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Gemzar

Last reviewed on RxList: 11/16/2017
Gemzar Side Effects Center

Last reviewed on RxList 11/16/2017

Gemzar (gemcitabine) is a chemotherapy drug used to treat certain types of malignant tumors, including some cases of ovarian cancer, lung cancer, pancreatic cancer, and breast cancer. Side effects of Gemzar include pale skin, easy bruising or bleeding, numbness or tingly feeling, weakness, nausea, vomiting, upset stomach, diarrhea, constipation, headache, swelling in your hands/ankles/feet, skin rash, drowsiness, or hair loss. Tell your doctor if you have serious side effects of Gemzar including unusual weakness, urinating less than usual or not at all, itching, loss of appetite, dark urine, clay-colored stools, yellowing of the skin or eyes (jaundice), chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling, sudden numbness or weakness (especially on one side of the body), sudden severe headache, confusion, problems with vision/speech/balance, fever, chills, body aches, flu symptoms, white patches or sores inside your mouth or on your lips, pain/swelling/skin changes where the needle was placed, hearing problems, blood in your urine, or breathing problems.

The recommended dose of Gemzar is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after Gemzar administration on Day 1 of each 21-day cycle. Gemzar may interact with other medications and "live" vaccines. Tell your doctor all medications and supplements you use, and all vaccines you recently received. Gemzar can harm the fetus if taken by a pregnant woman. It is not known whether gemcitabine passes into breast milk or if it could harm a nursing baby. Gemzar can lower the blood cell counts that help the body fight infection, making you more susceptible to infections. Regular blood tests are needed while taking this medication.

Our Gemzar Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Gemzar Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • pain, swelling, or skin changes where the needle was placed;
  • hearing problems;
  • blood in your urine; or
  • breathing problems.

Less serious side effects may include:

  • mild nausea, vomiting, upset stomach;
  • diarrhea or constipation;
  • swelling in your hands, ankles, or feet;
  • skin rash;
  • numbness or tingly feeling;
  • drowsiness; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Gemzar (Gemcitabine Hcl)

Gemzar Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in another section of the label

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

  All Patientsb
All Grades Grade 3 Grade 4
Laboratoryc
  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-laboratoryMd
  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
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.

  • 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
  • InfectionSepsis (<1%)
  • Extravasation — Injection-site reactions (4%)
  • Allergic — Bronchospasm (<2%); anaphylactoid reactions [see CONTRAINDICATIONS].
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

  Gemzar plus Cisplatinb Cisplatinc
All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4
Laboratoryd
  Hematologic            
    Anemia 89 22 3 67 6 1
    RBC Transfusionse 39     13    
    Neutropenia 79 22 35 20 3 1
    Thrombocytopenia 85 25 25 13 3 1
    Platelet Transfusionse 21     <1    
  Hepatic            
    Increased Transaminases 22 2 1 10 1 0
    Increased 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-laboratoryf
  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
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.

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

  Gemzar plus Cisplatinb Etoposide plus Cisplatinc
All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4
Laboratoryd
  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-laboratoryf
  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 - -
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.

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)]

  Gemzar plus Paclitaxel
(N=262)
Paclitaxel
(N=259)
All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4
Laboratoryb
  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 2 <1 0
Non-laboratoryc
  Alopecia 90 14 4 92 19 3
  Neuropathy-sensory 64 5 <1 58 5 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
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.

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)]

  Gemzar plus Carboplatin
(N=175)
Carboplatin
(N=174)
All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4
Laboratoryb
  Hematologic            
  Neutropenia 90 42 42 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
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.

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.

CardiovascularCongestive heart failure, myocardial infarction, arrhythmias, supraventricular arrhythmias

Vascular Disorders — Peripheral vasculitis, gangrene, and capillary leak syndrome [see WARNINGS AND PRECAUTIONS]

SkinCellulitis, severe skin reactions, including desquamation and bullous skin eruptions

Hepatic — Hepatic failure, hepatic veno-occlusive disease

PulmonaryInterstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and adult respiratory distress syndrome (ARDS)

Nervous System — Posterior reversible encephalopathy syndrome (PRES) [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Gemzar (Gemcitabine Hcl)

Related Resources for Gemzar

Read the Gemzar User Reviews »

© Gemzar Patient Information is supplied by Cerner Multum, Inc. and Gemzar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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