RADIO PHARMACEUTICAL PROCEDURE PROTOCOL: QUADRAMET (Sm- 153 lexidronam EDTMP) for metatstatic bone pain PRODUCT OVERVIEW: Samarium (Sm- 153) Lexidronam (Quadramet ) Quadramet is a radiopharmaceutical consisting of stable complexes of radioactive Samarium (Sm- 153) and tetraphosphonate chelators (EDTMP). Sm- 153 has a half life of 46.3 hours and emits both beta and gamma radiation. The gamma radiation can be used to follow the uptake of the radionuclide in vivo, whereas the beta radiation provides the therapeutic effect? of the compound. Quadramet has a high affinity to the skeleton and concentrates after intravenous injection in areas of elevated bone turnover (osteoblastic lesions). It is indicated as a palliative measure for the relief of pain from metastatic lesions that enhance on bone scans. The onset of pain relief observed with Quadramet is rapid, about one week after injection. Health Canada approved Quadramet for palliation of bone pain. For additional information regarding this agent, consult package insert or other standard references including consensus treatment guidelines recommending Quadramet (EANM, SNM, Cancer Care Ontario, ASCO.) TARGET PATIENT POPULATION Patients with pain secondary to cancer metastatic to bones with activity demonstrated on bone scan. Osteosarcoma patients are treated under a different protocol. Patients must have had a CBC/platelet count within the past 7 days. The results must be verified by the staffing nuclear medicine physician. 1
RADIO PHARMACEUTICAL PROCEDURE PROTOCOL: QUADRAMET (Sm- 153 lexidronam EDTMP) for metatstatic bone pain CONTENTS OF QUADRAMET (Sm- 153 lexidronam EDTMP) Procedure Protocol AUTHORIZATION SCHEDULING PROCESS PROCUCT PROCUREMENT GENERAL PREPARATION DOSE PREPARATION PATIENT PREPARATION PREPARATION OF INPATIENT TREATMENT ROOM ADMINISTRATION OF DOSE DOSE MEASUREMENTS INPATIENT DISCHARGE PROTOCOL OUTPATIENT TREATMENT AND RELEASE 2
RADIO PHARMACEUTICAL PROCEDURE PROTOCOL: QUADRAMET (Sm- 153 lexidronam EDTMP) for metatstatic bone pain INSTRUCTIONS/GUIDELINES FOR PATIENT AUTHORIZATION AND TREATMENT DIRECTIVE The treating physician (Radiation Oncologist, Medical Oncologist, Hematologist or Nuclear Medicine Physician) who is authorized to make a treatment decision will determine if Quadramet is appropriate therapy based on treatment guidelines and clinical assessment. A written directive will be given to initiate product procurement and preparations of the patient and the facility. SCHEDULING PROCESS 1. Clinic schedulers will contact the Nuclear Medicine scheduling staff with a request for a Samarium- 153 therapy. 2. The Nuclear Medicine schedulers will record information on a Nuclear Medicine Scheduling Sheet, deliver it to the Lead Nuclear Medicine Technologists Work room and notify the Lead Nuclear Medicine Technologist that the form is there. 3. Upon receipt of the Nuclear Medicine Scheduling Sheet, the Lead Nuclear Medicine Technologist will attach the written Directive and deliver to Nuclear Medicine Staff Physician for approval. 4. After approval, the Nuclear Pharmacy is contacted to check availability of drug. 5. The Lead Nuclear Medicine Technologist will then contact a Lead Scheduler to schedule the therapy. 6. The ordering clinic will then be contacted with the date and time. PRODUCT PROCUREMENT 1. Upon receipt of the written directive, the radiopharmacy will contact Superna Life Sciences/Lantheus Medical Imaging to arrange for product delivery. Sm- 153 EDTMP is ordered as a frozen, pre- calibrated intravenous bulk dose. 2. A minimum lead time of 72 hours is required. 3. The Radiopharmacy will order via phone with confirmation of the order returned by fax or e- mail. A time estimate of arrival of product will be communicated to the authorizing physician. 4. The Quadramet vial is calibrated for Wednesday, 12:00 noon, ET, and expires Friday, 8:00 PM ET, or 8 hours from thawing, whichever comes first. 5. Quadramet will be shipped via FedEx or other expedited commercial carrier. GENERAL PREP 1. Check the product identification tag attached to the vial to ensure accurate identification of the product and dose. 2. The Sm- 153 EDTMP product data and lot numbers are logged in the radiopharmacy computer and listed in the index of products. NM radiopharmacy labels are to be affixed to the lead pot. 3
