Drugs Details

Drugs Info of Zanosar
Drugs Details
  • Drugs Type  : FDA
  • Date : 9th Jul 2015 07:24 am
  • Brand Name : Zanosar
  • Generic Name : streptozocin (Pronunciation: STREP toe zoe sin)
Descriptions

Each vial of ZANOSAR contains 1 g of the active ingredient streptozocin 2-deoxy-2 [[(methylnitrosoamino) carbonyl] amino]-α (and ß)-D-glucopyranose and 220 mg citric acid anhydrous. ZANOSAR is available as a sterile, pale yellow, freeze-dried preparation for intravenous administration. The pH was adjusted with sodium hydroxide. When reconstituted as directed, the pH of the solution will be between 3.5 and 4.5. Streptozocin is a syntheticantineoplastic agent that is chemically related to other nitrosoureas used in cancer chemotherapy. Streptozocin is an ivory-colored crystalline powder with a molecular weight of 265.2. It is very soluble in water or physiologicalsaline and is soluble in alcohol. The structural formula is represented below:

 

ZANOSAR® (Streptozocin) Structural Formula Illustration

 

 

What are the possible side effects of streptozocin (Zanosar)?

If you experience any of the following serious side effects from streptozocin, contact your doctor immediately or seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • kidney damage (little or no urine production, blood in the urine);
  • liver problems (changes in blood test results, abdominal pain, yellowing of the skin or eyes, decreased appetite, nausea);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black,...

Read All Potential Side Effects and See Pictures of Zanosar »

Indications

ZANOSAR is indicated in the treatment of metastatic islet cell carcinoma of the pancreas. Responses have been obtained with both functional and nonfunctional carcinomas. Because of its inherent renal toxicity, therapy with this drug should be limited to patients with symptomatic or progressive metastatic disease.

Dosage Administration

ZANOSAR sterile powder should be administered intravenously by rapid injection or short/prolonged infusion. It is not active orally. Although it has been administered intra arterially, this is not recommended pending further evaluation of the possibility that adverse renal effects may be evoked more rapidly by this route of administration.

Two different dosage schedules have been employed successfully with ZANOSAR.

Daily Schedule

The recommended dose for daily intravenous administration is 500 mg/m² ofbody surface area for five consecutive days every six weeks until maximum benefit or until treatment-limiting toxicity is observed. Dose escalation on this schedule is not recommended.

Weekly Schedule

The recommended initial dose for weekly intravenous administration is 1000 mg/m² of body surface area at weekly intervals for the first two courses (weeks). In subsequent courses, drug doses may be escalated in patients who have not achieved a therapeutic response and who have not experienced significant toxicity with the previous course of treatment. However, A SINGLE DOSE OF 1500 mg/m² BODY SURFACE AREA SHOULD NOT BE EXCEEDED as a greater dose may cause azotemia. When administered on this schedule, the median time to onset of response is about 17 days and the median time to maximum response is about 35 days. The median total dose to onset of response is about 2000 mg/m² body surface area and the median total dose to maximum response is about 4000 mg/m² body surface area.

The ideal duration of maintenance therapy with ZANOSAR has not yet been clearly established for either of the above schedules.

For patients with functional tumors, serial monitoring of fasting insulin levels allows a determination of biochemical response to therapy. For patients with either functional or nonfunctional tumors, response to therapy can be determined by measurable reductions of tumor size (reduction of organomegaly, masses, or lymph nodes).

Reconstitute ZANOSAR with 9.5 mL of dextrose injection, USP, or 0.9% sodium chloride injection, USP. The resulting pale-gold solution will contain 100 mg of streptozocin and 22 mg of citric acid per mL. Where more dilute infusion solutions are desirable, further dilution in the above vehicles is recommended. The total storage time for streptozocin after it has been placed in solution should not exceed 12 hours. This product contains no preservatives and is not intended as a multiple-dose vial.

