IBANDRONIC ACID WARNINGS
Ibandronic acid should be used with caution in:
- People with digestive problems such as stomach or intestinal ulcers, problems swallowing, heartburn and acid reflux
- People who have or have had any jaw or dental health problems or have other risk factors for a bone condition with jaw damage (osteonecrosis of the jaw) such as cancer, chemotherapy, radiotherapy or treatment with systemic corticosteroids
- People with known hypersensitivity to other bisphosphonates
- People with parathyroid gland problems, as the gland produces hormones which are important in calcium metabolism
- People with vitamin D deficiency
- People taking aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, indometacin and naproxen (used to treat pain and inflammation), calcium supplements and medications containing aluminium, calcium, magnesium or iron
It should not be used in:
- People with a hypersensitivity (allergy) to ibandronic acid or to any of the ingredients in the medication
- People with a low blood calcium (hypocalcaemia) - this must be corrected before starting treatment
- People with certain problems of the oesophagus (food pipe), such as narrowing or difficulty swallowing
- People who have had problems of delayed transit or emptying of the oesophagus or intestine due to narrowing or other conditions
- People with severely reduced kidney function
- People who are unable to stay in the upright position for an hour (tablet only)
- Pregnant women
- Breast feeding women
- People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (tablets only)
Also see list of precautions and interactions
Tablets and prefilled syringes for osteoporosis (Bonviva): this product does not require any special storage conditions.
Tablets for bone cancer (Bondronat): store in the original package in order to protect from moisture
Concentrate for IV infusion (Bondronat): No special precautions for storage prior to reconstitution.
After reconstitution: Store at 2°C - 8°C (in a refrigerator).
IBANDRONIC ACID USES
What is it used for?
- Ibandronic acid is used to strengthen bones in women who have gone through the menopause and have weak bones (osteoporosis) and in people with breast cancer which has spread to the bones.
- It is a bisphosphonate.
- It is used to inhibit the loss of calcium from the bones and increase bone mass. Ibandronic acid is used to treat women with osteoporosis after the menopause. Osteoporosis is a thinning and weakening of the bones, which is common in post-menopausal women. Women with this condition are more likely to get a fracture from any falls. Ibandronic acid is also used to increase bone mass in people with breast cancer which has spread to the bones. It can also reduce bloodcalcium in people with excessive levels due to certain tumours.
- In general this drug is used to increase bone mass leading to stronger bones and reducing the risk of fractures in osteoporosis after the menopause and in breast cancer which has spread to the bones.
- Benefits of being on this drug can include increased bone mass and a reduced risk of getting a bone fracture (of the spine).
Listed below are the typical uses of ibandronic acid.
- Treatment of weak bones (osteoporosis) in postmenopausal women at increased risk of fracture
- Prevention of bone fractures and bone complications requiring radiotherapy or surgery in people with breast cancer and cancer which has spread to the bone
- Treatment of high blood calcium due to a tumour
On occasion your doctor may prescribe this medicine to treat a condition not on the above list.
HOW TO USE/TAKE
It is available as film coated tablets in different strengths, as a solution for intravenous (IV) infusion and as a prefilled syringe for IV injection.
How often do I take it?
- Tablets for osteoporosis
Take this medication by mouth usually once a month, without food. The tablets should be taken after an overnight fast (at least 6 hours) and 1 hour before you eat any food, take any other medications or have a drink other than water. Swallow the tablet whole with a glass of water while sitting or standing. Avoid chewing or sucking the tablet and also avoid lying down for an hour after taking this medication.
- Prefilled syringe (IV injection) for osteoporosis
This medication will be given to you by a doctor or nurse as an injection into a vein, usually every 3 months.
- Calcium and vitamin Dsupplements may also be given as treatment for osteoporosis.
- Use this medication regularly in order to get the most benefit from it.
- Remember to use it at the same time each month - unless specifically told otherwise by your doctor.
- Tablets for bone cancer
Take this medication by mouth usually once daily, without food. The tablets should be taken after an overnight fast (at least 6 hours) and 30 minutes before you eat any food, take any other medications or have a drink other than water. Swallow the tablet whole with a glass of water while sitting or standing. Avoid chewing or sucking the tablet and also avoid lying down for an hour after taking this medication.
- Remember to use it at the same time each day - unless specifically told otherwise by your doctor.
- IV infusion for bone cancer and high blood calcium due to a tumour
The concentrate for solution for infusion will be given to you by a doctor or nurse as an infusion into a vein. This medication is usually given every 3 to 4 weeks to treat people with bone cancer and usually once or twice to treat high calcium levels due to a tumour.
- Use this medication regularly in order to get the most benefit from it (except for treatment of high blood calcium due to a tumour).
- It may take some time before the full benefit of this drug takes effect.
- Certain medical conditions may require different dosage instructions as directed by your doctor.
- Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.
Do I need to avoid anything?
Avoid taking the medication with food, drink (other than water) or other medication. Food, particularly products contain calcium such as milk, cheese, yoghurts and other metals such as aluminium, magnesium, iron (e.g. fortified cereals) must be avoided the 6 hours before and for at least 30 minutes after you take ibandronic acid.
- Avoid lying down for an hour after taking this medication.
- It is not known whether this medicine affects driving ability or the ability to operate machinery. If you are affected, avoid carrying out these tasks until you feel safely able to do so. Consult your doctor or pharmacist for more details.
When can I stop?
- It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop. Treatment of high blood calcium due to a tumour is usually given only once or twice.
IBANDRONIC ACID SIDE EFFECTS
Ibandronic acid tablets for osteoporosis:
Ibandronic acid injection for osteoporosis:
Ibandronic acid tablets for bone cancer:
- Feeling sick (nausea)
- Stomach ache
- Inflammation of the oesophagus (oesophagitis)
- Low calcium levels in the blood
- Changes in taste
- Tingling feeling (pins and needles)
- Dry mouth
- Intestinal bleeding
- Intestinal ulcer
- Difficulty swallowing
- Inflammation of the stomach (gastritis)
- Chest pain
- Flu-like symptoms
- Feeling unwell
- Abnormal blood test: low haemoglobin, high levels of urea and high levels of parathyroid hormone
- Bone condition with damage to the jaw (osteonecrosis)
Similar side effects are seen with ibandronic acid infusion for bone cancer, but fever, bone pain and sudden chills are also common side effects. Some of the intestinal side affects such as difficulty swallowing, inflammation of the oesophagus (oesophagitis) and inflammation of the stomach (gastritis) are seen rarely with the infusion.
If any of these persist or you consider them severe then inform your doctor or pharmacist.
Tell your doctor immediately if you develop any of the following symptoms:
- Severe pains in the chest or after swallowing, severe nausea, or vomiting
- Signs of a serious allergic reaction (see below)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.
IBANDRONIC ACID PRECAUTIONS
Before taking ibandronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of:
- Hypersensitivity (allergy) to ibandronic acid or to any of the ingredients in the medication
- Low blood calcium (hypocalcaemia)
- Severe kidney problems
- Problems of the oesophagus (food pipe), such as narrowing or difficulty swallowing
- Delayed transit or emptying of the oesophagus or intestine the due to narrowing or other conditions
- If you are unable to stay in the upright position for at least 60 minutes after taking the tablet
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (tablets only)
Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following
- Any intestinal problems such as stomach or intestinal ulcers, problems swallowing, heartburn and acid reflux
- Any jaw or dental health problems
- Parathyroid gland problems, as the gland produces hormones which are important in calcium metabolism
- Vitamin D deficiency
Before having surgery, tell your doctor or dentist that you are taking this medication.
Does alcohol intake affect this drug?
- Alcohol intake is not known to affect ibandronic acid, but must not be taken in the 6 hours before or 30 minutes to one hour after taking the dose.
The elderly. Ibandronic acid can be used in the elderly.
Pregnancy and breastfeeding - please ensure you read the detailed information below
Ibandronic acid is not safe to take if you are, or are planning to become, pregnant.
It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Ibandronic acid is not safe to take if you are breastfeeding.
It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
IBANDRONIC ACID INTERACTIONS
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious, possibly fatal interactions may occur:
Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:
- Antibiotics known as aminoglycosides such as neomycin and streptomycin given by injection to treat certain bacterial infections
- Aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, indometacin and naproxen (used to treat pain and inflammation)
- Calcium supplements
- Antacids used to treat indigestion
- Ferrous sulphate (iron) used to treat anaemia
- Any other medications containing aluminium, calcium, iron or magnesium
This information does not contain all possible interactions. Therefore, before using ibandronic acid, tell your doctor or pharmacist of all the products you use.
IBANDRONIC ACID OVERDOSE
Taking too much ibandronic acid, may cause the following: intestinal problems (such as an upset stomach, indigestion, inflammation or an ulcer) or low blood calcium leading to muscle cramps and tingling feeling (pins and needles).
People who have taken too much ibandronic acid by mouth, should drink a full glass of milk and talk to a doctor straight away.
Do not make yourself vomit, and do not lie down — this could cause the medication to irritate your oesophagus.
If you think you, or someone you care for, might have accidentally taken more than the recommended dose of ibandronic acid or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.
Daily dosing by mouth
- If you miss a dose, take the tablet the next day and then resume your usual dosing schedule. Do not double the dose to catch up.
Monthly dosing by mouth
- If you miss a dose, take it as soon as you remember (the next morning after the day you remember), then continue taking one tablet a month on the usual scheduled day. If it is near the time of the next dose (within 7 days), skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up and do not take 2 tablets in the same week.