Infugem

Last updated on RxList: 1/15/2020
Infugem Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/15/2020

What Is Infugem?

Infugem (gemcitabine in sodium chloride injection) is a nucleoside metabolic inhibitor indicated in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy; in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated; in combination with cisplatin for the treatment of non-small cell lung cancer; and as a single agent for the treatment of pancreatic cancer.

What Are Side Effects of Infugem?

Common side effects of Infugem include:

Dosage for Infugem

The dose and administration regimen for Infugem depends on the condition being treated.

What Drugs, Substances, or Supplements Interact with Infugem?

Infugem may interact with other drugs. Tell your doctor all medications and supplements you use.

Infugem During Pregnancy and Breastfeeding

Infugem is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Infugem passes into breast milk. Due to the potential for serious adverse reactions in nursing infants from Infugem, breastfeeding is not recommended.

Additional Information

Our Infugem (gemcitabine in sodium chloride injection), for Intravenous Use 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.

QUESTION

Where does ovarian cancer occur? See Answer
Infugem Consumer Information

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

Also call your doctor at once if you have:

  • headache, confusion, change in mental status, vision loss, seizure (convulsions);
  • blisters or ulcers in your mouth, trouble eating or swallowing;
  • severe skin redness, swelling, oozing, or peeling during or after radiation treatment;
  • liver problems--loss of appetite, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low blood cell counts--fever, chills, tiredness, skin sores, cold hands and feet, feeling light-headed;
  • fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats; or
  • signs of damaged red blood cells--unusual bruising or bleeding, pale skin, bloody diarrhea, red or pink urine, swelling, rapid weight gain, and little or no urination.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • fever;
  • nausea, vomiting;
  • low blood cell counts;
  • abnormal blood or urine tests;
  • shortness of breath;
  • swelling in your hands or feet;
  • rash; or
  • red or pink urine.

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 Infugem (Gemcitabine in Sodium Chloride injection)

SLIDESHOW

Signs of Cancer in Women: Symptoms You Can't Ignore See Slideshow
Infugem Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity [see CONTRAINDICATIONS]
  • 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]
  • 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 practice.

Single Agent

The data described below reflect exposure to gemcitabine as a single agent administered at doses between 800 mg/m² to 1250 mg/m² intravenously over 30 minutes once weekly in 979 patients with various malignancies. The most common (≥20%) adverse reactions of single agent gemcitabine are nausea/vomiting, anemia, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (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, increased alkaline phosphatase, anemia, increased AST, and thrombocytopenia. Approximately 10% of the 979 patients discontinued gemcitabine due to adverse reactions. Adverse reactions resulting in discontinuation of gemcitabine in 2% of 979 patients were cardiovascular adverse reactions (myocardial infarction, cerebrovascular accident, arrhythmia, and hypertension) and adverse reactions resulting in discontinuation of gemcitabine in <1% of 979 patients were anemia, thrombocytopenia, hepatic dysfunction, renal dysfunction, nausea/vomiting, fever, rash, dyspnea, hemorrhage, infection, stomatitis, somnolence, flu-like syndrome, and edema.

Tables 7 and 8 present the incidence of selected adverse reactions and laboratory abnormalities reported in patients with various malignancies receiving single agent gemcitabine across 5 clinical trials. Additional clinically significant adverse reactions are provided following Table 8.

Table 7: Selected Adverse Reactions Occurring in ≥10% Patients Receiving Single Agent Gemcitabinea

Adverse ReactionsbGemcitabinec
All Grades (%)Grade 3 (%)Grade 4 (%)
Nausea and Vomiting69131
Fever4120
Rash30<10
Dyspnea233<1
Diarrhea1910
Hemorrhage17<1<1
Infection161<1
Alopecia15<10
Stomatitis11<10
Somnolence11<1<1
Paresthesias10<10
aGrade based on criteria from the World Health a Organization (WHO).
bFor approximately 60% of patients, non-laboratory adverse reactions were graded only if assessed to be possibly drug-related.
c N=699-974; all patients with laboratory or non-laboratory data.

Table 8: Selected Laboratory Abnormalities Occurring in Patients Receiving Single Agent Gemcitabinea

Laboratory AbnormalitybGemcitabinec
All Grades (%)Grade 3 (%)Grade 4 (%)
Hematologic
Anemia6871
Neutropenia63196
Thrombocytopenia2441
Hepatic
Increased ALT6882
Increased AST6762
Increased Alkaline Phosphatase5572
Hyperbilirubinemia132<1
Renal
Proteinuria45<10
Hematuria35<10
Increased BUN1600
Increased Creatinine8<10
aGrade based on criteria from the WHO.
b Regardless of causality.
c N=699-974; all patients with laboratory or non-laboratory data.

Additional adverse reactions include the following:

  • Transfusion requirements: Red blood cell transfusions (19%); platelet transfusions (<1%)
  • Edema: Edema (13%), peripheral edema (20%), generalized edema (<1%)
  • Flu-like symptoms: Fever, asthenia, anorexia, headache, cough, chills, myalgia, asthenia insomnia, rhinitis, sweating and/or malaise (19%)
  • Infection: Sepsis (<1%)
  • Extravasation: Injection-site reactions (4%)
  • Allergic: Bronchospasm (<2%); anaphylactoid reactions
Ovarian Cancer

Tables 9 and 10 present the incidence of selected adverse reactions and laboratory abnormalities, occurring in ≥10% of gemcitabine-treated patients and at a higher incidence in the gemcitabine with carboplatin arm, reported in a randomized trial (Study 1) of gemcitabine with 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 <10% of patients, are provided following Table 10.

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 adverse reactions (11% versus 10%), were similar between arms. Dose adjustment for gemcitabine occurred in 10% of patients and gemcitabine dose was omitted in 14% of patients in the gemcitabine/carboplatin arm.

Table 9: Adverse Reactions Occurring in >10% of Patients Receiving Gemcitabine with Carboplatin and at Higher Incidence than in Patients Receiving Single Agent Carboplatin [Between Arm Difference of ≥5% (All Grades ) or ≥2% (Grades 3-4)] in Study 1a

Adverse ReactionsbGemcitabine/ Carboplatin
(N=175)
Carboplatin
(N=174)
All Grades (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%)
Nausea69606130
Alopecia49001700
Vomiting4660362<1
Constipation42613730
Fatigue403<13250
Diarrhea253014<10
Stomatitis/Pharyngitis22<101300
aGrade based on National Cancer Institute CTC Version 2.0.
bRegardless of causality.

Table 10: Laboratory Abnormalities Occurring in Patients Receiving Gemcitabine with Carboplatin and at Higher Incidence than in Patients Receiving Single Agent Carboplatin [Between Arm Difference of ≥5% (All Grades ) or ≥2% (Grades 3-4)] in Study 1a

Laboratory AbnormalitybGemcitabine/ Carboplatin
(N=175)
Carboplatin
(N=174)
All Grades (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%)
Hematologic
Neutropenia90422958111
Anemia862267592
Thrombocytopenia7830557101
RBC Transfusionsc3815
Platelet Transfusionsc9--3--
aGrade based on National Cancer Institute CTC Version 2.0.
bRegardless of causality.
cPercent 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 gemcitabine-containing arm: leukocyte growth factor (24% and 10%) and erythropoiesis-stimulating agent (7% and 3.9%).

The following clinically relevant Grade 3 and 4 adverse reactions occurred more frequently in the gemcitabine with 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).

Breast Cancer

Tables 11 and 12 present the incidence of selected adverse reactions and laboratory abnormalities, occurring in ≥10% of gemcitabine-treated patients and at a higher incidence in the gemcitabine with paclitaxel arm, reported in a randomized trial (Study 2) of gemcitabine with 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]. Additional clinically significant adverse reactions, occurring in <10% of patients, are provided following Table 12.

The requirement for dose reduction of paclitaxel was higher for patients in the gemcitabine/paclitaxel arm (5% versus 2%). The number of paclitaxel doses omitted (<1%), the proportion of patients discontinuing treatment for adverse reactions (7% versus 5%) and the number of treatment-related deaths (1 patient in each arm) were similar between the two arms.

