ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in another section of the label
- Schedule-dependent Toxicity [see Warnings and Precautions ]
- Myelosuppression [see Warnings and Precautions]
- Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions ]
- Hemolytic Uremic Syndrome [see Warnings and Precautions]
- Hepatic Toxicity [see Warnings and Precautions ]
- Embryofetal Toxicity [see Warnings and Precautions (5.6), Use in Specific Populations (8.1), and Nonclinical Toxicology]
- Exacerbation of Radiation Toxicity [see Warnings and Precautions ]
- Capillary Leak Syndrome [see Warnings and Precautions]
- Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions ]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Single-Agent Use:
The data described below reflect exposure to Gemzar as a single agent administered at doses between 800 mg/m2 to 1250 mg/m2 over 30 minutes intravenously, once weekly, in 979 patients with a variety of malignancies. The most common (≥20%) adverse reactions of single-agent Gemzar are nausea/vomiting, anemia, increased ALT, increased AST, neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. The most common (≥5%) Grade 3 or 4 adverse reactions were neutropenia, nausea/vomiting; increased ALT, increase alkaline phosphatase, anemia, increased AST, and thrombocytopenia. Approximately 10% of the 979 patients discontinued Gemzar due to adverse reactions. Adverse reactions resulting in discontinuation of Gemzar in 2% of 979 patients were cardiovascular adverse events (myocardial infarction, cerebrovascular accident, arrhythmia, and hypertension) and adverse reactions resulting in discontinuation of Gemzar in less than 1% of the 979 patients were anemia, thrombocytopenia, hepatic dysfunction, renal dysfunction, nausea/vomiting, fever, rash, dyspnea, hemorrhage, infection, stomatitis, somnolence, flu-like syndrome, and edema.
Table 5 presents the incidence of adverse reactions reported in 979 patients with various malignancies receiving single-agent Gemzar across 5 clinical trials. Table 5 includes all clinical adverse reactions, reported in at least 10% of patients. A listing of clinically significant adverse reactions is provided following the table.
Table 5: Selected Per-Patient Incidence of Adverse Events in Patients Receiving Single-Agent Gemzara
a Grade based on criteria from the World Health Organization (WHO).
|
b N=699-974; all patients with laboratory or non-laboratory data.
|
c Regardless of causality.
|
d For approximately 60% of patients, non-laboratory adverse events were graded only if assessed to be possibly drug-related.
|
|
All Patients
b
|
All Grades
|
Grade 3
|
Grade 4
|
Laboratory
c
|
|
|
|
Hematologic
|
|
|
|
Anemia
|
68
|
7
|
1
|
Neutropenia
|
63
|
19
|
6
|
Thrombocytopenia
|
24
|
4
|
1
|
Hepatic
|
|
|
|
Increased ALT
|
68
|
8
|
2
|
Increased AST
|
67
|
6
|
2
|
Increased Alkaline Phosphatase
|
55
|
7
|
2
|
Hyperbilirubinemia
|
13
|
2
|
<1
|
Renal
|
|
|
|
Proteinuria
|
45
|
<1
|
0
|
Hematuria
|
35
|
<1
|
0
|
Increased BUN
|
16
|
0
|
0
|
Increased Creatinine
|
8
|
<1
|
0
|
Non-laboratory
d
|
|
|
|
Nausea and Vomiting
|
69
|
13
|
1
|
Fever
|
41
|
2
|
0
|
Rash
|
30
|
<1
|
0
|
Dyspnea
|
23
|
3
|
<1
|
Diarrhea
|
19
|
1
|
0
|
Hemorrhage
|
17
|
<1
|
<1
|
Infection
|
16
|
1
|
<1
|
Alopecia
|
15
|
<1
|
0
|
Stomatitis
|
11
|
<1
|
0
|
Somnolence
|
11
|
<1
|
<1
|
Paresthesias
|
10
|
<1
|
0
|
- Transfusion requirements — Red blood cell transfusions (19%); platelet transfusions (<1%)
- Fever — Fever occurred in the absence of clinical infection and frequently in combination with other flu-like symptoms.
- Pulmonary — Dyspnea unrelated to underlying disease and sometimes accompanied by bronchospasm.