RADIO PHARMACEUTICAL PROCEDURE PROTOCOL: QUADRAMET (Sm- 153 lexidronam EDTMP) for metatstatic bone pain 3. The technologist preparing the dose and the nuclear medicine physician administering the dose must wear gloves, a lab coat, a TLD, and a ring badge and adhere to good radiation safety practice. DOSE PREP 1. The patient s dose of Sm- 153 EDTMP is calculated using the following weight based calculation 1mCi x (patient weight in kilograms) and will be prescribed by a nuclear medicine physician 2. The Sm- 153 EDTMP product data and lot numbers are logged in the radiopharmacy computer and listed in the index of products. The computer is used to calculate the volume of Sm- 153 EDTMP for the prescribed dose. The contents of the vial and all product information must be verified prior to withdrawing the dose. 3. Initial preparation of the drug requires thawing. Quadramet must be used within 8 hours of thawing. 4. The dose is prepared in the [ENTER LOCATION for example, Radiopharmacy Laboratory] with work performed behind the shielded drawing station. 5. The dose is withdrawn into a lucite shielded syringe or equivalent wearing 2 pair of disposable gloves and a ring badge. 6. The dose is assayed in the dose calibrator and placed in a lead shielded transport box. The Radiopharmacy Label identifying the product, quantity and calibration date is affixed to the box. PATIENT PREP 1. The nuclear medicine physician confirms female patients are not pregnant when appropriate. 2. The nuclear medicine physician or radiation oncologist obtains the informed consent from the patient. 3. Immediately before administration, the patient is hydrated with approximately 500mL of normal saline. 4. Clinical staff will ascertain whether the patient is continent. If the patient is incontinent, precautions will be explained. A Health Facts for You for Quadramet (Samarium Sm- 153 Lexidronam Injection) will distributed to the patient. PREPARATION OF INPATIENT TREATMENT ROOM: 1. Patients receiving therapeutic doses are usually admitted to a radiotherapy room on[ INSERT APPROPRIATE LOCATION HERE for example, C7-100. ] These rooms have radioactive warning signs that must be overturned once the patient has received their treatment. However, there are times when these rooms are not available, and the patients have to be admitted to a non- radiotherapy room. If this is the case, a radioactive warning sign must be hung on the outside of the patient s door. 2. Tape absorbent pads with waterproof backing to the floor along the sides of the toilet to absorb potential urine contamination. 4
3. Ensure the special waste receptacle labeled [ENTER APPROPRIATE LABLE for example Nuclear Medicine ] is moved to the treatment room. The container must be lined with two large plastic bags obtained in the same room. 4. Ensure the entrance door to the room has a Radiation Warning Sign. 5. Ensure absorbent pads are available to place on the floor under the IV pole stand and under the patient s arm with the infusion site. 6. If the patient is treated as an inpatient, the patient s room is prepared according to the protocol for high dose I 131 treatments. (see I 131 treatment protocol). 7. The patient s treatment room must be decommissioned once the patient is discharged. ADMINISTRATION OF THERAPY: 1. The prescribed dose of Sm- 153 will be administered intravenously using a peripheral IV or central line. This will usually be performed as an outpatient. **Peripheral IV administration is typically used 2. Injection is through the existing IV line. An initial test injection is first administered, comprising of about 0.1mL of the dose. 3. Following the test injection, the Administering Clinician will survey the patient s chest with a GM meter on the surface above the heart, to confirm activity has been carried from the injection site through the circulatory system. 4. Following positive indications of patency of the IV line, the remaining solution is injected via IV push over approximately 2 minutes. 