INTRODUCTION

AZADUAL INJECTION contains Azacitidine which belongs to the group of medicines called Anticancer agents. It is used in adults to treat all sub-types of myelodysplastic syndromes (MDS; group of cancers associated with blood and bone marrow) and certain types of blood cancers known as Chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML).

In CMML, the bone marrow releases excess amount of monocytes (a type of blood cells) into the blood stream whereas, in the AML the bone marrow releases excess amount of immature white blood cells. Both are characterised by recurrent infections, fever, tiredness and increased bleeding or bruising.

AZADUAL INJECTION is typically used in adults who cannot undergo stem cell transplantation. Before receiving AZADUAL INJECTION inform your doctor if you have any lung, liver, kidney or heart problems.

AZADUAL INJECTION is not recommended for use in pregnant or breastfeeding women. Both men and women of childbearing potential must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with this medicine. Men may seek advice on sperm preservation, if necessary, prior to the therapy with this medicine.

The most common side effects of receiving AZADUAL INJECTION are increased bleeding, increased infections, tiredness, nausea, vomiting, diarrhea, constipation, loss of appetite, stomach pain, weakness, pain and redness at the site of injection, sore nose and throat, cold sores, headache, dizziness, trouble sleeping, weight loss, ulcers of mouth or tongue and hair loss. Consult your doctor if any of these side effects trouble you.

USES OF AZADUAL INJECTION

It is used in adults to treat:

• all sub-types of myelodysplastic syndromes (MDS; group of cancers associated with blood and bone marrow)
• Chronic myelomonocytic leukaemia (CMML; blood cancer of monocytes)
• acute myeloid leukaemia (AML; blood cancer of WBC)

HOW AZADUAL INJECTION WORKS

AZADUAL INJECTION is an anticancer medication. It works by blocking the actions of certain enzymes (DNA/RNA methyltransferase) within the cancer cells that is required for the cells to grow and multiply. It also reduces the production of new genetic material (RNA and DNA) within the cells. As a result, it prevents abnormal cell division within the body, slows down the growth of cancer cells and helps the bone marrow to produce normal blood cells.

DIRECTIONS FOR USE

AZADUAL INJECTION will be given to you only by a doctor or a nurse beneath the skin (subcutaneously) of thighs, arms or abdomen.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF AZADUAL INJECTION

HOW TO MANAGE SIDE EFFECTS

Mouth Ulcers

Avoid eating spicy foods. Drink plenty of water. Apply a pain-relieving gel on the affected areas of the mouth if required. Consult your doctor if the symptom did not improve.

Constipation

Try to eat more high-fibre foods such as fresh fruits, vegetables, cereals, and drink plenty of water. Exercise regularly. If this does not help, inform your doctor for receiving alternate treatments for constipation.

Injection Site Reactions

Place an ice pack on the injected site. Do not move the affected area frequently. If the symptom worsens, consult your doctor.

WARNING & PRECAUTIONS

PREGNANCY

Contraindicated

AZADUAL INJECTION is not recommended for use in pregnant women as it may harm the growing baby. Therefore, inform your doctor before receiving it. Women of childbearing potential must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with AZADUAL INJECTION and until 6 months after stopping the therapy. If you accidentally became pregnant while receiving AZADUAL INJECTION, inform your doctor immediately.

BREASTFEEDING

Contraindicated

AZADUAL INJECTION is not recommended for use in breastfeeding women. Therefore, inform your doctor before receiving it.

DRIVING AND USING MACHINES

Use with Caution

AZADUAL INJECTION may cause tiredness. Therefore, do not drive or operate any machines if your ability is affected by AZADUAL INJECTION.

KIDNEY

Use with Caution

AZADUAL INJECTION should be used with caution in patients with kidney diseases. Therefore, inform your doctor before receiving it.

LIVER

Consult your doctor

AZADUAL INJECTION is not recommended for use in patients with advanced liver cancer. It should be used with caution in patients with other liver diseases. Therefore, inform your doctor before receiving it.

ALLERGY

Contraindicated

Talk to your doctor before receiving AZADUAL INJECTION if you are allergic to Azacitidine.

LUNGS

Use with Caution

AZADUAL INJECTION should be used with caution in patients with a previous history of lung diseases. Therefore, inform your doctor before receiving it.

HEART DISEASE

Use with Caution

AZADUAL INJECTION should be used with caution in patients with a previous history of heart attack or any other heart conditions. Therefore, inform your doctor before receiving it.

USE IN PEDIATRICS

Contraindicated

AZADUAL INJECTION is not recommended for use in children and adolescents (aged below 18 years) due to lack of safety data. Therefore, consult your doctor for advice.

