Mannitol, Dotatate, O-Phenanthroline, Gentisic acid Solution for injection

What is this medicine?

Gallium Ga 68 Dotatate (GAL ee uh m Ga 68 DOH te tate) is a radiopharmaceutical. It is used with a PET scan to identify possible neuroendocrine tumors (NETs).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an unusual or allergic reaction to gallium, dotatate, other medicines, foods, dyes, or preservatives

• thyroid disease

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.

Drink plenty of water before and after the PET scan and urinate as often as possible during first few hours after PET scan to minimize radiation exposure.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

This medicine may interact with the following medications:

• lanreotide

• octreotide

• pasireotide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

Do not breast-feed an infant while taking this medicine. Pump and discard breast milk for 12 hours after receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.