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Doxorubicin Hydrochloride

Sun Pharma Global FZE

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use doxorubicin hydrochloride safely and effectively. See full prescribing information for doxorubicin hydrochloride liposome injection. Doxorubicin Hydrochloride Liposome Injection for intravenous infusionInitial U.S. Approval: 1995 RECENT MAJOR CHANGESContraindications, Nursing Mother (4) Removed          9/2012BOXED WARNINGWARNING: INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, SUBSTITUTION See full prescribing information for complete boxed warning. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin hydrochloride approaches 550 mg/m2. Cardiac toxicity may also occur at lower cumulative doses with mediastinal irradiation or concurrent cardiotoxic agents (5.1). Acute infusion-related reactions, sometimes reversible upon terminating or slowing infusion, occurred in up to 10% of patients. Serious and sometimes fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications/emergency equipment to treat such reactions should be available for immediate use (5.2). Severe myelosuppression may occur (5.3) Reduce dosage in patients with impaired hepatic function (2.6). Accidental substitution of doxorubicin hydrochloride liposome injection resulted in severe side effects. Do not substitute on mg per mg basis with doxorubicin hydrochloride (2.1). INDICATIONS AND USAGEDoxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer (1.1) After failure of platinum-based chemotherapy. • AIDS-related Kaposi’s Sarcoma (1.2) After failure of prior systemic chemotherapy or intolerance to such therapy.DOSAGE AND ADMINISTRATIONAdminister doxorubicin hydrochloride liposome injection at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution (2.1). Ovarian cancer: 50 mg/m2 IV every 4 weeks for 4 courses minimum (2.2) AIDS-related Kaposi’s Sarcoma: 20 mg/m2 IV every 3 weeks (2.3) DOSAGE FORMS AND STRENGTHS3CONTRAINDICATIONS Hypersensitivity reactions to a conventional formulation of doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome injection (4, 5.2) WARNINGS AND PRECAUTIONS Hand-Foot Syndrome may occur. Dose modification or discontinuation may be required (5.4) Radiation recall reaction may occur (5.5) Side Effects6To report SUSPECTED ADVERSE REACTIONS contact CARACO Pharmaceutical Laboratories Ltd. at 1-800-818-4555 orFDA at 1-800-FDA-1088 or www.fda.gov/medwatch.DRUG INTERACTIONS Doxorubicin hydrochloride may interact with drugs known to interact with conventional formulations of Doxorubicin hydrochloride. (7) USE IN SPECIFIC POPULATIONS Doxorubicin hydrochloride liposome injection can cause fetal harm when used during pregnancy. (5.6, 8.1) Discontinue nursing during treatment with doxorubicin hydrochloride liposome injection (8.3).


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNING: INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, ACCIDENTAL SUBSTITUTION

  • The use of doxorubicin hydrochloride liposome injection may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin hydrochloride approaches 550 mg/m2. In a clinical study in patients with advanced breast cancer, 250 patients received doxorubicin hydrochloride liposome injection at a starting dose of 50 mg/m2 every 4 weeks. At all cumulative anthracycline doses between 450 to 500 mg/m2 or between 500 to 550 mg/m2, the risk of cardiac toxicity for patients treated with doxorubicin hydrochloride liposome injection was 11%. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy [see Warnings and Precautions (5.1)].
  • Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with doxorubicin hydrochloride liposome injection. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction has resolved with slowing of the infusion rate. Serious and sometimes life-threatening or fatal allergic/anaphylactoid- like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. Doxorubicin hydrochloride liposome injection should be administered at an initial rate of 1 mg/min to minimize the risk of infusion reactions [see Warnings and Precautions (5.2)].
  • Severe myelosuppression may occur [see Warnings and Precautions (5.3)].
  • Dosage should be reduced in patients with impaired hepatic function [see Dosage and Administration (2.6) and Use in Specific Populations (8.6)].
  • Accidental substitution of doxorubicin hydrochloride liposome injection for doxorubicin hydrochloride has resulted in severe side effects. Doxorubicin hydrochloride liposome injection should not be substituted for doxorubicin hydrochloride on a mg per mg basis [see Dosage and Administration (2.1)].

