Paclitaxel

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Paclitaxel

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  • For more information, please download leaflet.

    • The brand name of your medication is ALVOPAX® and the generic name is Paclitaxel.
    • This medication is available in four dosage forms of 30 mg per 5 mL and 100 mg per 16.7 mL, 150 mg per 25 mL and 300 mg per 50 mL.
    • Each 1 mL of ALVOPAX® concentrate for solution for infusion contains 6 mg Paclitaxel.

    1 Why is ALVOPAX® prescribed?

    ALVOPAX® solution for injection is used with other medications to treat breast cancer, ovarian cancer, certain type of lung cancer (non-small cell lung cancer) and Kaposi's sarcoma (AIDS associated skin cancer). ALVOPAX® has been maybe used in cancers of bladder, cervical, stomach, testis, prostate, head and neck, lung and adenocarcinoma. It is not known if ALVOPAX® is safe or effective in children.

    2 How is injection solution of ALVOPAX® given?

    ALVOPAX® is usually given as an injection at your doctor's office, hospital, or clinic. This medication is injected into a vein through an IV (infusion) by healthcare providers. The infusion will take 1 hour at least. This medication would be administrated by a set of non–DEHP. According to physician discretion, you may also receive other medications with ALVOPAX®.

    3 What special precautions should you follow during your treatment with ALVOPAX®?

    • You may be at risk of infection, so wash your hands often and try to avoid contact with people who have colds, flu or infections.
    • ALVOPAX® may have unsafe effects on the bone marrow. The bone marrow may not be able to make cells found in the blood as well as it used to for a few weeks. That is why it is necessary to do regular blood tests to continue your treatment. If your white blood cell count is too low, your doctor may stop the treatment so long as there is enough white blood cell count.
    • Consult your doctor about all the medications you are taking. ALVOPAX® may interact with other medications.
    • Keep a list with you of all the medicines you use (including any prescription or nonprescription medicine, herbal preparation and vitamins) and show this list your doctor.
    • Do not receive any kind of vaccination without your doctor’s approval while taking ALVOPAX® and after the end of the treatment (at least for three months after completion of treatment).
    • Avoid coming into contact with anyone who has recently received a live vaccine. If it is not possible, wear a mask and cover your nose and mouth.
    • Talk with your doctor before using products that have aspirin, blood thinners, garlic, ginseng, ginkgo, ibuprofen, pain killers, or vitamin E and similar products. These medications may increase the risk of bleeding with ALVOPAX® concomitant use.
    • Avoid beer, wine, or mixed drinks.
    • Avoid smoking and tobacco.
    • Talk with your doctor if you often use grapefruit or its juice in your diet.
    • You may bleed more easily. Be careful and avoid injury.
    • Be careful using sharp objects such as razors or nail clippers and also during the brushing or dental flossing or toothpicks. Use a soft toothbrush and an electric razor.
    • Avoid exercise in which there is a risk of injury or bruising.
    • Consult with your doctor before you receive any dental care.
    • Use birth control that you can trust to stop pregnancy while taking this medication.
    • If you are a man and have sex, protect your partner from pregnancy. Use birth control that you can trust.
    • During infusion do not touch your eyes or the inside of your nose and mouth. washed your hands with soap after infusion session.