- Edema — Edema (13%), peripheral edema (20%), and generalized edema (<1%); <1% of patients. discontinued Gemzar due to edema.
- Flu-like Symptoms — Characterized by fever, asthenia, anorexia, headache, cough, chills, myalgia, asthenia insomnia, rhinitis, sweating, and/or malaise (19%); <1% of patients discontinued Gemzar due to flu-like symptoms
- Infection — Sepsis (<1%)
- Extravasation — Injection-site reactions (4%)
- Allergic — Bronchospasm (<2%); anaphylactoid reactions [see Contraindications (4)].
Non-Small Cell Lung Cancer:
Table 6 presents the incidence of selected adverse reactions, occurring in ≥10% of Gemzar-treated patients and at a higher incidence in the Gemzar plus cisplatin arm, reported in a randomized trial of Gemzar plus cisplatin (n=262) administered in 28-day cycles as compared to cisplatin alone (n=260) in patients receiving first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) [see Clinical Studies ].
Patients randomized to Gemzar plus cisplatin received a median of 4 cycles of treatment and those randomized to cisplatin received a median of 2 cycles of treatment. In this trial, the requirement for dose adjustments (>90% versus 16%), discontinuation of treatment for adverse reactions (15% versus 8%), and the proportion of patients hospitalized (36% versus 23%) were all higher for patients receiving Gemzar plus cisplatin arm compared to those receiving cisplatin alone. The incidence of febrile neutropenia (9/262 versus 2/260), sepsis (4% versus 1%), Grade 3 cardiac dysrhythmias (3% versus <1%) were all higher in the Gemzar plus cisplatin arm compared to the cisplatin alone arm. The two-drug combination was more myelosuppressive with 4 (1.5%) possibly treatment-related deaths, including 3 resulting from myelosuppression with infection and one case of renal failure associated with pancytopenia and infection. No deaths due to treatment were reported on the cisplatin arm.
Table 6: Per-Patient Incidence of Selected Adverse Reactions from Randomized Trial of Gemzar plus Cisplatin versus Single-Agent Cisplatin in Patients with NSCLC Occurring at Higher Incidence in Gemzar-Treated Patients [Between Arm Difference of ≥5% (All Grades) or ≥2% (Grades 3-4)]a
a National Cancer Institute Common Toxicity Criteria (CTC) for severity grading.
|
b N=217-253; all Gemzar plus cisplatin patients with laboratory or non-laboratory data Gemzar at 1000 mg/m2 on Days 1, 8, and 15 and cisplatin at 100 mg/m2 on Day 1 every 28 days.
|
c N=213-248; all cisplatin patients with laboratory or non-laboratory data. Cisplatin at 100 mg/m2 on Day 1 every 28 days.
|
d Regardless of causality.
|
e Percent of patients receiving transfusions. Percent transfusions are not CTC-graded events.
|
f Non-laboratory events were graded only if assessed to be possibly drug-related.
