at Docetaxel 100 mg/m2 with Normal or Elevated Liver Function Tests or 60 mg/m2 with Normal Liver Function Tests
Adverse Reaction Docetaxel 100 mg/m2 Docetaxel 60 mg/m2
Normal LFTsNormal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
n=730
%		 Elevated LFTsElevated Baseline LFTs: AST and/or ALT > 1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN
n=18
%		 Normal LFTsNormal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
n=174
%
Neutropenia
Any <2000 cells/mm3
98
 100
 95
Grade 4 <500 cells/mm3
84
 94
 75
Thrombocytopenia
Any <100,000 cells/mm3
11
 44
 14
Grade 4 <20,000 cells/mm3
1
 17
 1
Anemia <11 g/dL
 95
 94
 65
Infection Incidence of infection requiring hospitalization and/or intravenous antibiotics was 8.5% (n=62) among the 730 patients with normal LFTs at baseline; 7 patients had concurrent grade 3 neutropenia, and 46 patients had grade 4 neutropenia.
Any
 23
 39
 1
Grade 3 and 4
 7
 33
 0
Febrile Neutropenia Febrile Neutropenia: For 100 mg/m2, ANC grade 4 and fever > 38°C with intravenous antibiotics and/or hospitalization; for 60 mg/m2, ANC grade 3/4 and fever > 38.1°C
By Patient
 12
 33
 0
By Course
 2
 9
 0
Septic Death
2
 6
 1
Non-Septic Death
1
 11
 0

Table 4 - Non-Hematologic Adverse Reactions in Breast Cancer Patients Previously Treated with Chemotherapy Treated at Docetaxel 100 mg/m2 with Normal or Elevated Liver Function Tests or 60 mg/m2 with Normal Liver Function Tests
Adverse Reaction Docetaxel 100 mg/m2 Docetaxel 60 mg/m2
Normal LFTsNormal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
n=730
%		 Elevated LFTsElevated Baseline Liver Function: AST and/or ALT > 1.5 times ULN concurrent with alkaline phosphatase > 2.5 times ULN
n=18
%		 Normal LFTsNormal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
n=174
%
NA = not available
Acute Hypersensitivity Reaction
Regardless of Premedication
Any
 13
 6
 1
Severe
 1
 0
 0
Fluid RetentionFluid Retention includes (by COSTART): edema (peripheral, localized, generalized, lymphedema, pulmonary edema, and edema otherwise not specified) and effusion (pleural, pericardial, and ascites); no premedication given with the 60 mg/m2 dose
Regardless of Premedication
Any
 56
 61
 13
Severe
 8
 17
 0
Neurosensory
Any
 57
 50
 20
Severe
 6
 0
 0
Myalgia
23
 33
 3
Cutaneous
Any
 45
 61
 31
Severe
 5
 17
 0
Asthenia
Any
 65
 44
 66
Severe
 17
 22
 0
Diarrhea
Any
 42
 28
 NA
Severe
 6
 11
Stomatitis
Any
 53
 67
 19
Severe
 8
 39
 1
222222222222

222

Lung Cancer

Monotherapy with docetaxel for unresectable, locally advanced or metastatic NSCLC previously treated with platinum-based chemotherapy

2

Table 5- Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based ChemotherapyNormal Baseline LFTs: Transaminases ≤ 1.5 times ULN or alkaline phosphatase ≤ 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN
Adverse Reaction Docetaxel 75 mg/m2
n=176
%		 Best Supportive Care
n=49
%		 Vinorelbine/Ifosfamide
n=119
%
Neutropenia
Any
 84
 14
 83
Grade 3/4
 65
 12
 57
Leukopenia
Any
 84
 6
 89
Grade 3/4
 49
 0
 43
Thrombocytopenia
Any
 8
 0
 8
Grade 3/4
 3
 0
 2
Anemia
Any
 91
 55
 91
Grade 3/4
 9
 12
 14
Febrile NeutropeniaFebrile Neutropenia: ANC grade 4 with fever >38°C with intravenous antibiotics and/or hospitalization
6
 NANot Applicable
1
Infection
Any
 34
 29
 30
Grade 3/4
 10
 6
 9
Treatment Related Mortality
3
 NANot Applicable
3
Hypersensitivity Reactions
Any
 6
 0
 1
Grade 3/4
 3
 0
 0
Fluid Retention
Any
 34
 NDNot Done
23
Severe
 3
 3
Neurosensory
Any
 23
 14
 29
Grade 3/4
 2
 6
 5
Neuromotor
Any
 16
 8
 10
Grade 3/4
 5
 6
 3
Skin
Any
 20
 6
 17
Grade 3/4
 1
 2
 1
Gastrointestinal
Nausea
Any
 34
 31
 31
Grade 3/4
 5
 4
 8
Vomiting
Any
 22
 27
 22
Grade 3/4
 3
 2
 6
Diarrhea
Any
 23
 6
 12
Grade 3/4
 3
 0
 4
Alopecia
56
 35
 50
Asthenia
Any
 53
 57
 54
SevereCOSTART term and grading system
18
 39
 23
Stomatitis
Any
 26
 6
 8
Grade 3/4
 2
 0
 1
Pulmonary
Any
 41
 49
 45
Grade 3/4
 21
 29
 19
Nail Disorder
Any
 11
 0
 2
SevereCOSTART term and grading system
1
 0
 0
Myalgia
Any
 6
 0
 3
SevereCOSTART term and grading system
0
 0
 0
Arthralgia
Any
 3
 2
 2
SevereCOSTART term and grading system
0
 0
 1
Taste Perversion
Any
 6
 0
 0
SevereCOSTART term and grading system
1
 0
 0
Prostate Cancer

