Pamidronate Disodium 6 mg / ml Sterile concentrate – patient leaflet, side effects, dosage

1. WHAT PAMIDRONATE DISODIUM IS AND WHAT IT IS USED FOR

Pamidronate disodium is member of the group of medicines called bisphosphonates. It is useful in medicine because pamidronate disodium

binds to bone and reduces bone loss.

This medicinal product may be used in the treatment of a number of disorders associated with bone disease. For example, 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, medicines of the same group (bisphosphonates) or any of the other ingredients of this medicine (listed in section 6).

Tell your doctor if the above applies to you before this medicine is used. Warnings and precautions

Talk to your doctor or pharmacist before using pamidronate disodium if

• you have kidney problems
• you have heart problems
• you have liver problems
• you have had thyroid surgery
• you have been told you have, or think you may have, calcium or vitamin D deficiency

• you have been told you have, or think you may have, low levels of red blood cells (anaemia), white blood cells or platelets. Your doctor may do

  tests to check for these problems

• you have ear pain, discharge from the ear, and/or an ear infection.
• 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.
• 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.

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).

Before this medicine is given to you, tell your doctor if any of the above applies to you or if you are unsure.

The use of pamidronate disodium in children is not recommended. Other special warnings

• You must make sure that you do not become dehydrated while you are being treated with pamidronate disodium. Talk to your doctor to make sure you are aware how much you must drink.
• As pamidronate disodium may affect your blood (the number of particular cells and the chemistry of the blood), your doctor will monitor for these side effects with blood tests.

Going for a scan?

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 using, have recently used or might use any other medicines, including medicines obtained without a prescription. Special care is needed if you are taking/using other medicines as some could interact with pamidronate disodium, particularly the following:

Uncommo

• allergic re
• oedema (
• seizures
• inflamma
• itching
• muscle cr
• dizziness
• tiredness

• low blood general w

  dicines that may affect the kidneys (Your doctor or nurse will ch drugs these are.)

  ide (used to treat some cancers).

  e should not be used with other bisphosphonate medicines, e.g. cid (used to treat osteoporosis and Paget’s disease), tiludronic

  o treat Paget’s disease), or disodium etidronate (used to treat ases associated with breast cancer or multiple myeloma). breast-feeding and fertility

  egnant or breast feeding, think you may be pregnant or are have a baby, ask your doctor or pharmacist for advice before edicine. If you are pregnant, your doctor will only use this our life is in danger and no alternative treatment is available.

  • death of bone tissue (osteonecros
  • renal failure
  • pain or inflammation of the jaw
  • difficulty in breathing and cough
  • changes in liver function which sh Rare: may affect up to 1 in 1,000
  • kidney problems

Very rare: may affect up to 1 in 10

• flare up of cold sores or shingles (
• decreased number of white blood
• increase in levels of potassium an

Breast-feedi pamidronate Ask your do Driving and

Do not drive experience which may l outpatient at Information

This medicin say essentia

ng is not recommended if you are receiving treatment with disodium.

ctor or pharmacist for advice before taking any medicine. using machines

or use machines if you have blurred or poor vision, or if you any other side effect (e.g. drowsiness, dizziness, confusion) essen your ability to do so. If you have pamidronate as an a hospital/clinic you should not drive yourself home. about ingredients of this medicine

e contains less than 1 mmol (23 mg) sodium per vial, that is to lly “sodium-free”.

3. HOW TO U

Always use

SE PAMIDRONATE DISODIUM

this medicine exactly as your doctor or pharmacist has told you.

Check with This medicin infusion will Dose

Your doctor and how oft The usual d During treat samples.

If you are g

This medicin will be given have any co

your doctor or pharmacist if you are not sure.

e is diluted and then given by infusion (drip) into a vein. The last from one to several hours depending on the dose.

will work out the correct dose of pamidronate disodium for you en it must be given.

ose for each infusion is between 15 and 90 mg.

ment you will have blood tests and may be asked to provide urine

iven too much or too little pamidronate disodium

e will be given to you by a doctor or nurse. It is unlikely that you too much or too little, however, tell your doctor or nurse if you ncerns.

4. POSSIBLE S

Like all med everybody g If the follow doctor imm

• severe al swelling o cause diff going to f You may ne Tell your doc side effects frequencies: Very comm

  IDE EFFECTS

  icines, this medicine can cause side effects, although not ets them.

  ing very rare but serious reaction happens, tell your ediately:

  lergic reaction - you may experience a sudden itchy rash (hives), f the hands, feet, ankles, face, lips, mouth or throat (which may iculty in swallowing or breathing), and you may feel you are aint

  ed urgent medical attention or hospitalisation.

  tor immediately if you notice or are worried by any of the known listed below. These unwanted side effects occur at the following

  on: may affect more than 1 in 10 people

The most co in body tem treatment. Decrease in Common:

• pain, red
• tender or
• joint or m
• temporar
• conjuncti
• feeling or
• headache
• decrease

• anaemia

  mmon effects are flu-like symptoms and a mild fever (increase perature which may last for 48 hours) which occur at the start of

  the levels of calcium and phosphate in the blood. may affect up to 1 in 10 people

  ness or swelling at the injection site

  painful veins

  uscle pain, or generalised pain

  y increase in bone pain

  vitis

  being sick

  d number of white blood cells (lymphocytopenia)

