Ibandronic acid Accord
ibandronic acid
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4
What Ibandronic acid Accord is and what it is used for
What you need to know before you receive Ibandronic acid Accord
How to receive Ibandronic acid Accord
Possible side effects
How to store Ibandronic acid Accord
Contents of the pack and other information
Ibandronic acid Accord contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.
Ibandronic acid Accord is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases’).
It helps to prevent your bones from breaking (fractures).
It helps to prevent other bone problems that may need surgery or radiotherapy.
Ibandronic acid Accord can also be prescribed if you have a raised calcium level in your blood due to a tumour.
Ibandronic acid Accord works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.
if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6)
if you have, or have ever had low levels of calcium in your blood
Do not receive this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Ibandronic acid Accord.
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very
rarely in the post marketing setting in patients receiving ibandronic acid for cancer-related conditions. ONJ can also occur after stopping treatment.
It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Before receiving treatment, tell your doctor/nurse (health care professional) if:
you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
you don’t receive routine dental care or have not had a dental check up for a long time
you are a smoker (as this may increase the risk of dental problems)
you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
you have cancer.
Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.
While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with ibandronic acid.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Talk to your doctor, pharmacist or nurse before receiving Ibandronic acid Accord:
if you are allergic to any other bisphosphonates.
if you have high or low levels of vitamin D, calcium or any other minerals.
if you have kidney problems.
if you have heart problems and the doctor recommended to limit your daily fluid intake
Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
If you experience one of the following symptoms, such as shortness of breath/difficulty breathing,
tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).
Ibandronic acid Accord should not be used in children and adolescents below the age of 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This is because Ibandronic acid Accord can affect the way some other medicines work. Also, some other medicines can affect the way Ibandronic acid Accord works.
Do not receive Ibandronic acid Accord if you are pregnant, planning to get pregnant or if you are
breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.
You can drive and use machines as it’s expected that Ibandronic acid Accord has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use
machines or tools.
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free’.
Ibandronic acid Accord is normally given by a doctor or other medical staff who have experience with the treatment of cancer.
it is given as an infusion into your vein.
Your doctor may do regular blood tests while you are receiving Ibandronic acid Accord. This is to check that you are being given the right amount of this medicine.
Your doctor will work out how much Ibandronic acid Accord you will be given depending on your illness.
If you have breast cancer that has spread to your bones, then the recommended dose is 6 mg every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
If you have raised calcium level in your blood due to a tumour then the recommended dose is a single
administration of 2 mg or 4 mg, depending on the severity of your illness.
The medicine should be administered as an infusion in your vein over two hours. A repeated dose may be considered in case of insufficient response or if your illness reappears.
Your doctor may adjust your dose and duration of intravenous infusion if you have kidney problems.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 jaw bone).
Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.
itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be
having a serious, potentially life threatening allergic reaction (see section 2).
severe adverse skin reactions
asthma attack
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.
stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)
low calcium or phosphate levels in your blood
changes in blood test results such as Gamma GT or creatinine
a heart rhythm problem called ‘“bundle branch block”’
pain in your bone or muscles
headache, feeling dizzy or feeling weak
feeling thirsty, sore throat, changes in taste
swollen legs or feet
aching joints, arthritis, or other joint problems
problems with your parathyroid gland
bruising
infections
a problem with your eyes called ‘cataracts’
skin problems
tooth problems.
shaking or shivering
your body temperature getting too low (hypothermia)
a condition affecting the blood vessels in your brain called ‘“cerebrovascular disorder”’ (stroke or brain bleeding)
heart and circulatory problems (including palpitations, heart attack, hypertension (high blood pressure) and varicose veins)
changes in your blood cells (‘anaemia’)
a high level of alkaline phosphatase in your blood
fluid build up and swelling (‘“lymphoedema”’)
fluid in your lungs
stomach problems such as ‘“gastroenteritis”’ or ‘“gastritis”’
gallstones
being unable to pass water (urine), cystitis (bladder inflammation)
migraine
pain in your nerves, damaged nerve root
deafness
increased sensitivity of sound, taste or touch or changes in smell
difficulty swallowing
mouth ulcers, swollen lips (‘“cheilitis”’), oral thrush
itching or tingling skin around your mouth
pelvic pain, discharge, itching or pain in the vagina
a skin growth called a ‘“benign skin neoplasm”’
memory loss
sleep problems, feeling anxious, emotional instability, or mood swings
skin rash
hair loss
injury or pain at the injection site
weight loss
kidney cyst(fluid-filled sac in the kidney)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via thenationalreporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After dilution
Chemical and physical in-use stability after dilution in 0.9 % sodium chloride or 5% glucose solution has been demonstrated for 36 hours at 25°C and 2°C to 8°C.