    4 What are some side effects that you need to call your doctor about right away?

    • ALVOPAX® can cause severe or life threatening allergic reactions that required immediate medical intervention. So tell your doctor immediately if you have these symptoms.
    • Tell your doctor right away if you experience unexplained weight gain, difficulty breathing, chest discomfort or tightness, sever weakness and fatigue, irregular breathing, irregular heartbeat, swelling of the arms, hands, legs, feet or ankles. These can be signs of a fluid retention (edema) in your body.
    • Your doctor may ask you to use an oral corticosteroid (eg. Dexamethasone) a few days before starting treatment with ALVOPAX® for 1-3 days. It is in order to minimize allergic reactions and fluid retention caused by the medicine. Contact your doctor, pharmacist or nurse, if you miss this medication.
    • Tell your doctor right away if you develop signs of infection including fever (temperature higher than 38 C), shivering, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
    • Tell your doctor right away if you experience any signs numbness, pain, or tingling in the hands or feet, or around the mouth or throat. These can be signs of sensory or peripheral nerves damage.
    • Tell your doctor right away if you develop skin blister, skin flaking or redness on your arms or feet after receiving ALVOPAX®. These can be signs of severe skin reactions.
    • Tell your doctor right away if you feel vision changes including blurred vision, difficulty in reading and eye pain. These can be signs of sever eye problems.
    • Tell your doctor right away if you develop any unusual bleeding or bruising including nosebleed, gum bleeding, blood in urine, and dark, tarry, or bloody stools.
    • ALVOPAX® may leak from the vessel and come out on the skin during the injection causing pain, redness, swelling and inflammation at the injection site. Talk your nurse immediately to interrupt the infusion and to use of topical treatment.
    • Most medications used in cancer treatment cause nausea and vomiting. Your doctor may prescribe some medications to reduce the effects of nausea and vomiting associated with ALVOPAX®.

    5 What is the storage condition of ALVOPAX®?

    Store ALVOPAX® less than 25°C and away from light before dilution (keep in original outer carton). Diluted solution should be used immediately due to the risk of microbial contamination. ALVOPAX® should never be used after the expiration date printed on the packaging. Keep the medication out of the reach of children.

  • For more information, please download leaflet.

    • Paclitaxel is a natural product with antitumor activity.
    • Paclitaxel Injection is a clear colorless to slightly yellow viscous solution.
    • It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion.
    • Paclitaxel Injection is available in 30 mg (5 mL), 100 mg (16.7 mL), 150 mg (25 mL), and 300 mg (50 mL) single dose vials.

    1 INDICATIONS AND USAGE

    Docetaxel is a microtubule inhibitor indicated for:

    1.1. Ovarian cancer:

    Paclitaxel Injection is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection is indicated in combination with cisplatin.

    1.2. Breast cancer:

    Paclitaxel Injection is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.

    1.3. Non-small cell lung cancer:

    Paclitaxel Injection in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.

    1.4. AIDS-related Kaposi’s sarcoma:

    Paclitaxel Injection is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.

    1.5. Un-labeled uses:

    Treatment of bladder, cervical, small cell lung, and head and neck cancers; treatment of (unknown primary) adenocarcinoma.

    2 DOSAGE AND ADMINISTRATION

    For patients with carcinoma of the ovary, the following regimens are recommended:

    • For previously untreated patients with carcinoma of the ovary, one of the following recommended regimens may be given every 3 weeks. In selecting the appropriate regimen, differences in toxicities should be considered. 1 Paclitaxel administered intravenously over 3 hours at a dose of 175 mg/m2 followed by cisplatin at a dose of 75 mg /m2; or 2 Paclitaxel administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin at a dose of 75 mg/m2.
    • In patients previously treated with chemotherapy for carcinoma of the ovary, paclitaxel has been used at several doses and schedules; however, the optimal regimen is not yet clear. The recommended regimen is paclitaxel 135 mg/m2 or 175 mg/m2 administered intravenously over 3 hours every 3 weeks.
    • For patients with carcinoma of the breast, the following regimens are recommended:

    • For the adjuvant treatment of node-positive breast cancer, the recommended regimen is paclitaxel, at a dose of 175 mg/m2 intravenously over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. The clinical trial used 4 courses of doxorubicin and cyclophosphamide.
    • After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, paclitaxel at a dose of 175 mg/m2 administered intravenously over 3 hours every 3 weeks has been shown to be effective.
    • For patients with non-small cell lung carcinoma, the recommended regimen, given every 3 weeks, is paclitaxel administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin, 75 mg/m2.

