Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about MDP Skeletal Agent, otherwise known as Methylene Diphosphonic Acid (Medronic Acid). It does not contain all the available information.

It does not take the place of talking to your nuclear medicine physician or specialist. All medicines have potential risks and benefits associated with them. Your nuclear medicine physician or specialist has weighed the small risks of you being treated with an MDP injection against the benefits it is expected you will receive from it.

If you have any concerns about being given this injection, discuss them with your nuclear medicine specialist.

Keep this leaflet. You many need to read it again.

What MDP is used for

MDP Skeletal Agent is used with an imaging agent (radiotracer) to form an image of the skeleton.

The imaging agent

The imaging agent used is a radio tracer called Technetium-99m.Technetium-99m emits small amounts of radiation similar to X-rays. This radiation can be detected by a special camera, called a gamma camera, and produces an image known as a scan. A nuclear medicine physician or specialist interprets these scans and provides you with information related to your referral that otherwise may not be known or seen on plain X-rays.

Your nuclear medicine physician or specialist may be giving you MDP to help diagnose other conditions. Ask your nuclear medicine physician or specialist if you have any questions about why MDP is being given to you or why you have been referred for a scan.

For more information, ask for a copy of the booklet “Nuclear Medicine –Answering your Questions” available from the hospital, clinic or supplier.

Before you receive the injection

It is important to tell your nuclear medicine physician or specialist if:

1. You are pregnant

It is not known whether the injection is harmful to an unborn baby when administered to a pregnant woman. If you are pregnant, your physician will make a decision on the use of the medicine based on the risk benefit analysis
If you intend to become pregnant consult your doctor about the advised waiting period.

2. You are breast-feeding

It is normal practice to suspend breast-feeding for at least 12 hours after the injection. It is known that Technetium-99m MDP passes into breast milk.

3. You are taking other medicines

These medicines include vitamins, cough medicines and nasal congestants that you buy from a pharmacy, supermarket or health food shop, without a prescription.
Some medication may interfere with the expected results; you will be advised what to do.

If you have not told your nuclear medicine physician or technologist about any of the above, tell them BEFORE you are given an MDP injection.

How it is MDP Injection given

MDP can only be administered by qualified staff with specific training in the safe use and handling of radio pharmaceuticals. MDP is given as an injection into a vein in your arm. You may feel a slight pinprick from the needle when it is injected.

Test procedure

Following a 2 to 4 hour delay, you will have a scan that takes up to an hour. The scan is painless.

After being given a MDP Injection

It takes about 2 to 4 hours for MDP to work in your body and produce a clear picture of your bones. During this time you will be asked to drink a few glasses of fluid and pass urine. You will be advised of when you may leave and return for your scan.

Returning home

Continue your day to day activities with members of your family and friends as you would normally.

You will be asked to drink plenty of fluids and pass urine frequently over the 6 hour period following the scan to help flush the agent from your body.

Side effects

Tell your nuclear medicine specialist or technologist as soon as possible if you do not feel well after having an MDP injection.

No side effects directly related to MDP have been reported. A skin rash has been infrequently reported with similar agents.

Adequate long term studies have not been preformed in animals to determine whether this drug affects fertility, or has teratogenic or mutagenic potential. Safety and efficacy in children have not been established.

Storage

MDP is stored refrigerated by the hospital or clinic. Technetium-99m is produced fresh every day. Your nuclear medicine specialist or technologist will check the expiry date and time before giving you the MDP injection.

Product description

What it looks like

MDP is a freeze-dried white powder. It comes in a 10 mL vial. Technetium-99m is added to produce a clear colourless liquid. MDP is sterilised by gamma irradiation and is pyrogen free.

Ingredients

Active:

• Methylene Diphosphonic Acid (Medronic Acid)
• Technetium-99m.

Inactive:

• sodium chloride
• stannous chloride dihydrate
• ascorbic acid.

AUST R 10333

Supplier

ANSTO Health
Locked Bag 2001
Kirrawee DC, NSW 2232
Telephone: 1800 251 572
Facsimile: 02 9543 6111

ANSTO Health is a commercial enterprise of the Australian Nuclear Science and Technology Organization (ANSTO), which is located at Lucas Heights, in Sydney, NSW.

Date of Revision: January 2012

Date of Printing: January 2012

Published by MIMS April 2019

Name of the medicine

Each vial contains 10 mg medronic acid, 0.84 mg tin (II) chloride and 2.0 mg of ascorbic acid. Hydrochloric acid is used in the manufacture. Before lyophilisation the pH is adjusted to 5.0 with sodium hydroxide solution. The contents of the vial are lyophilized and stored under nitrogen.

