Description
Azacitidine injection is used to treat patients with French-American-British (FAB) myelodysplastic syndrome (bone marrow problem) subtypes, including refractory anemia or chronic leukemia. This medicine is also used to treat juvenile myelomonocytic leukemia (JMML).
Azacitidine belongs to the group of medicines called metabolites. It 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 to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Suspension
Before Using
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 azacitidine injection to treat myelodysplastic syndrome in children and to treat juvenile myelomonocytic leukemia in children younger than 1 month of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of azacitidine injection in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution in patients receiving azacitidine injection.
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 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.
- Cedazuridine
- Levoketoconazole
- Methotrexate
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:
- Allergy to mannitol or
- Cancerous liver tumors—Should not be used in patients with these conditions.
- Anemia or
- Liver disease, severe or
- Neutropenia (low white blood cells) or
- Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin or into a vein.
This medicine is given once a day, for 7 days (1 treatment cycle). Then, you may receive this medicine every 4 weeks. You may also receive medicines to help prevent nausea and vomiting.
Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic 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.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant or your partner has become pregnant while using this medicine, tell your doctor right away.
Azacitidine 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 the 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.
This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
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).
Side Effects
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 or nurse immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- cloudy urine
- body aches or pain
- burning or stinging of the skin
- chest pain or tightness
- chills
- congestion
- cough
- difficult breathing
- difficulty swallowing
- dizziness
- ear congestion
- fast heartbeat
- fever
- frequent urge to urinate
- headache
- hives, itching, or skin rash
- hoarseness
- increased menstrual flow or vaginal bleeding
- loss of voice
- lower back or side pain
- muscle aches
- nausea
- nosebleeds
- pain or tenderness around the eyes and cheekbones
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- pain, redness, swelling, tenderness, warmth on the skin
- pale skin
- paralysis
- pinpoint red spots on the skin
- prolonged bleeding from cuts
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- rapid heartbeat
- runny or stuffy nose
- sneezing
- sore throat
- sores, ulcers, or white spots on lips or in mouth
- swollen glands
- tender, swollen glands in the neck
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- voice changes
- vomiting
Less common
- Change in consciousness
- decreased urine
- drowsiness
- dry mouth
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain or cramps
- numbness or tingling in the hands, feet, or lips
- loss of consciousness
- seizures
Incidence not known
- Chest discomfort
- coughing or spitting up blood
- dilated neck veins
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- red or bloodshot eye
- seeing gloating spots before the eyes
- stroke
- swelling of the face, fingers, feet, or lower legs
- thickened bronchial secretions
- vomiting of blood or material that looks like coffee grounds
- weight gain
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Diarrhea
- nausea
- 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
- Acid or sour stomach
- appetite decreased
- belching
- bleeding after defecation
- bloody nose
- blurred vision
- bone pain
- bruise
- bumps on the skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning while urinating
- diarrhea
- difficulty having a bowel movement (stool)
- difficulty with moving
- discouragement
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry skin
- fainting
- fear
- feeling of discomfort or illness
- feeling of sluggishness
- feeling sad or empty
- feeling unusually cold
- flushing
- full or bloated feeling or pressure in the stomach
- heartburn
- heart murmur
- indigestion
- inflamed tissue from infection at the injection site
- injection site bruising
- irritability
- itching at injection site
- joint pain
- lack of appetite
- large, flat, blue or purplish patches in the skin
- loss of interest or pleasure
- mouth hemorrhage
- muscle stiffness
- nervousness
- night sweats
- pain in the joints
- postnasal drip
- post procedural hemorrhage
- redness of the skin
- shivering
- small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
- small lumps under the skin
- small red or purple spots in the mouth or on the skin
- soreness or discomfort to touch or pressure on the stomach
- stomach discomfort upset or pain
- sweating
- swelling of abdominal or stomach area
- swelling of the hands, ankles, feet, or lower legs
- swelling or inflammation of the mouth
- swelling with pits or depressions visible on the skin
- swollen joints
- tongue ulceration
- trouble concentrating
- trouble sleeping
- uncomfortable swelling around the anus
- unusual drowsiness
- unusually warm skin
- upper abdominal or stomach pain
- 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.
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