Netspot (Intravenous)

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

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

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

It is very important that your doctor checks you closely while you are receiving this medicine. This will help your doctor see if the medicine is working properly and decide if you should keep receiving 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. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on 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 they have been discussed with your doctor. 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. Additionally, other factors may affect test results. For this test, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been conducted on the effects of gallium Ga 68 dotatate injection in children. Safety and effectiveness have not been established for this age group.

Geriatric

Appropriate studies to date have not shown any specific problems in elderly patients that would limit the usefulness of gallium Ga 68 dotatate injection.

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

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor might want to adjust the dose, or take other precautions. When receiving this diagnostic test, it's very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted for their potential significance and may not be all-inclusive.

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

• Lanreotide
• Octreotide
• Pasireotide

Interactions with Food/Tobacco/Alcohol

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

Along with its necessary effects, a medicine may cause some unwanted effects. While not all of these side effects may happen, if they do, they 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 with 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. Also, your health care professional may be able to tell you how 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 happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may 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.