From a microbiological point of view, the solution for infusion should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° C to 8°C unless dilution has taken place in controlled
and validated aseptic condition.
Do not use this medicine if you notice that the solution is not clear or contains particles.
The active substance is ibandronic acid.
One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as
2.25 mg ibandronate sodium monohydrate).
One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as
6.75 mg ibandronate sodium monohydrate).
The other ingredients are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
Ibandronic acid Accord is a concentrate for solution for infusion (sterile concentrate). Colourless, clear
solution.
It is supplied in glass vials (type I) with rubber stopper and aluminium seals with flip-off cap.
Ibandronic acid Accord 2 mg concentrate for solution for infusion
Each vial contains 2 ml of concentrate. Each pack contains 1 vial.
Ibandronic acid Accord 6 mg concentrate for solution for infusion
Each vial contains 6 ml of concentrate. It is supplied as packs containing 1, 5 or 10 vials. Not all pack sizes may be marketed.
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare B.V., Winthontlaan 200,
3526 KV Utrecht, The Netherlands
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The following information is intended for healthcare professionals only:
Patients with renal impairment
For patients with mild renal impairment (CLcr ≥50 and <80 ml/min) no dosage adjustment is necessary. For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment
(CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed:
Creatinine Clearance (ml/min) Dosage Infusion Volume 1 and Time2
≥50 CLcr <80 6 mg (6 ml of concentrate for
solution for infusion)
≥30 CLcr <50 4 mg (4 ml of concentrate for
solution for infusion)
<30 2 mg (2 ml of concentrate for solution for infusion)
0.9% sodium chloride solution or 5% glucose solution
Administration every 3 to 4 week
100 ml over 15 minutes
500 ml over 1 hour
500 ml over 1 hour
A 15 minute infusion time has not been studied in cancer patients with CLcr <50 ml/min.
Ibandronic acid Accord is usually administered in a hospital setting. The dose is determined by the doctor considering the following factors.
Prior to treatment with Ibandronic acid Accord the patient should be adequately rehydrated with
9 mg/ml (0.9 %) sodium chloride. Consideration should be given to the severity of the hypercalcaemia as well as the tumour type. In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/l or ≥12 mg/dl) 4 mg will be an adequate single dosage. In patients with moderate hypercalcaemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl) 2 mg is an effective dose. The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.
* Note albumin-corrected serum calcium concentrations are calculated as follows:
Albumin-corrected serum calcium (mmol/l) | = | serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 |
Or |
Albumin-corrected serum calcium (mg/dl) | = | serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)] |
To convert the albumin-corrected serum calcium in mmol/l value to mg/dl, multiply by 4. | ||
In most cases a raised serum calcium level can be reduced to the normal range within 7 days. The median time to relapse (re-increase of serum albumin-corrected serum calcium above 3 mmol/l) was 18-19 days for the 2 mg and 4 mg doses. The median time to relapse was 26 days with a dose of 6 mg.
Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous
infusion.
For this purpose the contents of the vial are to be used as follows:
Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5 % dextrose solution and infused over at least
15 minutes. See also dosage section above for patients with renal impairment
Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over 2 hours
Note:
In order to avoid potential incompatibilities, Ibandronic acid Accord concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution.
Calcium containing solutions should not be mixed with Ibandronic acid Accord concentrate for
solution for infusion.
Diluted solutions are for single use. Only clear solutions without particles should be used.
It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Ibandronic Acid Accord’).
Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.Care must be taken not to administer Ibandronic acid Accord concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
For treatment of tumour induced hypercalcaemia, Ibandronic acid Accord concentrate for solution for
infusion is generally given as a single infusion.
For the prevention of skeletal events in patients with breast cancer and bone metastases, the Ibandronic acid Accord infusion is repeated at 3-4 week intervals.
A limited number of patients (50 patients) have received a second infusion for hypercalcaemia.
Repeated treatment may be considered in case of recurrent hypercalcaemia or insufficient efficacy.
For patients with breast cancer and bone metastases, Ibandronic acid Accord infusion should be administered every 3-4 weeks. In clinical trials, therapy has continued for up to 96 weeks.
Up to now there is no experience of acute poisoning with Ibandronic acid Accord concentrate for
solution for infusion. Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.
Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.