Caution in the handling and preparation of the powder and solution should be exercised, and the use of gloves is recommended. If the sterile powder of ZANOSAR or a solution prepared from ZANOSAR contacts the skin or mucosae, immediately wash the affected area with soap and water.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-7There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

How Supplied

ZANOSAR is supplied as follows:

 

NDC NUMBER  VIAL  PACKAGE
0703-4636-01  1 gram vials  Packaged Individually

 

Unopened vials of ZANOSAR should be stored at refrigeration temperatures (2° to 8°C) and protected from light (preferably stored in carton).

REFERENCES

1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U. S. Government Printing Office, Washington, DC 20402.

2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA. 1985; 2.53(11):1590–1592.

3. National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD. , Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.

4. Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia, 1983; 1:426–428.

5. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA—A Cancer Journal for Clinicians, 1983; (Sept/Oct) 258–263.

6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. AM J. Hosp Pharm, 1990; 47:1033–1049.

7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines), Am J Health-Syst Pharm, 1996; 53:1669–1685.

Manufactured by: Teva Parenteral Medicines, Inc. Irvine, CA 92618. Revised: 9/2012

Side Effects

Renal

See WARNINGS.

Gastrointestinal

Most patients treated with ZANOSAR have experienced severe nausea and vomiting, occasionally requiring discontinuation of drug therapy. Some patients experienced diarrhea. A number of patients have experienced hepatic toxicity, as characterized by elevated liver enzyme (SGOT and LDH) levels and hypoalbuminemia.

Hematological

Hematological toxicity has been rare, most often involving mild decreases inhematocrit values. However, fatal hematological toxicity with substantial reductions in leukocyte and platelet count has been observed.

Metabolic

Mild to moderate abnormalities of glucose tolerance have been noted in some patients treated with ZANOSAR. These have generally been reversible, but insulin shock with hypoglycemia has been observed.

Genitourinary

Two cases of nephrogenic diabetes insipidus following therapy with ZANOSAR have been reported. One had spontaneous recovery and the second responded to indomethacin.

Post-Marketing Experience

Spontaneous reports have been received of local inflammation (i.e., edema,erythema, burning, tenderness) following extravasation of the product. In most cases, these events resolved the same day or within a few days.

Interactions

ZANOSAR may demonstrate additive toxicity when used in combination with other cytotoxic drugs. Streptozocin has been reported to prolong the elimination half-life of doxorubicin and may lead to severe bone marrow suppression; a reduction of the doxorubicin dosage should be considered in patients receiving ZANOSAR concurrently. The concurrent use of streptozocin and phenytoin has been reported in one case to result in reduced streptozocin cytotoxicity.

Laboratory Tests

Patients who are treated with ZANOSAR must be monitored closely, particularly for evidence of renal, hepatic, and hematopoietic toxicity. Renal function tests are described in the WARNINGS section.

Patients should also be monitored closely for evidence of hematopoietic and hepatic toxicities. Complete blood counts and liver function tests should be done at least weekly. Dosage adjustments or discontinuance of the drug may be indicated, depending upon the degree of toxicity noted.

Mutagenesis, Carcinogenesis, Impairment Of Fertility

Warnings

Renal Toxicity

Many patients treated with ZANOSAR have experienced renal toxicity, as evidenced by azotemia, anuria, hypophosphatemia, glycosuria and renal tubular acidosis. Such toxicity is dose-related and cumulative and may be severe or fatal. Renal function must be monitored before and after each course of therapy. Serial urinalysis, blood urea nitrogen, plasma creatinine, serum electrolytes and creatinine clearance should be obtained prior to, at least weekly during, and for four weeks after drug administration. Serial urinalysis is particularly important for the early detection of proteinuria and should be quantitated with a 24 hour collection when proteinuria is detected. Mild proteinuria is one of the first signs of renal toxicity and may herald further deterioration of renal function. Reduction of the dose of ZANOSAR or discontinuation of treatment is suggested in the presence of significant renal toxicity. Adequate hydration may help reduce the risk of nephrotoxicity to renal tubular epithelium by decreasing renal and urinary concentration of the drug and its metabolites.