1 INDICATIONS AND USAGE

1.1 Ovarian Cancer


1.2 AIDS-Related Kaposi’s Sarcoma


2 DOSAGE AND ADMINISTRATION

2.1 Usage and Administration Precautions




[see Warnings and Precautions (5.2)]



2.2 Patients With Ovarian Cancer


2[see Warnings and Precautions (5.1)][see Dosage and Administration (2.5)]

2.3 Patients With AIDS-Related Kaposi’s Sarcoma


2

2.5 Dose Modification Guidelines


2[see Clinical Pharmacology (12.3)]


Table 1: Hand-Foot Syndrome (HFS)
Toxicity Grade Dose Adjustment
1
(mild erythema, swelling, or desquamation not interfering with daily activities)
 Redose unless patient has experienced previous Grade 3 or 4 HFS. If so, delay up to 2 weeks and decrease dose by 25%. Return to original dose interval.
2
(erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter)
 Delay dosing up to 2 weeks or until resolved to Grade 0-1. If after 2 weeks there is no resolution, doxorubicin hydrochloride liposome injection should be discontinued. If resolved to Grade 0-1 within 2 weeks, and there are no prior Grade 3-4 HFS, continue treatment at previous dose and return to original dose interval. If patient experienced previous Grade 3-4 toxicity, continue treatment with a 25% dose reduction and return to original dose interval.
3
(blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing)
 Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, doxorubicin hydrochloride liposome injection should be discontinued.
4
(diffuse or local process causing infectious complications, or a bed ridden state or hospitalization)
 Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, doxorubicin hydrochloride liposome injection should be discontinued
Table 2: Hematological Toxicity
Grade ANC Platelets Modification
1
1,500 to 1,900
 75,000 to 150,000
 Resume treatment with no dose reduction
2
1,000 to <1,500
 50,000 to <75,000
 Wait until ANC ≥ 1,500 and platelets ≥ 75,000; redose with no dose reduction
3
500 to 999
 25,000 to <50,000
 Wait until ANC ≥ 1,500 and platelets ≥ 75,000; redose with no dose reduction
4
<500
 <25,000
 Wait until ANC ≥ 1,500 and platelets ≥ 75,000; redose at 25% dose reduction or continue full dose with cytokine support

Table 3: Stomatitis
Toxicity Grade Dose Adjustment
1
(painless ulcers,
erythema, or mild
soreness)
Redose unless patient has experienced previous Grade 3 or 4 toxicity. If so, delay up to 2 weeks and decrease dose by 25%. Return to original dose interval.
2
(painful erythema,
edema, or ulcers, but can eat)
Delay dosing up to 2 weeks or until resolved to Grade 0-1. If after 2 weeks there is no resolution, doxorubicin hydrochloride liposome injection should be discontinued. If resolved to Grade 0-1 within 2 weeks and there was no prior Grade 3-4 stomatitis, continue treatment at previous dose and return to original dose interval. If patient experienced previous Grade 3-4 toxicity, continue treatment with a 25% dose reduction and return to original dose interval.
3
(painful erythema, edema, or ulcers, and cannot eat)
Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, doxorubicin hydrochloride liposome injection should be discontinued.
4
(requires parenteral or enteral support)
Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease dose by 25% and return to doxorubicin hydrochloride liposome injection original dose interval. If after 2 weeks there is no resolution, doxorubicin hydrochloride liposome injection should be discontinued.


2.6 Patients With Impaired Hepatic Function


2.7 Preparation for Intravenous Administration







Do not use with in-line filters.











2.8 Procedure for Proper Handling and Disposal








Doxorubicin hydrochloride liposome injection must not be given by the intramuscular or subcutaneous route.

