technetium Tc 99m succimer (Rx)

Postmarketing Reports

Immune system disorders: Hypersensitivity including urticaria, rash, pruritus, and erythema

General disorders: syncope, fever, and nausea

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

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.

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

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)