5. Following the injection, an additional 250 ml of normal saline is run through the IV line. 6. The Clinician removes the IV line. **When administering a high dose of Quadramet the following should be done: High dose Sm- 153 should be administered systemically through a central line using an infusion syringe pump. The syringe pump should be shielded with lucite and lead to reduce radiation exposure to the staff. The typical infusion time will be 30 mins. 7. Absorbent plastic lined pads should be placed under the infusion pump and work area to contain any contamination. 8. The nuclear medicine physician administering the dose must wear disposable double gloves, lab coat, TLD, and ring badge. 9. The empty dose syringe is placed in the lead container for transport to[insert APPROPRIATE NAME OF WASTE CONTAINER for example Nuclear Medicine. ] All other materials used in the administration of the Sm- 153 are to be collected in plastic bags for return to [INSERT APPROPRIATE NAME OF WASTE CONTAINER for example Nuclear Medicine] for monitoring and storage for decay as necessary. DOSE MEASUREMENTS 1. Dose measurements are to be recorded with a the Victoreen or Fluke dose rate survey meter at a distance of 1 meter from the patient. The measurements are to be taken and recorded as to time and date following administration of the therapy dose and daily and prior to discharge of the patient from the hospital. 5
2. Calibrate the Victoreen or Fluke prior to each measurement. [INSERT APPROPRIATE NAME if other methods or equipment are used.] 3. The radiation dose measurements are recorded with the patient standing and facing the survey meter. The meter distance is measured from the center of the patient. The center of the patient means mid height and mid width point. The height of the survey meter should be in line with the central point and at 1 meter from the patient to the calibration line on the cutie pie. 4. A background measurement is made in an area remote from any radioactivity. This background measurement is subtracted from the dose measured. 5. If an inpatient, all of the radiation dose measurements are recorded on the Instructions For Nursing of Patients Who Have Received Radionuclide Therapy form in the patient s chart, on the decommissioning form and on the requisition for post therapy scan. The formula is as follows: GBq in patient= Dose given (GBq x reading of patient at time x) msv/hr reading of patient at time (15 minutes) msv/hr) 6. Record the patient s dose rate at 15 minutes and at discharge. 7. The nuclear medicine physician will authorize the discharge of the patient. 8. After patient discharge, the RSOs delegate (nuclear medicine technologist on duty or on call) shall conduct a final survey of the room. DISCHARGE PROTOCOL NOTE: If a patient s residual radioactivity reading at the time of discharge is greater than 5, 200 MBq, The physician must fill out and give to the patient a copy of Authorization for the release of Patients with doses exceeding 1.1 GBq form AND a completed copy of Instructions for Out Patient Following Treatment with a radioactive material form. After patient discharge, the RSO's delegate (Nuclear Medicine technologist on duty or on- call) shall conduct a final survey of the room. The following steps will be taken to decommission a patient treatment room: 1. A Decommissioning Patient Treatment Room worksheet must be filled out for every patient and the worksheet record is retained by Nuclear Medicine. 2. Using the [Berthold] contamination survey meter, the following areas must be monitored: a) background b) phone c) door handle d) bed e) floor around bed f) faucet handles 6
g) toilet seat h) TV controls i) absorbent pads at the base of toilet j) personal waste & disposables k) other 3. The allowable limits on the CNSC licence are: a) Removable contamination: 3.0 Bq/cm2 averaged over an area 100 cm2 using Berthold contamination monitor (3,000 counts per minute at surface using pancake contamination monitor). b) Fixed contamination: 0.5 μsv/hr at 0.5 m using the Victoreen or Fluke survey meter c) Linen 2.5 μsv at external surface of laundry container using the Victoreen or Fluke survey meter. 4. If contamination is found, the decontamination supplies on the decommissioning cart, are used by the technologist to decontaminate the area to levels not to exceed the allowable limits as specified in #3 above. 