Pronunciation:

ay-za-THYE-oh-preen SOE-dee-um

Brand Names:

• Imuran

Dosage Forms:

• Powder for Solution

Warnings:

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 .

Classifications:

Therapeutic—

Antirheumatic, Cytotoxic

Pharmacologic—

Azathioprine

Uses of This Medicine:

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 active rheumatoid arthritis.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

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.

Older adults—

No information is available on the relationship of age to the effects of azathioprine injection in geriatric patients.

Breast-feeding—

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.

Other medicines—

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.

• Febuxostat

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
• 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 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.

• Acenocoumarol
• Phenprocoumon
• Warfarin

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:

• Anemia or
• Blood or bone marrow problems or
• Leukopenia (low white blood cells) or
• Stomach or bowel problems (eg, nausea, vomiting, diarrhea) or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

• Crohn's disease or
• Ulcerative colitis—Use with caution. May increase risk for more side effects.

• Infection—May decrease your body's ability to fight infection.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine for any problems that may be caused by this medicine. 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 keep from getting pregnant. 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 had 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 am and 3 pm Avoid 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 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.
• 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 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.

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.

Side Effects of This Medicine:

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

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.