Use of ZANOSAR in patients with preexisting renal disease requires a judgment by the physician of potential benefit as opposed to the known risk of serious renal damage.

This drug should not be used in combination with or concomitantly with other potential nephrotoxins.

When exposed dermally, some rats developed benign tumors at the site of application of streptozocin. Consequently, streptozocin may pose acarcinogenic hazard following topical exposure if not properly handled. (SeeDOSAGE AND ADMINISTRATION.) See additional warnings at the beginning of this insert.

Precautions

Injection-Site Reactions

ZANOSAR sterile powder is irritating to tissues. Extravasation may cause severe tissue lesions and necrosis.

Streptozocin is mutagenic in bacteria, plants, and mammalian cells. When administered parenterally, it has been shown to induce renal tumors in rats and to induce liver tumors and other tumors in hamsters. Stomach and pancreatic tumors were observed in rats treated orally with streptozocin. Streptozocin has also been shown to be carcinogenic in mice.

Streptozocin adversely affected fertility when administered to male and female rats.

Pregnancy Category D

Reproduction studies revealed that streptozocin is teratogenic in the rat and has abortifacient effects in rabbits. When administered intravenously to pregnant monkeys, it appears rapidly in the fetal circulation. There are no studies in pregnant women. ZANOSAR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether streptozocin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, nursing should be discontinued in patients receiving ZANOSAR.

Geriatric Use

Clinical studies of streptozocin did not include sufficient numbers of patients aged 65 years and older to determine whether there was a difference in either efficacy or toxicity as compared to younger patients. Other reported clinical experience has not identified differences in efficacy or safety between the elderly and younger patient populations. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

OverDose

No specific antidote for ZANOSAR is known.

ContrainDications

No information provided.

Clinical Pharamacology

Streptozocin inhibits DNA synthesis in bacterial and mammalian cells. In bacterial cells, a specific interaction with cytosine moieties leads to degradation of DNA. The biochemical mechanism leading to mammalian cell death has not been definitely established; streptozocin inhibits cell proliferation at a considerably lower level than that needed to inhibitprecursor incorporation into DNA or to inhibit several of the enzymes involved in DNA synthesis. Although streptozocin inhibits the progression of cells intomitosis, no specific phase of the cell cycle is particularly sensitive to its lethaleffects.

Streptozocin is active in the L1210 leukemic mouse over a fairly wide range of parenteral dosage schedules. In experiments in many animal species, streptozocin induced a diabetes that resembles human hyperglycemic nonketotic diabetes mellitus. This phenomenon, which has been extensively studied, appears to be mediated through a lowering of beta cell nicotinamide adenine dinucleotide (NAD) and consequent histopathologic alteration of pancreatic islet beta cells.

The metabolism and the chemical dissociation of streptozocin that occurs under physiologic conditions has not been extensively studied. When administered intravenously to a variety of experimental animals, streptozocin disappears from the blood very rapidly. In all species tested, it was found to concentrate in the liver and kidney. As much as 20% of the drug (or metabolites containing an N-nitrosourea group) is metabolized and/or excreted by the kidney. Metabolic products have not yet been identified.

Patient Information

Confusion, lethargy, and depression have been reported in a limited number of patients receiving continuous intravenous infusion of ZANOSAR for 5 days. Patients should be informed that there may be a potential risk in driving or using complex machinery.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Zanosar

Generic Name: streptozocin (Pronunciation: STREP toe zoe sin)

  • What is streptozocin (Zanosar)?
  • What are the possible side effects of streptozocin (Zanosar)?
  • What is the most important information I should know about streptozocin (Zanosar)?
  • What should I discuss with my healthcare provider before using streptozocin (Zanosar)?
  • How should I use streptozocin (Zanosar)?
  • What happens if I miss a dose (Zanosar)?
  • What happens if I overdose (Zanosar)?
  • What should I avoid while using streptozocin (Zanosar)?
  • What other drugs will affect streptozocin (Zanosar)?
  • Where can I get more information?

