Vidaza

DRUG DESCRIPTION

VIDAZA (azacitidine for injection) contains azacitidine, which is a pyrimidine nucleoside analog of cytidine. Azacitidine is 4-amino-1-?-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows:

 VIDAZA (azacitidine) Structural Formula Illustration

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.

What are the possible side effects of azacitidine (Vidaza)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • dry mouth, increased thirst, confusion, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting;
  • pain, itching, burning,...

Read All Potential Side Effects and See Pictures of Vidaza

What are the precautions when taking azacitidine (Vidaza)?

Before using azacitidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver cancer.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your...

Read All Potential Precautions of Vidaza


Vidaza Consumer (continued)

SIDE EFFECTS: Redness/pain/bruising at the injection site, tiredness, diarrhea, dizziness, trouble sleeping, constipation, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these serious side effects occur: easy bleeding/bruising, chest pain, muscle/joint pain, muscle cramps, irregular heartbeat, swollen ankles/feet, mental/mood changes (e.g., anxiety, depression).

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, dark urine, yellowing eyes/skin.

This medication can lower the body's ability to fight an infection. Tell your doctor immediately if you develop any signs of an infection such as fever, chills, cough, or persistent sore throat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using azacitidine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver cancer.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is not recommended for use during pregnancy. Also, men using this medication should avoid causing pregnancy during treatment. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms and birth control pills) while using this medication and for some time afterward. Consult your doctor for more details and to discuss reliable forms of birth control.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Vidaza Patient Information Including Side Effects

Brand Names: Vidaza

Generic Name: azacitidine (Pronunciation: ay za SYE ti deen)

  • What is azacitidine (Vidaza)?
  • What are the possible side effects of azacitidine (Vidaza)?
  • What is the most important information I should know about azacitidine (Vidaza)?
  • What should I discuss with my healthcare provider before receiving azacitidine (Vidaza)?
  • How is azacitidine given (Vidaza)?
  • What happens if I miss a dose (Vidaza)?
  • What happens if I overdose (Vidaza)?
  • What should I avoid while using azacitidine (Vidaza)?
  • What other drugs will affect azacitidine (Vidaza)?
  • Where can I get more information?

What is azacitidine (Vidaza)?

Azacitidine is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Azacitidine is used to treat certain types of bone marrow cancers and blood cell disorders.

Azacitidine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of azacitidine (Vidaza)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • dry mouth, increased thirst, confusion, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting;
  • pain, itching, burning, bleeding, or skin changes where the injection was given;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • seizure (black-out or convulsions);
  • urinating less than usual or not at all; or
  • severe ongoing nausea, vomiting, or diarrhea.

Less serious side effects may include:

  • white patches or sores inside your mouth or on your lips;
  • mild nausea, vomiting, loss of appetite;
  • diarrhea, constipation;
  • redness where the injection was given;
  • headache; or
  • joint pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about azacitidine (Vidaza)?

Do not use this medication if you are allergic to azacitidine or mannitol, or if you have liver cancer.

Before receiving azacitidine, tell your doctor if you are allergic to any drugs, or if you have kidney disease or liver disease.

Do not receive this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 4 weeks after you stop using azacitidine.

Tell your caregiver right away if this medication accidentally gets on your skin. Wash the area thoroughly with soap and warm water.

Do not receive a "live" vaccine while you are being treated with azacitidine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Azacitidine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor. Do not miss any scheduled visits to your doctor.

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