Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about RADPHARM HDP. It does not contain all of the available information and does not take the place of talking to your doctor or nuclear medicine specialist.

All medicines, including diagnostic agents, have risks and benefits. Your referring doctor, in consultation with the nuclear medicine specialist, has weighed the risks of giving you RADPHARM HDP injection, against the benefits they expect the procedure will have for you.

If you have any concerns about being given RADPHARM HDP, discuss with your doctor and/or nuclear medicine specialist.

Keep this leaflet as you may need to refer to it again.

What is RADPHARM HDP

RADPHARM HDP belongs to a group of medicines called radiopharmaceuticals.

RADPHARM HDP is only available through a doctor’s prescription.

RADPHARM HDP contains the active ingredient, sodium oxidronate and is reconstituted with sodium pertechnetate (^99mTc) prior to injection. Once reconstituted, the product becomes radioactive.

What RADPHARM HDP is used for

RADPHARM HDP is used in conjunction with an imaging agent to detect alterations of the skeletal system in adults.

The imaging agent used is a radiotracer called Technetium-99m. Technetium-99m emits small amounts of radiation similar to x-rays which can be detected by a special camera (gamma camera) to produce an image known as a scan. A nuclear medicine specialist interprets these scans and provides information related to your referral.

Your nuclear medicine specialist may be giving you RADPHARM HDP to help diagnose other conditions.

Ask your nuclear medicine specialist if you have any questions about why RADPHARM HDP is being given to you and why you have been referred for a scan.

Before receiving RADPHARM HDP

Tell your nuclear medicine specialist or technologist if:

1. You are or plan to become pregnant
   If you are pregnant, or if there is a chance you may be pregnant, the nuclear medicine specialist will need to talk to your referring doctor before deciding whether you should have RADPHARM HDP injection. The nuclear medicine specialist may choose to postpone or adjust the procedure to ensure the safety of your unborn baby.
2. You are breast feeding
   If breast feeding, express milk prior to your scan and store it. Suspend breast feeding and reduce contact with your child for 1 hour after receiving an injection of RADPHARM HDP. During this period, it is recommended that you express and discard at least one fraction of milk.
3. You have or are predisposed to hypocalcemia
   Tell your doctor and/or the nuclear medicine specialist if you have or are predisposed to hypocalcemia (i.e. alkalosis) as caution should be taken in administering RADPHARM HDP in such patients.
4. You are taking other medicines
   Tell your nuclear medicine specialist if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket, or health food shop.
   If you have not told your doctor, nuclear medicine specialist or technologist about any of the above, tell them BEFORE you are given RADPHARM HDP injection.

How RADPHARM HDP is given

RADPHARM HDP can only be administered by qualified staff with specific training in the safe use and handling of radiopharmaceuticals.

The amount of RADPHARM HDP that will be administered will be determined by the nuclear medicine specialist based on a number of various factors such as your weight etc.

RADPHARM HDP is injected into a vein in your arm. You may feel a pin prick from the needle when it is injected.

After receiving RADPHARM HDP Injection

It takes between 1-4 hours for RADPHARM HDP to be able to produce a clear picture of your bones. The scan is painless and may take up to an hour.

Do not take any other medicines during this time unless advised by your doctor.

Returning home

Continue your day-to-day activities as you would normally.

To minimise the radiation dose to the bladder, drink plenty of fluids and pass urine frequently to help flush RADPHARM HDP from your body.

Side Effects

Side effects from RADPHARM HDP are very rare however some patients may experience the following:

• Skin irritation e.g. rash, hives or redness
• Vomiting/nausea
• Faintness

Injection site inflammation.

These side effects, if experienced, are usually very mild.

Tell your doctor, nuclear medicine specialist or technologist if you do not feel well after having a RADPHARM HDP injection.

Storage of RADPHARM HDP

RADPHARM HDP is stored by the hospital or clinic. Technetium-99m is produced fresh everyday.

Your nuclear medicine specialist or technologist will check the expiry date and time before administering the RADPHARM HDP injection.

Product Description

What it looks like

RADPHARM HDP is a sterile, freeze-dried white powder. It comes in a 10mL glass vial. Technetium-99m is added to the vial to produce a clear colourless liquid for injection.

Ingredients

Active ingredients:

• 3.15mg sodium oxidronate

Inactive ingredients:

• 0.297 annous chloride dihydrate
• 0.84 gentisic acid
• 29mg sodium chloride

Australian Register Number

• AUST R 160732

Sponsor / Manufacturer

Radpharm Scientific
a Division of Global Medical Solutions Australia P/L
53-59 Oatley Court
Belconnen ACT 2617
Australia

For Further Information

For more information on nuclear medicine, request a copy of the booklet Nuclear Medicine - Answering Your Questions. This booklet is available from the hospital, clinic or supplier.

This Consumer Medicine Information leaflet was last prepared August 2011.

Published by MIMS October 2015

1 Name of Medicine

Sodium oxidronate.

2 Qualitative and Quantitative Composition

Radpharm HDP is supplied as sterile, pyrogen free, lyophilised powder, under nitrogen in borosilicate type 1 glass 10 mL vial for intravenous injection, following reconstitution with non-pyrogenic ^99mTc as pertechnetate sodium (^99mTcO4-).
Each 10 mL tinted vial contains: sodium oxidronate 3.15 mg as an active ingredient; stannous chloride dihydrate 0.297 mg, gentisic acid 0.84 mg and sodium chloride 29 mg as excipients.
The reconstituted product is a clear, colourless liquid.
Radpharm HDP contains no antimicrobial preservatives.

3 Pharmaceutical Form

Fine white powder in glass vials.

4 Clinical Particulars

4.9 Overdose

In the event of the administration of a radiation overdose with technetium [^99mTc] sodium oxidronate the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No long term animal studies have been performed to evaluate mutagenic potential effects on the foetus.
Carcinogenicity. No long term animal studies have been performed to evaluate carcinogenic effects.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSODOXI.gif Chemical name. Hydroxymethylenediphosphonate disodium salt (HDP).
Molecular formula. CH₄Na₂O₇P₂.
Molecular weight. 235.97.
CAS number. 14255-61-9.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/RADPHAST.gif

References

1. D A Weber et al. 'MIRD: Radionuclide Data and Decay Schemes'. The Society of Nuclear Medicine Inc. New York, 1989.
2. Risica S, Fattibene P, Mazzei F, Nuccetelli C, Rogani A. Radionuclides in pregnancy and breast feeding. Microchemical Journal. 2002; 73 (1-2): 251-64.
3. Australian Radiation Protection and Nuclear Safety Agency (2008). Safety Guide: Radiation Protection in Nuclear Medicine, Radiation Protection Series Publication No.14.2, Chief Executive Officer of ARPANSA, pp 29-31.
4. Silberstein EB, Ryan JR, Pharmacopeia Committee of the Society of Nuclear Medicine. Prevalence of Adverse Reactions in Nuclear Medicine. J Nucl Med. 1996; 37: 185-192.
5. The International Commission on Radiological Protection, Annals of the ICRP, ICRP Publication 80, Radiation Dose to Patients from Radiopharmaceuticals, Pergamon, (1993).