Vidaza

Generic name: azacitidine
Drug class: Miscellaneous antineoplastics

Medically reviewed by  A Ras MD.

What is Vidaza used for?

Vidaza is a prescription medicine that is used to treat a health problem called myelodysplastic syndrome (MDS). Vidaza may be given to you for other reasons.

Description

VIDAZA (azacitidine for injection) contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is

4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows:

AzacitidineStructuralFormula

The empirical formula is C8H12N4O5. The molecular weight is 244. Azacitidine is a white to off-white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO).

The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of VIDAZA contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder.

Mechanism of Action

VIDAZA is a pyrimidine nucleoside analog of cytidine. VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to azacitidine.

Before taking Vidaza, tell your doctor:

  • If you are allergic to Vidaza; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have liver tumors.
  • If you are breast-feeding. Do not breast-feed while you take Vidaza. You may also need to avoid breast-feeding for some time after your last dose. Talk with your doctor to see if you need to avoid breast-feeding after your last dose.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Vidaza with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Vidaza?

  • Tell all of your health care providers that you take Vidaza. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine may lower the ability of the bone marrow to make blood cells that the body needs. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. If you have questions, talk with the doctor.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • Talk with your doctor before getting any vaccines. Use of some vaccines with Vidaza may either raise the chance of an infection or make the vaccine not work as well.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Very bad and sometimes deadly kidney problems have happened in people getting Vidaza along with other cancer drugs for other health problems. Talk with the doctor.
  • Patients with cancer who take Vidaza may be at a greater risk of getting a severe health problem called tumor lysis syndrome (TLS).This may lead to death. Call your doctor right away if you have a fast or abnormal heartbeat; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, diarrhea, or not able to eat; or feel sluggish.
  • If you are 65 or older, use Vidaza with care. You could have more side effects.
  • This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy while you take Vidaza. Your sex partner may also need to avoid pregnancy for some time after your last dose. Talk with your doctor to see if your sex partner needs to avoid pregnancy after you stop Vidaza.
  • If you are a man and your sex partner gets pregnant while you take Vidaza or within several months after your last dose, call your doctor right away.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Vidaza. Talk with your doctor.
  • Use birth control to prevent pregnancy during treatment with Vidaza. You may also need to use birth control for some time after your last dose. Talk with your doctor to see if you need to use birth control after you stop Vidaza.
  • If you get pregnant while taking Vidaza or within several months after the last dose, call your doctor right away.

How is Vidaza best taken?

Use Vidaza as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin.
  • It is given as an infusion into a vein over a period of time.
  • Other drugs may be given before Vidaza to help avoid side effects.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are the side effects of Vidaza that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Chest pain or pressure.
  • Shortness of breath.
  • Very bad dizziness or passing out.
  • Very bad headache.
  • Very bad irritation where the shot was given.
  • Feeling very tired or weak.
  • A very bad skin problem (necrotizing fasciitis) has happened in people taking Vidaza. Sometimes, this has been deadly. Call your doctor right away if your skin is warm with red or purple areas of swelling that spread quickly. Call your doctor right away if you have ulcers, blisters, black spots on the skin, or any other skin changes that concern you.

What are some other side effects of Vidaza?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Mouth irritation or mouth sores.
  • Dizziness.
  • Not able to sleep.
  • Headache.
  • Feeling tired or weak.
  • Irritation where the shot is given.
  • Constipation.
  • Diarrhea.
  • Not hungry.
  • Dry skin.
  • Nose and throat irritation.
  • Muscle or joint pain.
  • Anxiety.
  • Belly pain.
  • Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Vidaza?

  • If you need to store Vidaza at home, talk with your doctor, nurse, or pharmacist about how to store it.

 

Label

PRINCIPAL DISPLAY PANEL

  • Package Label – Principal Display Panel – 100 mg Vial Label
Principal Display Panel - 100 mg Vial Label

 

  • Package Label – Principal Display Panel – 100 mg Carton Label
Principal Display Panel - 100 mg Carton Label

SRC: NLM .

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