Names and pronunciation
(jem-sit′a-been) Infugem
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Individual generic drug information
Extracted information for gemcitabine only.
(jem-sit′a-been) Infugem
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Func. class.: Antineoplastic—miscel- laneous
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Chem. class.: Pyrimidine analog
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ACTION: Exhibits antitumor activity by killing cells undergoing DNA synthesis (5 phase) and blocking G1/5-phase boundary
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USES: Adenocarcinoma of the pan- creas (nonresectable stage II, III, or metastatic stage IV); in combination with CISplatin for inoperable, advanced, or metastatic non–small-cell lung cancer; advanced breast cancer in combination with PACLitaxel; with CARBOplatin for ovarian cancer, pancreatic cancer, ovarin cancer, ovarian cancer relapse
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Unlabeled uses: Bladder cancer, biliary tract cancer
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Extracted information for gemcitabine only.
CONTRAINDICATIONS: Preg- nancy, breastfeeding, hypersensitivity Precautions: Children, geriatric patients, myelosuppression, radiation therapy, renal/hepatic disease, accidental expo- sure, alcoholism, dental disease, infection
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SIDE EFFECTS CNS: Posterior reversible encephalopathy syndrome (PRES) CV: Dysrthymias, hypertension ENDO: Hyperglycemia GI: Diarrhea, nausea, vomiting, anorexia, constipation, stomatitis, diarrhea, hepato- toxicity GU: Proteinuria, hematuria HEMA: Leukopenia, anemia, neutrope- nia, thrombocytopenia INTEG: Irritation at site, rash, alopecia META: Hypocalcemia, hypokalemia, hypomagnesemia RESP: Dyspnea, bronchospasm, pneu- monitis OTHER: Fever, hemorrhage, infection, flulike symptoms, paresthesia, peripheral edema, myalgia, capillary leak syndrome
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INTERACTIONS Increase: bleeding—NSAIDs, anti- coagulants Increase: myelosuppression, diarrhea— other antineoplastics, radiation Decrease: antibody response—live virus vaccines Drug/Lab Test Increase: BUN, AST, ALT, alk phos, biliru- bin, creatinine Decrease: Hb, WBC, neutrophils, platelets
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Extracted information for gemcitabine only.
DOSAGE AND ROUTES Breast cancer (metastatic) • Adult: IV: 1250 mg/m2 give over 30 min days 1 and 8 q21days (in combina- tion with paclitaxel), adjust dose on platelets and AGC on days 1, 8 of cycle, obtain CBC/differential before each dose Ovarian cancer (advanced) • Adult: IV: 1000 mg/m2 give over 30 min days 1 and 8; q21days (in combina- tion with carboplatin); check CBC/dif- ferential platelets before each dose Pancreatic cancer (adjuvant) • Adult: IV: 1000 mg/m2 on days 1, 8, 15 of 28-day cycle in combination with capecitabine × 6 cycles starting within 12 wk of pancreatic resection Non-small cell lung cancer (inopera- ble, locally advanced, or metastatic) • Adult: IV: 1000 mg/m2 give over 30 min days 1, 8, and 15; q28days (in combination with cisplatin) or 1250 mg/ m2 give over 30 min days 1 and 8; q21 days (in combination with cisplatin) Biliary tract cancer, advanced (unlabeled) • Adult: IV: 1000 mg/m2 over 30 min days 1 and 8; repeat cycle every 21 days (with cisplatin) or 1000 mg/m2 over 30 min days 1 and 8; repeat cycle every 21 days (with capecitabine) or 1000 mg/m2 infused at 10 