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Gemzar

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Gemzar

Gemzar Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

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. It is administered in intravenous form. Side effects can include pale skin, easy bruising or bleeding, numbness or weakness, nausea, diarrhea, or headache. Other side effects may occur.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Gemzar in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Gemzar Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, pain/redness at the injection site, and flu-like symptoms (e.g., fever, muscle aches) may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be needed to prevent or relieve nausea and vomiting. Changes in diet and lifestyle, such as eating several small meals or limiting activity, may help lessen some of these effects. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: dizziness/lightheadedness, fainting, mouth sores, numbness/tingling of hands/feet, sudden weight gain, swelling of ankles/feet, severe stomach/abdominal pain, easy bleeding/bruising, cough, difficulty catching your breath (shortness of breath, wheezing), unusual tiredness, fast/irregular heartbeat, change in amount of urine, dark urine, yellowing of the eyes/skin.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, jaw/left arm pain, weakness on one side of the body, slurred speech, vision changes, confusion.

This medication can lower your ability to fight an infection (bone marrow depression). Notify your doctor promptly if you develop any signs of infection (e.g., high fever, chills, persistent sore throat).

An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Gemzar (Gemcitabine Hcl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Gemzar FDA Prescribing Information: Side Effects
(Adverse Reactions)

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-laboratoryd
  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
aGrade based on criteria from the World Health Organization (WHO).
bN=699-974; all patients with laboratory or non-laboratory data.
cRegardless of causality.
dFor 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
  • Infection - Sepsis ( < 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 Transfusionc 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-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
aNational Cancer Institute Common Toxicity Criteria (CTC) for severity grading.
bN=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.
cN=213-248; all cisplatin patients with laboratory or non-laboratory data. Cisplatin at 100 mg/m² on Day 1 every 28 days.
dRegardless of causality.
ePercent of patients receiving transfusions. Percent transfusions are not CTC-graded events.
fNon-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 16 0 0 11 0 0
  Phosphatase
    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,g
  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
aGrade based on criteria from the World Health Organization (WHO).
bN=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.
cN=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.
dRegardless of causality.
eWHO grading scale not applicable to proportion of patients with transfusions
fNon-laboratory events were graded only if assessed to be possibly drug-related.
gPain data were not collected.

  • Flu-like syndrome: 3% in the Gemzar/cisplatin arm versus none in the etoposide/cisplatin arm.
  • Edema: 12% in the Gemzar/cisplatin arm versus 2% in the etoposide/cisplatin arm.
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 5 < 1 0
Non-laboratoryc
  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
aSeverity grade based on National Cancer Institute Common Toxicity Criteria (CTC) Version 2.0
bRegardless of causality.
cNon-laboratory events were graded only if assessed to be possibly drug-related.

The following clinically relevant, Grade 3 or 4 adverse reactions occurred with a higher incidence in the Gemzar plus paclitaxel arm compared with the paclitaxel arm: febrile neutropenia (5.0% versus 1.2%) and dyspnea (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 Cancer 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 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-laboratoryb
  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.

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]

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

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Gemzar - User Reviews

Gemzar User Reviews

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Here is a collection of user reviews for the medication Gemzar sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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