Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Genvir:
Genvir is handled and stored by a health care provider. Keep Genvir out of the reach of children and away from pets.
Overdose of Genvir in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Symptoms: The symptoms of overdosage are likely to be an extension of the pharmacological actions of Genvir. 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 Genvir. 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 Genvir?
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 Genvir, 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.
Genvir 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.
Genvir warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Schedule-Dependent Toxicity
In clinical trials evaluating the maximum tolerated dose of Genvir, 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 Genvir is influenced by the length of the infusion. Refer to the recommended Genvir dosing schedule.
Myelosuppression
Myelosuppression manifested by neutropenia, thrombocytopenia, and anemia occurs with Genvir as a single agent, and the risks are increased when Genvir 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 Genvir. 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 Genvir in combination with another drug.
Monitor patients receiving Genvir 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 Genvir.
Permanently discontinue Genvir 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 Genvir. 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 Genvir 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 Genvir 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 Genvir alone or in combination with other potentially hepatotoxic drugs. Administration of Genvir 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 Genvir and periodically during treatment. Permanently discontinue Genvir in patients that develop severe liver injury.
Embryo-Fetal Toxicity
Genvir can cause fetal harm when administered to a pregnant woman, based on its mechanism of action. Genvir 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 Genvir 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 Genvir.
Exacerbation of Radiation Therapy Toxicity
Genvir 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 Genvir 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 Genvir is administered more than 7 days before or after radiation. Radiation recall has been reported in patients who receive Genvir after prior radiation.
Capillary Leak Syndrome
Capillary leak syndrome (CLS) with severe consequences has been reported in patients receiving Genvir as a single agent or in combination with other chemotherapeutic agents. Permanently discontinue Genvir if CLS develops during therapy.
Posterior Reversible Encephalopathy Syndrome
Posterior reversible encephalopathy syndrome (PRES) has been reported in patients receiving Genvir 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 Genvir if PRES develops during therapy.
What should I discuss with my healthcare provider before taking Genvir?
If you have an allergy to Genvir or any other part of Genvir (Genvir).
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 Genvir (Genvir) and for 1 week after your last dose.
This is not a list of all drugs or health problems that interact with Genvir (Genvir).
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 Genvir (Genvir) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Genvir precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Prolongation of the infusion time and the increased dosing frequency have been shown to increase toxicity. In common with other cytotoxic agents, Genvir has demonstrated the ability to suppress the bone marrow. Leukopenia, thrombocytopenia and anemia are expected adverse events. However, myelosuppression is short-lived.
Hospira Genvir is for single use in 1 patient only.
Patients receiving therapy with Genvir 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 Genvir 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 Genvir treatment is necessary. Starting supportive treatment at an early stage may improve the situation.
Hepatic and Renal Impairment: Genvir 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 Genvir monotherapy, 8 out of 10 patients experienced toxicity at a Genvir 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 Genvir. However, the data based on 15 patients was not sufficient to make dosing recommendations.
All combination studies involving Genvir 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: Genvir 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 Genvir in an in vivo assay. Genvir 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 Genvir.
Genvir 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 Genvir 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 Genvir is excreted in human milk. However, studies in lactating rats have shown Genvir and/or its metabolites in the milk 10 min after an IV dose to the dam.
The use of Genvir should be avoided in nursing women because of the potential hazard to the infant.
Use in children: Genvir 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 Genvir in children.
Use in the
Elderly: Genvir has been well-tolerated in patients >65 years. There is no evidence to suggest that dose adjustments are necessary in the elderly, although Genvir clearance and t½ are affected by age.
What happens if I miss a dose of Genvir?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Contact your doctor if you miss a miss an appointment to receive your Genvir infusion.
