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Why is this medication prescribed?

Adults with acute myeloid leukaemia (AML; malignancy of the white blood cells) who responded to chemotherapy but were unable to finish aggressive curative therapy are treated with azacitidine. Azacitidine belongs to the group of drugs known as demethylation agents. It functions by destroying aberrant cells and assisting the bone marrow in producing healthy blood cells.

How should this medicine be used?

Azacitidine is available as an oral tablet. It is typically taken once daily for the first 14 days of a 28-day cycle, with or without food. Depending on how you respond to the drug and any adverse effects you may experience, your doctor will determine how many times you need repeat this cycle. Take azacitidine every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the azacitidine directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole.

Wash the exposed area as soon as possible with soap and water if powder from the inside of the pills comes into contact with your skin. If powder from the interior of the pills comes in contact with your eyes or mouth, immediately rinse the area with water.

For the first two cycles, you will receive antiemetic medication from your doctor 30 minutes before to each azacitidine dose. Depending on your needs, your doctor might prescribe you this drug for additional cycles.

Do not take another dose of azacitidine if you vomit after taking it. Continue taking your medication as usual.

If you have certain adverse effects, your doctor may lower your dose or temporarily or permanently stop your therapy. Throughout your azacitidine therapy, be careful to let your doctor know how you are feeling.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking azacitidine,

  • If you have an allergy to azacitidine, any other medications, or any of the ingredients in azacitidine tablets, let your doctor and pharmacist know right away. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have or have previously had liver or kidney disease, let your doctor know.
  • Inform your physician if you are expecting, intend to become pregnant, or intend to father a child. Pregnancy should not occur while you are using azacitidine, either for you or your partner. You must perform a pregnancy test before beginning therapy if you are a female, and you must use birth control to avoid getting pregnant while receiving treatment and for at least six months after your last dose. You should use reliable birth control during treatment and for three months following your last dose if you’re a man and your spouse is capable of getting pregnant. Call your doctor if you or your partner become pregnant while taking azacitidine. The foetus could suffer from azacitidine.
  • While using azacitidine and for one week following your last dose, refrain from breastfeeding.
  • You should be aware that this medicine may lower both male and female fertility. Describe the dangers of taking azacitidine to your doctor.
  • You should be aware that azacitidine frequently results in severe diarrhoea. As part of your azacitidine treatment, your doctor may likely advise you to take an anti-diarrhea drug to avoid dehydration (excessive water loss from your body).

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Take your dose as soon as you remember if you miss one or don’t take it at the scheduled time. The following day, take your next dose at the usual time. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Azacitidine might have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Reduced appetite
  • Tiredness
  • Abdominal pain
  • Aching joints
  • Muscle ache
  • Dizziness
  • Legs or hands may hurt.

Some adverse effects can be very harmful. Call your doctor right away if you encounter any of these symptoms, or seek emergency care:

  • Infection symptoms such a sore throat, fever, chills, body aches, or other symptoms
  • Breathing difficulties or pale skin
  • Unusual bleeding or bruising, bloody or coffee-ground-like vomit, or black, tarry, or bloody stools

Azacitidine could have other negative consequences. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088)

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom). To keep the tablets dry, store the two desiccant (drying agent) canisters in the prescription bottle. The desiccant canisters shouldn’t be eaten.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. In order to monitor your body’s reaction to azacitidine, your doctor will request specific lab tests both before and during your therapy.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Onureg®
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