Alkeran IV - Melphalan (Intravenous Route)

    Alkeran IV – Melphalan (Intravenous Route)

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    Description and Brand Names of Alkeran IV – Melphalan (Intravenous Route)

    US Brand Name

    1. Alkeran IV

    Descriptions

    Melphalan is used to treat multiple myeloma, which is a cancer in the bone marrow .

    Melphalan belongs to the group of medicines called alkylating agents. It works by interfering with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by melphalan, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious, but may cause concern. Some effects may not occur for months or years after the medicine is used .

    Before you begin treatment with melphalan, you and your doctor should talk about the good this medicine will do as well as the risks of using it .

    This medicine is available only with your doctor’s prescription .

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using Alkeran IV – Melphalan (Intravenous Route)

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of melphalan in the pediatric population. Safety and efficacy have not been established .

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of melphalan in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment of dose in patients receiving melphalan .

    Pregnancy

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Rotavirus Vaccine, Live

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Adenovirus Vaccine Type 4, Live
    • Adenovirus Vaccine Type 7, Live
    • Bacillus of Calmette and Guerin Vaccine, Live
    • Influenza Virus Vaccine, Live
    • Measles Virus Vaccine, Live
    • Mumps Virus Vaccine, Live
    • Rubella Virus Vaccine, Live
    • Smallpox Vaccine
    • Typhoid Vaccine
    • Varicella Virus Vaccine
    • Yellow Fever Vaccine

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Buthionine Sulfoximine
    • Nalidixic Acid

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Bone marrow suppression or
    • Leukopenia (low white blood cells in the blood) or
    • Thrombocytopenia (low platelets in the blood) – May make these conditions worse .
    • Infection – May decrease your body’s ability to fight infections .
    • Kidney disease – Use with caution. The effects may be increased because of slower removal of the medicine from the body .

    Proper Use of Alkeran IV – Melphalan (Intravenous Route)

    You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins .

    Precautions

    It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects .

    This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine .

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. You should not breastfeed during treatment with melphalan .

    If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children) .

    While you are being treated with melphalan, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor’s approval. Melphalan may lower your body’s resistance, and there is a chance you might get the infection the vaccine is meant to prevent. In addition, other persons living in your household should not receive certain vaccines, since there is a chance they could pass the infection on to you. If you have questions about this, talk to your doctor .

    Melphalan can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

    • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
    • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
    • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
    • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
    • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
    • Avoid contact sports or other situations where bruising or injury could occur .

    Side Effects of Alkeran IV – Melphalan (Intravenous Route)

    Along with its needed effects, a medicine 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 immediately if any of the following side effects occur:

    More common

    1. Chest pain
    2. chills
    3. cough or hoarseness
    4. fever
    5. lower back or side pain
    6. painful or difficult urination
    7. shortness of breath
    8. sores, ulcers, or white spots on the lips or in the mouth
    9. swollen glands
    10. unusual bleeding or bruising
    11. unusual tiredness or weakness

    Incidence not known

    1. Abdominal or stomach pain
    2. absent, missed, or irregular menstrual periods
    3. back or leg pains
    4. bleeding gums
    5. bloated abdomen
    6. blurred vision
    7. clay-colored stools
    8. confusion
    9. dark urine
    10. difficult or labored breathing
    11. difficulty swallowing
    12. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
    13. fast, pounding, or irregular heartbeat or pulse
    14. general body swelling
    15. headache
    16. hives
    17. indigestion
    18. itching
    19. light-colored stools
    20. loss of appetite
    21. nausea and vomiting
    22. noisy breathing
    23. nosebleeds
    24. pain and fullness in right upper abdomen
    25. pale skin
    26. puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
    27. rash
    28. reddening of the skin, especially around ears swelling of eyes, face, or inside of nose
    29. skin rash
    30. sore throat
    31. sweating
    32. swelling of face, hands, ankles, feet, or lower legs
    33. tightness in chest
    34. unpleasant breath odor
    35. unusual lumps or masses
    36. vomiting of blood
    37. weight gain
    38. weight loss
    39. wheezing
    40. yellow eyes or skin

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    1. Black, tarry stools
    2. blood in urine
    3. bloody stools
    4. change in frequency of urination or amount of urine
    5. coma
    6. convulsions
    7. cracked lips
    8. decrease in consciousness
    9. diarrhea
    10. drowsiness
    11. flushing of skin or feeling of warmth
    12. increased salivation or sweating
    13. increased thirst
    14. muscle pain or cramps
    15. no muscle tone or movement
    16. seizures
    17. severe nausea and vomiting
    18. stomach discomfort, cramps, or tenderness
    19. swelling or inflammation of the mouth
    20. troubled breathing
    21. vomiting of material that looks like coffee grounds
    22. watery or bloody diarrhea
    23. weakness

    Some side effects 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:

    Less common

    1. Indigestion
    2. passing of gas
    3. stomach fullness

    Incidence not known

    1. Blue-green to black skin discoloration
    2. hair loss, thinning of hair
    3. pain, redness, soreness, or sloughing of skin at place of injection
    4. sores, welting, or blisters

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.