- Breast cancer
- Gynecologic Cancers
- Pancreatic, thyroid, and other endocrine cancers
- Respiratory and thoracic cancers
Breast cancer:
Indications for: INFUGEM
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.
Adult Dosage:
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 Dosage:
Not established.
INFUGEM 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 Classification:
Antimetabolite.
INFUGEM Interactions:
Severe radiation toxicity with concomitant radiation therapy: not recommended.
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.
Drug Elimination:
Renal (92–98%). Half-life: 1.7–19.4 hours.
Generic Drug Availability:
NO
How Supplied:
Single-dose premixed infusion bag—1
Gynecologic Cancers:
Pancreatic, thyroid, and other endocrine cancers:
Indications for: INFUGEM
First-line treatment of locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) pancreatic cancer in patients previously treated with fluorouracil.
Adult Dosage:
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 Dosage:
Not established.
INFUGEM 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 Classification:
Antimetabolite.
INFUGEM Interactions:
Severe radiation toxicity with concomitant radiation therapy: not recommended.
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.
Drug Elimination:
Renal (92–98%). Half-life: 1.7–19.4 hours.
Generic Drug Availability:
NO
How Supplied:
Single-dose premixed infusion bag—1
Respiratory and thoracic cancers:
Indications for: INFUGEM
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.
Adult Dosage:
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 Dosage:
Not established.
INFUGEM 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 Classification:
Antimetabolite.
INFUGEM Interactions:
Severe radiation toxicity with concomitant radiation therapy: not recommended.
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.
Drug Elimination:
Renal (92–98%). Half-life: 1.7–19.4 hours.
Generic Drug Availability:
NO
How Supplied:
Single-dose premixed infusion bag—1