|
|
Gemzar plus Cisplatin
b
|
Cisplatin
c
|
All Grades
|
Grade 3
|
Grade 4
|
All Grades
|
Grade 3
|
Grade 4
|
Laboratory
d
|
|
|
|
|
|
|
Hematologic
|
|
|
|
|
|
|
Anemia
|
89
|
22
|
3
|
67
|
6
|
1
|
RBC Transfusione
|
39
|
|
| 13
|
|
|
Neutropenia
|
79
|
22
|
35
|
20
|
3
|
1
|
Thrombocytopenia
|
85
|
25
|
25
|
13
|
3
|
1
|
Platelet Transfusionse
|
21
|
|
| <1
|
|
|
Lymphopenia
|
75
|
25
|
18
|
51
|
12
|
5
|
Hepatic
|
|
|
|
|
|
|
Increased Transaminases
|
22
|
2
|
1
|
10
|
1
|
0
|
Increased Alkaline Phosphatase
|
19
|
1
|
0
|
13
|
0
|
0
|
Renal
|
|
|
|
|
|
|
Proteinuria
|
23
|
0
|
0
|
18
|
0
|
0
|
Hematuria
|
15
|
0
|
0
|
13
|
0
|
0
|
Elevated creatinine
|
38
|
4
|
<1
|
31
|
2
|
<1
|
Other Laboratory
|
|
|
|
|
|
|
Hyperglycemia
|
30
|
4
|
0
|
23
|
3
|
0
|
Hypomagnesemia
|
30
|
4
|
3
|
17
|
2
|
0
|
Hypocalcemia
|
18
|
2
|
0
|
7
|
0
|
<1
|
Non-laboratory
f
|
|
|
|
|
|
|
Nausea
|
93
|
25
|
2
|
87
|
20
|
<1
|
Vomiting
|
78
|
11
|
12
|
71
|
10
|
9
|
Alopecia
|
53
|
1
|
0
|
33
|
0
|
0
|
Neuro Motor
|
35
|
12
|
0
|
15
|
3
|
0
|
Diarrhea
|
24
|
2
|
2
|
13
|
0
|
0
|
Neuro Sensory
|
23
|
1
|
0
|
18
|
1
|
0
|
Infection
|
18
|
3
|
2
|
12
|
1
|
0
|
Fever
|
16
|
0
|
0
|
5
|
0
|
0
|
Neuro Cortical
|
16
|
3
|
1
|
9
|
1
|
0
|
Neuro Mood
|
16
|
1
|
0
|
10
|
1
|
0
|
Local
|
15
|
0
|
0
|
6
|
0
|
0
|
Neuro Headache
|
14
|
0
|
0
|
7
|
0
|
0
|
Stomatitis
|
14
|
1
|
0
|
5
|
0
|
0
|
Hemorrhage
|
14
|
1
|
0
|
4
|
0
|
0
|
Hypotension
|
12
|
1
|
0
|
7
|
1
|
0
|
Rash
|
11
|
0
|
0
|
3
|
0
|
0
|
Table 7 presents the incidence of selected adverse reactions, occurring in ≥10% of Gemzar-treated patients and at a higher incidence in the Gemzar plus cisplatin arm, reported in a randomized trial of Gemzar plus cisplatin (n=69) administered in 21-day cycles as compared to etoposide plus cisplatin alone (n=66) in patients receiving first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) [see Clinical Studies ]. A listing of clinically significant adverse reactions is provided following the table.
Patients in the Gemzar cisplatin (GC) arm received a median of 5 cycles and those in the etoposide/cisplatin (EC) arm received a median of 4 cycles. The majority of patients receiving more than one cycle of treatment required dose adjustments; 81% in the (GC) arm and 68% in the (EC) arm. The incidence of hospitalizations for treatment-related adverse events was 22% (GC) and 27% in the (EC) arm. The proportion of discontinuation of treatment for treatment-related adverse reactions was higher for patients in the (GC) arm (14% versus 8%). The proportion of patients hospitalized for febrile neutropenia was lower in the (GC) arm (7% versus 12%). There was one death attributed to treatment, a patient with febrile neutropenia and renal failure, which occurred in the Gemzar/cisplatin arm.
Table 7: Per-Patient Incidence of Selected Adverse Reactions in Randomized Trial of Gemzar plus Cisplatin versus Etoposide plus Cisplatin in Patients with NSCLCa
a Grade based on criteria from the World Health Organization (WHO).
|
b N=67-69; all Gemzar plus cisplatin patients with laboratory or non-laboratory data. Gemzar at 1250 mg/m2 on Days 1 and 8 and cisplatin at 100 mg/m2 on Day 1 every 21 days.
|
c N=57-63; all cisplatin plus etoposide patients with laboratory or non-laboratory data. Cisplatin at 100 mg/m2 on Day 1 and intravenous etoposide at 100 mg/m2 on Days 1, 2, and 3 every 21 days.
|
d Regardless of causality.
|
e WHO grading scale not applicable to proportion of patients with transfusions.
|
f Non-laboratory events were graded only if assessed to be possibly drug-related. Pain data were not collected.
|
g Flu-like syndrome and edema were not graded.
