Onureg

What is Onureg?

• Onureg (Azacitidine) is a nucleoside metabolic inhibitor used for continued treatment of adults with acute myeloid leukemia (AML).

Azacitidine

Azacitidine2DACS

What are the uses of this medicine?

Onureg (Azacitidine) is used for continued treatment of adults with acute myeloid leukemia (AML) who:

• had a first complete remission (CR) following intensive induction chemotherapy with or without recovery of your blood cell counts, and
• who are not able to complete intensive curative therapy.

How does this medicine work?

• Azacitidine (ay" za sye' ti deen: also spelled azacytidine) is a pyrimidine analogue (5-azacytidine) which is converted intracellularly to a triphosphate which becomes incorporated into RNA and DNA.
• Incorporation of azacitidine into the DNA of cancer cells in vitro, including acute myeloid leukemia cells, inhibited DNA methyltransferases, reduced DNA methylation and altered gene expression, including re-expression of genes regulating tumor suppression and cell differentiation. Incorporation of azacitidine into the RNA of cancer cells, including leukemic cells, inhibited RNA methyltransferases, reduced RNA methylation, decreased RNA stability and decreased protein synthesis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to azacitidine or any of the ingredients in Onureg.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Azacitidine was approved for use in the United States in 2004.

How should this medicine be used?

• Administer an antiemetic before each dose for at least the first 2 cycles.

Recommended dosage:

• Administer Onureg 300 mg orally once daily on Days 1 through 14 of each 28-day cycle.

Administration:

• Take Onureg by mouth 1 time each day beginning on Day 1 through Day 14 of each 28-day cycle.
• Take Onureg with or without food at about the same time each day.
• Swallow Onureg tablets whole. Do not cut, crush, or chew the tablets.
• If the powder from Onureg tablets comes in contact with your skin, wash the area well right away with soap and water.
• If the powder from Onureg tablets comes in contact with your eyes or mouth (mucous membranes), flush the area right away with water.
• If you miss a dose of Onureg, or if you do not take your dose at the usual time, take the dose as soon as possible that day. Take your next dose at the regular time the next day.
• Do not take 2 doses on the same day to make up for a missed dose.
• If you vomit after taking a dose of Onureg, do not take another dose on the same day. Take your next dose at the regular time the next day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 200 mg and 300 mg

This medicine is available in fallowing brand namesː

• Onureg

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea and vomiting
• diarrhea
• tiredness or weakness
• constipation
• stomach area (abdominal) pain
• pneumonia
• joint pain
• decreased appetite
• pain in arms or legs
• dizziness

Onureg can cause serious side effects, including:

• neutropenia
• thrombocytopenia

Onureg may cause fertility problems in males and females

What special precautions should I follow?

• Treatment of patients using intravenous or subcutaneous azacitidine at the recommended dosage of Onureg may result in a fatal adverse reaction. Do not substitute Onureg for intravenous or subcutaneous azacitidine.
• Myelosuppression may occur. Monitor complete blood counts every other week for the first 2 cycles and prior to the start of each cycle thereafter. Increase monitoring to every other week for the 2 cycles after any dose reduction. Withhold and then resume at same or reduced dose or discontinue Onureg based on severity
• Onureg can cause fetal harm. Advise patients of the potential risk to a fetus and use of effective contraception.
• The safety and effectiveness of Onureg for treatment of myelodysplastic syndromes have not been established. Treatment of patients with myelodysplastic syndromes with Onureg is not recommended outside of controlled trials.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Onureg can cause fetal harm when administered to a pregnant woman.
• There are no available data on Onureg use in pregnant women to evaluate for a drug-associated risk.
• Advise pregnant women of the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of Onureg in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient: azacitidine Inactive ingredients:

• Each core tablet contains: croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose.
• The pink 200 mg tablet coating contains: hypromellose, iron oxide red, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin.
• The brown 300 mg tablet coating contains: black iron oxide, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin.

Who manufactures and distributes this medicine?

Manufactured by:

• Celgene Corporation, A Wholly Owned Subsidiary of Bristol Myers Squibb, 86 Morris Avenue, Summit, NJ
• Onureg® is a registered trademark of Celgene Corporation.

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

• Store bottles or blisters of Onureg tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Onureg tablets in the original bottle or the original aluminum-aluminum blisters.
• Bottles of Onureg contain 2 drying agent (desiccant) canisters. Do not eat the desiccant canisters.
• Keep the Onureg bottle tightly closed.

• Dailymed label info on Onureg
• FDA Onureg

Onureg Resources
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