INTRODUCTION

ZOLDONA contains Zoledronic Acid which belongs to the group of medicines called Bisphosphonates. It is used to prevent bone complications such as fractures, bone metastases (cancer that has spread from the original (primary) tumor to the bone) in adult patients and helps to reduce the amount of calcium in the blood in adult patients (tumour-induced hypercalcaemia (TIH)).

Along treatment with ZOLDONA your doctor might ask you to make some lifestyle changes such as eating balanced diet rich in calcium and vitamin D. Prior to starting the treatment with ZOLDONA your doctor might want you to take some diagnostic tests to understand the existing condition.

Before receiving ZOLDONA inform your doctor if you had or have pain, swelling or numbness of the jaw, feeling of heaviness in the jaw or loosening of teeth, kidney disease, are having dental treatment or due to undergo dental surgery.

ZOLDONA is not recommended for use in pregnant and breast-feeding women. ZOLDONA is not recommended for use in children and adolescents (under 18 years of age) and should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving ZOLDONA.

The most common side effects of receiving ZOLDONA are headache, nausea, vomiting, loss of appetite, conjunctivitis and anaemia (low number of red blood cells). Inform your doctor if any of the symptom worsens.

USES OF ZOLDONA

Used in adult patients to:

• prevent bone complications such as fractures and bone metastases
• helps to reduce the amount of calcium in the blood (tumour-induced hypercalcaemia (TIH))

HOW ZOLDONA WORKS

ZOLDONA works by suppressing the activity of osteoclasts, cells that cause destruction of bone. This strengthens the bones and minimizes the risk of fractures.

DIRECTIONS FOR USE

ZOLDONA will be given to you only by a doctor or a nurse into a vein (intravenously). Your doctor will decide the correct dose and duration of ZOLDONA for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF ZOLDONA

HOW TO MANAGE SIDE EFFECTS

Headache:

Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Inform your doctor if the symptom does not improve.

Nausea or vomiting:

Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Inform your doctor if the symptom does not improve.

Dizziness:

Lie down until dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids. Inform your doctor if the symptom gets worse.

Constipation:

Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals, and drink plenty of water. If this does not help, inform your doctor for receiving alternate treatment for constipation.

Abdominal pain:

Try to rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, inform your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug – Drug interactions:

Before receiving ZOLDONA inform your doctor if you have received or receiving or taking any of the following medicines:

• aminoglycosides such as gentamicin (used to treat severe bacterial infections)
• calcitonin (used to treat post-menopausal osteoporosis and hypercalcaemia)
• loop diuretics such as chlorthalidone, indapamide (used to treat high blood pressure or oedema)
• other calcium-lowering medicines
• thalidomide (used to treat certain type of blood cancer involving the bone)
• other medicines (used to treat osteoporosis and other non-cancer diseases of the bone)
• any other bisphosphonates such as risedronate (used to treat bone problems such as osteopenia or osteoporosis)
• anti-angiogenic medicines such as bevacizumab, axitinib (used to treat cancer)

Overdosage:

ZOLDONA will be given to you only by a doctor or nurse in a hospital, and so it is unlikely to receive an overdose. However, if you experience any unusual symptoms such as serum electrolyte abnormalities (Ex. abnormal levels of calcium, phosphorus, and magnesium) and/or changes in kidney function including severe kidney impairment, consult your doctor immediately.

SYNOPSIS

MORE INFORMATION

• Keep ZOLDONA out of reach in children
• Store at a temperature not exceeding 30°C

FAQs ABOUT ZOLDONA

How long should I receive ZOLDONA?

ZOLDONA should be received in the dose and duration as advised by your doctor. The medicine takes around 6 months to show its maximum benefits on bones. However, in some cases, the doctor may suggest ZOLDONA for a longer duration. The exact duration will depend on the condition you are being treated for.

How is ZOLDONA administered?

ZOLDONA will be given to you only by a doctor or a nurse into a vein (intravenously). Your doctor will decide the correct dose and duration of ZOLDONA for you depending upon your age, body weight and disease condition.

What are the lifestyle changes should I follow while receiving ZOLDONA?

To get maximum benefit from this medicine, there are certain lifestyle changes that you must adhere to. Include some calcium or vitamin D rich foods for bone strength. Try to spend more time in sunlight to get natural vitamin D. Quit smoking and reduce alcohol consumption as they may harm your bones. You can take up an exercise regime such as walking and low-impact aerobics as they are good for your bones. Similarly, you can try strength-training exercises where you use your own body weight which in turn improve bone health.

Can ZOLDONA cause constipation?

Yes, ZOLDONA may cause constipation in some individuals. To manage this effect, try to eat more high-fiber foods such as fresh fruit, vegetables, cereals and drink plenty of water. If this does not help, inform your doctor for receiving alternate treatment for constipation.

Is ZOLDONA safe to use in pregnant or breast-feeding women?

ZOLDONA is not recommended for use in pregnant and breast-feeding women. Consult your doctor before receiving ZOLDONA if you are pregnant or planning to pregnant or breast-feeding.

REFERENCES

1. Briggs GG, Freeman RK, editors. A Reference Guide to Fetal and Neonatal Risk: Drugs in Pregnancy and Lactation. 10th ed. Philadelphia, PA: Wolters Kluwer Health; 2015. Page - 4229-4231.

2. J R Berenson. Zoledronic acid in cancer patients with bone metastases: results of Phase I and II trials. NIH: National Library of Medicine, National center of biotechnology Information Pubmed.gov. April 2001. [Accessed on 7th June 2022] https://pubmed.ncbi.nlm.nih.gov/11346862/

3. Ali Haidar, Morten Jonler, Troels B Folkmar, Lars Lund. Bisphosphonate (zoledronic acid)-induced osteonecrosis of the jaw. NIH: National Library of Medicine, National center of biotechnology Information Pubmed.gov. 2009. [Accessed on 7th June 2022] https://pubmed.ncbi.nlm.nih.gov/19903091/

4. Seacross Pharmaceuticals Ltd. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on 7th June 2022] https://www.medicines.org.uk/emc/files/pil.7205.pdf

USEFUL DIAGNOSTIC TESTS

• Calcium Test
• Intact Parathyroid Hormone