Gezt 1 Side effects

• Side effects of Gezt 1 in details
• Gezt 1 contraindications
• Gezt 1 reviews

What are the possible side effects of Gezt 1?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hair loss.
• Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating.
• Not hungry.
• Mouth irritation or mouth sores.
• Feeling tired or weak.
• Feeling sleepy.
• Constipation, diarrhea, throwing up, and upset stomach are common with Gezt 1 (Gezt 1). If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not go away, or get very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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Gezt 1 side effects (in more detail)

Side effects of Gezt 1 in details

Gezt 1 has been used in a wide variety of malignancies, both as a single agent and in combination with other cytotoxic drugs. In all studies to date, Gezt 1 has been reported to have a particularly modest toxicity profile with a low incidence of side effects normally associated with cytotoxics. The toxicity data from 18 single-agent studies across a range of tumors in which Gezt 1 was administered as a 30-min infusion once a week for 3 weeks, followed by a week of rest (starting doses 800-1250 mg/m²) have shown similar results. In addition, a specific review of toxicity and patient tolerability in 360 patients with NSCLS has confirmed this mild toxicity profile.

The potential side effects of Gezt 1 include bone marrow toxicity causing leucopenia and neutropenia. Myelosuppression is the dose-limiting toxicity with Gezt 1. However, Gezt 1-induced myelosuppression is mild. Neutropenia is transient and rarely associated with fever. Occasionally, anemia or thrombocytopenia may occur. Thrombocytopenia is frequently the cause of the modest numbers of dose reductions and omissions seen with Gezt 1. In the safety overview, 79% of patients experienced no platelet nadir lower than 100,000 microliters and WHO grade 3 and 4 leukocyte toxicity was recorded in 8.1% and 0.5% of patients, respectively.

Other severe side effects following Gezt 1 administration include occasional pulmonary toxicity with <2% of patients having grade 3 or 4 toxicity. However, treatment-emergent signs and symptoms have been reported in approximately 25% of patients and serious dyspnea in approximately 5% of patients. The severity of toxicity is slightly greater in the NSCLC group. This is thought to be caused by progressive lung disease or pulmonary manifestations of other malignancies. Some patients appear to develop dyspnea following Gezt 1 administration that is associated with bronchospasm. This suggests that there may be an allergic toxicity profile associated with Gezt 1. This should be treated with oxygen, nebulizers and parenteral therapy if required. Less than 1% of patients develop dyspnea associated with pulmonary infiltrates. There has been a report of fatal pulmonary toxicity associated with treatment with Gezt 1. Caution is advised in the repeated administration of Gezt 1 to patients who develop unexplained non-cardiogenic pulmonary edema.

Nausea and vomiting occur in about 1/3 of patients. Approximately 20% of patients who receive Gezt 1 need antiemetics of nausea and vomiting, although 5-HT antagonists are not usually required. Mild mucositis may occur in 7% of patients. Diarrhea has been reported in 8% of patients and constipation in 6%.

Transient elevations in liver function tests attributed to Gezt 1 have been reported. Mild transaminase (grade 1) elevations are seen in about 37-39% of patients. Data from the safety overview and the safety profile in NSCLC suggest grade 3 and 4 alanine transaminase and aspartate transaminase elevations occur in <10% of patients. All the available data suggest that grade 3 and 4 alkaline phosphatase elevations occur in about 7% of patients. Although these elevations are common, no significant hyperbilirubinemia has been observed. These elevations in liver enzymes are unrelated to gender or age.

Significant renal toxicity is minimal although mild grade 1 intermittent proteinuria is seen in approximately 50% of patients. Mild hematuria is seen in approximately 40% of patients. Creatinine levels greater than grade 1 have been seen in <1% of patients. Very rarely, cases of renal failure (including a hemolytic uremic syndrome) of uncertain etiology have been reported. Gezt 1 should be discontinued if microangiopathic hemolytic anemia is seen.

Other Effects: Headache, back pain, chills, rash, myalgia, paresthesia, asthenia and anorexia are the most commonly reported symptoms together with cough, rhinitis, malaise, sweating and insomnia. The symptoms are usually mild, of brief duration, and rarely dose-limiting. Approximately 20% of patients experience mild, transient flu-like symptoms, normally on the day of Gezt 1 treatment, that are readily controlled by standard analgesia. Transient cutaneous allergy is also observed in approximately 25% of patients.

Hair loss in patients treated with Gezt 1 is extremely mild with over 80% of patients experiencing no hair loss at all. Some of the patients experienced edema (13%), infections (16%), rarely 2% of patients discontinued therapy with Gezt 1 due to cardiovascular events eg, myocardial infarction, cerebral accident, arrhythmia and hypertension. Many of these patients had a previous history of cardiovascular disease.

What is the most important information I should know about Gezt 1?

• Gezt 1 may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Gezt 1 with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Gezt 1 may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Gezt 1 may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Gezt 1. Talk with your doctor before you receive any vaccine.
• Severe and sometimes fatal lung or breathing problems have occurred with the use of Gezt 1. These problems may occur up to 2 weeks after the last dose of Gezt 1. Tell your doctor right away if you develop shortness of breath, cough, or other breathing problems (eg, wheezing).
• Severe and sometimes fatal kidney problems have occurred with the use of Gezt 1. Kidney problems may not go away after Gezt 1 has stopped. Discuss any questions or concerns with your doctor.
• Severe and sometimes fatal liver problems have occurred with the use of Gezt 1. The risk of liver problems may be increased if you use other medicines that may harm the liver. The risk may also be increased if you have cancer that has spread to the liver, a history of liver problems (eg, cirrhosis), or alcoholism. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of liver problems. Discuss any questions or concerns with your doctor.
• Gezt 1 can cause capillary leak syndrome, a condition that can be life-threatening. Tell your doctor right away if you notice swelling, severe dizziness, fainting, irregular heartbeat, chest pain, trouble breathing, change in the amount of urine produced, mental or mood changes, severe stomach pain, or black stools.
• A serious and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has occurred with the use of Gezt 1. Contact your doctor right away if you experience vision problems (eg, blindness), confusion, trouble thinking, severe headache, high blood pressure, seizures, or unusual tiredness.
• Gezt 1 may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Lab tests, including liver or kidney function and complete blood cell counts, may be performed while you use Gezt 1. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: Gezt 1 may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gezt 1 while you are pregnant. It is not known if Gezt 1 is found in breast milk. Do not breast-feed while you are taking Gezt 1.

Gezt 1 contraindications

Hypersensitivity to Gezt 1 or to any of the other ingredients of Hospira Gezt 1.

Use in pregnancy: Category D: Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Hospira Gezt 1 must not be used during pregnancy.

Studies in experimental animals (mice and rabbits at doses up to 4.5 and 1.6 mg/m2/day IV respectively, administered during the period of organogenesis) have shown teratogenicity and embryotoxicity. Peri- and post-natal studies in mice at doses up to 4.5 mg/m2/day have shown retarded physical development in the offspring.

Women of childbearing age receiving Gezt 1 should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.

References

1. 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).
2. HSDB. "GEMCITABINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
3. NCIt. "Gemcitabine: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology