Dosing & Uses
Dosage Forms & Strengths
single-dose vial kit
- 5 single-dose vials, each vial containing lyophilized powder of 1 mg technetium Tc 99m succimer
Renal Scintigraphy
Indicated for use as an aid in scintigraphic evaluation of renal parenchymal disorders
74-222 MBq (2-6 mCi) IV bolus
Dosage Forms & Strengths
single-dose vial kit
- 5 single-dose vials, each vial containing lyophilized powder of 1 mg technetium Tc 99m succimer
Renal Scintigraphy
Indicated for use as an aid in scintigraphic evaluation of renal parenchymal disorders for adults and pediatric patients
Recommended amount of radioactivity for renal parenchymal imaging: 1.85 MBq/kg (0.05 mCi/kg); range:19-74 MBq (0.5-2 mCi) IV bolus
<11 kg: 19 MBq (0.5 mCi)
11-12 kg: 21 MBq (0.6 mCi)
13-14 kg: 26 MBq (0.7 mCi)
15-16 kg: 30 MBq (0.8 mCi)
17-18 kg: 33 MBq (0.9 mCi)
19-20 kg: 37 MBq (1 mCi)
21-22 kg: 41 MBq (1.1 mCi)
23-24 kg: 44 MBq (1.2 mCi)
25-26 kg: 49 MBq (1.4 mCi)
27-28 kg: 52 MBq (1.4 mCi)
29-30 kg: 56 MBq (1.5 mCi)
31-32 kg: 59 MBq (1.6 mCi)
33-34 kg: 63 MBq (1.7 mCi)
35-36 kg: 67 MBq (1.8 mCi)
37-38 kg: 70 MBq (1.9 mCi)
≥39 kg: 74 MBq (2 mCi)
Adverse Effects
Postmarketing Reports
Immune system disorders: Hypersensitivity including urticaria, rash, pruritus, and erythema
General disorders: syncope, fever, and nausea
Warnings
Contraindications
None
Cautions
Hypersensitivity reactions, including urticaria, rash, pruritus, erythema reported; onset of reactions varied within 2 hr to several hr after injection; monitor for hypersensitivity reactions and always have cardiopulmonary resuscitation equipment and personnel available
Technetium Tc 99m contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure is associated with an increased risk of cancer; ensure safe handling and preparation reconstitution procedures to protect patients and health care workers from unintentional radiation exposure; encourage patients to drink fluids and void as frequently as possible after administration
Use in patients with severely reduced eGFR may influence image interpretation as the kidneys may not absorb the technetium Tc 99m succimer and thus may distribute to organs or parts of the body other than kidneys; satisfactory images may be obt
Pregnancy & Lactation
Pregnancy
Insufficient data are available use in pregnant females to evaluate for a drug-associated risk of major birth defects and miscarriage
Animal data
- Studies have not been conducted
- Although all radiopharmaceuticals may potentially cause fetal harm depending on fetal stage of development and magnitude of the radiation dose, radiation exposure to fetus from technetium Tc 99m succimer is expected to be low (<0.50 mGy)
Lactation
Present in breast milk
There are no data on effects of technetium Tc 99m succimer on breastfed infants or effects on milk production
Use for imaging in infants with renal disease; exposure to technetium Tc 99m succimer via breast milk is expected to be lower.
Advise lactating females to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of at least 24 hr after administration
Consider developmental and health benefits of breastfeeding along with a mother’s clinical need, any potential adverse effects on the breastfed child from technetium Tc 99m succimer or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Technetium Tc 99m succimer binds to the cortical region of kidneys and in conjunction with gamma scintigraphy or single photon emission computed tomography (SPECT) is used to image the renal cortices
Distribution
Protein bound: 53-70%
Elimination
~16% of the technetium Tc 99m succimer activity is excreted in the urine within 2 hr
Administration
Technetium Tc 99m Succimer Preparation
Wear waterproof gloves
Place vial in lead shielding and disinfect stopper
Use a sterile syringe to transfer 5 mL sodium pertechnetate Tc 99m injection obtained from a technetium Tc 99m generator with a maximum activity of 1480 MBq (40 mCi) to vial; volume of sodium pertechnetate Tc 99m injection may be adjusted to 5 mL before adding to vial using 0.9% NaCl
Use same syringe to withdraw appropriate gas volume from vial for pressure compensation
Lightly shake vial to completely dissolve powder; ensure stopper is well moistened
Incubate vial for 10 minutes at controlled room temperature 20-25°C (68-77°F)
Measure product activity in a dose calibrator; complete radiolabeled product vial label and affix to vial shield
Refer to prescribing information to check radiochemical purity
Use within 4 hr and store at controlled room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Administration
Visually inspect prepared technetium Tc 99m succimer; solutions are clear without visible particles
Using a sterile shielded syringe, aseptically withdraw prepared technetium Tc 99m succimer, and measure radioactivity in syringe using a dose calibrator, before administration
Ensure that injected radioactivity is within ±10% of recommended dose; discard unused portion
Handle and dispose radioactive material in accordance with applicable regulations
Begin image acquisition 1-4 hr after IV administration; delay image acquisition up to 6-24 hr in patients with severely reduced glomerular filtration rate (eGFR); no specific eGFR threshold at which to delay imaging has been established
Adequate hydration
- Instruct patients to drink enough water to ensure adequate hydration before imaging and urge them to drink and urinate as often as possible during the first hours following the administration of Technetium Tc 99m Succimer Injection, to reduce radiation exposure
Storage
Unopened kit
- Refrigerate at 2-8°C (36-46°F)
Reconstituted product
- May store for up to 4 hr at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Images
Formulary
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