Gallium ga 68 dotatate (Intravenous)

Gallium Ga 68 dotatate injection is used with a PET scan (positron emission tomography) to locate somatostatin receptor positive neuroendocrine tumors (NETs) in adults and children.

Gallium Ga 68 dotatate is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that can be used to find and treat certain diseases or to study how the body's organs work.

This medicine is to be given only by or under the direct supervision of a doctor who has specialized training in nuclear medicine.

It is very important that your doctor closely monitors you while you are receiving this medicine. This will help your doctor determine if the medicine is working properly and if you should continue to receive it.

While receiving this medicine, you will be exposed to radiation. Avoid close contact with infants and pregnant women for at least 12 hours after you receive this medicine. If you have any questions about this, talk to your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Contact your doctor right away if you experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on your face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. Also, other factors may affect test results. For this test, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to gallium ga 68 dotatate (Intravenous) or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

Appropriate studies have not been done on the effects of gallium ga 68 dotatate injection in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies conducted so far have not shown any geriatric-specific problems that would limit the usefulness of gallium ga 68 dotatate injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and may not include all possibilities.

Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both of the medicines.

• Lanreotide
• Octreotide
• Pasireotide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Incidence not known

• Chest tightness
• Cough
• Difficulty swallowing
• Dizziness
• Fast heartbeat
• Hives, itching, or skin rash
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Trouble breathing
• Unusual tiredness or weakness

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

Incidence not known

• Nausea or vomiting
• Pain or burning at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Netspot

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have a PET scan.

Drink enough water to be hydrated before the PET scan.

Drink and urinate as often as possible during the first hours after the scan. This will help remove this radioactive medicine from your body.