[see References (15)]

3 DOSAGE FORMS AND STRENGTHS

  • Single use vial: 20 mg/10 mL
  • Single use vial: 50 mg/25 mL

4 CONTRAINDICATIONS


Doxorubicin hydrochloride [see Warnings and Precautions (5.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Cardiac Toxicity


22





2 22
Table 5: Number of Patients With Advanced Breast Cancer
  Doxorubicin Hydrochloride Liposome Injection (n=250)
Patients who Developed Cardiotoxicity (LVEF Defined)
 10
Cardiotoxicity (With Signs & Symptoms of CHF)
 0
Cardiotoxicity (no Signs & Symptoms of CHF)
 10
Patients With Signs and Symptoms of CHF Only
 2


5.2 Infusion Reactions








[see Dosage and Administration (2)]

5.3 Myelosuppression






33[see Adverse Reactions (6.2)]

[see Dosage and Administrations (2.5)]

2 [see Adverse Reactions (6.2)]

5.4 Hand-Foot Syndrome (HFS)


2 [see definitions of HFS grades in Dosage and Administration (2.5)]

2

[see Dosage and Administration (2.5)]

5.5 Radiation Recall Reaction


5.6 Fetal Mortality


Pregnancy Category D

[see Use in Specific Populations (8.1)]

5.7 Toxicity Potentiation


5.8 Monitoring: Laboratory Tests


[see Warnings and Precautions (5.3)]

6 ADVERSE REACTIONS

6.1 Overall Side Effects Profile

The following adverse reactions are discussed in more detail in other sections of the labeling.

  • Cardiac Toxicity [see Warnings and Precautions (5.1)]
  • Infusion reactions [see Warnings and Precautions (5.2)]
  • Myelosuppression [see Warnings and Precautions (5.3)]
  • Hand-Foot syndrome [see Warnings and Precautions (5.4)]




[see Adverse Reactions in Clinical Trials (6.2)]

6.2 Side Effects in Clinical Trials








2

Table 6
Table 6: Ovarian Cancer Randomized Study Hematology Data Reported in Patients With Ovarian Cancer
Doxorubicin Hydrochloride Liposome Injection Patients
(n = 239)		 Topotecan Patients
(n = 235)
Neutropenia
500 to <1000/mm3
19 (7.9%)
 33 (14%)
<500/mm3
10 (4.2%)
 146 (62.1%)
Anemia
6.5 to <8 g/dL
 13 (5.4%)
 59 (25.1%)
< 6.5 g/dL
 1 (0.4%)
 10 (4.3%)
Thrombocytopenia
10,000 to <50,000/mm3
3 (1.3%)
 40 (17%)
<10,000/mm3
0 (0%)
 40 (17%)
Table 7
Table 7: Ovarian Cancer Randomized Study
Non-Hematologic Adverse Reaction 10% or Greater Doxorubicin Hydrochloride Liposome Injection (%) treated
(n = 239)		 Topotecan (%) treated
(n =235)
All grades
Grades 3-4
All grades
Grades 3-4
Body as a Whole
Asthenia
 40.2
 7.1
 51.5
 8.1
Fever
 21.3
 0.8
 30.6
 5.5
Mucous Membrane Disorder
 14.2
 3.8
 3.4
 0
Back Pain
 11.7
 1.7
 10.2
 0.9
Infection
 11.7
 2.1
 6.4
 0.9
Headache
 10.5
 0.8
 14.9
 0
Digestive
Nausea
 46
 5.4
 63
 8.1
Stomatitis
 41.4
 8.3
 15.3
 0.4
Vomiting
 32.6
 7.9
 43.8
 9.8
Diarrhea
 20.9
 2.5
 34.9
 4.2
Anorexia
 20.1
 2.5
 21.7
 1.3
Dyspepsia
 12.1
 0.8
 14
 0
Nervous
Dizziness
 4.2
 0
 10.2
 0
Respiratory
Pharyngitis
 15.9
 0
 17.9
 0.4
Dyspnea
 15.1
 4.1
 23.4
 4.3
Cough increased
 9.6
 0
 11.5
 0
Skin and Appendages
Hand-foot syndrome
 50.6
 23.8
 0.9
 0
Rash
 28.5
 4.2
 12.3
 0.4
Alopecia
 19.2
 N/A
 52.3
 N/A




Cardiovascular:

Digestive:

Hemic and Lymphatic:

Metabolic and Nutritional:

Nervous:

Respiratory:

Skin and Appendages:

Special Senses:

Urinary:



