Bondronat ® 2 mg Injection

BONDRONAT contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.

BONDRONAT is used in adults to:

• Treat high levels of calcium in the blood caused by tumours (tumour-induced hypercalcaemia).
• Prevent bone problems in patients with breast cancer that has spread to the bones (bone metastases), such as:
• bone fractures
• the need for surgery or radiotherapy to the bones.

BONDRONAT works by reducing the loss of calcium from your bones. This helps to keep them strong and reduce the risk of complications.

BONDRONAT should not be administered to you:

• If you are hypersensitive (allergic) to ibandronic acid or any of the other ingredients of BONDRONAT listed in section 6.
• If you have low levels of calcium in your blood (hypocalcaemia).
• If you are pregnant or breastfeeding (see section on Pregnancy and breastfeeding).

Warnings and precautions

Tell your doctor or health care provider before being given BONDRONAT injection if:

• you have had an allergic reaction to other bisphosphonates (used to treat or prevent bone disorders)
• have low blood calcium
• you have any other mineral imbalances, (such as vitamin D deficiency)
• you have had other medicines to treat or prevent bone conditions (especially bisphosphonates)
• you have cancer.
• you are a smoker (smoking increases the risk of dental problems and jawbone damage)
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• you have problems with your mouth or teeth (e.g., gum disease, poor dental health, or a planned tooth extraction)
• you do not receive routine dental care or have not had a dental check-up for a long time
• you have kidney problems
• you have heart problems, and your doctor has advised you to limit fluid intake

Take special care with BONDRONAT if any of the following apply to you:

Severe allergic reactions (Anaphylaxis) BONDRONAT can sometimes cause serious allergic reactions, including anaphylactic shock, which can be life-threatening. You should immediately alert your doctor or other healthcare professional if you have any of the following:

• trouble breathing or shortness of breath
• tightness in your chest or throat
• swelling of your tongue, lips, face, or throat
• dizziness, fainting
• rash, redness, or itching
• nausea or vomiting

Problems with your jaw or mouth (Osteonecrosis of the jaw – ONJ)

A rare but serious condition called osteonecrosis of the jaw (ONJ) has been reported in patients receiving BONDRONAT, especially those with cancer. To lower your risk:

• Your doctor may refer you for a dental check-up before you start treatment.
• Keep your mouth clean and brush your teeth regularly.
• Go for regular dental check-ups.
• Make sure dentures fit properly.
• Tell your dentist you are being treated with BONDRONAT before having any dental work.
• Tell your doctor or dentist straight away if you notice:
• loose teeth
• pain, swelling, or non-healing sores in your mouth
• any discharge from your mouth or gums

You will not be expected to give yourself BONDRONAT injection. It will be given to you by a person who is qualified to do so. You will receive BONDRONAT as an intravenous infusion (a drip into a vein). During treatment, your blood may be monitored to make sure you are receiving the correct amount of BONDRONAT. Your doctor will determine how much BONDRONAT you will be given depending on your illness. Your doctor may adjust your dose if you have moderate or severe kidney problems.

If more BONDRONAT is given to you than recommended

BONDRONAT will be given to you by a healthcare provider, who will ensure that the correct dose is administered. If you receive too much, your doctor will manage the overdose.

If a dose of BONDRONAT is missed

Since a health care provider will administer BONDRONAT, it is unlikely that the dose will be missed. If a dose is missed, your doctor will decide when to give the next dose.

If you stop receiving BONDRONAT

Do not stop the treatment without speaking to your doctor. If you stop receiving BONDRONAT, the benefits of your treatment may be reduced. For example:

• If you are receiving BONDRONAT to help prevent bone problems due to breast cancer that has spread to the bones, stopping treatment may increase the risk of bone fractures or the need for surgery or radiotherapy to the bones.
• If you are receiving BONDRONAT to lower high levels of calcium in your blood caused by a tumour, stopping treatment may allow your calcium levels to rise again, which can cause symptoms such as weakness, nausea, or confusion.

Not all side effects reported for BONDRONAT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving BONDRONAT please consult your healthcare provider for advice. If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• itching, swelling of your face, lips, tongue and throat, with difficulty breathing,
• severe adverse skin reactions: sores, blistering and peeling of the skin.

These are all very serious side effects. If you have them, you may have had a serious reaction to BONDRONAT. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• persistent eye pain and inflammation
• new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone
• pain or sore in your mouth or jaw. You may have early signs of severe jaw problems (necrosis (dead bone tissue) in the jawbone)
• ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear
• worsening of asthma attacks

These are all serious side effects. You may need urgent medical attention.

Common side effects:

• infections
• flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints. These symptoms usually disappear within a couple of hours or days. Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days
• rise in body temperature
• low blood calcium levels (hypocalcaemia), symptoms include muscle cramps and/or tingling sensation in the fingers or lips
• headache, feeling dizzy or feeling weak
• a problem with your eyes called ‘cataracts’
• a heart rhythm problem called ‘bundle branch block’
• feeling thirsty, sore throat, changes in taste
• stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)
• tooth problems.
• skin problems
• bruising
• aching joints, arthritis, or other joint problems
• pain in your bone or muscles
• swollen legs or feet
• changes in blood test results (Gamma-GT increased, creatinine increased)

Uncommon side effects

• oral thrush
• vaginitis
• a skin growth called a ‘benign skin neoplasm”
• changes in your blood cells (‘anaemia’)
• Hypophosphataemia (low level of phosphate in the blood)
• sleep problems, feeling anxious, emotional instability, or mood swings
• a condition affecting the blood vessels in your brain called ‘cerebrovascular disorder’ (stroke or brain bleeding)
• memory loss
• migraine
• pain in your nerves, damaged nerve root
• itching or tingling skin around your mouth
• increased sensitivity of sound, taste or touch or changes in smell
• stiff muscle tone (hypertonia). Symptoms may include limited range of motion, slow movements, and stiff arms and legs.
• deafness
• heart and circulatory problems (including palpitations, heart attack, hypertension (high blood pressure) and varicose veins)
• a condition caused by excessive fluid in the lungs called lung oedema. Symptoms may include difficulty in breathing, cough, chest pain and fatigue
• Stridor (a high-pitched, whistling sound most often heard while taking-in a breath)
• stomach problems such as ‘gastroenteritis” or ‘gastritis’
• mouth ulcers, swollen lips (‘cheilitis’), oral thrush
• difficulty swallowing (dysphagia)
• gall stones (cholelithiasis)
• skin rash
• hair loss
• being unable to pass water (urine), cystitis (bladder inflammation)
• kidney cyst (fluid-filled sac in the kidney)
• pelvic pain
• your body temperature getting too low (‘hypothermia’)
• a high level of alkaline phosphatase in your blood
• weight loss
• injury or pain at the injection site

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, nurse or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of BONDRONAT. For reporting of side effects directly to Adcock Ingram Limited, email: [email protected].

• Store ampoules or vials at or below 25 °C. Keep in original container until required for use.
• After dilution the infusion solution is stable for 24 hours at 2 - 8 ºC (in a refrigerator).
• Store all medicines out of reach of children.
• Do not use BONDRONAT after the expiry date which is stated on the carton and label.
• Do not use BONDRONAT if you notice that the solution is not clear or contains particles.
• Infusion solutions should be used immediately after dilution. Discard any unused medicine.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).