Busulfex

Generic name: Busulfan
Drug class: Alkylating agents

Usage of Busulfex

Busulfan injection is used in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for treatment of chronic myelogenous leukemia.

Busulfan belongs to the group of medicines known as alkylating agents. It seems to act by interfering with the function of the bone marrow. Since the growth of normal body cells may also be affected by busulfan, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with busulfan, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.

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

Busulfex 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

bloated abdomen or stomach

blood in the urine or stools

blurred vision

chest pain

cough or hoarseness

dizziness

fast or irregular breathing

fast, pounding, or irregular heartbeat or pulse

fever or chills

headache

lower back or side pain

nervousness

pain and fullness in the upper abdominal or stomach

painful or difficult urination

pinpoint red spots on the skin

pounding in the ears

skin rash or itching

slow heartbeat

swelling of the eyes or eyelids

tightness in the chest

trouble breathing

unusual bleeding or bruising

weight gain

yellow eyes and skin

Incidence not known

seizures

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

back pain

belching

bloody nose

depression

diarrhea

difficulty having a bowel movement (stool)

fear

heartburn

indigestion

loss of appetite

lack or loss of strength

sneezing

stomach discomfort or upset

stuffy nose or runny nose

swelling or inflammation of the mouth

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

trouble sleeping

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.

Before taking Busulfex

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 busulfan injection in the pediatric population. 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 busulfan injection in the elderly.

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.

Interactions with 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 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.

Blinatumomab

Bupropion

Deferasirox

Deferiprone

Deferoxamine Mesylate

Itraconazole

Ketoconazole

Levoketoconazole

Methotrexate

Metronidazole

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.

Fosphenytoin

Ketobemidone

Phenytoin

Interactions with Food/Tobacco/Alcohol

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.

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How to use Busulfex

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.

Busulfan must be given slowly, so the needle will remain in place for 2 hours. You may also receive medicines to help prevent seizures after using busulfan.

Warnings

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. 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 you or your sexual partner from getting pregnant during or after treatment. If you think you have become pregnant while using this medicine, tell your doctor right away.

Busulfan 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 hepatic veno-occlusive disease (HVOD). This usually occurs if you receive too much busulfan, or receive this medicine before radiation treatment, or have a prior progenitor cell transplant. Call your doctor right away if you have a bloated abdomen or stomach, upper right abdominal or stomach pain, weight gain, or yellow eyes or skin.

While you are being treated with busulfan, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Busulfan may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some body tissue studies may be affected by this medicine.

Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).

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.

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