Gallium ga 68 dotatoc (Intravenous)

Gallium Ga 68 dotatoc injection is used along with a PET scan (positron emission tomography) to locate neuroendocrine tumors (NETs) that have somatostatin receptors.

Gallium Ga 68 dotatoc is a radiopharmaceutical. Radiopharmaceuticals are radioactive substances that can be used to find and treat some diseases or to examine how the body's organs work.

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

It is very important for your doctor to monitor you closely while you or your child are receiving this medicine. This will help your doctor determine if the medicine is working correctly and if you should continue receiving it.

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 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, or unusual tiredness or weakness.

While receiving this medicine, you will be exposed to radiation. If you have any questions about this, consult your doctor.

In deciding to use a diagnostic test, any risks must be considered alongside the benefits it may provide. This is a choice you and your doctor will make together. Additionally, other factors may influence test results. For this test, keep the following in mind:

Allergies

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

Pediatric

Current studies have not shown pediatric-specific issues that would limit the effectiveness of gallium ga 68 dotatoc injection in children.

Geriatric

Current studies have not shown geriatric-specific issues that would limit the effectiveness of gallium ga 68 dotatoc injection in elderly patients. However, older adults are more likely to have heart, kidney, or liver problems, which may require caution when receiving gallium ga 68 dotatoc injection.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor might adjust the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the following medicines while receiving this diagnostic test. The interactions listed are based on their potential significance and are not necessarily a complete list.

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

• Lanreotide
• Octreotide
• Pasireotide

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain foods because interactions may occur. Consuming alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine in relation to food, alcohol, or tobacco.

Along with its needed effects, gallium ga 68 dotatoc (Intravenous) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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 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 occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to gallium ga 68 dotatoc. Also, your health care professional may be able to tell you about 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:

Less common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• feeling of warmth
• nausea
• redness of the face, neck, arms, and occasionally, upper chest

Other side effects not listed may also occur 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.

A doctor or other trained health professional will give you or your child 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.

You will need to urinate right away and as often as possible for at least 1 hour after the PET scan.