Pamidronate Disodium 3 mg / ml concentrate for solution for infusion – patient leaflet, side effects, dosage

1. What Pamidronate disodium is and what it is used for

Pamidronate disodium belongs to a group of medicines called bisphosphonates, which binds to bone and reduces bone loss.

Pamidronate disodium is used in the treatment of a number of disorders associated with bone disease. It is used to help reduce the amount of calcium in the blood and/or reduce bone loss which may occur in certain types of cancer.

Pamidronate disodium is used to treat patients with specific tumours such as bone metastases (secondaries) associated with breast cancer or multiple myeloma which is a type of bone marrow cancer. It can also be used in the prevention of skeletal-related events with a history of bone metastases which can lead to bone pain, radiation or surgery to the bone, spinal cord compression, pathological fractures and hypercalcaemia (high level of calcium in the blood). In addition, it can also be used to treat a bone disorder called ‘Paget’s disease of bone’.

2. What you need to know before you use Pamidronate disodium

Do not use Pamidronate disodium:

• If you are allergic to pamidronate disodium, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Talk to your doctor before using Pamidronate disodium

• If you have kidney problems
• If you have heart problems
• If you have liver problems
• If you have had thyroid surgery
• If you have or are at risk of having calcium or vitamin D deficiency
• If you suffer from blood disorders (anaemia, leukopenia or thrombocytopenia)
• If you suffer from ear pain, discharge from the ear, and/or an ear infection
• If you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth. Your doctor may recommend a dental examination before you start treatment with Pamidronate disodium
• If you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Pamidronate disodium and inform your doctor about your dental treatment
• If you have tumour-induced hypercalcemia (calcium levels are above normal in the blood) as your doctor will need to ensure you are adequately hydrated

While being treated with Pamidronate disodium you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.

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 a condition called osteonecrosis of the jaw.

Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw.

Contact your doctor if you experience any thigh, hip or groin pain (see section 4).

Contact your doctor if you experience any bone, joint and/or muscle pain (see section 4).

The use of Pamidronate disodium in children is not recommended.

Other special warnings

• You must make sure that you do not become dehydrated and maintain urine output while you are being treated with Pamidronate disodium, particularly during the initial treatment of tumour-induced hypercalcaemia
• As Pamidronate disodium may affect your blood, your doctor will perform blood tests
• If you are asked to have a bone scan, tell the doctor doing the scan that you are being treated with Pamidronate disodium

Other medicines and Pamidronate disodium

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may influence the effect of Pamidronate disodium, or their effect may be influenced by Pamidronate disodium:

• This medicine should not be used with other bisphosphonate medicines, e.g. zoledronic acid (used to treat osteoporosis and Paget’s disease), tiludronic acid (used to treat Paget’s disease), or disodium etidronate (used to treat bone metastases associated with breast cancer or multiple myeloma)
• Other medicines that may affect the kidneys (your doctor will know which medicines these are)
• Thalidomide, used to treat some cancers

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

If you are pregnant, your doctor will only advise you to use this medicine if your life is at risk and no alternative treatment is available.

Breast-feeding

Breast-feeding is not recommended if you are being treated with Pamidronate disodium.

Driving and using machines

• Do not drive or use machines if you have blurred or poor vision, or if you experience drowsiness, dizziness or confusion
• If you have received Pamidronate disodium as an outpatient at a hospital/clinic, you should not drive yourself home

Pamidronate disodium contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per vial, which is to say essentially “sodium-free”.

3. How to use Pamidronate disodium

Always use Pamidronate disodium exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• Pamidronate disodium should only be given under the supervision of a doctor
• Pamidronate disodium must be diluted (calcium-free solution) and then given by slow infusion (drip) into a vein
• The infusion will last from one to several hours depending on the dose

Adults

Your doctor will work out the correct dose of Pamidronate disodium for you and how often it must be given.

The usual dose for each infusion is between 15 and 90 mg.

During treatment you will have blood tests and may be asked to provide urine samples.

If you are given too much or too little Pamidronate disodium:

This medicine will be given to you by a doctor or nurse. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

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

4. Possible side effects

Like all medicines, Pamidronate disodium can cause side effects, although not everybody gets them.

Seek medical advice immediately if you develop the following symptoms:

• Allergic reactions: swelling of the face, throat, or tongue, difficulty in breathing or dizziness
• Difficulty breathing or dizziness (anaphylaxis)
• Difficulty in breathing/shortness of breath or wheezing (bronchospasm/dyspnoea)
• Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)
• A life-threatening lung condition that prevents enough oxygen from getting to the lungs and into the blood (acute respiratory distress syndrome)

PACKAGE LEAFLET: INFORMATION FOR

THE USER

Pamidronate disodium

3, 6, 9 mg/ml

concentrate for solution for infusion

175 mm

42

₀ mm

Phama-

code

area

Very common side effects (may affect more than 1 in 10 people):