2 2 22

333



Table 8: Hematology Data Reported in Patients With AIDS-Related Kaposi’s Sarcoma
Patients With Refractory or Intolerant AIDS-Related Kaposi's Sarcoma
(n = 74)		 Total Patients With AIDS-Related Kaposi's Sarcoma
(n = 720)
Neutropenia
< 1000/mm3
34
 (45.9%)
 352
 (48.9%)
< 500/mm3
8
 (10.8%)
 96
 (13.3%)
Anemia
< 10 g/dL
 43
 (58.1%)
 399
 (55.4%)
< 8 g/dL
 12
 (16.2%)
 131
 (18.2%)
Thrombocytopenia
< 150,000/mm3
45
 (60.8%)
 439
 (60.9%)
< 25,000/mm3
1
 (1.4%)
 30
 (4.2%)

Table 9: Probably and Possibly Drug-Related Non-Hematologic Adverse Reactions Reported in ≥ 5% of Patients With AIDS-Related Kaposi’s Sarcoma
Adverse Reactions Patients With Refractory or Intolerant AIDS-Related Kaposi’s Sarcoma
(n = 77)		 Total Patients With AIDS-Related Kaposi’s Sarcoma
(n = 705)
Nausea
14
 (18.2%)
 119
 (16.9%)
Asthenia
5
 (6.5%)
 70
 (9.9%)
Fever
6
 (7.8%)
 64
 (9.1%)
Alopecia
 7
 (9.1%)
 63
 (8.9%)
Alkaline Phosphatase Increase
1
 (1.3%)
 55
 (7.8%)
Vomiting
6
 (7.8%)
 55
 (7.8%)
Diarrhea
4
 (5.2%)
 55
 (7.8%)
Stomatitis
4
 (5.2%)
 48
 (6.8%)
Oral Moniliasis
1
 (1.3%)
 39
 (5.5%)




Body as a Whole: Cardiovascular:

Cutaneous:

Digestive:

Metabolic and Nutritional:

Other:



Body As A Whole:

Cardiovascular:

Digestive:

Metabolic and Nutritional Disorders:

Respiratory:

Skin and Appendages:

Special Senses:

6.3 Post Marketing Experience




Musculoskeletal and Connective Tissue Disorders:

Respiratory, Thoracic and Mediastinal Disorders:

Hematologic disorders

Skin and subcutaneous tissue disorders

7 DRUG INTERACTIONS


8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy


[see Warnings and Precautions (5.6)]

2 2

8.3 Nursing Mothers


8.4 Pediatric Use


8.5 Geriatric Use


8.6 Hepatic Impairment


[see Dosage and Administration (2.6)]

[see Dosage and Administration (2.6)]

10 OVERDOSAGE




11 DESCRIPTION




Streptomyces peucetius . caesius


Doxorubicin Hydrochloride
272911




Doxorubicin Hydrochloride

Doxorubicin Hydrochloride

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action







Doxorubicin Hydrochloride


12.3 Pharmacokinetics


2 2
Table 11: Pharmacokinetic Parameters of Doxorubicin Hydrochloride Liposome Injection in Patients With AIDS-Related Kaposi’s Sarcoma
  Dose
Parameter (units) 10 mg/m2 20 mg/m2
N = 23
Mean ± Standard Error
Peak Plasma Concentration (mcg/mL)
 4.12 ± 0.215
 8.34 ± 0.49
Plasma Clearance (L/h/m2)
 0.056 ± 0.01
 0.041 ± 0.004
Steady State Volume of Distribution (L/m2)
 2.83 ± 0.145
 2.72 ± 0.12
AUC (mcg/mL∙h)
 277 ± 32.9
 590 ± 58.7
First Phase (λ1) Half-Life (h)
 4.7 ± 1.1
 5.2 ± 1.4
Second Phase (λ1) Half-Life (h)
 52.3 ± 5.6
 55 ± 4.8
2

