STRONTIUM CHLORIDE SR-89- strontium chloride sr-89 injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

STRONTIUM CHLORIDE SR-89 (UNII: 5R78837D4A) (STRONTIUM CATION SR-89 - UNII:06A33308KH)

Available from:

Q BioMed Inc

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

STRONTIUM CHLORIDE Sr-89 INJECTION, USP is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy. None known.

Product summary:

STRONTIUM CHLORIDE Sr-89 INJECTION, USP is supplied in a 5 mL vial containing 148 MBq, 4 mCi. The vial is shipped in a transportation shield-container with a package insert, and two therapeutic agent-warning labels. The vial and its contents should be stored inside its transportation container at room temperature (15-25°C, 59-77°F). The calibration date and expiration date are quoted on the vial label. Do not use after the expiration date.  Stability studies have shown no change in any of the product characteristics monitored during routine product quality control over the period from manufacture to expiration. This radiopharmaceutical is licensed by the Texas Department of Health, or under equivalent licesnses of the U.S. Nuclear Regulatory Comminssion or an agreement state.  NDC72928-089-01 PRODUCT INFORMATION ISSUED: January 20, 2020 Manufactured for: Q BioMed, Inc. 366 Madison Ave, Third Floor New York, NY 10017 Manufactured by:  Isotherapeutics Group LLC 1004 S. Velasco St. Angleton, Texas (TX) 77515 Printed in U.S.A. L-089-11I Product Code: P089-0

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

STRONTIUM CHLORIDE SR-89- STRONTIUM CHLORIDE SR-89 INJECTION
Q BIOMED INC
----------
THERAPEUTIC
FOR INTRAVENOUS ADMINISTRATION • RX ONLY • SINGLE DOSE
DESCRIPTION
STRONTIUM CHLORIDE Sr-89 INJECTION, USP is a sterile, non-pyrogenic,
aqueous
solution of Strontium-89 Chloride for intravenous administration. The
solution contains
no preservative. Each milliliter contains:
Strontium Chloride 10.9 - 22.6 mg
Water for Injection q.s. to 1 mL
The radioactive concentration is 37 MBq/mL, 1 mCi/mL, and the specific
activity is 2.96-
6.17 MBq/mg, 80-167 µCi/mg at calibration. The pH of the solution is
4 - 7.5.
PHYSICAL CHARACTERISTIC
Strontium-89 decays by beta emission with a physical half-life of 50.5
days. The
maximum beta energy is 1.463 MeV (100%). The maximum range of ß-
particles from
Strontium-89 in tissue is approximately 8 mm.
Radioactive decay factors to be applied to the stated value for
radioactive concentration
at calibration, when calculating injection volumes at the time of
administration, are given
in Table 1.
TABLE 1: DECAY OF STRONTIUM-89
DAY*
FACTOR DAY*FACTOR
-24
1.39
+6
0.92
-22
1.35
+8
0.90
-20
1.32
+10 0.87
-18
1.28
+12 0.85
-16
1.25
+14 0.83
-14
1.21
+16 0.80
-12
1.18
+18 0.78
-10
1.15
+20 0.76
-8
1.12
+22 0.74
-6
1.09
+24 0.72
-4
1.06
+26 0.70
-2
1.03
+28 0.68
0=calibration 1.00
* Days before (-) or after (+) the calibration date stated on the
vial.
CLINICAL PHARMACOLOGY
Following intravenous injection, soluble strontium compounds behave
like their calcium
analogs, clearing rapidly from the blood and selectively localizing in
bone mineral. Uptake
of strontium by bone occurs preferentially in sites of active
osteogenesis; thus primary
bone tumors and areas of metastatic involvement (blastic lesions) can
accumulate
significantly greater concentrations of strontium than surrounding
normal bone.
Strontium-89 Chloride is retained in metastatic bone lesions much
longer than in normal
bone, where turnover is about 14 days. In patients with extensive
skeletal metastases,
well over half of the injected