USE IN GERIATRICS

Use with Caution

AZADUAL INJECTION should be used with caution in elderly patients (aged 65 years or above). Therefore, consult your doctor before receiving it.

INTERACTIONS

A. Drug - Drug interactions:

Before receiving AZADUAL INJECTION, inform your doctor about all the prescription medicines, non-prescription medicines and over-the counter health or herbal supplements taken by you as a precaution.

Overdosage:

If you or anyone else accidentally took more AZADUAL INJECTION, consult your doctor immediately or visit the nearby hospital straight away.

SYNOPSIS

MORE INFORMATION

• Keep AZADUAL INJECTION out of reach of children
• Before opening: Store AZADUAL INJECTION at room temperature
• After opening: Store AZADUAL INJECTION in refrigerator between 2-8°C

FAQs ABOUT AZADUAL INJECTION

Q: What is the use of AZADUAL INJECTION?

A: AZADUAL INJECTION is used in adults to treat all sub-types of myelodysplastic syndromes (MDS; group of cancers associated with blood and bone marrow) and certain types of blood cancers known as Chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML).

Q: How does AZADUAL INJECTION works?

A: AZADUAL INJECTION is an anticancer medication. It works by blocking the actions of certain enzymes (DNA/RNA methyltransferase) within the cancer cells that is required for the cells to grow and multiply. It also reduces the production of new genetic material (RNA and DNA) within the cells. As a result, it prevents abnormal cell division within the body, slows down the growth of cancer cells and helps the bone marrow to produce normal blood cells.

Q: Can I take AZADUAL INJECTION during breastfeeding?

A: No. AZADUAL INJECTION is not recommended for use in breast-feeding women. Therefore, inform your doctor before receiving it.

Q: Can AZADUAL INJECTION increase the risk of infections?

A: AZADUAL INJECTION may cause a drop in the number of white blood cells in the body and may weaken your immune system. As a result, you may be at a greater risk of getting infected while receiving AZADUAL INJECTION. To avoid this, your doctor will regular monitor your blood counts as a precaution. However, inform your doctor if you experience any signs of infection such as fever.

Q: Can the use of AZADUAL INJECTION make me feel tired?

A: Yes. AZADUAL INJECTION may make you feel tired easily. This is because, it reduces the levels of red blood cells in your blood and may make you anaemic. Consult your doctor if you experience tiredness after receiving AZADUAL INJECTION. Tiredness can also occur if you have any pre-existing disease conditions such as liver or kidney impairment while receiving this medicine.

Q: Can I drive a car after receiving AZADUAL INJECTION?

A: AZADUAL INJECTION may make you feel tired or weak. Therefore, do not drive or operate any heavy tools or machines if your ability is affected by AZADUAL INJECTION.

Q: How AZADUAL INJECTION is administered?

A: AZADUAL INJECTION will be given to you only by a doctor or a nurse beneath the skin (subcutaneously) of thighs, arms or abdomen.

Q: How to control nausea caused due to AZADUAL INJECTION?

A: Generally, anticancer medicines are associated with uncontrollable nausea and vomiting. To avoid this, your doctor would prescribe a suitable medicine to control them along with AZADUAL INJECTION. If not, consult your doctor for a suitable anti-emetic medicine. Do not self-treat nausea.

REFERENCES

1. Goodman & Gilman’s: The Pharmacological Basis of Therapeutics. Cytotoxic agents. Chemotherapy of Neoplastic Diseases. 12th Edition. Page – 1700.

2. Cyrus Khan, Neeta Pathe, Salman Fazal, John Lister, and James M. Rossetti. Azacitidine in the management of patients with myelodysplastic syndromes. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. December 2012. [Accessed on 21st March 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3627328/

3. Zentiva Pharma UK Limited. Azacitidine 25 mg/ml powder for suspension for injection azacitidine. European Medicines Compendium. [Revised in September 2022]. [Accessed on 21st March 2023] https://www.medicines.org.uk/emc/files/pil.12470.pdf

4. American Society of Health-System Pharmacists. Azacitidine Injection. Medlineplus.gov. [Accessed on 21st March 2023] https://medlineplus.gov/druginfo/meds/a607068.html

5. Central Drugs Standard Control Organization. Azacitidine for injection 100 mg/vial. April 2014. Azacitidine Injection 100mg/vial. September 2015. [Accessed on 21st March 2023] https://cdscoonline.gov.in/CDSCO/Drugs

USEFUL DIAGNOSTIC TESTS

• Bone marrow smear microscopy examination
• Complete Blood Count
• Peripheral Smear Examination