Pemetrexed

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Pemetrexed

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  • For more information, please download leaflet.

    • The brand name of your medication is ALVOPEM® and the generic name is Pemetrexed.
    • ALVOPEM® is a cancer medication that interferes with the growth and spread of cancer cells in the body.
    • This medication is a sterile lyophilized powder available in two doses, 100 mg or 500 mg Pemetrexed in 1 vial-containing packages.

    1 Why is ALVOPEM® prescribed?

    ALVOPEM® is used to treat a type of lung cancer called nonsquamous non-small cell lung cancer (NSCLC). ALVOPEM® is also used with another medication called Cisplatin to treat mesothelioma, a form of lung cancer associated with exposure to asbestos. This product may be prescribed for indications which had not been mentioned in this leaflet. It is not known if ALVOPEM® is safe or effective in children.

    2 How is injection solution of ALVOPEM® given?

    ALVOPEM® 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. Each 100 and 500 mg vial is reconstituted with 4.2 and 20 ml of 0.9% Sodium Chloride Injection respectively. Further reconstitution of either size vial with Sodium chloride 0.9%, gives a final solution administered as an intravenous infusion over 10 minutes. According to physician discretion, you may also receive other medications with ALVOPEM®.

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

    • Contact your doctor, if you have history of radiotherapy and face any skin reaction in radiotherapy site (like inflammation or exfoliation).
    • It is possible to experience serious or life-threatening reactions after Alvopem® injection. Contact your doctor if you face any skin reaction.
    • Take your complementary drugs like folic acid and Vitamin B12 and never stop them with your doctor’s permission.
    • It is possible to have nausea and vomiting during treatment with Alvopem®, Taking small food portions, protect mouth mucus, using sugar free candies and chewing gums can be helpful.
    • You may be at risk of infection, so wash your hands often and try to avoid contact with people who have infection, Influenza, colds, Chicken pox and measles. If you notice any symptom of an infection call your doctor immediately.
    • During taking ALVOPEM®,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.
    • Tell your doctor or anesthesiologist before you receive any dental care or surgery.
    • Do not receive any kind of vaccination without your doctor’s approval while taking ALVOPEM® 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. Some of These vaccines are MMR (Munps Measles Rubella), Poliovirus Oral Vaccine, Chickenpox Vaccine and Typhoid Vaccine.
    • ALVOPEM® 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 use plastic gloves while cleaning patient’s fluids, managing the wastes or changing clothes. They should wash their hands before and after taking the gloves. Bed covers should be washed separately.
    • Trashes which had been in contact with patient’s fluid should be kept in tightly closed plastic bags and then put in trash bin.
    • 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 to any doctor or other healthcare provider who treats you. Alvopem® may interact with some medications.
    • Talk with your doctor before using products that have aspirin, blood thinners, garlic, ginseng, ginkgo, ibuprofen or like products, pain drugs, or vitamin E. These medications may increase the risk of bleeding with ALVOPEM® concomitant use.
    • If you are a woman of childbearing potential, use birth control that you can trust to stop pregnancy while taking and 3 months after taking this medication. You should use two forms of birth control together.
    • If you are a man and have sexually active life, protect your partner from pregnancy. Use birth control that you can trust.
    • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else during the ALVOPEM® infusion time.

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

    • ALVOPEM® 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, irregular breathing, irregular heartbeat and swelling of the arms, hands, legs, feet or ankles. These can be signs of a fluid retention (edema) in your body.
    • Tell your doctor right away if you experience fever, swollen gums, painful mouth sores, cold or flu symptoms, sore throat, pale skin, easy bruising or bleeding, skin sores, red or pink urine, rapid heart rate, feeling light-headed or short of breath. These can be signs of bone marrow suppression.
    • Tell your doctor right away if you see any fever, shivering, sweating, sever sore throat, earache or pain in sinuses, cough, massive or discoloration in Phlegm, mouth ulcers, late healing injuries, itching or pain in anus or pain during urination. These could be signs of an infection.
    • Tell your doctor right away if you experience swelling, rapid weight gain, little or no urinating. These can be signs of kidney problems.
    • Tell your doctor right away if you develop feeling any muscular pain, sever thirsty, being unable to urinate, heavy sweating, hot and dry skin. These can be signs of dehydration.
    • Tell your doctor right away if you experience fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. These can be signs of severe skin reaction.
    • Tell your doctor right away if you have any continues diarrhea or vomiting.
    • Contact your doctor if you become pregnant, in spite of using contraception method.
    • Contact your doctor if you experience any side effect which had not be resolved.

    5 What is the storage condition of ALVOPEM®?

    Store ALVOPEM® at 15-30°C and away from light before opening (keep in original outer carton).
    Reconstituted solution should be used immediately due to the risk of microbial contamination. ALVOPEM® should never be used after the expiration date printed on the packaging.
    Reconstitute should be clear and free of any particulate matters. If not, avoid using it.

  • For more information, please download leaflet.

    • ALVOPEM® is supplied as a sterile lyophilized powder for solution for intravenous infusion available in single-dose vials.
    • The product is a white to either light yellow or green-yellow lyophilized solid.
    • Each 100-mg or 500-mg vial of ALVOPEM® contains pemetrexed disodium equivalent to 100 mg pemetrexed or 500 mg.

    1 INDICATIONS AND USAGE

    1.1. Non-Squamous Non-Small Cell Lung Cancer (NSCLC) PEMETREXED is indicated:

    • in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, nonsquamous, non-small cell lung cancer (NSCLC).