|
|
Gemzar plus Cisplatin
b
|
Etoposide plus Cisplatin
c
|
All Grades
|
Grade 3
|
Grade 4
|
All Grades
|
Grade 3
|
Grade 4
|
Laboratory
d
|
|
|
|
|
|
|
Hematologic
|
|
|
|
|
|
|
Anemia
|
88
|
22
|
0
|
77
|
13
|
2
|
RBC Transfusionse
|
29
|
-
|
-
|
21
|
-
|
-
|
Neutropenia
|
88
|
36
|
28
|
87
|
20
|
56
|
Thrombocytopenia
|
81
|
39
|
16
|
45
|
8
|
5
|
Platelet Transfusionse
|
3
|
-
|
-
|
8
|
-
|
-
|
Hepatic
|
|
|
|
|
|
|
Increased ALT
|
6
|
0
|
0
|
12
|
0
|
0
|
Increased AST
|
3
|
0
|
0
|
11
|
0
|
0
|
Increased Alkaline Phosphatase
|
16
|
0
|
0
|
11
|
0
|
0
|
Bilirubin
|
0
|
0
|
0
|
0
|
0
|
0
|
Renal
|
|
|
|
|
|
|
Proteinuria
|
12
|
0
|
0
|
5
|
0
|
0
|
Hematuria
|
22
|
0
|
0
|
10
|
0
|
0
|
BUN
|
6
|
0
|
0
|
4
|
0
|
0
|
Creatinine
|
2
|
0
|
0
|
2
|
0
|
0
|
Non-laboratory
f
|
|
|
|
|
|
|
Nausea and Vomiting
|
96
|
35
|
4
|
86
|
19
|
7
|
Fever
|
6
|
0
|
0
|
3
|
0
|
0
|
Rash
|
10
|
0
|
0
|
3
|
0
|
0
|
Dyspnea
|
1
|
0
|
1
|
3
|
0
|
0
|
Diarrhea
|
14
|
1
|
1
|
13
|
0
|
2
|
Hemorrhage
|
9
|
0
|
3
|
3
|
0
|
3
|
Infection
|
28
|
3
|
1
|
21
|
8
|
0
|
Alopecia
|
77
|
13
|
0
|
92
|
51
|
0
|
Stomatitis
|
20
|
4
|
0
|
18
|
2
|
0
|
Somnolence
|
3
|
0
|
0
|
3
|
2
|
0
|
Paresthesias
|
38
|
0
|
0
|
16
|
2
|
0
|
Flu-like syndromeg
|
3
|
-
|
-
|
0
|
-
|
-
|
Edemag
|
12
|
-
|
-
|
2
|
-
|
-
|
Breast Cancer
Table 8 presents the incidence of selected adverse reactions, occurring in ≥10% of Gemzar-treated patients and at a higher incidence in the Gemzar plus paclitaxel arm, reported in a randomized trial of Gemzar plus paclitaxel (n=262) compared to paclitaxel alone (n=259) for the first-line treatment of metastatic breast cancer (MBC) in women who received anthracycline-containing chemotherapy in the adjuvant/neo-adjuvant setting or for whom anthracyclines were contraindicated [see Clinical Studies].
The requirement for dose reduction of paclitaxel were higher for patients in the Gemzar/paclitaxel arm (5% versus 2%). The number of paclitaxel doses omitted (<1%), the proportion of patients discontinuing treatment for treatment-related adverse reactions (7% versus 5%), and the number of treatment-related deaths (1 patient in each arm) were similar between the two arms.
Table 8: Per-Patient Incidence of Selected Adverse Reactions from Comparative Trial of Gemzar plus Paclitaxel versus Single-Agent Paclitaxel in Breast Cancera Occurring at Higher Incidence in Gemzar-Treated Patients [Between Arm Difference of ≥5% (All Grades) or ≥2% (Grades 3-4)]
a Severity grade based on National Cancer Institute Common Toxicity Criteria (CTC) Version 2.0.
|
b Regardless of causality.
|
c Non-laboratory events were graded only if assessed to be possibly drug-related.