What is streptozocin (Zanosar)?

 

Streptozocin is an antineoplastic medication. Streptozocin interferes with the growth of cancer cells and slows their growth and spread in the body.

Streptozocin is used to treat cancer of the pancreas.

Streptozocin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of streptozocin (Zanosar)?

 

If you experience any of the following serious side effects from streptozocin, contact your doctor immediately or seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • kidney damage (little or no urine production, blood in the urine);
  • liver problems (changes in blood test results, abdominal pain, yellowing of the skin or eyes, decreased appetite, nausea);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection); or
  • severe nausea, vomiting, loss of appetite, or diarrhea.

In some cases, secondary cancers have been reported to occur during and following treatment with streptozocin. Talk to your doctor about the risks and benefits of this medication.

Other, less serious side effects may be more likely to occur. Continue taking streptozocin and talk to your doctor if you experience:

  • mild nausea, vomiting, loss of appetite, or diarrhea;
  • drowsiness;
  • confusion;
  • depression; or
  • swelling, redness, burning, or tenderness at the injection site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Zanosar (streptozocin) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about streptozocin (Zanosar)?

 

Streptozocin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of streptozocin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); kidney damage (little or no urine production, blood in the urine); liver problems (changes in blood test results, abdominal pain, yellowing of the skin or eyes, decreased appetite, nausea); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection); severe nausea, vomiting, and diarrhea; secondary cancers; and others. Talk to your doctor about the possible side effects from treatment with streptozocin.

Treatment with streptozocin may cause drowsiness or confusion. Use caution when driving, operating machinery, or performing other hazardous activities if drowsiness or confusion occurs.

Patient Detailed How Take

What should I discuss with my healthcare provider before using streptozocin (Zanosar)?

 

Do not use streptozocin without first talking to your doctor if you have

  • kidney disease;
  • liver problems;
  • bleeding or blood clotting problems; or
  • poor bone marrow function.

The use of streptozocin may be dangerous if you have any of the conditions listed above.

Streptozocin is in the FDA pregnancy category D. This means that streptozocin is known to be harmful to an unborn baby. Do not use streptozocin without first talking to your doctor if you are pregnant or could become pregnant during treatment. Discuss with your doctor the appropriate use of birth control during treatment with streptozocin if necessary.

It is not known whether streptozocin passes into breast milk. Breast-feeding should be avoided during treatment with streptozocin.

How should I use streptozocin (Zanosar)?

 

Streptozocin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with streptozocin, depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Streptozocin is usually administered as an intravenous (into a vein) injection.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with streptozocin to monitor progress and side effects.

Your healthcare provider will store streptozocin as directed by the manufacturer. If you are storing streptozocin at home, follow the directions provided by your healthcare provider.

Patient Detailed Avoid Taking

What happens if I miss a dose (Zanosar)?

 

Contact your doctor if you miss a dose of streptozocin.

What happens if I overdose (Zanosar)?

 

If an overdose of streptozocin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a streptozocin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using streptozocin (Zanosar)?

 

Streptozocin can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with streptozocin. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Treatment with streptozocin may cause drowsiness or confusion. Use caution when driving, operating machinery, or performing other hazardous activities if drowsiness or confusion occurs.

What other drugs will affect streptozocin (Zanosar)?

 

Do not receive "live" vaccines during treatment with streptozocin. Administration of a live vaccine may be dangerous during treatment with streptozocin.

Other medications may interact with streptozocin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with streptozocin.

Where can I get more information?

 

Your healthcare provider may have additional information about streptozocin that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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