Ibandronic Acid Accord 6 mg concentrate for infusion solution

Introduction

Package Leaflet: Information for the Patient

Ibandronic Acid Accord 2 mg Concentrate for Solution for Infusion EFG

Ibandronic Acid Accord 6 mg Concentrate for Solution for Infusion EFG

ibandronic acid

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ibandronic Acid Accord and what is it used for
2. What you need to know before you are given Ibandronic Acid Accord
3. How to use Ibandronic Acid Accord
4. Possible side effects
5. Storage of Ibandronic Acid Accord
6. Contents of the pack and further information

1. What is Ibandronic Acid Accord and what is it used for

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 has been prescribed to you if you have breast cancer that has spread to the bones (called "bone metastases").

• It helps prevent your bones from breaking (fractures)
• It helps prevent other bone problems that may need surgery or radiotherapy

You may also be given Ibandronic Acid Accord if you have high levels of calcium in your blood due to a tumor.

Ibandronic Acid Accord works by reducing the amount of calcium that is lost from your bones. This helps to slow down the weakening of your bones.

2. What you need to know before you are given Ibandronic Acid Accord

Do not use Ibandronic Acid Accord:

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
• if you have or have had low levels of calcium in your blood

Do not use this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before using Ibandronic Acid Accord.

Warnings and precautions:

A side effect called osteonecrosis of the jaw (damage to the bone of the jaw) has been reported very rarely in patients receiving ibandronic acid for cancer-related conditions. Osteonecrosis of the jaw can also occur after stopping treatment.

It is important to try to prevent the development of osteonecrosis of the jaw as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.

Before you start treatment, tell your doctor/nurse (healthcare professional) if:

• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned dental extraction
• you do not receive regular dental check-ups or have not had a dental check-up for a long time
• you are a smoker (as this can increase the risk of dental problems)
• you have been treated with a bisphosphonate (used to treat or prevent bone disorders) in the past
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer.

Your doctor may ask you to have a dental check-up before starting treatment with ibandronic acid.

While you are being treated, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups. If you wear dentures, you should make sure they fit properly. If you are having dental treatment or are going to have a dental operation (e.g. tooth extraction), tell your doctor about the dental treatment and inform 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 a loose tooth, pain, or swelling, ulcers that do not heal, or discharge, as these could be signs of osteonecrosis of the jaw.

Atypical fractures of long bones, such as the forearm (ulna) and lower leg (tibia), have also been reported in patients receiving long-term treatment with ibandronate. These fractures occur after minimal or no trauma and some patients experience pain in the area of the fracture before a complete fracture occurs.

Talk to your doctor, pharmacist, or nurse before taking Ibandronic Acid Accord

• if you are allergic to any other bisphosphonate
• if you have high or low levels of vitamin D, calcium, or any other mineral
• if you have kidney problems
• if you have heart problems and your doctor has recommended that you limit your daily fluid intake
• fluids.

Severe, sometimes life-threatening allergic reactions have been reported in patients treated with intravenous ibandronic acid.

You should immediately inform your doctor or nurse if you experience any of the following symptoms, such as shortness of breath/difficulty breathing, feeling of choking, swelling of the tongue, dizziness, feeling of loss of consciousness, redness or swelling of the face, body rash, nausea, and vomiting (see section 4).

Children and adolescents

Ibandronic Acid Accord should not be used in children and adolescents under 18 years of age.

Using Ibandronic Acid Accord with other medicines:

Tell your doctor or pharmacist if you are using or have recently used or might use other medicines. This is because Ibandronic Acid Accord may affect the way other medicines work. Other medicines may also affect the way Ibandronic Acid Accord works.

In particular, tell your doctor or pharmacistif you are being treated with a type of injected antibiotic called "aminoglycoside" such as gentamicin. This is because both aminoglycosides and Ibandronic Acid Accord can lower the level of calcium in your blood.

Pregnancy and breastfeeding

Do not use Ibandronic Acid Accord if you are pregnant, planning to become pregnant, or if you are breastfeeding. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

You can drive and use machines as it is expected that Ibandronic Acid Accord will have no or negligible effect on your ability to drive and use machines. Consult your doctor first if you want to drive, use machines, or tools.

The medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., it is essentially "sodium-free".

3. How to use Ibandronic Acid Accord

Administration of this medicine

• Ibandronic Acid Accord is usually given by a doctor or other healthcare professional with experience in the treatment of cancer
• it is given by infusion into a vein

Your doctor may perform regular blood tests while you are receiving Ibandronic Acid Accord. This is to check that you are receiving the correct amount of this medicine.