|
|
Gemzar plus Paclitaxel
(N=262)
|
Paclitaxel
(N=259)
|
All Grades
|
Grade 3
|
Grade 4
|
All Grades
|
Grade 3
|
Grade 4
|
Laboratory
b
|
|
|
|
|
|
|
Hematologic
|
|
|
|
|
|
|
Anemia
|
69
|
6
|
1
|
51
|
3
|
<1
|
Neutropenia
|
69
|
31
|
17
|
31
|
4
|
7
|
Thrombocytopenia
|
26
|
5
|
<1
|
7
|
<1
|
<1
|
Hepatobiliary
|
|
|
|
|
|
|
Increased ALT
|
18
|
5
|
<1
|
6
|
<1
|
0
|
Increased AST
|
16
|
2
|
0
|
5
|
<1
|
0
|
Non-laboratory
c
|
|
|
|
|
|
|
Alopecia
|
90
|
14
|
4
|
92
|
19
|
3
|
Neuropathy-sensory
|
64
|
5
|
<1
|
58
|
3
|
0
|
Nausea
|
50
|
1
|
0
|
31
|
2
|
0
|
Fatigue
|
40
|
6
|
<1
|
28
|
1
|
<1
|
Vomiting
|
29
|
2
|
0
|
15
|
2
|
0
|
Diarrhea
|
20
|
3
|
0
|
13
|
2
|
0
|
Anorexia
|
17
|
0
|
0
|
12
|
<1
|
0
|
Neuropathy-motor
|
15
|
2
|
<1
|
10
|
<1
|
0
|
Stomatitis/pharyngitis
|
13
|
1
|
<1
|
8
|
<1
|
0
|
Fever
|
13
|
<1
|
0
|
3
|
0
|
0
|
Rash/desquamation
|
11
|
<1
|
<1
|
5
|
0
|
0
|
Febrile neutropenia
|
6
|
5
|
<1
|
2
|
1
|
0
|
Clinically relevant Grade 3 or 4 dyspnea occurred with a higher incidence in the Gemzar plus paclitaxel arm compared with the paclitaxel arm (1.9% versus 0).
Ovarian Cancer
Table 9 presents the incidence of selected adverse reactions, occurring in ≥10% of gemcitabine-treated patients and at a higher incidence in the Gemzar plus carboplatin arm, reported in a randomized trial of Gemzar plus carboplatin (n=175) compared to carboplatin alone (n=174) for the second-line treatment of ovarian cancer in women with disease that had relapsed more than 6 months following first-line platinum-based chemotherapy [see Clinical Studies ]. Additional clinically significant adverse reactions, occurring in less than 10% of patients, are provided following Table 9.
The proportion of patients with dose adjustments for carboplatin (1.8% versus 3.8%), doses of carboplatin omitted (0.2% versus 0), and discontinuing treatment for treatment-related adverse reactions (10.9% versus 9.8%), were similar between arms. Dose adjustment for Gemzar occurred in 10.4% of patients and Gemzar dose was omitted in 13.7% of patients in the Gemzar /carboplatin arm.
Table 9: Per-Patient Incidence of Adverse Reactions in Randomized Trial of Gemzar plus Carboplatin versus Carboplatin in Ovarian Cancera Occurring at Higher Incidence in Gemzar-Treated Patients [Between Arm Difference of ≥5% (All Grades) or ≥2% (Grades 3-4)]
a Grade based on Common Toxicity Criteria (CTC) Version 2.0.
|
b Regardless of causality.
|
c Percent of patients receiving transfusions. Transfusions are not CTC-graded events. Blood transfusions included both packed red blood cells and whole blood.
|
|
Gemzar plus Carboplatin
(N=175)
|
Carboplatin
(N=174)
|
All Grades
|
Grade 3
|
Grade 4
|
All Grades
|
Grade 3
|
Grade 4
|
Laboratory
b
|
|
|
|
|
|
|
Hematologic
|
|
|
|
|
|
|
Neutropenia
|
90
|
42
|
29
|
58
|
11
|
1
|
Anemia
|
86
|
22
|
6
|
75
|
9
|
2
|
Thrombocytopenia
|
78
|
30
|
5
|
57
|
10
|
1
|
RBC Transfusionsc
|
38
|
|
| 15
|
|
|
Platelet Transfusionsc
|
9
|
|
| 3
|
|
|
Non-laboratory
b
|
|
|
|
|
|
|
Nausea
|
69
|
6
|
0
|
61
|
3
|
0
|
Alopecia
|
49
|
0
|
0
|
17
|
0
|
0
|
Vomiting
|
46
|
6
|
0
|
36
|
2
|
<1
|
Constipation
|
42
|
6
|
1
|
37
|
3
|
0
|
Fatigue
|
40
|
3
|
<1
|
32
|
5
|
0
|
Diarrhea
|
25
|
3
|
0
|
14
|
<1
|
0
|
Stomatitis/pharyngitis
|
22
|
<1
|
0
|
13
|
0
|
0
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Hematopoietic growth factors were administered more frequently in the Gemzar-containing arm: granulocyte growth factors (23.6% and 10.1%) and erythropoietic agents (7.3% and 3.9%).
