Chronic immunosuppression with azathioprine, a purine antimetabolite, increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with azathioprine .
Azathioprine injection is used to prevent rejection of a transplanted kidney. It belongs to the group of medicines known as immunosuppressive agents. Azathioprine will lower the body's natural immunity in patients who receive transplants to prevent rejection of the new kidney. It is also used to relieve joint pain and swelling for patients with rheumatoid arthritis.
This medicine is to be given only by or under the immediate supervision of your doctor.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of azathioprine injection in the pediatric population. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of azathioprine injection in geriatric patients.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
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.
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.
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.
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:
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.
Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any questions about this, talk to your doctor.
It is very important that your doctor check you carefully while you are receiving this medicine for any problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.
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 this medicine, tell your doctor right away.
Do not use this medicine if you are also taking mercaptopurine (Purinethol®). Using these medicines together could cause serious unwanted effects.
If you are using azathioprine for arthritis, make sure your doctor knows if you received chlorambucil (Leukeran®), cyclophosphamide (Cytoxan®, Neosar®), or melphalan (Alkeran®) to treat your arthritis in the past. Using azathioprine after these medicines may increase your risk for unwanted effects. Talk to your doctor if you have questions about this.
This medicine may increase your risk of getting certain types of cancer, especially of the skin, lymph system (lymphoma), or blood (leukemia). Talk to your doctor if you have concerns about this risk.
Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats, and stay out of direct sunlight between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.
While you are being treated with azathioprine, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Azathioprine may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Azathioprine 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:
This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
Check with your doctor right away if you have more than one of these symptoms while you are using this medicine: severe nausea or vomiting, diarrhea, fever, rash, a general feeling of discomfort or illness, muscle or joint pain, lightheadedness or dizziness, or unusual tiredness or weakness. These could be symptoms of a serious reaction to the medicine in your bowel (intestine).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:
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:
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.