Copper Histidinate Injection

Copper histidinate injection is used for the treatment of Menkes disease (an inherited disease in which the body has a problem processing copper in the body). Copper histidinate is in a class of medications called copper replacement agents. It works by providing copper throughout the body.

Copper histidinate injection comes as a powder for injection. It is given subcutaneously (under the skin) once or twice a day by a healthcare provider or you may be given the medication to use at home.

A caregiver will be shown how to prepare the solution and inject the medicine. You will also be given the instructions for use. Read these carefully. Talk to your doctor or pharmacist if you have any questions on how to give the medicine.

Remove the vial from the refrigerator about 30 minutes before you plan to prepare it. You will need to add a liquid to the powder in the vial to make a solution. Do not shake the solution. If you do not use the solution immediately, store in the refrigerator for up to 24 hours or for 4 hours at room temperature. If not used within these times, discard the solution.

You can inject copper histidinate injection anywhere in your buttocks, the outer part of your arm or thigh, or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. Do not inject into an area where the skin is tender, bruised, red, or hard, or where there are scars. Discard any remaining solution in the vial after use. Do not give more than one dose from each vial.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using copper histidinate,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using copper histidinate, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Give the missed dose as soon as you remember it. Then give the next dose at least 6 hours later. Do not use a double dose to make up for a missed one.

Copper histidinate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, redness, swelling at the place of injection
• vomiting, diarrhea

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• seizure
• shortness of breath
• sore throat, cough, fever, chills, burning or pain when urinating, and other signs of infection
• fast heartbeat

Copper histidinate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator until the expiration date on the carton.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to copper histidinate.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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