KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE

Other

Brand names: LOCAMETZ

Intravenous

Mechanism of Action

12.1 Mechanism of Action Gallium Ga 68 gozetotide binds to PSMA. It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium-68 is a β+ emitting radionuclide that allows PET.

Indications

1 INDICATIONS AND USAGE LOCAMETZ

after radiolabeling with gallium-68

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risk for Misinterpretation: Gallium Ga 68 gozetotide uptake may occur in other tumor types and in non-malignant processes
1 ) Radiation Risk: Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure
1 Risk for Misinterpretation Image interpretation errors can occur with LOCAMETZ PET
2 Radiation Risk Gallium Ga 68 gozetotide contributes to the patient’s overall long-term cumulative radiation exposure

Known Side Effects

11 documented side effects by frequency

Drug Not Working

>10%

Fatigue

1-10%

Nausea

1-10%

Itching

1-10%

Vomiting

1-10%

Headache

1-10%

Diarrhea

1-10%

Falls

1-10%

Dizziness

1-10%

Rash

1-10%

Shortness of Breath

1-10%

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Formulations

Dosage Forms

Tablet

Route

Intravenous