      For patients with AIDS-related Kaposi’s sarcoma, paclitaxel administered at a dose of 135 mg/m2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m2 given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45 to 50 mg/m2/week). In the 2 clinical trials evaluating these schedules, the former schedule (135 mg/m2 every 3 weeks) was more toxic than the latter. In addition, all patients with low performance status were treated with the latter schedule (100 mg/m2 every 2 weeks). Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:

    • Reduce the dose of dexamethasone as 1 of the 3 premedication drugs to 10 mg PO (instead of 20 mg PO);
    • Initiate or repeat treatment with Paclitaxel Injection only if the neutrophil count is at least 1000 cells/mm3;
    • Reduce the dose of subsequent courses of Paclitaxel Injection by %20 for patients who experience severe neutropenia (neutrophil <500 cells/ mm3 for a week or longer); and
    • Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.
    • For the therapy of patients with solid tumors (ovary, breast, and NSCLC), courses of paclitaxel injection should not be repeated until the neutrophil count is at least 1500 cells/mm3 and the platelet count is at least 100,000 cells/mm3.

      Paclitaxel Injection should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline or subsequent neutrophil count is less than 1000 cells/ mm3. Patients who experience severe neutropenia (neutrophil <500 cells/mm3 for a week or longer) or severe peripheral neuropathy during paclitaxel injection therapy should have dosage reduced by %20 for subsequent courses of paclitaxel injection. The incidence of neurotoxicity and the severity of neutropenia increase with dose.

    3 PREPARATION AND ADMINISTRATION PRECAUTIONS:

    Procedures for proper handling and disposal of anticancer drugs should be considered. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing Paclitaxel Injection. If Paclitaxel Injection solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning, and redness. If Paclitaxel Injection contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.

    4 STABILITY:

    Unopened vials of Paclitaxel Injection are stable until the date indicated on the package when stored below 25° C (77° F), in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Upon refrigeration, components in the Paclitaxel Injection vial may precipitate, but will redissolve upon reaching room temperature with little or no agitation. There is no impact on product quality under these circumstances. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded. Solutions for infusion prepared as recommended–from microbiological point of view- should be used promptly.

    5 COMPATIBILITY

    5.1. Stability:

    Paclitaxel Injection is stable in D5W, NS, D5S.

    5.2. Y-site administration:

    Compatible: Acyclovir, amikacin, aminophylline, ampicillin/sulbactam, anidulafungin, bleomycin, butorphanol, calcium chloride, carboplatin, cefepime, cefotetan, ceftazidime, cimetidine, cisplatin, cladribine, cyclophosphamide, cytarabine, dacarbazine, dexamethasone sodium phosphate, diphenhydramine, doripenem, doxorubicin, droperidol, etoposide, etoposide phosphate, famotidine, floxuridine, fluconazole, zhaloperidol, heparin, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydromorphone, ifosfamide, linezolid, lorazepam, magnesium sulfate, mannitol, meperidine, mesna, methotrexate, metoclopramide, morphine, nalbuphine, ondansetron, ondansetron with ranitidine, oxaliplatin, palonosetron, pemetrexed, pentostatin, potassium chloride, prochlorperazine edisylate, propofol, ranitidine, sodium bicarbonate, thiotepa, topotecan, vancomycin, vinblastine, vincristine, zidovudine. Incompatible: AmphotericinB, amphotericin B cholesteryl sulfate complex, chlorpromazine, doxorubicin liposome, hydroxyzine, methylprednisolone sodium succinate, mitoxantrone. Variable (consult detailed reference): Ceftriaxone.

    5.3. Compatibility in syringe:

    Incompatible: Ceftriaxone.

    6 CONTRAINDICATIONS

    • Paclitaxel Injection is contraindicated in patients who have a history of hypersensitivity reactions to Paclitaxel Injection or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil).
    • In patients previously treated with chemotherapy for carcinoma of the ovary, paclitaxel has been used at several doses and schedules; however, the optimal regimen is not yet clear. The recommended regimen is paclitaxel 135 mg/m2 or 175 mg/m2 administered intravenously over 3 hours every 3 weeks.
    • Paclitaxel Injection should not be used in patients with solid tumors who have baseline neutrophil counts of <1500 cells/ mm3 or in patients with AIDS-related Kaposi’s sarcoma with baseline neutrophil counts of <1000 cells/mm3.

    7 USE IN SPECIFIC POPULATIONS

      7.1. Pregnancy:

      Pregnancy Risk Factor: D Paclitaxel can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If Paclitaxel Injection is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

      7.2. NURSING MOTHERS:

      Enters breast milk/not recommended. It is not known whether the drug is excreted in human milk.

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