What happens if I overdose Gezt 1?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Gezt 1:
Gezt 1 is handled and stored by a health care provider. Keep Gezt 1 out of the reach of children and away from pets.
Overdose of Gezt 1 in details
Symptoms: The symptoms of overdosage are likely to be an extension of the pharmacological actions of Gezt 1. Possible symptoms of toxicity are those listed under Adverse Reactions.
Hematopoietic, gastrointestinal, hepatic or renal toxicity may be seen depending on the dosage given and the physical condition of the patient. Toxicity may be delayed and life-threatening (eg, myelosuppression).
Treatment: There is no antidote for overdosage of Gezt 1. Single doses as high as 5.7 g/m2 have been administered by IV infusion over 30 min every 2 weeks with clinically acceptable toxicity.
In the event of suspected overdose, the patient should be monitored with appropriate blood counts and should receive supportive therapy, as necessary.
In case of overdose, immediately contact the poison information center for advice.
What should I avoid while taking Gezt 1?
Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury.
Do not receive a "live" vaccine while using Gezt 1, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Gezt 1 can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Gezt 1 warnings
Schedule-Dependent Toxicity
In clinical trials evaluating the maximum tolerated dose of Gezt 1, prolongation of the infusion time beyond 60 minutes or more frequent than weekly dosing resulted in an increased incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia. The half-life of Gezt 1 is influenced by the length of the infusion. Refer to the recommended Gezt 1 dosing schedule.
Myelosuppression
Myelosuppression manifested by neutropenia, thrombocytopenia, and anemia occurs with Gezt 1 as a single agent, and the risks are increased when Gezt 1 is combined with other cytotoxic drugs. In clinical trials, Grade 3-4 neutropenia, anemia, and thrombocytopenia occurred in 25%, 8%, and 5%, respectively of patients receiving single-agent Gezt 1. The frequencies of Grade 3-4 neutropenia, anemia, and thrombocytopenia varied from 48% to 71%, 8 to 28%, and 5 to 55%, respectively, in patients receiving Gezt 1 in combination with another drug.
Monitor patients receiving Gezt 1 prior to each dose with a complete blood count (CBC), including differential and platelet count, and modify the dosage as recommended.
Pulmonary Toxicity and Respiratory Failure
Pulmonary toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and adult respiratory distress syndrome (ARDS), has been reported. In some cases, these pulmonary events can lead to fatal respiratory failure despite discontinuation of therapy. The onset of pulmonary symptoms may occur up to 2 weeks after the last dose of Gezt 1.
Permanently discontinue Gezt 1 in patients who develop unexplained dyspnea, with or without bronchospasm, or have any evidence of pulmonary toxicity.
Hemolytic Uremic Syndrome
Hemolytic uremic syndrome (HUS), including fatalities from renal failure or the requirement for dialysis, can occur in patients treated with Gezt 1. In clinical trials, HUS was reported in 6 of 2429 patients (0.25%). Most fatal cases of renal failure were due to HUS.
Assess renal function prior to initiation of Gezt 1 and periodically during treatment. Consider the diagnosis of HUS in patients who develop anemia with evidence of microangiopathic hemolysis, elevation of bilirubin or LDH, or reticulocytosis; severe thrombocytopenia; or evidence of renal failure (elevation of serum creatinine or BUN). Permanently discontinue Gezt 1 in patients with HUS or severe renal impairment. Renal failure may not be reversible even with discontinuation of therapy.
Hepatic Toxicity
Drug-induced liver injury, including liver failure and death, has been reported in patients receiving Gezt 1 alone or in combination with other potentially hepatotoxic drugs. Administration of Gezt 1 in patients with concurrent liver metastases or a preexisting medical history of hepatitis, alcoholism, or liver cirrhosis can lead to exacerbation of the underlying hepatic insufficiency.
Assess hepatic function prior to initiation of Gezt 1 and periodically during treatment. Permanently discontinue Gezt 1 in patients that develop severe liver injury.
Embryo-Fetal Toxicity
Gezt 1 can cause fetal harm when administered to a pregnant woman, based on its mechanism of action. Gezt 1 was teratogenic, embryotoxic, and fetotoxic in mice and rabbits.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Gezt 1 and for 6 months after the final dose. Advise male patients with female partners of reproductive potential to use effective contraception during and for 3 months following the final dose of Gezt 1.
Exacerbation of Radiation Therapy Toxicity
Gezt 1 is not recommended for use in combination with radiation therapy.
Concurrent (given together or ≤7 days apart) — Life-threatening mucositis, especially esophagitis and pneumonitis occurred in a trial in which Gezt 1 was administered at a dose of 1000 mg/m2 to patients with non-small cell lung cancer for up to 6 consecutive weeks concurrently with thoracic radiation.
Non-concurrent (given >7 days apart) — Excessive toxicity has not been observed when Gezt 1 is administered more than 7 days before or after radiation. Radiation recall has been reported in patients who receive Gezt 1 after prior radiation.