5. Contaminated linen exceeding the limits is moved to the [INSERT APPROPRIATE NAME for example long term radioactive storage room.] 6. The personal waste and disposables collected in the blue receptacle labelled [INSERT APPROPRIATE NAME for example "Nuclear Medicine " ] must be monitored and removed. If the garbage is contaminated, the technologist is to attach a label to the garbage bag identifying the radionuclide and date, and to wheel the receptacle to the long- term radioactive storage room. The receptacle is to be left in the soiled utility room [SPECIFY LOCATION. For example, on level 1, between the C and D zones for cleaning (housekeeping will return it to C71 once cleaned).] If the garbage is not contaminated, the Nuclear Medicine technologist is responsible for transporting the "Nuclear Medicine" waste receptacle from the patient's room to the soiled utility room [SPECIFY LOCATION. For example on level 1, between the C and D zones. ] The plastic bag of garbage is to be left in the room per arrangement with Housekeeping. 7. If the technologist encounters any problem, i.e. cannot decontaminate the room within allowable limits, the RSO or his/her delegate is to be notified. If this occurs on the weekend, the room is to remain closed until the RSO or his/her delegate is available to act on it Monday morning. The RSO or delegate will then decide the next step of action to be taken. The technologist is not responsible for ordering room closures. 8. The personal waste in the long- term radioactive storage room is to be monitored on a consistent basis after the treatment so that once it has decayed to background levels, it can be sent for disposal in order to avoid the creation of bad odours, etc. in the room. Once the waste can be discarded, remove radioactive waste label and call Housekeeping to remove waste from the storage area. 7
OUTPATIENT TREATMENT AND RELEASE Criteria for Selection of Patients for Out- patient Treatment with Sm- 153 EDTMP: 1. The patient must, in the opinion of the physician, be able to follow the instructions and be likely to comply with them. 2. The patient does not require hospitalization for medical reasons. 3. The patient must confirm that separate sleeping arrangements are possible for the recommended time. 4. If there are small children or pregnant women in the home, contact should deliver an estimated dose of no more than 1 msv to them. 5. The dose calculation will be based on Regulatory Guide 8.39 - Release of Patients Administered Radioactive Materials, US Nuclear Regulatory Commission, April 1997. 6. Ideally there should be more than one bathroom in the house and one of them designated for the exclusive use of the patient. 7. Care provided by family members shall be provided by non- pregnant adults who undertake to give the support knowingly and willingly. The situation regarding radiation exposure will be described to the provider with instructions regarding time, proximity and cumulative dosage. 8. An estimated dose of up to 5 msv is permissible without badging or bioassaying the care provider. The dose calculation will be based on Regulatory Guide 8.39 - Release of Patients Administered Radioactive Materials, US Nuclear Regulatory Commission, April 1997. INSTRUCTIONS/GUIDELINES FOR THE PATIENTS: 1. Male patients must sit on the toilet to void/urinate/empty bladder. 2. Flush the toilet twice after use. 3. Wash hands with soap and plenty of water every time after using the toilet and rinse the sink. 4. Visitors restricted for 30 minute visits to a maximum of three times per day while maintaining a minimal distance of 1 meter from the patient. Children and pregnant females are not permitted to visit. 5. Dose readings: The patient will be monitored after administration of the therapy dose and each day thereafter until discharge. 6. Explain that absorbent pads with waterproof backing will be taped to the floor along the sides of the toilet to absorb potential urine contamination. 7. There will be a special waste container in the room where all disposable items and personal waste are to be placed. Drink containers should be emptied into the sink before placing in the waste container. 8. Inform the patient that the nursing staff are aware of all radiation precautions. 9. Assure the patient that if he/she runs into any problems, there are nuclear medicine staff available and on call to provide answers. 8