Azacitidine Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Azacitidine Tablet (generic name azacitidine, brand name Onureg) is a nucleoside metabolic inhibitor, also called a hypomethylating agent or antineoplastic chemotherapy medicine. It is taken by mouth as a maintenance treatment to help keep acute myeloid leukaemia (AML) under control after initial treatment, in adults who cannot have more intensive curative therapy. It is taken once daily for 14 days of each 28-day cycle, followed by 14 days without medicine.

What is Azacitidine Tablet

Azacitidine tablets (brand name Onureg) are a chemotherapy medicine taken by mouth. They are used as a maintenance treatment to help keep acute myeloid leukaemia (AML) under control after initial treatment, in adults who cannot have more intensive curative therapy.

Azacitidine Tablet uses

• Continued (maintenance) treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy
• Continued treatment of acute myeloid leukemia
• Used after achieving complete remission

Benefits of Azacitidine Tablet

• Helps keep AML under control after it has gone into remission
• Associated with longer overall survival compared with placebo in clinical studies
• Provides an oral AML maintenance treatment
• May extend remission in appropriate patients
• Allows treatment without repeated azacitidine injections

How Azacitidine Tablet works

Azacitidine works by turning back on genes that cancer cells have switched off, including genes that normally suppress cancer growth. It also gets built into the cell's DNA and RNA, which blocks cancer cells from making proteins they need, stopping them from growing and dividing.

Azacitidine Tablet dosage

Take azacitidine by mouth once a day for 14 days of each 28-day cycle, followed by 14 days without the medicine. Take it with or without food, at about the same time each day. Swallow the tablet whole with a full glass of water; do not break, crush, dissolve, or chew it.

Your doctor will give you anti-sickness tablets to take 30 minutes before each dose, usually needed only for the first two treatment cycles. If you are sick (vomit) after taking a tablet, do not take another dose that day — wait until the next day and take your normal dose.

If you forget a dose, take it as soon as you remember on the same day; if it is already the next day, just take your usual dose at the usual time — never take a double dose.

If powder from a broken tablet touches your skin, wash it off right away with soap and water; if it gets in your eyes, nose, or mouth, flush the area thoroughly with water. Do not stop taking azacitidine tablets without talking to your haematology team first.

Available forms and strengths

• Film-coated tablets (200 mg and 300 mg)

Side effects of Azacitidine Tablet

Common

• Nausea and vomiting
• Diarrhoea
• Constipation
• Feeling tired or weak
• Pain in the tummy (abdomen)
• Joint pain
• Loss of appetite
• Pain in arms or legs
• Dizziness
• Throat, nose or sinus infections
• Lung infections including pneumonia
• Low white blood cell count (may mean more frequent or longer infections)
• Low platelet count (may cause unexpected bruising or bleeding)
• Flu
• Urine infections
• Runny nose or cough
• Anxiety
• Weight loss

Serious

• Fever of 38°C or higher with chills, shakes, or shivers (febrile neutropenia)
• Signs of pneumonia: cough, chest pain, high temperature, shortness of breath, wheezing, aching body, feeling very tired, loss of appetite
• Unusual bruising or bleeding, such as nosebleeds, bleeding gums, blood spots or rashes
• Serious hypersensitivity (allergic) reactions
• Tumor lysis syndrome
• Interstitial lung disease
• Necrotizing fasciitis (including fatal cases)

Warnings and precautions

• Do not substitute these tablets for the injectable form of azacitidine — they have different dosing and uses, and mixing them up could be dangerous or ineffective.
• This medicine can lower blood cell counts, raising the risk of infections, bleeding, or anaemia. Regular blood tests are needed to monitor this.
• This medicine contains lactose, so tell your healthcare team if you have lactose intolerance.
• Do not stop taking this medicine on your own without speaking to your haematology team first.
• Azacitidine can harm an unborn baby and must not be used during pregnancy. Women who could become pregnant should use effective birth control during treatment and for at least 6 months after the last dose. 
• Men should use effective contraception during treatment and for at least 3 months after the last dose.
• It is not known if azacitidine passes into breast milk, but because of the risk of serious side effects in a nursing child, women should not breastfeed during treatment and for 1 week after the last dose.
• Patients with severe kidney impairment should be monitored more closely for side effects, and the dose may need to be adjusted.
• This medicine has not been studied in people with severe liver impairment, and a safe dose has not been established for people with moderate liver impairment.
• Alcohol should be discussed with the oncology team because treatment can cause gastrointestinal and blood-related adverse effects.
• This medicine may make you feel tired, weak, or find it hard to concentrate, so take care if you are driving or using tools or machinery.

Storage

• Store bottles at room temperature between 68°F to 77°F (20°C to 25°C)
• Store and dispense in the original bottle with both desiccant canisters inside
• Keep the bottle tightly closed
• Do not eat the desiccant canisters
• Talk to your healthcare provider about how to safely dispose of any unused or expired medicine
• Keep out of the reach of children

When to see a doctor

• Get medical help right away if you have a high fever, chills, shakes, body aches, feel very tired or unwell, or have a poor appetite — these can be signs of a serious drop in white blood cells.
• Get medical help right away if you develop a cough, chest pain, shortness of breath, or wheezing, which may be signs of a lung infection such as pneumonia.
• Tell your healthcare provider right away if you have unusual bruising or bleeding.
• Tell your healthcare provider right away if you become pregnant while taking this medicine.

Alternatives

• Decitabine
• Injectable azacitidine
• Venetoclax-based therapy
• Other hematologist-selected AML maintenance or post-remission therapy