Combination therapy with docetaxel in patients with prostate cancer


Table 6- Clinically Important Treatment Emergent Adverse Reactions (Regardless of Relationship) in Patients with Prostate Cancer who Received Docetaxel in Combination with Prednisone (TAX327)
Docetaxel 75 mg/m2 every 3 weeks +
prednisone 5 mg twice daily
n=332
%		 Mitoxantrone 12 mg/m2 every 3 weeks +
prednisone 5 mg twice daily
n=335
%
Adverse Reaction Any Grade 3/4 Any Grade 3/4
Anemia
 67
 5
 58
 2
Neutropenia
 41
 32
 48
 22
Thrombocytopenia
 3
 1
 8
 1
Febrile neutropenia
 3
 N/A
 2
 N/A
Infection
 32
 6
 20
 4
Epistaxis
 6
 0
 2
 0
Allergic Reactions
 8
 1
 1
 0
Fluid RetentionRelated to treatment
Weight GainRelated to treatment
Peripheral EdemaRelated to treatment
24
8
18
 1
0
0
 5
3
2
 0
0
0
Neuropathy Sensory
 30
 2
 7
 0
Neuropathy Motor
 7
 2
 3
 1
Rash/Desquamation
 6
 0
 3
 1
Alopecia
 65
 N/A
 13
 N/A
Nail Changes
 30
 0
 8
 0
Nausea
 41
 3
 36
 2
Diarrhea
 32
 2
 10
 1
Stomatitis/Pharyngitis
 20
 1
 8
 0
Taste Disturbance
 18
 0
 7
 0
Vomiting
 17
 2
 14
 2
Anorexia
 17
 1
 14
 0
Cough
 12
 0
 8
 0
Dyspnea
 15
 3
 9
 1
Cardiac left ventricular function
 10
 0
 22
 1
Fatigue
 53
 5
 35
 5
Myalgia
 15
 0
 13
 1
Tearing
 10
 1
 2
 0
Arthralgia
 8
 1
 5
 1

6.2 Post-marketing Experiences




Body as a whole

Cardiovascular

Cutaneous

Gastrointestinal

Hematologic

Hypersensitivity

Hepatic

Neurologic

Ophthalmologic

Hearing

Respiratory

Renal

7 DRUG INTERACTIONS


In vitro

In vivo[see Dosage and Administration (2.7) and Clinical Pharmacology (12.3)]

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy


[see ‘Warnings and Precautions’ section]



2

8.3 Nursing Mothers


8.4 Pediatric Use


8.5 Geriatric Use




Prostate Cancer

8.6 Hepatic Impairment


[see Boxed Warning, Warnings and Precautions (5.2), Clinical Pharmacology (12.3)].

10 OVERDOSAGE




22

22222

11 DESCRIPTION


tert
DOCEFREZ435314

DOCEFREZ (Lyophilized Powder for Injection and Diluent)



12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics


Absorption:22222

Distribution:In vitro1in vitro

Metabolism:In vitro[see Drug Interactions (7)]

Elimination:14tert

Effect of Age:2

Effect of Gender:

Hepatic Impairment:[see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)].

