Imuran (Intravenous)

Azathioprine injection is used to stop the body from rejecting a transplanted kidney. It is part of a group of medicines called immunosuppressive agents. Azathioprine will reduce the body's natural immunity in patients who have had transplants to help prevent rejection of the new kidney. It is also used to help with joint pain and swelling in patients with active rheumatoid arthritis.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor closely monitors your progress while you are receiving this medicine for any problems that may arise. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while receiving 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 have previously received chlorambucil (Leukeran®), cyclophosphamide (Cytoxan®, Neosar®), or melphalan (Alkeran®) to treat your arthritis. 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 skin cancer, lymphoma (cancer of the lymph system), or leukemia (cancer of the blood). 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 regularly when you are outdoors. Wear protective clothing and hats, and avoid direct sunlight between the hours of 10 am and 3 pm. Stay away from sunlamps and tanning beds.

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 happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have 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 your 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.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could occur.

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 using this medicine. Wash your hands often. Tell your doctor if you have lupus or any kind of infection before you start using this medicine. Also, inform 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 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 signs of a serious reaction to the medicine in your bowel.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. Please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have been no appropriate studies on how azathioprine injection affects children. Its safety and effectiveness in this age group have not been established.

Geriatric

There is no information about how azathioprine injection affects older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together, but an interaction might occur. Your doctor may need to adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant 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 other medicines you take.

• Febuxostat

Using this medicine with any of the following medicines is usually not recommended, but may be necessary 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
• Alacepril
• Alfalfa
• Allopurinol
• Bacillus of Calmette and Guerin Vaccine, Live
• Benazepril
• Black Cohosh
• Captopril
• Cilazapril
• Dengue Tetravalent Vaccine, Live
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Enalaprilat
• Enalapril Maleate
• Fosinopril
• Influenza Virus Vaccine, Live
• Lisinopril
• Measles Virus Vaccine, Live
• Mercaptopurine
• Moexipril
• Mumps Virus Vaccine, Live
• Mycophenolic Acid
• Olsalazine
• Oxypurinol
• Pentopril
• Perindopril
• Poliovirus Vaccine, Live
• Quinapril
• Ramipril
• Ribavirin
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Ruxolitinib
• Smallpox Vaccine
• Spirapril
• Sulfamethoxazole
• Sulfasalazine
• Tofacitinib
• Trandolapril
• Trimethoprim
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zofenopril
• Zoster Vaccine, Live

Using this medicine with any of the following medicines may increase the 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.

• Acenocoumarol
• Phenprocoumon
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Anemia or
• Blood or bone marrow problems or
• Leukopenia (low white blood cells) or
• Stomach or bowel problems (for example, nausea, vomiting, diarrhea) or
• Thrombocytopenia (low number of platelets)—Use with caution. This may worsen these conditions.

• Crohn's disease or
• Ulcerative colitis—Use with caution. There may be a higher risk for more side effects.

• Infection—This may lower your body's ability to fight infection.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Chest pain
• Chills
• Cough
• Fever
• Painful or difficult urination
• Pinpoint red spots on the skin
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Swollen glands
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Less common

• Cloudy urine
• Diarrhea
• Fever sores on the skin
• General feeling of illness
• Greatly decreased frequency of urination or amount of urine
• Skin rash
• Swelling of the feet or lower legs
• Weight loss
• Yellow skin or eyes

Rare

• Bloating
• Clay-colored stools
• Constipation
• Dark urine
• Decreased appetite
• Fast heartbeat
• Headache
• Indigestion
• Itching
• Loss of appetite
• Nausea (severe)
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Stomach pain or tenderness
• Vomiting (severe)

Incidence not known

• Difficulty with breathing
• Difficulty with moving
• Fat in the stool
• General feeling of illness
• Hoarseness
• Lower back or side pain
• Muscle pain or stiffness
• Pain in the joints
• Pale skin
• Sores on the skin
• Stomach cramps
• Sudden loss of weight
• Swollen glands
• Troubled breathing with movement
• Weight loss

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

• Nausea (mild)
• Swollen joints
• Vomiting (mild)

Less common

• Hair loss or thinning of the hair

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.

In the U.S.

• Imuran

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antirheumatic, Cytotoxic

Pharmacologic Class: Azathioprine

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into 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.