• Low levels of calcium in the blood (hypocalcaemia)
• Low level of phosphates in the blood (hypophosphataemia)
• Mild fever and flu-like symptoms

Common side effects (may affect up to 1 in 10 people):

• Infection that causes inflammation of the eye, red eyes, itchiness and discharge (conjunctivitis)
• Low level of white blood cells (lymphocytopenia)
• A reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• Looking pale and feeling tired (anaemia)
• Changes in blood test results (including low potassium [hypokalaemia], low magnesium [hypomagnesaemia] and raised serum creatinine levels)
• Loss of appetite (anorexia)
• Muscle spasms (tetany)
• Sleeplessness (insomnia)
• Tingling or numbness in hands and feet (paraesthesia)
• Headache
• Tiredness (somnolence)
• High blood pressure (hypertension)
• Feeling sick (nausea) or being sick (vomiting)
• Stomach pain, inflammation of the stomach (gastritis)
• Diarrhoea
• Constipation
• Skin rash
• Bone pain, joint (arthralgia) or muscle (myalgia) pain
• Pain, redness, swelling or inflammation at the infusion site

Uncommon side effects (may affect up to 1 in 100 people):

• Feeling agitated
• Dizziness
• Fits (seizures)
• A lack of energy (lethargy)
• Inflamed painful red eyes
• Low blood pressure (hypotension)
• Indigestion (dyspepsia)
• Severe itching (pruritus)
• Muscle cramps
• Reduced blood supply to bones in the joints, particularly of the jaw (osteonecrosis)
• Deterioration of kidney function (e.g. unexpected change in the amount of urine produced and/or its appearance), abnormal liver function tests or increases in serum urea

Rare side effects (may affect up to 1 in 1000 people):

• A deterioration of kidney function known as focal segmental glomerulosclerosis (scar tissue in the filtering unit of the kidney). This is generally associated with high dosage (exceeding the recommended dose or reduced dosing intervals) and/or long-term use

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

• A flare-up of cold sores or shingles
• A reduction in white blood cells (leukopenia)
• Abnormally high levels of potassium in blood (hyperkalaemia)
• Abnormally high levels of salt (sodium) in blood (hypernatraemia)
• Hallucinations (seeing or hearing things that are not real)
• Confusion
• Inflammation of the white outer coating of the eye (scleritis/episcleritis)
• Condition in which all objects appear to have a yellowish tinge to them (xanthopsia)
• 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
• Heart problems which may include a difficulty in breathing and fluid retention
• Inflammation of the lungs (interstitial lung disease)
• Worsening of an existing kidney problem e.g. blood in urine (haematuria)
• Fracture of the thigh bone

Other side effects (frequency not known)

• Redness around the eye area (inflammation)
• Irregular heartbeat (atrial fibrillation)
• Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis). Tell your doctor and dentist immediately if you experience such symptoms while being treated with Pamidronate disodium or after stopping treatment

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pamidronate disodium

• Keep Pamidronate disodium out of the sight and reach of children
• Do not use Pamidronate disodium after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month
• Unused portions of opened vials must not be stored for later use
• Prepared product should be used immediately. If this is not possible it can be stored for up to 24 hours at 2-8°C before use
• Do not use this medicine if you notice visible particles

6. Contents of the pack and other information

What Pamidronate disodium contains:

• The active substance is: Pamidronate disodium 15 mg, 30 mg, 60 mg or 90 mg

• 1 vial of 5 ml of sterile concentrate contains 15 mg of Pamidronate disodium.

  Each ml of concentrate for solution for infusion contains 3 mg Pamidronate disodium

• 1 vial of 10 ml of sterile concentrate contains 30 mg or 60 mg or 90 mg of Pamidronate disodium. Each ml of concentrate for solution for infusion contains 3 mg or 6 mg or 9 mg Pamidronate disodium

The other ingredients are: mannitol, sodium hydroxide, phosphoric acid, water for injection.

What Pamidronate disodium looks like and the contents of the pack:

Pamidronate disodium is a clear and colourless solution and comes in clear, colourless glass vials.

Pamidronate disodium is available in:

Pamidronate disodium 3 mg, 6 mg and 9 mg are available in packs of 1, 2, 4, 5, 6, or 10 vials.

Not all pack sizes may be marketed.

Product Licence Numbers:

• Pamidronate disodium 3 mg/ml Concentrate for Solution for Infusion (15 mg) – PL 11311/0217
• Pamidronate disodium 3 mg/ml Concentrate for Solution for Infusion (30 mg) – PL 11311/0218
• Pamidronate disodium 6 mg/ml Concentrate for Solution for Infusion (60 mg) – PL 11311/0219
• Pamidronate disodium 9 mg/ml Concentrate for Solution for Infusion (90 mg) – PL 11311/0220

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

Manufacturer:

Lek Pharmaceuticals d.d.

Verovskova 57, 1526 Ljubljana

Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

D-39179 Barleben, Germany

This leaflet was last revised in March 2023

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Code 0325003LFT/Till-Ver.5