Effect of Race:222

Effect of Ketoconazole[see Dosage and Administration (2.7) and Drug-Drug Interactions (7)]

Effect of Combination Therapies:
Dexamethasone

Prednisone

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility




in vitro1in vivothth2

th2rdth2

14 CLINICAL STUDIES

14.1 Locally Advanced or Metastatic Breast Cancer




Randomized Trials

222
Table 7- Efficacy of Docetaxel in the Treatment of Breast Cancer Patients Previously Treated with an Anthracycline-Containing Regimen (Intent-to-Treat Analysis)
Efficacy Parameter
Docetaxel
(n=203)
Mitomycin/
Vinblastine
(n=189)
p-value
Median Survival
 11.4 months
 8.7 months
 p=0.01
Log Rank
Risk RatioFor the risk ratio, a value less than 1.00 favors docetaxel., Mortality (Docetaxel: Control)
95% CI (Risk Ratio)
 0.73
0.58-0.93
Median Time to Progression
 4.3 months
 2.5 months
 p=0.01
Log Rank
Risk RatioFor the risk ratio, a value less than 1.00 favors docetaxel., Progression (Docetaxel: Control)
95% CI (Risk Ratio)
 0.75
0.61-0.94
Overall Response Rate
Complete Response Rate
 28.1%
3.4%
 9.5%
1.6%
 p<0.0001
Chi Square
22
Table 8- Efficacy of Docetaxel in the Treatment of Breast Cancer Patients Previously Treated with an Alkylating-Containing Regimen (Intent-to-Treat Analysis)
Efficacy Parameter Docetaxel (n=161) Doxorubicin (n=165) p-value
Median Survival
 14.7 months
 14.3 months
 p=0.39
Log Rank
Risk RatioFor the risk ratio, a value less than 1.00 favors docetaxel., Mortality (Docetaxel: Control)
95% CI (Risk Ratio)
 0.89
0.68-1.16
Median Time to Progression
 6.5 months
 5.3 months
 p=0.45
Log Rank
Risk RatioFor the risk ratio, a value less than 1.00 favors docetaxel., Progression (Docetaxel: Control)
95% CI (Risk Ratio)
 0.93
0.71-1.16
Overall Response Rate
Complete Response Rate
 45.3%
6.8%
 29.7%
4.2%
 p=0.004
Chi Square
22222222

Single Arm Studies

2

22

14.3 Non-Small Cell Lung Cancer (NSCLC)




Monotherapy with Docetaxel for NSCLC Previously Treated with Platinum-Based Chemotherapy

22 Boxed Warning, Dosage and Administration (2.7), Warnings and Precautions (5.3)]

222
22222
Table 9- Efficacy of Docetaxel in the Treatment of Non-Small Cell Lung Cancer Patients Previously Treated with a Platinum-Based Chemotherapy Regimen (Intent-to-Treat Analysis)
  TAX317 TAX320
Docetaxel
75 mg/m2
n=55		 Best Supportive Care
n=49		 Docetaxel
75 mg/m2
n=125		 Control
(V/IVinorelbine/Ifosfamide)
n=123
Overall Survival Log-rank Test
 p=0.01
 p=0.13
Risk Ratioa value less than 1.00 favors docetaxel., Mortality (Docetaxel: Control)
95% CI (Risk Ratio)
 0.56
(0.35, 0.88)
 0.82
(0.63, 1.06)
Median Survival
95% CI
 7.5 monthsp≤0.05
(5.5, 12.8)
 4.6 months
(3.7, 6.1)
 5.7 months
(5.1, 7.1)
 5.6 months
(4.4, 7.9)
% 1-year Survival
95% CI
 37%p≤0.05 uncorrected for multiple comparisons
(24, 50)
 12%
(2, 23)
 30%p≤0.05 uncorrected for multiple comparisons
(22, 39)
 20%
(13, 27)
Time to Progression
95% CI
 12.3 weeksp≤0.05
(9.0, 18.3)
 7.0 weeks
(6.0, 9.3)
 8.3 weeks
(7.0, 11.7)
 7.6 weeks
(6.7, 10.1)
Response Rate
95% CI
 5.5%
(1.1, 15.1)
 Not Applicable
 5.7%
(2.3, 11.3)
 0.8%
(0.0, 4.5)
2

Figure 1- TAX317 Survival K-M Curves - Docetaxel 75 mg/m2 vs. Best Supportive Care
DOCEFREZ
Figure 2 - TAX320 Survival K-M Curves – Docetaxel 75 mg/m2 vs. Vinorelbine or Ifosfamide Control
DOCEFREZ
2

14.4 Hormone Refractory Prostate Cancer


  • Docetaxel 75 mg/m2 every 3 weeks for 10 cycles.
  • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6-week cycle for 5 cycles.
  • Mitoxantrone 12 mg/m2 every 3 weeks for 10 cycles.

