Consumer medicine information

RADPHARM HDP

Technetium Tc-99m oxidronate

BRAND INFORMATION

Brand name

Radpharm HDP

Active ingredient

Technetium Tc-99m oxidronate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using RADPHARM HDP.

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

BRAND INFORMATION

Brand name

Radpharm HDP

Active ingredient

Technetium Tc-99m oxidronate

Schedule

Unscheduled

 

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

4.1 Therapeutic Indications

Technetium [99mTc] sodium oxidronate may be used as a skeletal imaging agent to delineate areas of altered osteogenesis in adult patients.

4.2 Dose and Method of Administration

Adult.

The recommended intravenous dose of technetium [99mTc] sodium oxidronate for the average adult patient (70 kg) is 555 MBq, with a minimum administered activity of 370 MBq and maximum administered activity is 740 MBq. The administered dose of sodium oxidronate should not exceed 0.05 mg/kg.

General instructions.

The administered dose of sodium oxidronate is between 0.001-0.05 mg/kg. The ideal administered dose of sodium oxidronate is 0.005 mg/kg. The radioactivity of each dose should be measured by an appropriate radiation calibration system immediately prior to administration. The dose should be administered intravenously by slow injection. For optimal results bone imaging should be performed 1-4 hours postinjection.

Radiation dosimetry.

The estimated absorbed radiation doses and effective doses from an intravenous administration of technetium [99mTc] sodium oxidronate are presented in Table 1.

Procedural precautions.

1. Visually inspect vial, ensure vial contains product (dry white powder).
2. Waterproof gloves should be worn, and aseptic technique adhered to during the preparation of technetium [99mTc] sodium oxidronate and for all subsequent dose withdrawals.
3. As Radpharm HDP is a multidose kit, precaution must be taken in order to prevent contamination of the vial. If there is more than one patient being administered technetium [99mTc] sodium oxidronate from the same Radpharm HDP vial on a single day all doses must be withdrawn from the reconstituted vial using aseptic technique and a shielded syringe prior to the first dose administration.
4. Usual precautions regarding radioprotection should be implemented.
5. Solutions of sodium pertechnetate [99mTc] which contain oxidizing agents should not be used.

Dose preparation procedure.

Note.

If the Radpharm HDP vial requires reconstitution for a single adult patient or paediatric patients take extra care in ensuring that no more than 0.05 mg/kg of sodium oxidronate is administered.
1. Remove the protective disc from the Radpharm HDP vial and swab the rubber stopper with an appropriate antiseptic. Allow rubber stopper to dry completely.
2. Place the Radpharm HDP vial in a suitable lead vial shield with a minimum wall thickness of 3 mm and a fitted lead cap.
3. Using aseptic technique and a shielded syringe withdraw 3 mL to 6 mL of sterile nonpyrogenic sodium pertechnetate [99mTc] eluted from a technetium-99m generator. The recommended activity range of sodium pertechnetate [99mTc] to be added to the Radpharm HDP vial is 2 to 11 GBq.
4. Using aseptic technique and a shielded syringe add the sodium pertechnetate [99mTc] to the Radpharm HDP vial. Mix by gentle inversion for approximately 30 seconds to ensure complete dissolution.
5. The resulting solution should be clear and free of particulate matter. If not, the vial should not be used. Affix a label to the lead vial shield recording the date and time prepared and the activity and volume of sodium pertechnetate [99mTc] added to the Radpharm HDP vial.
6. The radiochemical purity of the reconstituted solution must be checked prior to administration to the patient using the current British Pharmacopeia Medronate method.
7. Withdraw each patient dose of technetium [99mTc] sodium oxidronate using aseptic technique and a shielded syringe. If there is more than one patient being administered technetium [99mTc] sodium oxidronate from the same kit, all doses must be withdrawn from the reconstituted vial prior to the first dose administration.
8. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The technetium [99mTc] sodium oxidronate solution is stable at room temperature and may be used up to 8 hours after preparation.

Note.

In order to reduce the radiation dose to the bladder and other organs, the patient should be encouraged to drink and void as frequently as possible for a period of 4 to 6 hours after the administration of technetium [99mTc] sodium oxidronate.

4.3 Contraindications

None known.

4.4 Special Warnings and Precautions for Use

General precautions.

This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to hypocalcemia (alkalosis).
The contents of the kit are not radioactive. However, after sodium pertechnetate [99mTc] is added, adequate shielding of the final preparation must be maintained to minimize radiation exposure to occupational workers and patients.
Adequate hydration of the patient is recommended before and after examination to promote urinary flow. Also, urination is recommended as often as possible for 4 to 6 hours after the examination to reduce bladder exposure radiation.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered must be such that the resulting dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic or therapeutic result.
For most diagnostic investigations using a nuclear medicine procedure the radiation dose delivered (EDE) is less than 20 mSv. Higher doses may be justified in some clinical circumstances.
Radiopharmaceuticals should only be used by physicians who are qualified by specific training in the safe use and handling of radionuclides.
Contents of the vial are intended only for use in the preparation of technetium [99mTc] sodium oxidronate.
The radioactivity of the dose should be checked with a suitable instrument immediately prior to administration.

Use in patients with impaired gastrointestinal tract.

Patients with gastrointestinal tract obstructions may give rise to a higher level of radiation exposure.

Use in renal impairment.

Patients with renal impairment or suffering from renal obstructions may give rise to a higher level of radiation exposure.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Calcium gluconate and calcium chloride.

