Gallium Ga 68 Dotatate

Gallium Ga 68 Dotatate is a prescription medication used as a diagnostic agent with certain scans to identify neuroendocrine tumors.

• Gallium Ga 68 Dotatate is available under various brand names: Netspot

Common side effects of Gallium Ga 68 Dotatate include:

• nausea,
• vomiting, and
• injection site and burning sensation

Serious side effects of Gallium Ga 68 Dotatate include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• cough,
• difficulty swallowing,
• dizziness,
• fast heartbeat,
• hives,
• itching,
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue,
• skin rash,
• tightness in the chest,
• unusual tiredness, and
• weakness

Rare side effects of Gallium Ga 68 Dotatate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Single-dose kit

• Reaction vial (lyophilized powder): 40 mcg dotatate
• Buffer vial: 1 mL of reaction buffer solution

Neuroendocrine Tumors

Adult and pediatric dosage

• 2 MBq/kg of body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi) administered as an IV bolus injection

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Gallium Ga 68 Dotatate has severe interactions with no other drugs.
• Gallium Ga 68 Dotatate has serious interactions with no other drugs.
• Gallium Ga 68 Dotatate has moderate interactions with the following drugs:
  • lanreotide
  • octreotide
  • pasireotide
• Gallium Ga 68 Dotatate has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Gallium Ga 68 Dotatate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Gallium Ga 68 Dotatate?”

Cautions

• Radiation risk
  • Avoid close contact with infants and pregnant women during the first 12 hours after administration of Ga 68 Dotatate
  • Contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure associated with increased cancer risk
  • Ensure safe handling and preparation procedures to protect patients and healthcare workers from unintentional radiation exposure
• Risk for image misinterpretation
  • Uptake of Ga 68 Dotatate reflects somatostatin receptor density in NETs
  • Uptake can also be seen in a variety of other tumor types (eg, those derived from neural crest tissue)
  • Increased uptake might be seen in sites of splenosis or other pathologic conditions (eg, thyroid disease or subacute inflammation) or might occur as a normal physiologic variant (eg, the uncinate process of the pancreas)
  • PET images with Ga 68 Dotatate should be interpreted visually and the uptake may need to be confirmed by histopathology or other assessments to confirm the NET diagnosis
  • A negative scan after administration of Ga 68 Dotatate in patients who do not have a history of NETs, including in patients suspected of ectopic ACTH-secreting tumors, does not rule out the presence of NETs
• Drug interaction overview
  • Nonradioactive somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 Dotatate
  • Image patients with Ga 68 Dotatate PET just before dosing with long-acting analogs of somatostatin
  • Short-acting analogs of somatostatin can be used up to 24 hours before imaging with Ga 68 Dotatate
  • Corticosteroids can down-regulate somatostatin subtype 2 receptors; repeated administration of high doses of glucocorticoid before Ga 68 Dotatate administration may result in false negative imaging

Pregnancy & Lactation

• There are no studies on pregnant women to inform any drug-associated risks; however, all radiopharmaceuticals have the potential to cause fetal harm
• Lactation
  • There is no information on the presence of Ga 68 Dotatate in human milk, the effect on the breastfed infant, or the effect on milk production
  • Advise breastfeeding women to interrupt breastfeeding and pump and discard breast milk for 12 hr after administration to minimize radiation exposure to a breastfed infant