Consumer medicine information

GALLIUM CITRATE GA 67 INJECTION USP

Gallium (67Ga) citrate

BRAND INFORMATION

Brand name

Lantheus Gallium (67Ga) Citrate Injection USP

Active ingredient

Gallium (67Ga) citrate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using GALLIUM CITRATE GA 67 INJECTION USP.

What is in this leaflet

This leaflet answers some of the common questions about Gallium Citrate Ga 67. It does not contain all of the available information about Gallium Citrate Ga 67. It does not replace talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you receiving Gallium Citrate Ga 67 against the benefits he or she expects it will have.

If you have any concerns about having this medicine, ask your doctor.

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

What is Gallium Citrate Ga 67

Gallium Citrate Ga 67 Injection contains an isotope of the element Gallium and belongs to a group of medicines called radiopharmaceutical agents, which are all radioactive.

What Gallium Citrate Ga 67 is used for

Gallium Citrate Ga 67 is used to demonstrate the presence of following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.

Your doctor may have prescribed Gallium Citrate Ga 67 for another purpose. Ask your doctor if you have any questions about why Gallium Citrate Ga 67 has been prescribed for you. If you have any concerns, you should discuss these with your doctor.

This medicine is only available with a doctor’s prescription.

Before you are given Gallium Citrate Ga 67

Before you are given Gallium Citrate Ga 67 your doctor will explain to you the procedure you are about to undergo, and the radioactive medicine you will be given. You must discuss any concerns you have with your doctor.

Gallium Citrate Ga 67 is not recommended for patients less than 18 years of age. If your doctor believes it is necessary to give Gallium Citrate Ga 67 to a patient under 18, he or she will discuss the benefits and risks with you.

You must tell your doctor if you have allergies to:

  • any other medicines
  • any other substances such as foods, preservatives or dyes

Tell your doctor if you are or plan to become pregnant. Like most medicines Gallium Citrate Ga 67 is not recommended for use during pregnancy. If there is a need to consider Gallium Citrate Ga 67 during your pregnancy, your doctor will discuss the benefits and risks of giving it to you. If you are given Gallium Citrate Ga 67 when you are pregnant, your developing baby will be exposed to the radiation.

Tell your doctor if you are breastfeeding or plan to breastfeed. Like most medicines Gallium Citrate Ga 67 is not recommended while you are breastfeeding. However if you are breastfeeding, formula feedings should be substituted for breastfeeding for 24 hours following the administration of Gallium Citrate Ga 67. Breast milk produced within that time should be discarded.

Tell your doctor if you have any other medical conditions, especially if you suffer from heart disease or from diabetes.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from pharmacy, supermarket or health food shop.

How Gallium Citrate Ga 67 is given

How much is given

Your doctor will decide how much you will be given.

You will receive Gallium Citrate Ga 67 as a single intravenous one injection. The uptake of Ga 67 may be measured form a period of 6 hours up to 72 hours after administration of the dose.

How it is given

Gallium Citrate Ga 67 is given as an injection into a vein. Gallium Citrate Ga 67 should only be given by a doctor or a nurse.

When you are given Gallium Citrate Ga 67

Things you must do

You must take daily laxatives and/or enemas during the first week after the procedure. This will remove as much radioactivity as possible from your bowel and minimise the possibility of false positive studies.

Things you must not do

Do not take any other medicines until advised by your doctor.

Things to be careful of

Do not drive or operate machinery until you know how Gallium Citrate Ga 67 affects you. Gallium Citrate Ga 67 may cause dizziness in some people. Make sure you know how you react to Gallium Citrate Ga 67 before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy.

Side effects

Tell your doctor as soon as possible if you do not feel well after being given Gallium Citrate Ga 67.

Tell your doctor or a nurse immediately if you notice any of the following:

  • dizziness
  • light-headedness
  • itchiness
  • rash

Product description

What it looks like

Gallium Citrate Ga 67 is a clear solution supplied in vials. An injection is prepared from the vial immediately before it is injected.

Ingredients

Active ingredient:
Gallium Citrate Ga 67.

Inactive Ingredients:

  • sodium citrate,
  • sodium chloride,
  • benzyl alcohol.

Sponsor

Lantheus MI Australia Pty Ltd
Unit 8/24-26 Carrick Drive
Tullamarine
Victoria 3043

Registration Number

AUST R 19144

Date of Preparation

Updated: April 2012

Gallium Citrate(cmi)2.doc

Published by MIMS January 2015

BRAND INFORMATION

Brand name

Lantheus Gallium (67Ga) Citrate Injection USP

Active ingredient

Gallium (67Ga) citrate

Schedule

Unscheduled

 

1 Name of Medicine

Gallium (67Ga) citrate.

2 Qualitative and Quantitative Composition

Gallium Citrate Ga 67 Injection, U.S.P. is supplied in isotonic solution as a sterile, non-pyrogenic diagnostic radiopharmaceutical for intravenous administration. Each milliliter of the isotonic solution contains 74 MBq of Gallium Ga 67 on the calibration date, as a complex formed from 9 nanogram Gallium Chloride Ga 67, 2 mg of sodium citrate dihydrate, 6.8 mg sodium chloride, and 0.9% benzyl alcohol w/v added as preservative. The pH is adjusted to between 4.5-8 with hydrochloric acid and/or sodium hydroxide solution. Gallium Ga 67, with a half-life of 78 hours, is cyclotron produced by the proton irradiation of enriched zinc oxide, is essentially carrier-free and contains negligible concentrations of other radioactive isotopes.
This medical product is for diagnostic use only.

3 Pharmaceutical Form

Gallium Citrate Ga 67 Injection, U.S.P is a clear, colourless intravenous injection solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Gallium Citrate Ga 67 Injection, U.S.P. may be useful in demonstrating the presence of the following malignancies: Hodgkin's disease, lymphomas and bronchogenic carcinoma. Positive Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.

4.2 Dose and Method of Administration

The recommended adult (70 kg) dose of Gallium Citrate Ga 67 Injection, U.S.P. is 74-185 MBq. Gallium Citrate Ga 67 Injection, U.S.P. is intended for intravenous administration only.
Approximately 10% of the administered dose is excreted in the feces during the first week after injection. Daily laxatives and/or enemas are recommended during the first week after injection until the final images are obtained in order to cleanse the bowel of radioactive material and minimize the possibility of false positive studies.
Studies indicate the optimal tumor to background concentration ratios are often obtained about 48-72 hours post-injection. However, considerable biological variability may occur in individuals, and acceptable images may be obtained as early as 6 hours and as late as 120 hours after injection.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
The dosimetry values listed in Table 1 for Gallium Citrate Ga 67 Injection, U.S.P. are extracted from ICRP 80, Radiation dose to patients from radiopharmaceuticals.

4.3 Contraindications

None known.

4.4 Special Warnings and Precautions for Use

Warnings.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of nuclides.
Gallium Citrate Ga 67 Injection, U.S.P. should not be administered to children or to patients who are pregnant or to nursing mothers unless the information to be gained outweighs the potential hazards.

Precautions.

A thorough knowledge of the normal distribution of intravenously administered Gallium Citrate Ga 67 Injection, U.S.P. is essential in order to accurately interpret pathologic studies.
The finding of an abnormal gallium concentration usually implies the existence of underlying pathology, but further diagnostic studies should be done to distinguish benign from malignant lesions. Gallium Citrate Ga 67 Injection, U.S.P. is intended for use as an adjunct in the diagnosis of certain neoplasms. Certain pathologic conditions may yield up to 40% false negative gallium studies. Therefore a negative study cannot be definitively interpreted as ruling out the presence of disease.
Lymphocytic lymphoma frequently does not accumulate Gallium Ga 67 sufficiently for unequivocal imaging; and the use of gallium with this histologic type of lymphoma is not recommended at this time.
Gallium Ga 67 localization cannot differentiate between tumor and acute inflammation; and other diagnostic studies must be added to define the underlying pathology.
Gallium Citrate Ga 67 Injection, U.S.P., as well as any other radioactive drugs, must be handled with care, and appropriate safety measures should be used to minimize external radiation exposure to clinical personnel. Also, care should also be taken to minimize radiation exposure to patients consistent with proper patient management.

