Copper CU 64 Dotatate

Copper CU 64 Dotatate is a radioactive diagnostic agent used with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

• Copper CU 64 Dotatate is available under the following different brand names: Detectnet 

Common side effects of Copper CU 64 Dotatate include:

• Nausea,
• Vomiting, and
• Flushing

Serious side effects of Copper CU 64 Dotatate include:

• 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 

Rare side effects of Copper CU 64 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 dosage

Injection, solution

• 148 MGq (4mCi)/vial (37 MBq [1 mCi]/mL)

Neuroendocrine Tumors

Adult dosage

• 148 MBq (4 mCi) IV bolus over approximately 1 minute

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.

• Copper CU 64 Dotatate has severe interactions with no other drugs.
• Copper CU 64 Dotatate has serious interactions with noother drugs.
• Copper CU 64 Dotatate has moderate interactions with the following drugs:
  • lanreotide
  • octreotide
  • pasireotide
• Copper CU 64 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 health care 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 Copper CU 64 Dotatate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Copper CU 64 Dotatate?”

Cautions

• Hypersensitivity reactions consisting of cutaneous reactions such as rash and pruritus reported; reactions reversed either spontaneously or with routine symptomatic management; less frequently hypersensitivity reactions included angioedema or cases with features of anaphylaxis
• Radiation risk
  • Contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure is 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 copper CU 64 Dotatate reflects somatostatin receptor density in NETs
  • Uptake can also be seen in a variety of other tumor types that express somatostatin receptors (. g, thyroid disease) or in subacute inflammation, or a normal physiologic variant (. g, the uncinate process of the pancreas)
  • Uptake may need to be confirmed by histopathology or other assessments to confirm the NET diagnosis
• Drug interaction overview
  • Nonradioactive somatostatin analogs competitively bind to the same somatostatin receptors as copper CU 64 Dotatate
  • Long-acting somatostatin analogs: 28-day washout period recommended before imaging
  • Short-acting somatostatin analogs: 2-day washout period recommended before imaging

Pregnancy and Lactation

• There are no studies on pregnant females to inform any drug-associated risks; however, all radiopharmaceuticals have the potential to cause fetal harm
• Assess pregnancy status in females of reproductive potential before administering
• Lactation
  • There is no information on the presence of copper CU 64 Dotatate in human milk, the effect on the breastfed infant, or the effect on milk production
  • Advise breastfeeding females to interrupt breastfeeding and pump and discard breast milk for 12 hours after administration to minimize radiation exposure to a breastfed infant.