Caution must be taken in administering technetium [99mTc] sodium oxidronate to patients with calcium gluconate and calcium chloride for hypocalcemia (i.e. alkalosis) as oxidronate is known to complex with calcium cations.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Examinations using radiopharmaceuticals, especially those elective in nature, of women of childbearing capability, should be performed during the first 10 days following the onset of menses.
(Category C)
Women of reproductive age presenting for a technetium [99mTc] sodium oxidronate study must be carefully interviewed to assess the likelihood of pregnancy. Irradiation of a foetus should be avoided whenever possible. Technetium [99mTc] sodium oxidronate should only be given to a pregnant woman if in the judgement of the treating physician the expected benefits outweigh the potential hazards. In cases where medical radiation exposure is justified and considered necessary, the practice should be optimized in order to both minimize the dose to the foetus and achieve a diagnostic study2. It is suggested that in order to achieve this, the use of smaller administered activities and longer imaging times, together with maternal hydration and frequent voiding will lead to a reduced dose to the foetus and a clinically diagnostic study. If clinically justifiable a slight postponement of the examination to a later stage of the pregnancy will also lead to a reduced dose to the foetus2. It should be noted that contamination from radionuclide and radiopharmaceutical impurities can considerably affect the amount of activity transferred to the foetus. Therefore, in order to avoid unjustified doses to the foetus, attention should be paid to quality control of radiopharmaceutical compounds administered2.
 Technetium [99mTc] sodium oxidronate is excreted in human milk. If the patient is breastfeeding following administration of technetium [99mTc] sodium oxidronate a procedure should be in place to ensure that the infant will receive a total effective dose of no more than 1 mSv3. In order to achieve this, it is recommended that the patient express and store milk prior to administration of technetium [99mTc] sodium oxidronate. Following administration of technetium [99mTc] sodium oxidronate, a 1 hour interruption to breastfeeding and reduced contact with the infant is recommended3. During this period of interruption, it is recommended that the mother express and discard at least one fraction of milk. Where sample counting facilities are available it may be preferable to directly measure the concentration of the radionuclide in the breast milk to determine the time at which breastfeeding can resume3. To ensure the infant receives a total effective dose of no more than 1 mSv breastfeeding may resume when the milk activity concentration falls on or below 1 kBq/mL3. It should be noted that contamination from radionuclide and radiopharmaceutical impurities can considerably affect the amount of activity in the milk. Therefore, attention should be paid to quality control of radiopharmaceutical compounds administered, in order to avoid unjustified doses to the infant2.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions to technetium [99mTc] sodium oxidronate are rare. However, some hypersensitivity reactions, dermatological manifestations (erythema) and diaphoresis, as well as nausea, vomiting and heartburn have been infrequently associated with technetium [99mTc] oxidronate administration4.
Hypersensitivity and allergic reactions can often be treated with a nonselective histamine H1 antagonist.

Body as a whole.

Hypersensitivity reactions.

Digestive.

Nausea, vomiting, heartburn.

Skin and appendages.

Dermatological manifestations (erythema), injection site inflammation/ reaction.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Physical characteristics of technetium-99m.

Technetium 99m, with a physical half life of 6 hours, decays by isomeric transition to technetium-99. Photons associated with this transition that are useful for detection and imaging studies is listed in Table 2, followed by the physical decay chart for technetium-991 (see Table 3).

External radiation.

The specific gamma ray constant for technetium-99m is 0.19 mGy/MBq-h at 1 cm. The first half value thickness of lead (Pb) for technetium-99m is 0.2 mm. Attenuation by lead is given in Table 4.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Skeletal uptake of sodium oxidronate appears to be related to bone metabolic activity and skeletal blood flow. The exact mechanism of localisation of technetium [99mTc] sodium oxidronate in bone is not entirely known. It is hypothesised that uptake occurs via chemisorption primarily in the mineral phase of bone, with insignificant binding to the organic matrix. Technetium [99mTc] sodium oxidronate demonstrates specific affinity for areas of altered osteogenesis.

Metabolism and excretion.

After intravenous administration, technetium [99mTc] sodium oxidronate is rapidly distributed in and cleared from blood with approximately 50% of the injected dose localizing in bone and less than 4% remaining in circulation at three hours postinjection. The major pathway of elimination of technetium [99mTc] sodium oxidronate is via the kidneys. At 24 hours the percentage cumulative activity excreted in urine is 75% in patients with normal renal function.

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

6.1 List of Excipients

For the full list of excipients, see Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

For incompatibilities, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

Reconstituted shelf life of Radpharm HDP is 8 hours. Discard any unused portions.
The shelf life is 12 months from the date of manufacture. The expiry date is stated on the vial and carton.

6.4 Special Precautions for Storage

Radpharm HDP vials may be stored at room temperature, below 25°C before reconstitution.
Reconstituted Radpharm HDP vials may be stored at room temperature, below 25°C.

6.5 Nature and Contents of Container

Radpharm HDP is supplied as a carton of sterile, pyrogen free, under nitrogen, multidose, tinted 10 mL vials enclosed in a carton.
Radpharm HDP is available in 10 x 10 mL vials and 30 x 10 mL vial cartons.

6.6 Special Precautions for Disposal

In Australia, disposal of all radioactive wastes should be carried out in accordance with the NHMRC "Code of Practice for the Disposal of Radioactive Wastes by the User" which is published on the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) website as Radiation Protection Series (RPS C-6).

6.7 Physicochemical Properties

Chemical structure.


Chemical name.

Hydroxymethylenediphosphonate disodium salt (HDP).

Molecular formula.

CH4Na2O7P2.

Molecular weight.

235.97.

CAS number.

14255-61-9.

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).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes