Decitabine, Injection

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KEY POINTS

• This medicine is given by IV to treat diseases of the bone marrow.
• This medicine may cause birth defects if you or your partner get pregnant.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: decitabine, injection; Dacogen Injection

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat myelodysplastic syndromes (a group of diseases of the bone marrow).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Kidney or liver problems

Also tell your provider if you have recently had any kind of infection or if you are taking radiation therapy or chemotherapy.

Males: This medicine may harm a man's sperm. Men must use effective birth control during treatment and for 2 months after stopping this medicine.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Use effective birth control during treatment and for 1 month after stopping this medicine. Talk with your healthcare provider about effective birth control. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I use it?

The infusions are given by your healthcare provider. The length of treatment depends on your response. Keep all your appointments for the infusions.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause birth defects. Males must use effective birth control while receiving this medicine and for 2 months after treatment is complete. Females must use effective birth control while receiving this medicine and for 1 month after treatment is complete. Talk with your healthcare provider about effective birth control.

This medicine may cause nausea, vomiting, diarrhea, or sores in your mouth. Use a soft bristle brush or mouth swab to brush your teeth. Contact your healthcare provider if these continue or get worse.

You may get infections more easily or bleed more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are receiving this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fever; chills; chest pain; fast or irregular heartbeat; decreased or increased urination; increased thirst; confusion; severe mouth sores; unusual bruising or bleeding; unexplained sore throat or cough; black or tarry bowel movements; blood in the urine; swelling in your hands, feet, or ankles; severe tiredness or weakness; sudden or severe headache; loss of vision; trouble swallowing; dark urine, yellowing of the skin or eyes, light-colored bowel movements; severe nausea, vomiting, or stomach pain; severe constipation or diarrhea.

Other: Hair loss, nausea, vomiting, mild cough, mild headache, trouble sleeping, tiredness, dizziness, muscle or joint pain, back pain, decreased appetite, flushing, blurred vision, white patches in mouth or throat.

What products might interact with this medicine?

No significant drug interactions have been reported. However, do not have any vaccinations with live virus vaccines unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.