mg/m2/min every 2 wk (with oxaliplatin) Bladder cancer (unlabeled) • Adult: Advanced or metastatic: IV: 1000 mg/m2 over 30 to 60 min days 1, 8, and 15; repeat cycle every 28 days (in com- bination with cisplatin) or 1000 mg/m2 over 30 min days 1 and 8; repeat cycle every 21 days (with carboplatin) until disease pro- gression or unacceptable toxicity; transi- tional cell carcinoma (refractory): Intra- vesicular instillation: 2000 mg (in 100 mL G NS; retain for 1 hr) twice weekly for 3 wk; repeat cycle every 4 wk for at least 2 cycles
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Available forms: solution for injection 200 mg (1- and 2-g vials); powder for injec- tion 200 mg (1-g vial); injection 10 mg/mL
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Administer: Intermittent IV route • Prepare in biologic cabinet using gown, mask, gloves; use cytotoxic han- dling procedures • After reconstituting with 0.9% NaCl 5 mL/200-mg vial of product or 25 mL/1-g vial of product (38 mg/mL), shake; may be further diluted with 0.9% NaCl to concentra- tions as low as 0.1 mg/mL; discard unused portions, give over 30 min, do not admix • Diluted solution stable at room tem- perature for 24 hr; do not refrigerate • Infusion longer than 60 min increases toxicity; infusion-related reactions in- clude hypotension, severe flulike symp- toms, myelosuppression, asthenia • Bone marrow depression: CBC, differ- ential, platelet count before each dose; single agent: absolute granulocyte count >1000/mm3 and platelets >100,000/mm3, give complete dose; absolute granulocyte count 500-999/mm3, platelets 50,000- 99,999/mm3, give 75%; absolute granulo- <500/mm3 cyte count or platelets <50,000/mm3, do not give; combination with PACLitaxel for breast cancer: absolute granulocyte count >1200/mm3 and plate- lets >75,000/mm3, give complete dose; absolute granulocyte count 1000-1199/ mm3 or platelets 50,000-75,000/mm3, give 75%; absolute granulocyte count 700-999/mm3 or platelets ≥50,000/mm3, give 50%; absolute granulocyte count <700/mm3 or platelets <50,000/mm3, do not give; combination with CARBOplatin for ovarian cancer: absolute granulocyte count >1500/mm3 and platelet count >100,000/mm3, give complete dose; abso- lute granulocyte count 1000-1499/mm3 or platelets 75,000-99,000/mm3, give 75%; absolute granulocyte count <1000/mm3 or platelets <75,000/mm3, do not give compatibilities: Alemtuzumab, Y-site alfentanil, allopurinol, amifostine, amikacin, aminophylline, ampicillin, anid- ulafungin, argatroban, aztreonam, bivali- rudin, bleomycin, bumetanide, butorpha- nol, calcium gluconate, caspofungin, cefOXitin, cefTAZidime, ceftizoxime, cef- TRIAXone, chlorproMAZINE, cimetidine, ciprofloxacin, CISplatin, clindamycin, cyclophosphamide, cytarabine, DACTINo- mycin, DAUNOrubicin, diphenhydrAMINE, DOBUTamine, DOCEtaxel, DOPamine, DOXOrubicin, droperidol, enalaprilat, eto- poside, famotidine, floxuridine, flucon- azole, fludarabine, fluorouracil, gentami- cin, granisetron, haloperidol, heparin, hydrocortisone, HYDROmorphone, IDA- rubicin, ifosfamide, leucovorin, linezolid, LORazepam, mannitol, meperidine, mesna, metoclopramide, metroNIDA- ZOLE, minocycline, mitoXANtrone, mor- phine, nalbuphine, ondansetron, PACLi- taxel, promethazine, ranitidine, streptozocin, teniposide, thiotepa, ticarcil- lin, tigecycline, tobramycin, topotecan, trimethoprim/sulfamethoxazole, vancomy- cin, vinBLAStine, vinCRIStine, vinorelbine, voriconazole, zidovudine, zoledronic acid
Source pages 617, 618
Extracted information for gemcitabine only.
Assess: • Blood dyscrasias: assess for bruising, bleeding, petechiae • Renal, hepatic studies before and dur- ing treatment; may increase AST, ALT, alk phos, bilirubin, BUN, creatinine, calcium, potassium, glucose, magnesium, urine protein, monitor I&O • Buccal cavity for dryness, sores, ulcer- ation, white patches, oral pain, bleeding, dysphagia • Blood studies: Monitor blood studies (neutrophils, platelets) often • PRES: monitor for headache seizures, hypertension, vision changes, if con- firmed with MRI, discontinue • Hepatotoxicity: May be fatal, monitor LFTs, baseline and periodically, those with preexisting liver conditions are at a greater risk • Pulmonary toxicity: May be fatal, may occur up to 2 wk after last dose, if dys- pnea, bronchospasm occur, discontinue • Capillary leak syndrome: hemocon- centration, decreased albumin, B/P; dis- continue if these occur • Hemolytic uremic syndrome (HUS): more frequent when given with bleomycin; assess renal function before use and peri- odically; anemia with microangiopathic he- molysis, elevated bilirubin or LDH, reticulo- cytosis, severe thrombocytopenia, or increases in BUN/creatinine (HUS); perma- nently discontinue if evidence of pulmonary toxicity, may occur ≤2 wk after last dose • Radiation therapy risks: avoid radiation therapy 7 days before and 7 days after treat- ment; there is increased risk of life-threat- ening mucositis and toxicity at any time • Pregnancy/breastfeeding: No con- trolled studies, avoid use in pregnancy, do not breastfeed
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Evaluate: • Therapeutic response: decrease in tu- mor size; decrease in spread of cancer; symptom relief
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To avoid foods with citric acid, hot temperature, or rough texture if stomatitis is present; to drink adequate fluids; to avoid use with NSAIDs, alcohol, salicylates • To report stomatitis and any bleeding, white spots, ulcerations in mouth; to ex- amine mouth daily, report symptoms • To report signs of anemia: fatigue, headache, faintness, SOB, irritability; he- maturia, dysuria • Not to receive vaccinations during treatment • About possible hair loss and what can be done • Infection: to report sore throat, fever, flulike symptoms immediately • That continuing follow-up exams and lab work will be needed • Pregnancy/breastfeeding: to use con- traception during and for 4 mo after; do not breastfeed
Source page 619
Extracted information for gemcitabine only.
PHARMACOKINETICS Half-life 2.5-18 hr; crosses placenta; excretion: renal, 92%-98% peak 30 min
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Filter the extracted dose blocks for this individual drug.
Breast cancer (metastatic)
• Adult: IV: 1250 mg/m2 give over 30 min days 1 and 8 q21days (in combina- tion with paclitaxel), adjust dose on platelets and AGC on days 1, 8 of cycle, obtain CBC/differential before each dose Ovarian cancer (advanced)
Candidate age grouping · source page 617
Breast cancer (metastatic)
• Adult: IV: 1000 mg/m2 give over 30 min days 1 and 8; q21days (in combina- tion with carboplatin); check CBC/dif- ferential platelets before each dose Pancreatic cancer (adjuvant)
Candidate age grouping · source page 617
Breast cancer (metastatic)
• Adult: IV: 1000 mg/m2 on days 1, 8, 15 of 28-day cycle in combination with capecitabine × 6 cycles starting within 12 wk of pancreatic resection Non-small cell lung cancer (inopera- ble, locally advanced, or metastatic)
Candidate age grouping · source page 617
Breast cancer (metastatic)
• Adult: IV: 1000 mg/m2 give over 30 min days 1, 8, and 15; q28days (in combination with cisplatin) or 1250 mg/ m2 give over 30 min days 1 and 8; q21 days (in combination with cisplatin) Biliary tract cancer, advanced (unlabeled)
Candidate age grouping · source page 617
Breast cancer (metastatic)
• Adult: IV: 1000 mg/m2 over 30 min days 1 and 8; repeat cycle every 21 days (with cisplatin) or 1000 mg/m2 over 30 min days 1 and 8; repeat cycle every 21 days (with capecitabine) or 1000 mg/m2 infused at 10 mg/m2/min every 2 wk (with oxaliplatin) Bladder cancer (unlabeled)
Candidate age grouping · source page 617
Breast cancer (metastatic)
• Adult: Advanced or metastatic: IV: 1000 mg/m2 over 30 to 60 min days 1, 8, and 15; repeat cycle every 28 days (in com- bination with cisplatin) or 1000 mg/m2 over 30 min days 1 and 8; repeat cycle every 21 days (with carboplatin) until disease pro- gression or unacceptable toxicity; transi- tional cell carcinoma (refractory): Intra- vesicular instillation: 2000 mg (in 100 mL G NS; retain for 1 hr) twice weekly for 3 wk; repeat cycle every 4 wk for at least 2 cycles
Candidate age grouping · source page 617