Specification

Newbona 5mg Infusion 100ml
NEWBONA 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 NEWBONA 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 NEWBONA your doctor might want you to take some diagnostic tests to understand the existing condition.
Before receiving NEWBONA 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.
NEWBONA is not recommended for use in pregnant and breast-feeding women. NEWBONA 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 NEWBONA.
The most common side effects of receiving NEWBONA 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 NEWBONA
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 NEWBONA WORKS
NEWBONA 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
NEWBONA 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 NEWBONA for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF NEWBONA

COMMON

Headache

Flu-like symptoms such as fever, fatigue, weakness, drowsiness, chills and bone, joint or muscle pain

Gastrointestinal reactions such as nausea, vomiting, loss of appetite

Conjunctivitis

Low level of phosphate in blood

Low level of red blood cells (anaemia)

UNCOMMON

Allergic reactions

High or low blood pressure, chest pain

Rash, itching, redness and swelling at the infusion site

Shortness of breath

Dizziness, anxiety

Sleep disturbances

Taste disturbances

Trembling

Tingling or numbness of the hands or feet

Diarrhoea, constipation, abdominal pain

Dry mouth

Weight gain

Increased sweating

Sleepiness

Blurred vision, tearing of the eye, eye sensitivity to light

Sudden coldness with fainting, limpness or collapse

Difficulty in breathing with wheezing or coughing

Urticaria

RARE

Slow heartbeat

Confusion

Unusual fracture of the thigh bone (symptoms such as pain, weakness or discomfort in thigh, hip, or groin)

Interstitial lung disease (inflammation of the tissue around the air sacs of the lungs)

Joint swelling

Painful redness and/or swelling of the eye
Consult your doctor if you experience any of the following side effects after receiving NEWBONA:
Severe kidney impairment (signs include nausea, vomiting, fluid retention, decreased or increased urination)

Low levels of calcium in blood (hypocalcademia) (symptoms such as muscle cramps, dry skin, burning sensation, irregular heartbeat, seizures, spasm and twitching (tetany))

Bone damage in jaw (osteonecrosis) (symptoms such as pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or feeling of heaviness in jaw or loosening of a tooth)

Irregular heart rhythm (atrial fibrillation)

Severe allergic reaction (symptoms such as shortness of breath, swelling mainly of the face and throat)

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

PREGNANCY
NEWBONA is not recommended for use in pregnant women. Consult your doctor before receiving NEWBONA.
BREASTFEEDING
NEWBONA is not recommended for use in breastfeeding women. Consult your doctor before receiving NEWBONA.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel drowsiness and sleepiness after receiving NEWBONA.
KIDNEY
NEWBONA should be used with caution in patients with kidney problem. Consult your doctor before receiving NEWBONA.
ALLERGY
Do not receive NEWBONA if you are allergic to Zoledronic Acid or other bisphosphonate (such as alendronate) or any of the other ingredients of this medicine.
OTHERS
Before receiving NEWBONA 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

Are having dental treatment or are due to undergo dental surgery
Use in paediatrics:
NEWBONA is not recommended for use in children and adolescents (under 18 years of age). Consult child?s doctor for advice.
Use in geriatrics:
NEWBONA should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving NEWBONA.
INTERACTIONS
A.?Drug ? Drug interactions:
Before receiving NEWBONA 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:
NEWBONA 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

Drug :
Zoledronic Acid
Pharmacological Category :
Bisphosphonates
Therapeutic Indication :
Prevents fractures and bone metastases, Reduces the amount of calcium in the blood
Dosage Forms :
Injection, Infusion
MORE INFORMATION

Keep NEWBONA out of reach in children

Store at a temperature not exceeding 30?C

FAQs ABOUT NEWBONA
How long should I receive NEWBONA?
NEWBONA 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 NEWBONA for a longer duration. The exact duration will depend on the condition you are being treated for.
How is NEWBONA administered?
NEWBONA 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 NEWBONA for you depending upon your age, body weight and disease condition.
What are the lifestyle changes should I follow while receiving NEWBONA?
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 NEWBONA cause constipation?
Yes, NEWBONA 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 NEWBONA safe to use in pregnant or breast-feeding women?
NEWBONA is not recommended for use in pregnant and breast-feeding women. Consult your doctor before receiving NEWBONA 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
PRODUCT DETAILS
Net Qty

1 N
Item Weight

120 g
Ingredient

ZOLEDRONATE 5MG
Hsn Code

30049099

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Additional information

Weight
120 g

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