Monday, February 26, 2024

Gemcitabine Bladder Instillation Side Effects

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Patient Assistance & Co

Gemcitabine Bladder Irrigation using PhaSeal Optima.

Patients under the age of 65 years, or those with private insurance plans: If you have insurance and are looking for patient assistance or copay assistance for Gemcitabine + Cisplatin, we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Gemcitabine + Cisplatin. Depending upon your income, they may be able to help cover the cost of:

  • Gemcitabine
  • Cisplatin

For Branded medications , check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients : The clinic providing treatment will likely pre-authorize medications and immune therapies such as Gemcitabine + Cisplatin and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Vi Immunotherapy Cytotoxic And Therapeutic Medications Used:

  • Intravesical Mitomycin C, Epirubicin, and Gemcitabine are cytotoxic agents that inhibit DNA synthesis in bladder cancer cells. They may be given immediately, post-transurethral resection of bladder tumor in absence of perforation.
  • Sodium bicarbonate, which raises the pH of serum and urine, may be used orally or intravesically in combination with Mitomycin C to buffer urine pH to optimize therapy and decrease recurrence of bladder tumors.
  • Intravesical Bacillus Calmette-Guérin , an immunotherapy using an attenuated live strain of Mycobacterium bovis, is used as induction and maintenance intravesical therapy for patients with intermediate- and high-risk NMIBC.
  • Chemotherapy agents, including Mitomycin C, Doxorubicin, and Epirubicin, may be given as induction intravesical chemotherapy for intermediate- or high-risk NMIBC patients.
  • Gemcitabine, Docetaxel, Paclitaxel, and Valrubicin are intravesical options for patients who are unfit or unwilling to undergo cystectomy and/ or demonstrate BCG-refractory disease.
  • When You Go Home

    Having bladder cancer and its treatment can be difficult to cope with. Tell your doctor or nurse about any problems or side effects that you have. The nurse will give you telephone numbers to call if you have any problems at home.

    Youll be told you need to drink lots of fluid after this treatment. It helps clear your system of chemotherapy.

    You have to be careful when you pass urine so that you don’t get it on your skin. Men should sit down to pass urine, to reduce the chance of splashing. The urine contains some chemicals from the chemotherapy which could irritate your skin.

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    Efficacy Of Bladder Intravesical Chemotherapy With Three Drugs For Preventing Non

    Zhixin Ling

    1Department of Urology, The First Affiliated Hospital of Soochow University, Suzhou 215006, China

    Abstract

    1. Introduction

    Bladder cancer has the clinical characteristics of high recurrence rate, high progression rate, and high mortality rate. Most of it comes from epithelial tissue. The urothelial cell carcinoma accounts for nearly 90% of bladder cancer worldwide . According to the extent of cancer cells invading the bladder wall, non-muscle-invasive bladder cancer and muscle-invasive bladder cancer are the two main types of bladder cancer, and non-muscle-invasive bladder cancer is among the most common types of bladder cancer. The non-muscle-invasive bladder cancer is responsible for 75%85% of newly diagnosed cases .

    2. Materials and Methods

    2.1. Research Object

    This study retrospectively analyzed a total of 335 intermediate- and high-risk patients who underwent transurethral bladder tumor resection in our hospital from October 2015 to October 2019, and they were regularly perfused with epirubicin, gemcitabine, and pirarubicin. The risk of patients was classified with intermediate- or high-risk non-muscle-invasive bladder cancer. According to the different perfusion drugs, the patients were divided into an epirubicin group , gemcitabine group , and pirarubicin group .

    2.1.1. Inclusion Criteria
    2.1.2. Exclusion Criteria
    2.2. Surgical Plan
    2.3. Perfusion Scheme
    2.4. Follow-Up
    2.5. Observation Indicators
    2.6. Data Analysis

    3. Results

    Questions To Ask Your

    Figure 1 from Effect of Intravesical Instillation of ...

    A better understanding of your treatments will allow you to ask more questions of your healthcare team. We then hope that with the answers, you will get better results and have greater satisfaction with your care. Because we know it’s not always easy to know what questions to ask, we’ve tried to make it easy for you!

    Choose any healthcare provider below to see common questions that you may want to ask of this person. Then, either print each list to bring to your clinic visits, or copy the questions and send them as a message to your healthcare team through your electronic medical record.

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    Selecting And Testing Gemcitabine

    When Dr. Messing began research on gemcitabine as a possible way to reduce recurrences more than a decade ago, the drug was not widely used for bladder cancer. “We tried to pick an agent that we thought would be safe and effective,” he said.

    The researchers decided to compare gemcitabine against placebo rather than mitomycin C, based on studies showing how infrequently patients received some form of chemotherapy following surgery despite guidelines recommending this approach.

    “If the new procedure were adopted widely, we could spare patients a lot of suffering from repeated surgeries and save health care costs associated with those surgeries,” Dr. Messing said.

    “Now that we have the results of the trial,” he went on, “we hope that patients and physicians will embrace this approach to treatment.”

    Sex After Intravesical Chemotherapy

    Men should use a condom during sex for the first 48 hours after chemotherapy. If you are a woman having chemotherapy, your partner should use a condom during this time. This protects your partner from any of the drug that may be present in semen or vaginal fluid. Your doctor or specialist nurse can give you more information about this.

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    Side Effects Requiring Immediate Medical Attention

    Along with its needed effects, gemcitabine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur while taking gemcitabine:

    More common

    • bloating or swelling of the face, arms, hands, lower legs, or feet
    • blood in the urine or stools
    • blurred vision
    • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    • chest pain
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fever
    • increased menstrual flow or vaginal bleeding
    • joint pain
    • lack or loss of strength
    • loss of appetite
    • lower back or side pain
    • muscle ache, cramps, pain, or stiffness
    • pinpoint red spots on the skin
    • prolonged bleeding from cuts
    • red or black, tarry stools
    • red or dark brown urine
    • swelling of the hands, ankles, feet, or lower legs
    • swelling or inflammation of the mouth
    • swollen glands
    • fast, slow, or irregular heartbeat
    • headache
    • pain or discomfort in the arms, jaw, back, or neck
    • pounding in the ears
    • slurred speech
    • temporary blindness
    • weakness in the arm or leg or on one side of the body

    Rare

    Another Option For Reducing Recurrences

    BATTLING BLADDER CANCER WITH GEMCITABINE

    Other studies have demonstrated that giving patients with low-grade bladder cancer the chemotherapy drug mitomycin C through a catheter following surgery can reduce the chance of a recurrence. These studies led professional groups in the United States and Europe to recommend this approach for patients with low-grade disease that has not invaded the muscle.

    In the United States, however, few patients receive this treatment, in part because of concerns about the side effects of mitomycin C, as well as the availability and cost of the drug, noted Dr. Messing. Mitomycin C can be toxic if it leaks out of the bladder through a hole, and the drug can also cause severe rashes when it comes in contact with skin.

    Gemcitabine, on the other hand, is a well-tolerated, readily available drug that “comes at relatively little cost in terms of side effects or expense,” said Dr. Messing. The side effects were similar between the two groups in the trial and were generally manageable, he added.

    Some patients with advanced bladder cancer already receive gemcitabine, noted Piyush Agarwal, M.D., who heads the Bladder Cancer Section in NCI’s Center for Cancer Research and was not involved in the trial. “So, it makes sense that the drug would be used to treat patients with low-grade bladder cancer.”

    Dr. Agarwal predicted that the new study would lead to revisions in treatment guidelines to include gemcitabine as an option for reducing recurrences in the patients with low-grade bladder cancer.

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    Viii Contraindications To Administration:

    Patients who are pregnant or lactating, have liver disease, a history of active or prior tuberculosis should not receive chemotherapeutic drugs.

  • Intravesical BCG is contraindicated the following conditions:
  • Within 7 to 14 days of bladder or prostatic surgery, including biopsy
  • Within 7 to 14 days following traumatic catheterization
  • Traumatic catheterization or gross hematuria day of treatment
  • Immunosuppressed patients with congenital or acquired immune deficiency, whether due to concurrent disease , cancer therapy or immunosuppressive therapy .
  • If these conditions are present, but treatment is still deemed necessary, informed consent should be discussed by prescribing provider and documented in patient’s record.
  • Symptomatic urinary tract infection
  • In the presence of febrile illness
  • Patients on treatment with certain antibiotics that may interfere with effectiveness of BCG.
  • Discuss with prescribing or collaborating provider before administration.
  • Fluoroquinolones should be used with caution as they may alter the therapeutic effects of BCG.
  • Any previous allergies or adverse reactions to BCG.
  • Intravesical chemotherapy is contraindicated the following conditions:
  • Any previous allergy or adverse reactions to the chemotherapeutic agent
  • bladder perforation
  • Jointly Developed With The Society Of Urologic Nurses And Associates

    Revised: June 2020

    Workgroup Members:AUA: Roxy Baumgartner, RN, APN-BC Sam Chang, MD Susan Flick, CNP Howard Goldman, MD, FACS Jim Kovarik, MS, PA-C Yair Lotan, MD Elspeth McDougall, MD, FRCSC, MHPE Arthur Sagalowsky, MD Edouard Trabulsi, MD SUNA: Debbie Hensley, RN Christy Krieg, MSN, CUNP Leanne Schimke, MSN, CUNP

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    Side Effects Not Requiring Immediate Medical Attention

    Some side effects of gemcitabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

    Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • thinning of hair

    Less common

    • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

    Applies to gemcitabine: intravenous powder for injection, intravenous solution

    V Guidelines And Principles:

    [PDF] Effect of Intravesical Instillation of Gemcitabine ...

    Health care personnel performing intravesical therapy must be educated, demonstrate competency, and understand the implications of non-muscle invasive bladder cancer. . This should include associated health and safety issues regarding handling of cytotoxic, and immunotherapeutic agents and documented competency of safe practical skills. At a minimum, each institution or office practice setting should implement an established, annual competency program to review safety work practices and guidelines regarding storage, receiving, handling/ transportation, administration, disposal, and handling a spill of hazardous drugs.

    Also Check: Why Do I Get Frequent Bladder Infections

    Assessment Of Gemcitabine Degradation In Urine

    Dog and human urine was examined to evaluate for degradation of gemcitabine. Prior to gemcitabine treatment, catheterized urine was obtained and stored to be examined later as a negative control. After the first treatment of both animals in the 100-mg group, urine was taken and treated with or without THU. Two samples of human urine were collected from a healthy volunteer with no evidence of proteinuria, and gemcitabine was added to make an approximate concentration of 1 mg/ml. These samples were incubated overnight with and without THU to examine for any ex vivo degradation of the drug in urine.

    A Bladder Instillation Or Wash Can Assist In Managing Many Different Bladder Problems

    Sometimes referred to as a bladder wash or bath, a bladder instillation is a treatment involving a solution inserted into the bladder through a catheter and released after a short period of time.

    • One of the most common reasons a urologist may recommend instillations of the bladder is interstitial cystitis , a chronic inflammation condition caused by nerve miscommunication that’s sometimes mistaken for a urinary tract infection.
    • IC isn’t curable, although it’s often manageable with bladder instillations in combination with other treatments.

    Contact Us Today

    Also Check: Chronic Bladder Infection In Men

    What Is Bladder Cancer

    A disease of the cells that line the inside of the bladder. Bladder cancer is a rare disease that is most commonly seen in older adults. It is known to cause blood in the urine in up to 90% of patients at diagnosis. Causes of bladder cancer include smoking, exposure to certain chemicals , and chronic bladder infections.

    Treatment includes surgery , chemotherapy, immunotherapy , or thermotherapy . The stage of bladder cancer can vary at diagnosis and throughout treatment. Bladder cancer is staged using the Tumor, Node, Metastasis system, as well as Stage Grouping 0, I, II, III, or IV. Staging systems describe the extent of cancer throughout the body and help doctors determine which treatments to offer. The effectiveness of the treatment may depend upon the stage at diagnosis.

    NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

    What Does Cure Mean

    BLADDER INSTILLATION PATIENT INSTRUCTIONS

    The word cure means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRIs, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word remission is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

    Doctors usually do not consider a patient cured until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

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    What Is A Cbc

    A Complete Blood Count is a frequently ordered blood test that tells clinicians the status of your: 1)White blood cell count,2)Hemoglobin, and 3)Platelet count at the time the test was taken.

    Common uses:1)White blood cell count : is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

    2)Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

    3)Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

    Other Reasons For Bladder Instillations

    In addition to IC, bladder washes may be a suggested treatment for patients with chronic UTIs, accumulated sediment in urine, or other conditions that reduce bladder capacity and contribute to frequent urination not caused by an underlying problem such as a tumor or enlarged prostate. Bladder baths may also help with issues related to blocked urinary catheters.

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    When Is Intravesical Chemotherapy Used

    You usually have intravesical chemotherapy after surgery to remove a non-muscle-invasive bladder cancer. This type of surgery is called a transurethral resection of a bladder tumour . The chemotherapy reduces the risk of the cancer coming back in the bladder lining.

    Most people have 1 treatment of intravesical chemotherapy after surgery. If you have a low risk of the cancer coming back, you usually do not need chemotherapy after this.

    If you have an intermediate risk of the cancer coming back, you may have more intravesical chemotherapy. This is usually given once a week for 6 weeks. After this, you may be offered more intravesical chemotherapy. These are called maintenance doses.

    Common Gemcitabine And Cisplatin Starting Doses

    Effect of Intravesical Instillation of Gemcitabine vs ...

    Every 28-Day Regimen Schedule

    • Gemcitabine 1000 mg/m2 intravenous infusion over 30 minutes on Days 1, 8, and 15
    • Cisplatin 70 mg/m2 I.V. over one hour on Day 2

    Every 21-Day Regimen Schedule

    • Gemcitabine 1250 mg/m2 I.V. over 30 minutes on Days 1 and 8
    • Cisplatin 70 mg/m2 I.V. over one hour on Day 2

    NOTE: the gemcitabine doses differ between the 28-Day and 21-Day regimens. In addition, some physicians may recommend cisplatin to be given on Day 1 instead of Day 2.

    Individual doses may vary based upon your Doctor’s recommendation, or drug availability.

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    Assessment Of Gemcitabine Levels In Dogs Undergoing Toxicology Experiments

    Blood was taken for gemcitabine assay, with each instillation of gemcitabine in the animals undergoing toxicology studies. The samples were collected 1 h after each instillation had begun. These assays were undertaken to determine whether detectable levels of drug were present in the serum after repeated treatments.

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