2 2 2



2



2



2 22













2

13 NON-CLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility




in vitroin vivo

2 2 2 2 2 2

14 CLINICAL STUDIES

14.1 Ovarian Cancer




2

Table 12
Table 12: Patient Demographics for Patients With Refractory Ovarian Cancer From Single Arm Ovarian Cancer Studies
Study 1 (U.S.)
(n = 27)		 Study 2 (U.S.)
(n = 82)		 Study 3 (non-U.S.)
(n = 36)
Age at Diagnosis (Years)
Median
64
 61.5
 51.5
Range
46 to 75
 34 to 85
 22 to 80
Drug-Free Interval (Months)
Median
1.8
 1.7
 2.6
Range
0.5 to 15.6
 0.6 to 7
 0.7 to 15.2
Sum of Lesions at Baseline (cm2)
Median
25
 18.3
 32.4
Range
1.2 to 230
 1.3 to 285
 0.3 to 114
FIGO Staging
I
1 (3.7%)
 3 (3.7%)
 4 (11.1%)
II
3 (11.1%)
 3 (3.7%)
 1 (2.8%)
III
15 (55.6%)
 60 (73.2%)
 24 (66.7%)
IV
8 (29.6%)
 16 (19.5%)
 6 (16.7%)
Not Specified
—
 —
 1 (2.8%)
CA-125 at Baseline
Median
123.5
 199
 1004.5
Range
20 to 14,012
 7 to 46,594
 20 to 12,089
Number of Prior Chemotherapy Regimens
1
7 (25.9%)
 13 (15.9%)
 9 (25%)
2
11 (40.7%)
 44 (53.7%)
 19 (52.8%)
3
6 (22.2%)
 25 (30.5%)
 8 (22.8%)
4
3 (11.1%)
 —
 —


Table 13
Table 13: Response Rates in Patients With Refractory Ovarian Cancer From Single Arm Ovarian Cancer Studies
Study 1 (U.S.) Study 2 (U.S.) Study 3 (non-U.S.)
Response Rate
 22.2% (6/27)
 17.1% (14/82)
 0% (0/36)
95% Confidence Interval
 8.6% to 42.3%
 9.7% to 27%
 0% to 9.7%


2 2

Table 14
Table 14: Ovarian Cancer Randomized Study Baseline Demographic and Clinical Characteristics
Doxorubicin Hydrochloride Liposome Injection
(n = 239)		 Topotecan
(n = 235)
Age at Diagnosis (Years)
Median
60
 60
Range
27 to 87
 25 to 85
Drug-Free Interval (Months)
Median
7
 6.7
Range
0.9 to 82.1
 0.5 to 109.6
FIGO Staging
I
11 (4.6%)
 15 (6.4%)
II
13 (5.4%)
 8 (3.4%)
III
175 (73.2%)
 164 (69.8%)
IV
40 (16.7%)
 48 (20.4%)
Platinum Sensitivity
Sensitive
109 (45.6%)
 110 (46.8%)
Refractory
130 (54.4%)
 125 (53.2%)
Bulky Disease
Present
108 (45.2%)
 105 (44.7%)
Absent
131 (54.8%)
 130 (55.3%)
Table 15
Table 15: Results of Efficacy AnalysesAnalysis based on investigators’ strata for protocol defined ITT population.
  Protocol Defined ITT Population
  Doxorubicin Hydrochloride Liposome Injection Topotecan
 
 (n = 239)
 (n = 235)
TTP (Protocol Specified Primary Endpoint)
Median (Months)Kaplan-Meier estimates.
4.1
 4.2
p-valuep-value is based on the stratified log-rank test.
0.617
Hazard RatioHazard ratio is based on Cox proportional-hazard model with the treatment as single independent variable. A hazard ratio less than 1 indicates an advantage for doxorubicin hydrochloride liposome injection.
0.955
95% CI for Hazard Ratio
(0.762, 1.196)
Overall Survival
Median (Months)Kaplan-Meier estimates.
14.4
 13.7
p-valuep-value not adjusted for multiple comparisons.
0.05
Hazard RatioHazard ratio is based on Cox proportional-hazard model with the treatment as single independent variable. A hazard ratio less than 1 indicates an advantage for doxorubicin hydrochloride liposome injection.
0.822
95% CI for Hazard Ratio
(0.676, 1)
Response Rate
Overall Response n (%)
47 (19.7)
 40 (17)
Complete Response n (%)
9 (3.8)
 11 (4.7)
Partial Response n (%)
38 (15.9)
 29 (12.3)
Median Duration of Response (Months)Kaplan-Meier estimates.
6.9
 5.9