Table 10- Efficacy of Docetaxel in the Treatment of Patients with Androgen Independent (Hormone Refractory) Metastatic Prostate Cancer (Intent-to-Treat Analysis)
  Docetaxel+Prednisone
every 3 weeks		 Mitoxantrone+Prednisone
every 3 weeks
Number of patients
Median survival (months)
95% CI
Hazard ratio
95% CI
p-valueStratified log rank test. Threshold for statistical significance = 0.0175 because of 3 arms.
335
18.9
(17.0-21.2)
0.761
(0.619-0.936)
0.0094
 337
16.5
(14.4-18.6)
--
--
--
Figure 3- TAX327 Survival K-M Curves
DOCEFREZ

15 REFERENCES

  • NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
  • OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
  • American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling Hazardous Drugs. Am J Health-Syst Pharm. 2006;63:1172-1193
  • Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh , PA : Oncology Nursing Society.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied


DOCEFREZ (Lyophilized Powder for Injection and Diluent)







16.2 Storage


16.3 Handling and Disposal


[see References (15)]

17 PATIENT COUNSELING INFORMATION


See FDA-Approved Patient Labeling
  • DOCEFREZ may cause fetal harm. Advise patients to avoid becoming pregnant while receiving this drug. Women of childbearing potential should use effective contraceptives if receiving DOCEFREZ [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1)].
  • Obtain detailed allergy and concomitant drug information from the patient prior to DOCEFREZ administration.
  • Explain the significance of oral corticosteroids such as dexamethasone administration to the patient to help facilitate compliance. Instruct patients to report if they were not compliant with oral corticosteroid regimen.
  • Instruct patients to immediately report signs of a hypersensitivity reaction.
  • Tell patients to watch for signs of fluid retention such as peripheral edema in the lower extremities, weight gain and dyspnea.
  • Explain the significance of routine blood cell counts. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever.
  • Instruct patients to report myalgia, cutaneous, or neurologic reactions.
  • Explain to patients that side effects such as nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion site reactions, and hair loss are associated with docetaxel administration.

Patient Information


DOCEFREZ™ (‘dō-sə-‘frāz)
(docetaxel)
for Injection



What is the most important information I should know about DOCEFREZ?

DOCEFREZ can cause serious side effects, including death.
  • The chance of death in people who receive DOCEFREZ is higher if you:
    • have liver problems
    • receive high doses of DOCEFREZ
    • have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum
  • DOCEFREZ can affect your blood cells.  Your doctor should do routine blood tests during treatment with DOCEFREZ. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your doctor may not treat you with DOCEFREZ until you have enough white blood cells. People with low white blood counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your doctor’s instructions for how often to take your temperature while taking DOCEFREZ. Call your doctor right away if you have a fever.
  • Serious allergic reactions can happen in people who take DOCEFREZ. Serious allergic reactions are medical emergencies that can lead to death and must be treated right away. Tell your doctor right away if you have any of these signs of a serious allergic reaction:
    • trouble breathing
    • sudden swelling of your face, lips, tongue, throat, or trouble swallowing
    • hives (raised bumps), rash, or redness all over your body
  • Your body may hold too much fluid (severe fluid retention) during treatment with DOCEFREZ.  This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each DOCEFREZ treatment. You must take the corticosteroid exactly as your doctor tells you. Tell your doctor or nurse before your DOCEFREZ treatment if you forget to take corticosteroid dose or do not take it as your doctor tells you.
What is DOCEFREZ?
 
DOCEFREZ
  • breast cancer
  • non-small cell lung cancer
  • prostate cancer


Who should not take DOCEFREZ?

  • have had a severe allergic reaction to:
    • docetaxel, the active ingredient in DOCEFREZ, or
    • any other medicines that contain polysorbate 80.  Ask your doctor or pharmacist if you are not sure.

See “What is the most important information I should know about DOCEFREZ?” for the signs and symptoms of a severe allergic reaction.

  • have a low white blood cell count.
What should I tell my doctor before receiving DOCEFREZ?

  • are allergic to any medicines. See “Who should not take DOCEFREZ?” Also, see the end of this leaflet for a list of the ingredients in DOCEFREZ.
  • have liver problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. DOCEFREZ can harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if DOCEFREZ passes into your breast milk. You and your doctor should decide if you will take DOCEFREZ or breast-feed.