Description

Each vial contains 10 mg medronic acid, 0.84 mg tin (II) chloride and 2.0 mg of ascorbic acid. Hydrochloric acid is used in the manufacture. Before lyophilisation the pH is adjusted to 5.0 with sodium hydroxide solution. The contents of the vial are lyophilized and stored under nitrogen.
As supplied the product is sterile and pyrogen free. It contains no preservative.
The product is designed for diagnostic use. Use by intravenous administration after reconstitution with sodium pertechnetate (^99mTc) injection.
Physical Characteristics of ^99mTc. Technetium-99m with a physical half life of six hours, decays by isomeric transition to ⁹⁹Tc. Photons associated with this transition that are useful for detection and imaging studies are listed in Table 1.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MDPKIT01.gif See Table 2 for physical decay chart.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MDPKIT02.gif External radiation. The specific gamma ray constant for ^99mTc is 0.19 mGy per MBq^-h at 1 cm. The first half value thickness of lead (Pb) for ^99mTc is 0.2 mm. Attenuation by lead is given in Table 3.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MDPKIT03.gif

Pharmacology

Upon intravenous injection, skeletal uptake of technetium (^99mTc) MDP appears to be related to bone metabolic activity and to skeletal blood flow. Technetium (^99mTc) MDP exhibits a specific affinity for areas of altered osteogenesis.
Localized areas of decreased skeletal accumulation of technetium (^99mTc) MDP may be seen after therapeutic external irradiation. Technetium (^99mTc) MDP has been known to accumulate in areas of acute myocardial infarction from one to fourteen days after the initial event.
During the first 24 hours post injection about 50% of the dose is renally excreted; less than 2% of the dose remains in the vascular system. Blood levels fall to 3-5% of the injected dose by three hours post injection.

Indications

Technetium (^99mTc) MDP may be used as a bone imaging agent to delineate areas of altered osteogenesis.

Contraindications

None known.

Precautions

General. Radiopharmaceuticals should be used only by physicians who are qualified and licensed to handle radioactives. Contents of the vial are intended only for use in the preparation of technetium (^99mTc) MDP. They should not be administered directly to the patient. Technetium (^99mTc) MDP should be formulated within six hours prior to use.
Imaging should be carried out between one and four hours after injection.
Dose handling. Radiation exposure to clinical personnel must be minimized. Care and appropriate safety measures should always be used. The radioactivity of the dose should be checked with a suitable instrument immediately prior to administration. Disposal of all radioactive wastes should be carried out in accordance with the NH and MRC "Code of Practice for the Disposal of Radioactive Wastes by the User" 1985.
Patient care. Care should be taken to minimize unwanted radiation exposure to patients, consistent with proper patient management.
In order to reduce radiation dose to the bladder the patient should be encouraged to drink fluids and to void as frequently as possible following the administration of the radiopharmaceutical for a period of four to six hours.
Use in pregnancy. It is not known if technetium (^99mTc) MDP can cause foetal harm when administered to a pregnant woman. Technetium (^99mTc) should only be given to a pregnant woman if in the judgement of the treating physician the expected benefits outweigh the potential hazards.
Use in lactation. Technetium (^99mTc) is excreted in human milk. If administered to a nursing mother, formula feeding must be substituted.

Adverse effects

Adverse reactions have not been reported that are specifically attributable to the use of technetium (^99mTc) MDP. Allergic dermatological manifestations (erythema) have been infrequently reported with other similar agents.
Note. Adequate long-term studies have not been performed in animals to determine whether this drug affects fertility, or has teratogenic or mutagenic potential.
Safety and efficacy in children have not been established.

Dosage and Administration

Technetium (^99mTc) MDP Skeletal Agent is prepared for clinical use as follows:
(1) Using an aseptic technique add the required amount of sodium pertechnetate (^99mTc) solution to a vial of the reagent. The volume of solution added should be in the range 3-8 mL and the maximum activity should be 15 GBq.
(2) Mix by shaking gently for approximately 10 seconds.
(3) Administer by IV injection.
Note. (1) The vial is sealed under nitrogen. A vent needle should be used when adding the pertechnetate solution to the vial.
(2) After reconstitution with sodium pertechnetate (^99mTc) the contents are radioactive and adequate shielding and handling precautions must be maintained.
(3) Using proper shielding, the vial containing the reconstituted solution should be visually inspected to ensure it is free from particulate matter.
(4) The product should be used as soon as possible after reconstitution.
The suggested dose range for IV administration to be used in the average patient (70 kg) is: Bone Imaging: 370-740 MBq of technetium (^99mTc) MDP.
The patient dose should be measured by a suitable radioactivity calibrator immediately before the administration. Radiochemical purity should be checked prior to patient administration. Shielding should be used when preparing technetium (^99mTc) MDP.
Scanning post injection is optimal at about one to four hours.
Radiation dosimetry. The estimated absorbed radiation doses to a standard (70 kg) patient from a maximum dose of 740 MBq of technetium (^99mTc) MDP are shown in Table 4. As approximately half of the injected activity is excreted in the urine, the dose to the bladder and other organs will depend upon the patients voiding pattern.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MDPKIT04.gif Note. In order to reduce radiation dose to the bladder the patient should be encouraged to drink fluids and to void as frequently as possible following the administration of the radiopharmaceutical for a period of four to six hours.

Presentation

MDP Skeletal Agent kit is a set of five sterile and pyrogen free multi-dose vials. Each vial is packed under nitrogen and contains: medronic acid 10.0 mg, tin (II) chloride 0.84 mg, ascorbic acid 2.0 mg.

Storage

Store between 2-8°C.
(Refrigerate. Do not freeze).
Expiry. Expiry is 24 months after manufacture. The expiry date is found on the vial label and on the pack. Studies have shown that the product is stable at 30°C and 40°C for a limited time.

Poison schedule

Unscheduled.