Infugem Generic Name & Formulations
Legal Class
Rx
General Description
Gemcitabine 1200mg/120mL, 1300mg/130mL, 1400mg/140mL, 1500mg/150mL, 1600mg/160mL, 1700mg/170mL, 1800mg/180mL, 1900mg/190mL, 2000mg/200mL, 2200mg/220mL; in 0.9% sodium chloride; per premixed bag; soln for IV infusion.
Pharmacological Class
Antimetabolite.
How Supplied
Single-dose premixed infusion bag—1
Manufacturer
Generic Availability
NO
Infugem Indications
Indications
In combination with paclitaxel for the first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were contraindicated.
Infugem Dosage and Administration
Adult
Infuse over 30mins. 1250mg/m2 on Days 1 and 8 of each 21-day cycle (in combination with paclitaxel 175mg/m2 administered on Day 1 before gemcitabine). Dose modifications: see full labeling.
Children
Not established.
Infugem Contraindications
Not Applicable
Infugem Boxed Warnings
Not Applicable
Infugem Warnings/Precautions
Warnings/Precautions
Increased risk of hypotension, severe flu-like symptoms, myelosuppression, and asthenia with prolonged infusion beyond 60mins or more frequent than weekly dosing. Permanently discontinue if unexplained dyspnea, severe pulmonary toxicity, hemolytic uremic syndrome (HUS), severe renal impairment, severe hepatotoxicity, capillary leak syndrome (CLS), or posterior reversible encephalopathy syndrome (PRES; confirm with MRI) occurs. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Monitor for myelosuppression; obtain CBCs (w. differential), platelets prior to each dose. Assess renal and hepatic function prior to initiation, then periodically thereafter. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise use of effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
Infugem Pharmacokinetics
See Literature
Infugem Interactions
Interactions
Severe radiation toxicity with concomitant radiation therapy: not recommended.
Infugem Adverse Reactions
Adverse Reactions
Nausea, vomiting, anemia, hepatic transaminitis, neutropenia, increased ALK, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, peripheral edema; pulmonary toxicity, HUS, renal failure, hepatotoxicity, CLS, PRES.
Infugem Clinical Trials
See Literature
Infugem Note
Not Applicable
Infugem Patient Counseling
See Literature
Infugem Generic Name & Formulations
Legal Class
Rx
General Description
Gemcitabine 1200mg/120mL, 1300mg/130mL, 1400mg/140mL, 1500mg/150mL, 1600mg/160mL, 1700mg/170mL, 1800mg/180mL, 1900mg/190mL, 2000mg/200mL, 2200mg/220mL; in 0.9% sodium chloride; per premixed bag; soln for IV infusion.
Pharmacological Class
Antimetabolite.
How Supplied
Single-dose premixed infusion bag—1
Manufacturer
Generic Availability
NO
Infugem Indications
Indications
Advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy, in combination with carboplatin.
Infugem Dosage and Administration
Adult
Infuse over 30mins. 1000mg/m2 on Days 1 and 8 of each 21-day cycle (in combination with carboplatin AUC 4 administered on Day 1 after gemcitabine). Dose modifications: see full labeling.
Children
Not established.
Infugem Contraindications
Not Applicable
Infugem Boxed Warnings
Not Applicable
Infugem Warnings/Precautions
Warnings/Precautions
Increased risk of hypotension, severe flu-like symptoms, myelosuppression, and asthenia with prolonged infusion beyond 60mins or more frequent than weekly dosing. Permanently discontinue if unexplained dyspnea, severe pulmonary toxicity, hemolytic uremic syndrome (HUS), severe renal impairment, severe hepatotoxicity, capillary leak syndrome (CLS), or posterior reversible encephalopathy syndrome (PRES; confirm with MRI) occurs. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Monitor for myelosuppression; obtain CBCs (w. differential), platelets prior to each dose. Assess renal and hepatic function prior to initiation, then periodically thereafter. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise use of effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
Infugem Pharmacokinetics
See Literature
Infugem Interactions
Interactions
Severe radiation toxicity with concomitant radiation therapy: not recommended.
Infugem Adverse Reactions
Adverse Reactions
Nausea, vomiting, anemia, hepatic transaminitis, neutropenia, increased ALK, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, peripheral edema; pulmonary toxicity, HUS, renal failure, hepatotoxicity, CLS, PRES.
Infugem Clinical Trials
See Literature
Infugem Note
Not Applicable
Infugem Patient Counseling
See Literature
Infugem Generic Name & Formulations
Legal Class
Rx
General Description
Gemcitabine 1200mg/120mL, 1300mg/130mL, 1400mg/140mL, 1500mg/150mL, 1600mg/160mL, 1700mg/170mL, 1800mg/180mL, 1900mg/190mL, 2000mg/200mL, 2200mg/220mL; in 0.9% sodium chloride; per premixed bag; soln for IV infusion.
Pharmacological Class
Antimetabolite.
How Supplied
Single-dose premixed infusion bag—1
Manufacturer
Generic Availability
NO
Infugem Indications
Indications
First-line treatment of locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) pancreatic cancer in patients previously treated with fluorouracil.
Infugem Dosage and Administration
Adult
Infuse over 30mins. 1000mg/m2 once weekly for the first 7 weeks, followed by 1 week of rest; subsequent cycles: infuse once weekly on Days 1, 8, and 15 of each 28-day cycle. Dose modifications: see full labeling.
Children
Not established.
Infugem Contraindications
Not Applicable
Infugem Boxed Warnings
Not Applicable
Infugem Warnings/Precautions
Warnings/Precautions
Increased risk of hypotension, severe flu-like symptoms, myelosuppression, and asthenia with prolonged infusion beyond 60mins or more frequent than weekly dosing. Permanently discontinue if unexplained dyspnea, severe pulmonary toxicity, hemolytic uremic syndrome (HUS), severe renal impairment, severe hepatotoxicity, capillary leak syndrome (CLS), or posterior reversible encephalopathy syndrome (PRES; confirm with MRI) occurs. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Monitor for myelosuppression; obtain CBCs (w. differential), platelets prior to each dose. Assess renal and hepatic function prior to initiation, then periodically thereafter. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise use of effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
Infugem Pharmacokinetics
See Literature
Infugem Interactions
Interactions
Severe radiation toxicity with concomitant radiation therapy: not recommended.
Infugem Adverse Reactions
Adverse Reactions
Nausea, vomiting, anemia, hepatic transaminitis, neutropenia, increased ALK, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, peripheral edema; pulmonary toxicity, HUS, renal failure, hepatotoxicity, CLS, PRES.
Infugem Clinical Trials
See Literature
Infugem Note
Not Applicable
Infugem Patient Counseling
See Literature
Infugem Generic Name & Formulations
Legal Class
Rx
General Description
Gemcitabine 1200mg/120mL, 1300mg/130mL, 1400mg/140mL, 1500mg/150mL, 1600mg/160mL, 1700mg/170mL, 1800mg/180mL, 1900mg/190mL, 2000mg/200mL, 2200mg/220mL; in 0.9% sodium chloride; per premixed bag; soln for IV infusion.
Pharmacological Class
Antimetabolite.
How Supplied
Single-dose premixed infusion bag—1
Manufacturer
Generic Availability
NO
Infugem Indications
Indications
First-line treatment of inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer (NSCLC), in combination with cisplatin.
Infugem Dosage and Administration
Adult
Infuse over 30mins. 4-week schedule: 1000mg/m2 on Days 1, 8, and 15 of each 28-day cycle. 3-week schedule: 1250mg/m2 on Days 1 and 8 of each 21-day cycle. Both: give in combination with cisplatin 100mg/m2 administered on Day 1 after gemcitabine. Dose modifications: see full labeling.
Children
Not established.
Infugem Contraindications
Not Applicable
Infugem Boxed Warnings
Not Applicable
Infugem Warnings/Precautions
Warnings/Precautions
Increased risk of hypotension, severe flu-like symptoms, myelosuppression, and asthenia with prolonged infusion beyond 60mins or more frequent than weekly dosing. Permanently discontinue if unexplained dyspnea, severe pulmonary toxicity, hemolytic uremic syndrome (HUS), severe renal impairment, severe hepatotoxicity, capillary leak syndrome (CLS), or posterior reversible encephalopathy syndrome (PRES; confirm with MRI) occurs. Concurrent liver metastases. History of hepatitis, alcoholism, liver cirrhosis. Monitor for myelosuppression; obtain CBCs (w. differential), platelets prior to each dose. Assess renal and hepatic function prior to initiation, then periodically thereafter. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise use of effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).
Infugem Pharmacokinetics
See Literature
Infugem Interactions
Interactions
Severe radiation toxicity with concomitant radiation therapy: not recommended.
Infugem Adverse Reactions
Adverse Reactions
Nausea, vomiting, anemia, hepatic transaminitis, neutropenia, increased ALK, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, peripheral edema; pulmonary toxicity, HUS, renal failure, hepatotoxicity, CLS, PRES.
Infugem Clinical Trials
See Literature
Infugem Note
Not Applicable
Infugem Patient Counseling
See Literature