The following clinically relevant, Grade 3 and 4 adverse reactions occurred more frequently in the Gemzar plus carboplatin arm: dyspnea (3.4% versus 2.9%), febrile neutropenia (1.1% versus 0), hemorrhagic event (2.3% versus 1.1 %), motor neuropathy (1.1% versus 0.6%), and rash/desquamation (0.6% versus 0).
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of Gemzar. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular — Congestive heart failure, myocardial infarction, arrhythmias, supraventricular arrhythmias
Vascular Disorders — Peripheral vasculitis, gangrene, and capillary leak syndrome [see Warnings and Precautions ]
Skin — Cellulitis, severe skin reactions, including desquamation and bullous skin eruptions
Hepatic — Hepatic failure, hepatic veno-occlusive disease
Pulmonary — Interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and adult respiratory distress syndrome (ARDS)
Nervous System — Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions]
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REPORTS OF SUSPECTED GEMZAR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Gemzar. The information is not vetted and should not be considered as verified clinical evidence.
Possible Gemzar side effects / adverse reactions in 72 year old female
Reported by a physician from Colombia on 2011-10-03
Patient: 72 year old female
Reactions: Neoplasm Progression
Adverse event resulted in: death
Suspect drug(s):
Gemzar
Other drugs received by patient: Cisplatin
Possible Gemzar side effects / adverse reactions in 47 year old female
Reported by a physician from Greece on 2011-10-04
Patient: 47 year old female weighing 69.0 kg (151.8 pounds)
Reactions: Constipation
Adverse event resulted in: hospitalization
Suspect drug(s):
Gemzar
Dosage: 800 mg, every 2 weeks
Indication: Pancreatic Carcinoma Metastatic
Start date: 2011-06-07
Temsirolimus
Dosage: 25 mg, weekly
Indication: Pancreatic Carcinoma Recurrent
Start date: 2011-06-07
Other drugs received by patient: Dexamethasone; Zantac; Zofron; Primperan TAB; Fenistil; Cilroton; Laprazol
Possible Gemzar side effects / adverse reactions in 72 year old male
Reported by a consumer/non-health professional from United States on 2011-10-06
Patient: 72 year old male weighing 71.0 kg (156.2 pounds)
Reactions: Dyspnoea, Chest Pain, Acute Myocardial Infarction, Paraesthesia
Adverse event resulted in: hospitalization
Suspect drug(s):
Erbitux
Dosage: drug interrupted on 12nov2010(57dy)no of infisions:7 held on:18nov10,resumed on 3dec10
Indication: non-Small Cell Lung Cancer
Start date: 2010-09-17
Carboplatin
Dosage: drug interrupted on 12nov2010(57dy).no of infisions:3 held on:18nov10
Indication: non-Small Cell Lung Cancer
Start date: 2010-09-17
Gemzar
Dosage: drug interrupted on 12nov2010(57dy)no of infisions:5 held on:18nov10,resumed on 3dec10
Indication: non-Small Cell Lung Cancer
Start date: 2010-09-17
Other drugs received by patient: Coumadin; Enalapril Maleate; Amiodarone HCL; Lipitor; Esomeprazole Sodium; Plavix; Tamsulosin HCL; Budesonide; Amlodipine; Simvastatin; Nexium; Magnesium; Fluticasone Propionate; Salmeterol Xinafoate; Formoterol Fumarate; Digoxin; Atorvastatin; Furosemide; Advair Diskus 100/50; Symbicort; Lisinopril; Atenolol
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