Table 11: Selected Adverse Reactions Occurring in Patients Receiving Gemcitabine with Paclitaxel and at Higher Incidence than in Patients Receiving Single Agent Paclitaxel [Between Arm Difference of ≥5% (All Grades ) or ≥2% (Grades 3-4)] in Study 2a

Adverse ReactionsbGemcitabine/ Paclitaxel
(N=262)
Paclitaxel
(N=259)
All Grades (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%)
Alopecia9014492193
Neuropathy-Sensory645<15830
Nausea50103120
Fatigue406<1281<1
Vomiting29201520
Diarrhea20301320
Anorexia170012<10
Neuropathy-Motor152<110<10
Stomatitis/Pharyngitis131<18<10
Fever13<10300
Rash/Desquamation11<1<1500
Febrile Neutropenia65<1210
aGrade based on National Cancer Institute CTC Version 2.0.
bNon-laboratory events were graded only if assessed to be possibly drug-related.

Table 12: Selected Laboratory Abnormalities Occurring in >10% of Patients Receiving Gemcitabinewith Paclitaxel and at a Higher Incidence than Patients Receiving Single Agent Paclitaxel [Between Arm Difference of ≥5% (All Grades ) or ≥2% (Grades 3-4)] in Study 2a

Laboratory AbnormalitybGemcitabine/ Paclitaxel
(N=262)
Paclitaxel
(N=259)
All Grades (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%)
Hematologic
Anemia6961513<1
Neutropenia6931173147
Thrombocytopenia265<17<1<1
Hepatobiliary
Increased ALT185<16<10
Increased AST16205<10
aGrade based on National Cancer Institute CTC Version 2.0.
bRegardless of causality.

Clinically relevant Grade 3 or 4 dyspnea occurred with a higher incidence in the gemcitabine with paclitaxel arm compared with the paclitaxel arm (1.9% versus 0).

Non-Small Cell Lung Cancer

Tables 13 and 14 present the incidence of selected adverse reactions and laboratory abnormalities occurring in ≥10% of gemcitabine-treated patients and at a higher incidence in the gemcitabine with cisplatin arm, reported in a randomized trial (Study 3) of gemcitabine with cisplatin (n=260) administered in 28-day cycles as compared to cisplatin alone (n=262) in patients receiving first-line treatment for locally advanced or metastatic NSCLC [see Clinical Studies].

Patients randomized to gemcitabine with cisplatin received a median of 4 cycles of treatment and those randomized to cisplatin alone 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 gemcitabine with cisplatin compared to those receiving cisplatin alone. The incidence of febrile neutropenia (3% versus <1%), sepsis (4% versus 1%), Grade 3 cardiac dysrhythmias (3% versus <1%) were all higher in the gemcitabine with 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 13: Selected Adverse Reactions Occurring in ≥10% of Patients Receiving Gemcitabine with Cisplatin and at Higher Incidence than in Patients Receiving Single Agent Cisplatin [Between Arm Difference of ≥5% (All Grades) or ≥2% (Grades 3-4)] in Study 3a

Adverse ReactionsbGemcitabine/ CisplatincCisplatind
All Grades (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%)
Nausea932528720<1
Vomiting78111271109
Alopecia53103300
Neuro Motor351201530
Diarrhea24221300
Neuro Sensory23101810
Infection18321210
Fever1600500
Neuro Cortical1631910
Neuro Mood16101010
Local1500600
Neuro Headache1400700
Stomatitis1410500
Hemorrhage1410400
Hypotension1210710
Rash1100300
aGrade based on National Cancer Institute Common Toxicity Criteria (CTC).
bNon-laboratory events were graded only if assessed to be possibly drug-related.
cN=217-253; all gemcitabine/cisplatin patients with laboratory or non-laboratory data.
dN=213-248; all cisplatin patients with laboratory or non-laboratory data.

Table 14: Selected Laboratory Abnormalities Occurring in >10% of Patients Receiving Gemcitabine with Cisplatin and at Higher Incidence than in Patients Receiving Single Agent Cisplatin [Between Arm Difference of ≥5% (All Grades ) or ≥2% (Grades 3-4)] in Study 3a

Laboratory AbnormalitybGemcitabine/ CisplatincCisplatind
All Grades (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%)
Hematologic
Anemia892236761
Thrombocytopenia8525251331
Neutropenia7922352031
Lymphopenia75251851125
RBC Transfusionse3913
Platelet Transfusionse21<1
Hepatic
Increased Transaminases22211010
Increased Alkaline Phosphatase19101300
Renal
Increased Creatinine384<1312<1
Proteinuria23001800
Hematuria15001300
Other Laboratory
Hyperglycemia30402330
Hypomagnesemia30431720
Hypocalcemia182070<1
aGrade based on National Cancer Institute CTC.
bRegardless of causality.
cN=217-253; all gemcitabine/cisplatin patients with laboratory or non-laboratory data.
dN=213-248; all cisplatin patients with laboratory or non-laboratory data.
ePercent of patients receiving transfusions. Percent transfusions are not CTC-graded events.

Tables 15 and 16 present the incidence of selected adverse reactions and laboratory abnormalities occurring in ≥10% of gemcitabine-treated patients and at a higher incidence in the gemcitabine with cisplatin arm, reported in a randomized trial (Study 4) of gemcitabine with cisplatin (n=69) administered in 21-day cycles as compared to etoposide with cisplatin (n=66) in patients receiving first-line treatment for locally advanced or metastatic NSCLC [see Clinical Studies]. Additional clinically significant adverse reactions are provided following Table 16.

Patients in the gemcitabine/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 adverse reactions was 22% in the GC arm and 27% in the EC arm. The proportion of patients who discontinued treatment for adverse reactions was higher in the GC arm (14% versus 8%). The proportion of patients who were 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 GC arm.

Table 15: Selected Adverse Reactions in Patients Receiving Gemcitabinewith Cisplatin in Study 4a

Adverse ReactionsbGemcitabine/ CisplatincEtoposide/ Cisplatind
All Grades (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%)
Nausea and Vomiting9635486197
Alopecia7713092510
Paresthesias38001620
Infection28312180
Stomatitis20401820
Diarrhea14111302
Edemae12--2--
Rash1000300
Hemorrhage903303
Fever600300
Somnolence300320
Flu-like Syndromee3--0--
Dyspnea101300
aGrade based on criteria from the WHO.
bNon-laboratory events were graded only if assessed to be possibly drug-related. Pain data were not collected.
cN=67-69; all gemcitabine/cisplatin patients with laboratory or non-laboratory data
dN=57-63; all Etoposide/cisplatin patients with laboratory or non-laboratory data
eFlu-like syndrome and edema were not graded.

Table 16: Selected Laboratory Abnormalities Occurring in Patients Receiving Gemcitabinewith Cisplatin in Study 4a

Laboratory AbnormalitybGemcitabine/ CisplatincEtoposide/ Cisplatind
All Grades (%)Grade 3 (%)Grade 4 (%)All Grades (%)Grade 3 (%)Grade 4 (%)
Hematologic
Anemia8822077132
Neutropenia883628872056
Thrombocytopenia8139164585
RBC Transfusionse29--21--
Platelet Transfusionse3--8--
Hepatic
Increased Alkaline Phosphatase16001100
Increased ALT6001200
Increased AST3001100
Renal
Hematuria22001000
Proteinuria1200500
Increased BUN600400
Increased Creatinine200200
aGrade based on criteria from the WHO.
bRegardless of causality.
cN=67-69; all gemcitabine/cisplatin patients with laboratory or non-laboratory data.
dN=57-63; all Etoposide/cisplatin patients with laboratory or non-laboratory data.
eWHO grading scale not applicable to proportion of patients with transfusions.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of gemcitabine. 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.

Blood and lymphatic system: Thrombotic microangiopathy (TMA)

Cardiovascular: Congestive heart failure, myocardial infarction, arrhythmias, and supraventricular arrhythmias

Vascular: Peripheral vasculitis, gangrene, and capillary leak syndrome

Skin: Cellulitis, pseudocellulitis, severe skin reactions, including desquamation and bullous skin eruptions

Hepatic: Hepatic failure, hepatic veno-occlusive disease

Pulmonary: Interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, adult respiratory distress syndrome (ARDS), pulmonary eosinophilia

Nervous System: Posterior reversible encephalopathy syndrome (PRES)

Read the entire FDA prescribing information for Infugem (Gemcitabine in Sodium Chloride injection)

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

Health Solutions From Our Sponsors