Use in the elderly.

No data available.

Pediatric use.

Safety and effectiveness in children below the age of 18 have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No long-term animal studies have been performed to evaluate whether Gallium Citrate Ga 67 Injection, U.S.P. affects fertility in males or females.
Animal reproductive studies have not been conducted with Gallium Citrate Ga 67 Injection, U.S.P. It is also not known whether Gallium Citrate Ga 67 Injection, U.S.P. can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gallium Citrate Ga 67, Injection, U.S.P. should be given to a pregnant woman or women of childbearing potential only when in the judgement of the physician, the anticipated benefits clearly outweigh the potential risk.
Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability, should be performed during the first few (approximately 10) days following the onset of menses.
Gallium Citrate Ga 67 Injection, U.S.P. is excreted in human milk during lactation; therefore, formula feedings should be substituted for breast feeding for at least 4 weeks.

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)

Severe itching, erythema, and rash were observed in one patient of 300 studied.

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 https://www.tga.gov.au/reporting-problems.

4.9 Overdose

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.

Gallium Citrate Ga 67 Injection, U.S.P. is not absorbed if given orally, subcutaneously or intramuscularly. Following I.V. administration approximately 30% is bound to plasma proteins. It leaves the blood pool slowly, partly by excretion and partly by slow concentration into various organs where it stays for several days.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following I.V. administration, approximately 30% is bound to plasma proteins.

Distribution.

Carrier-free Gallium Citrate Ga 67 Injection, U.S.P. has been found to concentrate in certain viable primary and metastatic tumors (see Section 4.1 Therapeutic Indications). In some cases up to 95% of the administered dose may be retained in the body for several weeks, thereby increasing the total body dose.

Metabolism.

It has been reported in the scientific literature that following intravenous injection, the highest tissue concentration of Gallium Ga 67, other than tumors, is in the renal cortex. After the first day, the maximum concentration shifts to bone and lymph nodes, and after the first week, to liver and spleen. The mechanism of concentration is unknown, but investigational studies have shown that Gallium Ga 67 accumulates in lysosomes and is bound to a soluble intercellular protein.

Excretion.

Gallium is excreted relatively slowly from the body. The average whole body retention is 65% after 7 days, with 26% having been excreted in the urine and 9% in the stools. Because of its long residence in the colon, this organ receives the highest radiation dose.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No long-term animal studies have been performed to evaluate carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

The expiration date of the drug is fourteen days post manufacture.

6.4 Special Precautions for Storage

Store below 25°C.
The contents of the vial are radioactive and adequate shielding and handling precautions must be maintained.
Storage of radiopharmaceuticals should be in accordance with national regulations on radioactive materials (Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) website (www.arpansa.gov.au).

6.5 Nature and Contents of Container

Vials are available in the following quantities of radioactivity: 244, 326, 488, and 733 MBq on calibration date.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or radioactive waste material should be disposed of in accordance with Code 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

Physical characteristics.

Gallium Ga 67 decays to stable Zinc Zn 67 by electron capture with a physical half-life of 78 hours. See Tables 2 and 3.

External radiation.

The specific gamma ray constant for Gallium Ga 67 is 5.58 microcoloumbs/kg.hr.MBq at 1 cm. The first half value thickness of lead is 0.66 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thickness of Pb is shown in Table 4. For example, the use of 4.1 mm of Pb will decrease the external radiation exposure by a factor of 101.

CAS number.

41183-64-6.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes