Dosage of Gezt 1 in details
Gezt 1 is for IV use only.
Pancreatic Cancer: Gezt 1 should be administered by IV infusion at a dose of 1000 mg/m2 over 30 min once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequently, each cycle consists of once-a-week administration for 3 consecutive weeks, followed by a rest of 1 week.
Dose Modifications: Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient.
A full blood count should be performed prior to each course of Gezt 1 and every other week on therapy. A dose reduction of Gezt 1 is advised for myelotoxicity as given in the table.
Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine should be performed prior to initiation of therapy and periodically thereafter. Gezt 1 should be administered with caution in patients with evidence of significant renal or hepatic impairment.
If the recommended dose is well tolerated during the 1st cycle, [absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively], the dose may be increased to 1250 mg/m2 for the next cycle and, if well tolerated, it can be increased further to 1500 mg/m2.
Non-Small Cell Lung Cancer: Two treatment schedules have been tried with Gezt 1; however, the optimum schedule has not been determined. With 4-week schedule, Gezt 1 should be administered IV at 1000 mg/m2 over 30 min on days 1, 8 and 15 of each 28-day cycle. Cisplatin should be administered IV at 100 mg/m2 on day 1 after the infusion of Gezt 1. With the 3-week schedule, Gezt 1 should be administered IV at 1250 mg/m2 over 30 min on days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered IV after the infusion of Gezt 1 on day 1.
Dose Modifications: Dosage adjustments for hematologic toxicity may be required for Gezt 1 and for cisplatin. Gezt 1 dose adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Gezt 1 should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in the previous table.
In case of developing severe (grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gezt 1 plus cisplatin should be held or decreased by 50%. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium and serum magnesium should be carefully monitored (grade 3/4 serum creatinine toxicity for Gezt 1 plus cisplatin was 5% vs 2% for cisplatin alone).
Gezt 1 can be administered on an outpatient basis.
What other drugs will affect Gezt 1?
Other drugs may affect Gezt 1, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
See also:
Gezt 1 drug interactions (in more detail)
Gezt 1 interactions
Radiotherapy: Concurrent (Given Together or Equal to or 7 Days Apart): Toxicity associated with this multimodality therapy is dependent on many different factors, including dose of Gezt 1, frequency of Gezt 1 administration, dose of radiation, radiotherapy planning technique, the target tissue and target volume. In a single trial where Gezt 1 at a dose of 1,000 mg/m2 was administered concurrently for up to 6 consecutive weeks with therapeutic thoracic radiation to patients with NSCLC, significant toxicity in the form of severe and potentially life-threatening, esophagitis and pneumonitis was observed, particularly in patients receiving large volumes of radiotherapy (median treatment volumes 4,795 cm3). The optimum regimen for safe administration of Gezt 1 with therapeutic doses of radiation has not yet been determined.
Radiation injury has been reported on targeted tissues (eg, esophagitis, colitis and pneumonitis) in association with both concurrent and noncurrent use of Gezt 1.
When given in combination with paclitaxel, cisplatin or carboplatin, the pharmacokinetics of Gezt 1 were not altered. Gezt 1 had no effect on paclitaxel pharmacokinetics.
Laboratory Tests: Therapy should be started cautiously in patients with compromised bone marrow function. As with other oncolytics, the possibility of cumulative bone marrow suppression when using combination or sequential chemotherapy should be considered.
Patients receiving Gezt 1 should be monitored prior to each dose for platelet, leucocyte and granulocyte counts. Suspension or modification of therapy should be considered when drug-induced marrow depression is detected. For guidelines regarding dose modifications, see Dosage & Administration. Peripheral blood counts may continue to fall after the medicine is stopped.
Laboratory evaluation of renal and hepatic function should be performed periodically. Raised liver transaminases (AST/ALT) and alkaline phosphatase are seen in approximately 60% of the patients. These increases are usually mild, transient and not progressive and seldom lead to cessation of treatment. Increased bilirubin (WHO toxicity degrees 3 and 4) was observed in 2.6% of the patients. Hospira Gezt 1 should be given with caution to patients with impaired hepatic function.
Administration of Gezt 1 in patients with concurrent liver metastases or a preexisting medical history of hepatitis, alcoholism or liver cirrhosis may lead to exacerbation of the underlying hepatic insufficiency.
A few cases of renal failure, including hemolytic uremic syndrome have been reported.
Gezt 1 should be administered with caution to patients with impaired renal function. Hospira Gezt 1 treatment should be withdrawn if there is any sign of microangiopathic hemolytic anemia eg, rapidly falling hemoglobin levels with simultaneous thrombocytopenia, elevation of serum bilirubin, serum creatinine, urea or lactate dehydrogenase (LDH). Renal failure may be irreversible despite withdrawal of Hospira Gezt 1 treatment and may require dialysis.
References
- FDA/SPL Indexing Data. "B76N6SBZ8R: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Radiation-Sensitizing Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "(+)-2'-Deoxy-2',2'-difluorocytidine hydrochloride: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Gezt 1 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Gezt 1. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported frequency of use
No survey data has been collected yetConsumer reported doses
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Information checked by Dr. Sachin Kumar, MD Pharmacology