Dose that you will receive

Your doctor will decide the dose of Ibandronic Acid Accord that you will be given, depending on your illness.

If you have breast cancer that has spread to the bones, the recommended dose is 6 mg every 3-4 weeks, given by infusion into a vein over at least 15 minutes. If you have high levels of calcium in your blood due to a tumor, the recommended dose is a single dose of 2 mg or 4 mg, depending on the severity of your illness. The medicine should be given by infusion into a vein over 2 hours. A further dose may be considered if you do not respond adequately or if your illness returns.

If you have kidney problems, your doctor will adjust the dose and infusion time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

Rare(may affect up to 1 in 1,000 people)

• persistent eye pain and inflammation
• new pain, weakness, or discomfort in the thigh, hip, or groin. These can be early symptoms of a possible unusual fracture of the thigh bone.

Very rare(may affect up to 1 in 10,000 people)

• pain or discomfort in the mouth or jaw. These can be early symptoms of serious jaw problems [necrosis (death of bone tissue) of the jaw bone].
• tell your doctor if you have ear pain, discharge from the ear, and/or ear infection. These could be signs of bone damage in the ear.
• itching, swelling of the face, lips, tongue, and throat, with difficulty breathing. You may be having a severe allergic reaction that can be life-threatening (see section 2)
  • severe skin reactions

Frequency not known(cannot be estimated from the available data)

• asthma attack

Other possible side effects

Common(affects more than 1 in 10 people)

• flu-like symptoms, including fever, chills, and flushing, feeling unwell, fatigue, bone pain, muscle pain, and joint pain. These symptoms usually go away within a couple of hours or days. Talk to your nurse or doctor if any effect becomes bothersome or lasts more than a couple of days
• increased body temperature
• stomach pain, indigestion, vomiting, or diarrhea (intestinal losses)
• decreased levels of calcium or phosphorus in the blood
• changes in blood test results such as Gamma GT or creatinine
• a heart problem called "bundle branch block"
• muscle pain or bone pain
• headache, feeling dizzy or weak
• thirst, sore throat, changes in taste
• swelling of the legs or feet
• joint pain, arthritis, or other joint problems
• parathyroid gland problems
• bruising
• infections
• a problem in your eyes called cataracts
• skin changes
• dental changes.

Uncommon(affects less than 1 in 100 people)

• shaking or shivering
• excessive lowering of body temperature (hypothermia)
• a disease that affects the blood vessels in the brain called "cerebrovascular disorder" (stroke or cerebral hemorrhage)
• cardiovascular changes (including palpitations, heart attack, hypertension, varicose veins)
• changes in blood cells ("anemia")
• increased levels of alkaline phosphatase in the blood
• fluid accumulation and swelling ("lymphedema")
• fluid in the lungs
• stomach problems such as "gastroenteritis" or "gastritis"
• gallstones
• urination problems (urinary retention), cystitis (inflammation of the bladder)
• migraine
• nerve pain, nerve root damage
• deafness
• increased sensitivity to stimuli of sound, taste, touch, or changes in smell
• difficulty swallowing
• mouth ulcers, swollen lips ("cheilitis"), oral thrush
• itching or tingling around the mouth
• pain in the pelvis, discharge, itching, or pain in the vagina
• skin growth called "benign skin neoplasia"
• memory loss
• sleep changes, anxiety, mood changes, or emotional instability
• skin rash
• hair loss
• pain or damage at the injection site
• weight loss
• kidney cyst (fluid-filled sac in the kidney).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid Accord

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

After dilution

the chemical and physical in-use stability of the solution for infusion has been demonstrated for 36 hours at 25°C and between 2°C and 8°C in sodium chloride 0.9% or glucose 5% solution.

From a microbiological point of view, the solution for infusion should be used immediately. If not used immediately, the in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has been made in aseptic and controlled conditions.

Do not use this medicine if you notice that the solution is not clear or contains particles.

6. Container Contents and Additional Information

Composition of Ibandronic Acid Accord

• The active ingredient is ibandronic acid.

Ibandronic Acid Accord 2 mg concentrate for solution for infusion One vial with 2 ml of concentrate for solution for infusion contains 2 mg of ibandronic acid (as 2.25 mg of sodium ibandronate monohydrate).

Ibandronic Acid Accord 6 mg concentrate for solution for infusion

A vial with 6 ml of concentrate for solution for infusion contains 6 mg of ibandronic acid (as 6.75 mg of sodium ibandronate monohydrate).