14.2 AIDS-Related Kaposi’s Sarcoma


2

3



2 2










Table 16: Response in Patients with RefractoryPatients with disease that progressed on prior combination chemotherapy or who were intolerant to such therapy. AIDS-related Kaposi’s Sarcoma
Investigator Assessment All Evaluable Patients
(n = 34)		 Evaluable Patients Who Received Prior Doxorubicin
(n = 20)
ResponseThere were no complete responses in this population.
Partial (PR)
 27%
 30%
Stable
 29%
 40%
Progression
 44%
 30%
Duration of PR (Days)
Median
 73
 89
Range
 42+ to 210+
 42+ to 210+
Time to PR (Days)
Median
43
 53
Range
 15 to 133
 15 to 109
Indicator Lesion Assessment
 All Evaluable Patients
(n = 42)
 Evaluable Patients Who Received Prior Doxorubicin
(n = 23)
ResponseThere were no complete responses in this population.
Partial (PR)
 48%
 52%
Stable
 26%
 30%
Progression
 26%
 17%
Duration of PR (Days)
Median
 71
 79
Range
 22+ to 210+
 35 to 210+
Time to PR (Days)
Median
 22
 48
Range
 15 to 109
 15 to 109

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
  • NIH [2002]. 1999 recommendations for the safe handling of cytotoxic drugs. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NIH Publication No. 92-2621.
  • American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling Hazardous Drugs.
  • 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










Table 19
mg in vial fill volume vial size NDC #s
20 mg vial
10 mL
10 mL
47335-049-40
50 mg vial
25 mL
30 mL
47335-050-40

17 PATIENT COUNSELING INFORMATION




Hand-Foot Syndrome

Stomatitis:

Fever and Neutropenia:

Nausea, vomiting, tiredness, weakness, rash, or mild hair loss:





Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Ind. Ltd.






PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 10 ML


NDC 47335-049-40
DOXOrubicin Hydrochloride Liposome Injection
20 mg/10 mL (2 mg/mL)
Sterile
Must be diluted
Cytotoxic Agent
LIPOSOMAL FORMULATION
DO NOT SUBSTITUTE
FOR INTRAVENOUS INFUSION ONLY


Doxorubicin Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON - 10 ML


NDC 47335-049-40
DOXOrubicin Hydrochloride Liposome Injection
20 mg/10 mL (2 mg/mL)
Sterile
Cytotoxic Agent
MUST BE DILUTED PRIOR TO ADMINISTRATION
LIPOSOMAL FORMULATION
DO NOT SUBSTITUTE
FOR INTRAVENOUS INFUSION ONLY
Rx only
10 mL Single Use Vial
SUN PHARMA
Doxorubicin Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 25 ML


NDC 47335-050-40
DOXOrubicin Hydrochloride Liposome Injection
50 mg/25 mL (2 mg/mL)
Sterile

Must be diluted
Cytotoxic Agent
LIPOSOMAL FORMULATION
DO NOT SUBSTITUTE
FOR INTRAVENOUS INFUSION ONLY


Doxorubicin Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON - 25 ML


NDC 47335-050-40
DOXOrubicin Hydrochloride Liposome Injection
50 mg/25 mL (2 mg/mL)
Sterile
Cytotoxic Agent
MUST BE DILUTED PRIOR TO ADMINISTRATION
LIPOSOMAL FORMULATION
DO NOT SUBSTITUTE
FOR INTRAVENOUS INFUSION ONLY
Rx only
25 mL Single Use Vial
SUN PHARMA
Doxorubicin Hydrochloride

Doxorubicin Hydrochloride

Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-049
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN 2 mg

Inactive Ingredients

Ingredient Name Strength
HYDROGENATED SOYBEAN LECITHIN
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT
CHOLESTEROL
AMMONIUM SULFATE
HISTIDINE
SUCROSE
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 VIAL, SINGLE-USE
2 NDC:47335-049-40 1 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203263 2013-02-05


Doxorubicin Hydrochloride

Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:47335-050
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN 2 mg

Inactive Ingredients

Ingredient Name Strength
HYDROGENATED SOYBEAN LECITHIN
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT
CHOLESTEROL
AMMONIUM SULFATE
HISTIDINE
SUCROSE
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 VIAL, SINGLE-USE
2 NDC:47335-050-40 1 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203263 2013-02-05


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