Drax Exametazime

Drax Exametazime is a kit containing five (5) single-dose vials. Each 10 mL, clear glass vial contains a non-radioactive lyophilized mixture of: 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure.

When reconstituted with the technetium Tc 99m eluate, each vial will contain a clear, colorless, and foreign particles-free solution of 370 MBq up to 2000 MBq (10 mCi up to 54 mCi) [74 - 370 MBq / mL (2 - 10 mCi / mL)]. The radioactive solution produced will be used for leukocyte labeling before intravenous administration to the patient.

The following adverse reactions are described elsewhere in the labeling;

• Hypersensitivity reactions [see Warnings and Precautions (5.1)].

The following adverse reactions associated with the use of technetium Tc 99m exametazime have been identified in clinical trials or post-marketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Cardiovascular: transient blood pressure increase
• Skin and subcutaneous tissue disorders: rash, generalized erythema, urticaria, angioedema, pruritus.
• General disorders and administration site conditions: facial edema, fever, asthenic conditions (e.g., malaise, fatigue).
• Nervous system disorders: headache, dizziness, paraesthesia.
• Vascular disorders: flushing.
• Gastrointestinal disorders: nausea, vomiting.

Applies to exametazime: injection kit

Along with its needed effects, exametazime (the active ingredient contained in Drax Exametazime) 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 while taking exametazime:

• Fever
• flushing or redness of the skin
• rash
• swelling or puffiness of the face
• unusually warm skin

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Drax Exametazime (technetium tc 99m exametazime), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: March 7, 2018