Capillary Leak Syndrome
Capillary leak syndrome (CLS) with severe consequences has been reported in patients receiving Gezt 1 as a single agent or in combination with other chemotherapeutic agents. Permanently discontinue Gezt 1 if CLS develops during therapy.
Posterior Reversible Encephalopathy Syndrome
Posterior reversible encephalopathy syndrome (PRES) has been reported in patients receiving Gezt 1 as a single agent or in combination with other chemotherapeutic agents. PRES can present with headache, seizure, lethargy, hypertension, confusion, blindness, and other visual and neurologic disturbances.
Confirm the diagnosis of PRES with magnetic resonance imaging (MRI) and permanently discontinue Gezt 1 if PRES develops during therapy.
What should I discuss with my healthcare provider before taking Gezt 1?
- If you have an allergy to Gezt 1 or any other part of Gezt 1 (Gezt 1).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you are getting radiation.
- If you are breast-feeding. Do not breast-feed while you take Gezt 1 (Gezt 1) and for 1 week after your last dose.
This is not a list of all drugs or health problems that interact with Gezt 1 (Gezt 1).
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Gezt 1 (Gezt 1) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Gezt 1 precautions
Prolongation of the infusion time and the increased dosing frequency have been shown to increase toxicity. In common with other cytotoxic agents, Gezt 1 has demonstrated the ability to suppress the bone marrow. Leukopenia, thrombocytopenia and anemia are expected adverse events. However, myelosuppression is short-lived.
Hospira Gezt 1 is for single use in 1 patient only.
Patients receiving therapy with Gezt 1 must be monitored closely. Laboratory facilities should be available to monitor drug tolerance. Resources to protect and maintain a patient compromised by drug toxicity may be required.
Interstitial pneumonitis together with pulmonary infiltrates has been seen in <1% of the patients. In such cases, Hospira Gezt 1 treatment must be stopped. Steroids may relieve the symptoms in such situations. Severe rarely fatal pulmonary effects eg, pulmonary edema, interstitial pneumonitis and acute respiratory distress syndrome (ARDS) have been reported as less common or rare. In such cases, cessation of Hospira Gezt 1 treatment is necessary. Starting supportive treatment at an early stage may improve the situation.
Hepatic and Renal Impairment: Gezt 1 should be used with caution in patients with hepatic insufficiency or with impaired renal function as there is insufficient information from clinical studies to allow clear dose recommendation for this patient population. Dose reduction is recommended in patients with elevated serum bilirubin concentration because such patients are at increased risk of toxicity.
In a study of cancer patients with elevated serum bilirubin concentrations (median 50 mmol/L, range 30-100 mmol/L) who were administered Gezt 1 monotherapy, 8 out of 10 patients experienced toxicity at a Gezt 1 dose of 950 mg/m2 compared with 3 out of 8 at 800 mg/m2. The toxicity was mostly related to the liver.
In the same study, patients with elevated serum creatinine concentration appeared to experience increased sensitivity to Gezt 1. However, the data based on 15 patients was not sufficient to make dosing recommendations.
All combination studies involving Gezt 1 and cisplatin have been performed in patients with creatinine clearance (CrCl) >60 mL/min. There are no safety or pharmacokinetic data available for this combination in patients with creatinine clearance <60 mL/min.
Effects on the Ability to Drive or Operate Machinery: Gezt 1 has been reported to cause somnolence. Patients should be cautioned against driving or operating machinery until it is established that they do not become somnolent.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Cytogenetic damage has been produced by Gezt 1 in an in vivo assay. Gezt 1 induced forward mutation in vitro in a mouse lymphoma (L5178Y) assay. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of Gezt 1.
Gezt 1 caused a dose and schedule-dependent hypospermatogenesis in male mice (0.9 mg/m2/day or 10.5 mg/m2 weekly administration IP). Although animal studies have shown an effect of Gezt 1 on male fertility (1.5 mg/m2/day IP or 30 mg/m2 IP weekly), no effect has been seen on female fertility (up to 4.5 mg/m2/day IV).
Use in lactation: It is not known whether Hospira Gezt 1 is excreted in human milk. However, studies in lactating rats have shown Gezt 1 and/or its metabolites in the milk 10 min after an IV dose to the dam.
The use of Gezt 1 should be avoided in nursing women because of the potential hazard to the infant.
Use in children: Gezt 1 has been studied in limited phase 1 and 2 trials in children in a variety of tumor types. These studies did not provide sufficient data to establish the efficacy and safety of Gezt 1 in children.
Use in the
Elderly: Gezt 1 has been well-tolerated in patients >65 years. There is no evidence to suggest that dose adjustments are necessary in the elderly, although Gezt 1 clearance and t½ are affected by age.
What happens if I miss a dose of Gezt 1?
Contact your doctor if you miss a miss an appointment to receive your Gezt 1 infusion.
References
- DrugBank. "gemcitabine". http://www.drugbank.ca/drugs/DB00441 (accessed September 17, 2018).
- MeSH. "Radiation-Sensitizing Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
