Quadramet (Page 5 of 5)

OVERDOSAGE

Overdosage with QUADRAMET® has not been reported. An antidote for QUADRAMET® overdosage is not known. The anticipated complications of overdosage would likely be secondary to bone marrow suppression from the radioactivity of 153 Sm, or secondary to hypocalcemia and cardiac arrhythmias related to the EDTMP.

DOSAGE AND ADMINISTRATION

The recommended dose of QUADRAMET® is 1.0 mCi/kg, administered intravenously over a period of one minute through a secure in-dwelling catheter and followed with a saline flush. Dose adjustment in patients at the extremes of weight have not been studied. Caution should be exercised when determining the dose in very thin or very obese patients.

The dose should be measured by a suitable radioactivity calibration system, such as a radioisotope dose calibrator, immediately before administration.

The dose of radioactivity to be administered and the patient should be verified before administering QUADRAMET®. Patients should not be released until their radioactivity levels and exposure rates comply with federal and local regulations.

The patient should ingest (or receive by i.v. administration) a minimum of 500 mL (2 cups) of fluids prior to injection and should void as often as possible after injection to minimize radiation exposure to the bladder.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should not be used if it is cloudy or if it contains particulate matter.

QUADRAMET® contains calcium and may be incompatible with solutions that contain molecules that can complex with and form calcium precipitates.

QUADRAMET® should not be diluted or mixed with other solutions.

Thaw at room temperature before administration and use within 8 hours of thawing.

Radiation Dosimetry

The estimated absorbed radiation doses to an average 70 kg adult patient from an i.v. injection of QUADRAMET® are shown in Table 7. The dosimetry estimates were based on clinical biodistribution studies using methods developed for radiation dose calculations by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine.

Radiation exposure is based on a urinary voiding interval of 4.8 hours. Radiation dose estimates for bone and marrow assume that radioactivity is deposited on bone surfaces, as noted in autoradiograms of biopsy bone samples in 7 patients who received QUADRAMET®. Although electron emissions from 153 Sm are abundant, with energies up to 810 keV, rapid blood clearance of QUADRAMET® and low energy and abundant photon emissions generally result in low radiation doses to those parts of the body where the complex does not localize.

When blastic osseous lesions are present, significantly enhanced localization of the radiopharmaceutical will occur, with correspondingly higher doses to the lesions compared with normal bones and other organs. (See Clinical Pharmacology, Skeletal Uptake and Pharmacodynamics Sections).

TABLE 7
RADIATION ABSORBED DOSES70 kg ADULT
Target Organ Rad/mCi mGy/MBq
Bone Surfaces 25.0 6.76
Red Marrow 5.70 1.54
Urinary Bladder Wall 3.60 0.097
Kidneys 0.065 0.018
Whole Body 0.040 0.011
Lower large intestine 0.037 0.010
Ovaries 0.032 0.0086
Muscle 0.028 0.0076
Small Intestine 0.023 0.0062
Upper Large Intestine 0.020 0.0054
Testes 0.020 0.0054
Liver 0.019 0.0051
Spleen 0.018 0.0049
Stomach 0.015 0.0041

HOW SUPPLIED

QUADRAMET® is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.

QUADRAMET® is available in the following size:

NDC# 11994-016-01 3mL fill size with total activity of 5550 MBq (150mCi).

The vial is shipped in a lead shield; a package insert is included.

The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.

STORAGE

Store frozen at -10° to -20°C (14° to -4°F) in a lead shielded container.

Storage and disposal of QUADRAMET® should be controlled in a manner that complies with the appropriate regulations of the government agency authorized to license the use of this radionuclide.

This radioactive drug is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.100 for the uses listed in 105 CMR 120.589 or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.

THIS PRODUCT INFORMATION ISSUED March 2018.

Lantheus Medical Imaging, Inc.
331 Treble Cove Road
N. Billerica, Massachusetts 01862
USA

For Ordering Call Toll Free: 800-299-3431
All other business: 800-362-2668
For Massachusetts and International call: 978-667-9531

Printed in U.S.A.

Logo

513145-0318
March 2018

PRINCIPAL DISPLAY PANEL — 3 mL Vial Label

Quadramet ® Samarium Sm153 Lexidronam Injection

Sterile, Non-pyrogenic, Intravenous Injection
Contents & Assay: 35 mg/mL EDTMP•H2 O; 5.3 mg/mL
Ca[as Ca(OH)2 ]; 14.1 mg/mL Na[as NaOH]; 5-46 µg Samarium;
1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of Samarium–153
at calibration. Store frozen at -10° to -20°C (14° to -4° F).
Thaw at room temperature before administration
and use within 8 hours of thawing. Rx only
See Package Insert for dosing information.
Vial Stopper Contains Dry Natural Rubber Latex.

Caution: Radioactive Material

Manufacturer:
Lantheus
Medical ImagingN. Billerica, MA 01862

515127-0114

PRINCIPAL DISPLAY PANEL -- 3 mL Vial Label
(click image for full-size original)
QUADRAMET samarium sm 153 lexidronam injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11994-016
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAMARIUM SM-153 LEXIDRONAM PENTASODIUM (SAMARIUM SM-153) SAMARIUM SM-153 50 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
LEXIDRONAM 35 mg in 1 mL
CALCIUM HYDROXIDE 5.3 mg in 1 mL
SODIUM HYDROXIDE 14.1 mg in 1 mL
SAMARIUM 25 ug in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11994-016-01 3 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020570 05/19/1997
Labeler — Lantheus Medical Imaging, Inc. (176786812)
Establishment
Name Address ID/FEI Operations
Lantheus Medical Imaging, Inc. 176786812 MANUFACTURE (11994-016), PACK (11994-016), LABEL (11994-016)

Revised: 03/2018 Lantheus Medical Imaging, Inc.

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