    • in combination with carboplatin and pembrolizumab for the initial treatment of patients with metastatic, non-squamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

    • as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. as a single agent for the treatment of patients with recurrent, metastatic non squamous, NSCLC after prior chemotherapy.

    • Limitations of use: PEMETREXED is not indicated for the treatment of patients with squamous cell, nonsmall cell lung cancer.

    1.2. Mesothelioma:

    PEMETREXED in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unrespectable or who are otherwise not candidates for curative surgery.

    2 DOSAGE AND ADMINISTRATION

    • The recommended dose of PEMETREXED when administered with cisplatin for initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/ min or greater is 500 mg/m² as an intravenous infusion over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.

    • The recommended dose of PEMETREXED for maintenance treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum based first-line chemotherapy.

    • The recommended dose of PEMETREXED for treatment of recurrent NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. The recommended dose of PEMETREXED when administered with carboplatin and pembrolizumab for the initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft- Gault equation) of 45 mL/min or greater is 500 mg/m² administered a s a n intravenous infusion over 1 0minutes prior to carboplatin on Day 1 of each 21-day cycle for 4 cycles. Following completion of platinum based therapy, PEMETREXED may be administered as maintenance therapy, alone or with pembrolizumab, until disease progression or unacceptable toxicity. Pembrolizumab should be administered prior to PEMETREXED when given on the same day. Please refer to the full prescribing information for pembrolizumab and for carboplatin.

    3 PREPARATION AND ADMINISTRATION PRECAUTIONS:

    As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of infusion solutions of PEMETREXED. The use of gloves is recommended. If a solution of PEMETREXED contacts the skin, wash the skin immediately and thoroughly with soap and water. If PEMETREXED contacts the mucous membranes, flush thoroughly with water. Several published guidelines for handling and disposal of anticancer agents are available. PEMETREXED is not a vesicant. There is no specific antidote for extravasation of PEMETREXED. To date, there have been few reported cases of PEMETREXED extravasation, which were not assessed as serious by the investigator. PEMETREXED extravasation should be managed with local standard practice for extravasation as with other non-vesicants.

    4 STABILITY:

    Unopened vials of PEMETREXED are stable until the date indicated on the package when stored in the original package protected from light. PEMETREXED contains no antimicrobial preservative. Reconstituted PEMETREXED should be administered immediately after preparation because of microbiological concerns. If not used immediately, in-use storage times and conditions prior to use are the responsibility of user. by the investigator. PEMETREXED extravasation should be managed with local standard practice for extravasation as with other non-vesicants.

    5 COMPATIBILITY

    5.1. Stability:

    PEMETREXED for Injection, is stable in D5W, NS.

    PEMETREXED physically incompatible with calcium containing products, including Ringer’s and lactated Ringer’s injection.

    5.2. Y-site administration:

    Compatible: Acyclovir, amifostine, amikacin, aminophylline, ampicillin, ampicillin/sulbactam, aztreonam, bumetanide, buprenorphine, butorphanol, carboplatin, cefuroxime, cimetidine, cisplatin, clindamycin, cyclophosphamide, cytarabine, dexamethasone sodium phosphate, dexrazoxane, diphenhydramine, docetaxel, dopamine, enalaprilat, famotidine, fluconazole, fluorouracil, ganciclovir, granisetron, haloperidol, heparin, hydromorphone, hydroxyzine, ifosfamide, leucovorin calcium, lorazepam, mannitol, meperidine, mesna, methylprednisolone sodium succinate, metoclopramide, morphine, paclitaxel, potassium chloride, promethazine, ranitidine, sodium bicarbonate, ticarcillin/clavulanate potassium, trimethoprim/sulfamethoxazole, vancomycin, vinblastine, vincristine, zidovudine.

    Incompatible: Amphotericin B, calcium gluconate, cefazolin, cefotaxime, cefotetan, cefoxitin, ceftazidime, chlorpromazine, ciprofloxacin, dobutamine, doxorubicin, doxycycline, droperidol, gemcitabine, gentamicin, irinotecan, metronidazole, minocycline, mitoxantrone, nalbuphine, ondansetron, prochlorperazine edisylate, tobramycin, topotecan.

    Variable (consult detailed reference): Ceftriaxone.

    6 CONTRAINDICATIONS

    Hypersensitivity to the active substance or to any of the excipients, B reast-feeding, Concomitant yellow fever vaccine.

    7 USE IN SPECIAL POPULATIONS

      7.1. Pregnancy:

      Pregnancy Risk Factor: D

      Pregnancy Implications: Adverse effects (embryotoxicity, fetotoxicity and teratogenicity) were observed in animal reproduction studies. Based on the mechanism of action, may cause fetal harm if administered to a pregnant woman. Women of childbearing potential should have a negative serum pregnancy test prior to treatment and should use effective contraceptive measures to avoid becoming pregnant during treatment and for at least 6 months after the final dose of PEMETREXED. Irreversible infertility has been reported in males; prior to receiving treatment, males should be counseled on sperm storage. It is recommended that males receiving therapy use effective contraceptive measures and not father a child during, and for up to 3 months after therapy.

      7.2. NURSING MOTHERS:

      Enters breast milk/not recommended Breast-Feeding Considerations: The decision to continue or discontinue breast-feeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.

SIMILAR PRODUCTS