• The other components are: sodium chloride, sodium acetate trihydrate, glacial acetic acid, water for injectable preparations

Appearance of Ibandronic Acid Accord and Container Contents

Ibandronic Acid Accord is a concentrate for solution for infusion (sterile concentrate). Colorless and transparent solution.

It is presented in glass vials (type I) with a rubber stopper and aluminum seals with a removable 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 in packs containing 1, 5, or 10 vials. Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Date of Last Revision of this Leaflet {MM/YYYY}

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu/.

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The following information is intended for healthcare professionals only

Dosage: Prevention of Bone Events in Patients with Breast Cancer and Bone Metastases

The recommended dose for the prevention of bone events in patients with breast cancer and bone metastases is 6 mg by intravenous infusion every 3-4 weeks. The dose should be infused over at least 15 minutes.

Patient with renal impairment.

No dose adjustment is required for patients with mild renal impairment (CLcr ≥ 50 and <80 ml min). patients with moderate renal impairment (clcr ≥ 30 and < 50 min) or severe min), who also have breast cancer bone metastases are being treated for the prevention of events, should follow following dosing recommendations:< p>

1 Sodium chloride 0.9% solution or glucose 5% solution

2 Administration every 3-4 weeks

A 15-minute infusion time has not been studied in cancer patients with a CLcr <50 ml min.< p>

Dosage: Treatment of Tumor-Induced Hypercalcemia

Ibandronic Acid Accord is administered in a hospital setting. The dose will be determined by the doctor, taking into account the following factors:

Prior to treatment with Ibandronic Acid Accord, the patient should be adequately rehydrated with 9 mg/ml of a 0.9% sodium chloride solution. Both the severity of hypercalcemia and the type of tumor should be taken into account. In most patients with severe hypercalcemia (albumin-corrected serum calcium ≥ 3 mmol/l or ≥ 12 mg/dl), 4 mg is an adequate single dose. In patients with moderate hypercalcemia (albumin-corrected serum calcium <3 mmol l or < 12 mg dl), 2 is an effective dose. the maximum dose used in clinical trials was 6 mg, but this does not provide any additional benefit terms of efficacy.< p>

• Note: Albumin-corrected serum calcium concentrations are calculated as follows:

To convert the albumin-corrected serum calcium value from mmol/l to mg/dl, multiply by 4.

In most cases, an elevated serum calcium level can be reduced to normal levels within 7 days. The median time to relapse (new increase above 3 mmol/l of albumin-corrected serum calcium) was 18-19 days for the 2 mg and 4 mg doses. The median time to relapse was 26 days with the 6 mg dose.

Method and Route of Administration

Ibandronic Acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.

To do this, the contents of the vial should be used as follows:

• Prevention of bone events in patients with breast cancer and bone metastases - add to 100 ml of isotonic sodium chloride solution or 100 ml of 5% dextrose solution and infuse over at least 15 minutes. See the dosing section above for patients with renal impairment.

Treatment of tumor-induced hypercalcemia - add to 500 ml of isotonic sodium chloride solution or 500 ml of 5% dextrose solution and infuse over 2 hours.

Note:

To avoid potential incompatibilities, Ibandronic Acid Accord concentrate for solution for infusion should only be mixed with isotonic sodium chloride solution or 5% dextrose solution. It should not be mixed with solutions containing calcium.

Diluted solutions are for single use. Only clear and particle-free solutions should be administered.

It is recommended that the product be used immediately after dilution (see section 5 of this leaflet: "Storage of Ibandronic Acid Accord").

Ibandronic Acid Accord concentrate for solution for infusion should be administered intravenously. Care should be taken not to administer Ibandronic Acid Accord concentrate for solution for infusion intra-arterially or by extravasation, as this could cause tissue damage.

Frequency of Administration

For the treatment of tumor-induced hypercalcemia, Ibandronic Acid Accord concentrate for solution for infusion is generally administered as a single infusion.

For the prevention of bone events in patients with breast cancer and bone metastases, Ibandronic Acid Accord infusions are repeated at 3-4 week intervals.

Duration of Treatment

A limited number of patients (50 patients) received a second infusion for hypercalcemia. In the event of recurrent hypercalcemia or insufficient efficacy, the possibility of repeating treatment may be considered.

For patients with breast cancer and bone metastases, Ibandronic Acid Accord infusions should be administered every 3-4 weeks. In clinical trials, treatment was continued for up to 96 weeks.

Overdose:

So far, there is no experience with acute overdose of Ibandronic Acid Accord concentrate for solution for infusion. Given that in preclinical studies at high doses, both the kidney and liver were found to be target organs for toxicity, renal and hepatic function should be monitored.

Clinically relevant hypocalcemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.