• reduced
• reduced l
• tingling s
• numbnes
• sleepless
• high bloo
• diarrhoea
• constipati
• skin rash
• increase
• muscle s
• loss of ap
• stomach
• drowsine

• generalis

  number of platelets in the blood (thrombocytopenia) evel of potassium and magnesium in the blood ensation in hands and feet

  s

  ness

  d pressure

  on

  in blood test values used to measure kidney function pasms

  petite

  pain

  ss

  ed pain

  n: may affect up to 1 in 100 people

  actions

  excess retention of fluid in the body)

  (fits)

  tion of the eye (uveitis, iritis)

  amps, indigestion

  , agitation

  pressure (symptoms may include light-headedness, fainting or eakness)

  This leaflet was last revised in 12/

  Ref: gxPS 3_2

  is)

  ow up in blood tests people

  ,000 people

  reactivation of Herpes virus) cells (leukopenia)

  d sodium in the blood

  • confusion
  • hallucinations (seeing things or he
  • problems with vision/eye pain (scl
  • heart failure
  • respiratory problems
  • lung disease
  • kidney problems (usually in patien
  • talk to your doctor if you have ear ear infection. These could be sign
  • unusual fracture of the thigh bone treatment for osteoporosis, may o experience pain, weakness or dis may be an early indication of a po Not known: frequency cannot be e

  • redness around the eye area

    aring things that are not there) eritis)

    ts with previous kidney problems) pain, discharge from the ear, and/or an s of bone damage in the ear

    , particularly in patients on long-term ccur rarely. Contact your doctor if you comfort in your thigh, hip or groin as this ssible fracture of the thigh bone. stimated from the available data

  • irregular heart rhythm (atrial fibrilla receiving pamidronate. It is curren causes this irregular heart rhythm. experience irregular heart rhythm
  • pain in the mouth, teeth and/or jaw the mouth or jaw, discharge, num jaw, or loosening of a tooth. Thes the jaw (osteonecrosis). Tell your experience such symptoms while or after stopping treatment. Reporting of side effects

If you get any side effects, talk to you includes any possible side effects no side effects directly via the Yellow Ca

tion) has been seen in patients tly unclear whether pamidronate You should report to your doctor if you during treatment with pamidronate , swelling or non-healing sores inside bness or a feeling of heaviness in the e could be signs of bone damage in doctor and dentist immediately if you being treated with pamidronate disodium r doctor, pharmacist or nurse. This t listed in this leaflet. You can also report rd Scheme at:

www.mhra.gov.uk/yellowcard

or sear

ch for MHRA Yell

ow Card in the Google

Play or Apple App Store. By r information on the safety of th

eporting is medi

side effects you cine.

can help provide more

5. HOW TO STORE PAMIDRON

Keep this medicine out of the

ATE D

sight a

ISODIUM

nd reach of childr

en.

Expiry date

Do not use this medicine after carton after ‘EXP’. Where onl refers to the last day of that m

the ex y a mon onth.

piry date which is th and year is st

stated on the vial and ated, the expiry date

Storage condit

ions

Do not store abo order to protect f

ve 25°C. The vials rom light.

should be kept in th

e outer carton, in

Shelf life after

Unused portions

dilution

of opened vials mus

t not be stored for l

ater use.

Prepared injections or infusions shou is not possible they can be stored for Visible signs of deterioration

Do not use this medicine if you notic Disposal

Medicines should not be disposed of Ask your pharmacist how to dispose measures will help to protect the env

ld be used immediately, however, if this up to 24 hours at 2-8°C before use.

e visible particles.

via wastewater or household waste. of medicines no longer required. These ironment.

6. CONTENTS OF THE PACK AND OT What pamidronate disodium con

The active substance is pamidronate contains either 3, 6 or 9 milligrams (

HER INFORMATION tains

disodium. Each millilitre (ml) of solution mg) of pamidronate disodium.

The other ingredients are mannitol, p section 2 “Information about ingredie Injections.

What pamidronate disodium look

Pamidronate disodium is a clear, col infusion which comes in glass contai It may be supplied in packs containin

• 5 x 15 mg/5 ml vials
• 1 x 30 mg/10 ml vial
• 1 x 60 mg/10 ml vial
• 1 x 90 mg/10 ml vial

Not all pack sizes may be marketed. Marketing Authorisation Holder a

Hospira UK Limited, Horizon, Honey

hosphoric acid, sodium hydroxide (see nts of this medicine”) and Water for s like and contents of the pack ourless concentrate for solution for ners called vials.

g:

nd Manufacturer

Lane, Hurley, Maidenhead, SL6 6RJ, UK.

2021.

Pamidronate Disodium 3 mg/ml, 6 mg/ml and 9 mg/ml

Sterile Concentrate The following information is intended for medical or healthcare professionals only

Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.

Incompatibilities

Pamidronate will form complexes with divalent cations and should not be added to calcium-containing intravenous solutions such as Ringer’s solution.

Instructions for use and handling

Must be diluted prior to administration.

The concentration of pamidronate disodium in the infusion solution should not exceed 90 mg/250 ml.

Do not use solution if particles are present.

Any portion of the contents remaining after use should be discarded.

In use storage precautions

Following dilution in 0.9% sodium chloride and 5% glucose infusion solutions, chemical and physical in-use stability has been demonstrated for 24 hours at temperatures not exceeding 25°C.

From a microbiological point of view, the product 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 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.