Azacitidine (Subcutaneous Route)

    Azacitidine (Subcutaneous Route)

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    Description and Brand Names of Azacitidine (Subcutaneous Route)

    Descriptions

    Azacitidine belongs to the group of medicines known as antimetabolites. It is used to treat some kinds of cancer.

    Azacitidine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by azacitidine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Some effects may not occur for months or years after the medicine is used.

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

    This product is available in the following dosage forms:

    • Powder for Suspension

    Before Using Azacitidine (Subcutaneous 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

    There is no specific information comparing use of azacitidine in children with use in other age groups.

    Geriatric

    Azacitidine has been tested in elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older patients are more likely to have age-related kidney problems which may require monitoring

    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 taking 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

    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:

    • Cancerous liver tumors – The risk of side effects that affect the liver may be increased. Azacitidine should not be used in patients with cancerous liver tumors.
    • Kidney disease or
    • Liver disease – These conditions sometimes increase the effects of medicines by causing them to be removed from the body more slowly.

    Proper Use of Azacitidine (Subcutaneous Route)

    Azacitidine sometimes causes nausea and vomiting. Tell your doctor if this occurs, especially if you have stomach pain

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    Missed Dose

    Call your doctor or pharmacist for instructions.

    Precautions

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

    Side Effects of Azacitidine (Subcutaneous 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.

    Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    1. Black, tarry stools
    2. bladder pain
    3. bleeding gums
    4. blood in urine or stools
    5. cloudy urine
    6. body aches or pain
    7. burning or stinging of skin
    8. chest pain
    9. chills
    10. congestion
    11. cough
    12. difficult breathing
    13. difficulty swallowing
    14. dizziness
    15. ear congestion
    16. fast heartbeat
    17. fever
    18. frequent urge to urinate
    19. headache
    20. hives
    21. hoarseness
    22. itching
    23. loss of voice
    24. lower back or side pain
    25. muscle aches
    26. nasal congestion
    27. nausea
    28. pain or tenderness around eyes and cheekbones
    29. painful cold sores or blisters on lips, nose, eyes, or genitals
    30. painful or difficult urination
    31. pain, redness, swelling, tenderness, warmth on skin
    32. pale skin
    33. pinpoint red spots on skin
    34. puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
    35. rapid heartbeat
    36. runny nose
    37. shortness of breath
    38. skin rash
    39. sneezing
    40. sore throat
    41. sores, ulcers, or white spots on lips or in mouth
    42. stuffy nose
    43. swollen glands;
    44. tender, swollen glands in neck
    45. tightness in chest
    46. troubled breathing with exertion
    47. unusual bleeding or bruising
    48. unusual tiredness or weakness
    49. voice changes
    50. vomiting
    51. wheezing

    Less common

    1. Change in consciousness
    2. convulsions
    3. decreased urine
    4. drowsiness
    5. dry mouth
    6. increased blood creatinine
    7. increased blood pressure
    8. increased thirst
    9. irregular heartbeat
    10. loss of appetite
    11. mood changes
    12. muscle pain or cramps
    13. numbness or tingling in hands, feet, or lips
    14. loss of consciousness

    Symptoms of Overdose

    1. Diarrhea
    2. nausea
    3. vomiting

    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:

    More Common

    1. Acid or sour stomach
    2. appetite decreased
    3. belching
    4. bleeding after defecation
    5. bloody nose
    6. blurred vision
    7. bruise
    8. bumps on skin
    9. burning, crawling, itching, numbness, prickling, “pins and needles”; or tingling feelings
    10. burning while urinating
    11. confusion
    12. diarrhea
    13. difficulty having a bowel movement (stool)
    14. difficulty in moving
    15. discouragement
    16. dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
    17. dry skin
    18. fainting
    19. fear
    20. feeling of discomfort or illness;
    21. feeling of sluggishness
    22. feeling sad or empty
    23. feeling unusually cold
    24. flushing
    25. full or bloated feeling or pressure in the stomach
    26. heartburn
    27. heart murmur
    28. indigestion
    29. inflamed tissue from infection at the site of injection
    30. injection site bruising
    31. irritability
    32. itching at injection site
    33. joint pain
    34. lack of appetite
    35. large, flat, blue or purplish patches in the skin
    36. loss of interest or pleasure
    37. mouth hemorrhage
    38. muscle stiffness
    39. nervousness
    40. night sweats
    41. pain in joints
    42. postnasal drip
    43. post procedural hemorrhage
    44. redness of skin
    45. shivering
    46. sleeplessness
    47. small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
    48. small lumps under the skin
    49. small red or purple spots in mouth
    50. soreness or discomfort to touch or pressure on stomach
    51. stomach discomfort upset or pain
    52. sweating
    53. swelling of abdominal or stomach area
    54. swelling of hands, ankles, feet, or lower legs
    55. swelling or inflammation of the mouth
    56. swelling with pits or depressions visible on skin
    57. swollen joints
    58. tongue ulceration
    59. trouble concentrating
    60. trouble sleeping
    61. uncomfortable swelling around anus
    62. unusual drowsiness
    63. unusually warm skin
    64. upper abdominal pain
    65. weight loss

    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.