How will I receive DOCEFREZ?
  • DOCEFREZ will be given to you as an intravenous injection into your vein, usually over 1 hour.
  • DOCEFREZ is usually given every 3 weeks.
  • Your doctor will decide how long you will receive treatment with DOCEFREZ
  • Your doctor will check your blood cell counts and other blood tests during your treatment with DOCEFREZ to check for side effects of DOCEFREZ.
  • Your doctor may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while taking DOCEFREZ.
What are the possible side effects of DOCEFREZ?

DOCEFREZ may cause serious side effects including death.
  • See “What is the most important information I should know about DOCEFREZ?”
  • Acute Myeloid Leukemia (AML), a type of blood cancer, can happen in people who take DOCEFREZ  along with certain other medicines. Tell your doctor about all the medicines you take.
  • Other Blood Disorders – Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with Docefrez.
  • Skin Reactions including redness and swelling of your arms and legs with peeling of your skin.
  • Neurologic Symptoms including numbness, tingling, or burning in your hands and feet.
  • changes in your sense of taste
  • feeling short of breath
  • constipation
  • decreased appetite
  • changes in your fingernails or toenails
  • swelling of your hands, face or feet
  • feeling weak or tired
  • joint and muscle pain
  • nausea and vomiting
  • diarrhea
  • mouth or lips sores
  • hair loss
  • rash
  • redness of the eye, excess tearing
  • skin reactions at the site of DOCEFREZ administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin.
  • tissue damage if DOCEFREZ leaks out of the vein into the tissues






General information about DOCEFREZ




 
What are the ingredients in DOCEFREZ?



Every three-week injection of DOCEFREZ for breast, and non-small cell lung cancers
 
Take your oral corticosteroid medicine as your doctor tells you.
 
Oral corticosteroid dosing:
 
Day 1 Date:_________ Time:______AM _______PM
 
Day 2 Date:_________ Time:______AM _______PM
(DOCEFREZ Treatment Day)
 
Day 3 Date:_________ Time:______AM _______PM
 
 
Every three-week injection of DOCEFREZ for prostate cancer
 
Take your oral corticosteroid medicine as your doctor tells you.
 
Oral corticosteroid dosing:
 
Date:___________      Time:___________
 
Date:___________      Time:___________
(DOCEFREZ Treatment Day)
 
                                 Time:___________
 


Sun Pharmaceutical Ind. Ltd.




Caraco Pharmaceutical Laboratories, Ltd.




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DOCEFREZ-20MG-LABEL


NDC 47335-285-40
DocefrezTM
(Docetaxel) for Injection
20 mg
For Intravenous Infusion Only
Each Docefrez for Injection vial contains a slight overfill to deliver 20 mg of Docetaxel per 0.8 mL after reconstitution
Rx ONLY
DOCEFREZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DOCEFREZ-20MG-CARTON



NDC 47335-285-41
DocefrezTM
(Docetaxel) for Injection
20 mg*
For Intravenous Infusion Only
*Each Docefrez for Injection vial contains a slight overfill to deliver 20 mg of Docetaxel per 0.8 mL after reconstitution
Each carton contains:
One vial of Docefrez (docetaxel) for Injection 20 mg
One vial of DILUENT for Docefrez 20 mg

Rx ONLY
DOCEFREZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DILUENT-20MG-LABEL


NDC 47335-287-40
DILUENT for DocefrezTM 20 mg
1.13 mL
Single Use Vial-Discard Unused Portion.
Rx ONLY
DOCEFREZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DOCEFREZ-80MG-LABEL


NDC 47335-286-40
DocefrezTM
(Docetaxel) for Injection
80 mg
For Intravenous Infusion Only
Each Docefrez for Injection vial contains a slight overfill to deliver 80 mg of Docetaxel
(24 mg/mL after reconstitution)
DOCEFREZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DOCEFREZ-80MG-CARTON



NDC 47335-286-41
DocefrezTM
(Docetaxel) for Injection
80 mg*
For Intravenous Infusion Only
*Each Docefrez for Injection vial contains a slight overfill to deliver 80 mg of Docetaxel (24 mg/mL after reconstitution)
Each carton contains:
One vial of Docefrez (docetaxel) for Injection 80 mg
One vial of DILUENT for Docefrez 80 mg
Rx ONLY
DOCEFREZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-DILUENT-80MG-LABEL


NDC 47335-288-40
DILUENT for DocefrezTM 80 mg
4.21 mL
Rx ONLY
DOCEFREZ

DOCEFREZ

docetaxel anhydrous KIT

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-285
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47335-285-41 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022534 2011-05-03


DOCEFREZ

docetaxel anhydrous KIT

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-286
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47335-286-41 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022534 2011-05-03


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