Copper histidinate

Copper histidinate is used to treat Menkes disease (a genetic disorder that affects how the body absorbs copper) in children.

Copper histidinate should not be used to treat Occipital Horn Syndrome.

Copper histidinate may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Copper histidinate is injected under the skin. A healthcare provider may give your child this injection or may teach the child's caregiver how to properly give copper histidinate. The doctor will determine the treatment schedule based on your child's age.

Read and carefully follow any Instructions for Use provided with the medicine. Ask the doctor or pharmacist if you do not understand how to use an injection.

Prepare an injection only when you are ready to give it. Be sure you understand how to properly mix this medicine with a liquid (diluent) and how to store the mixture. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not inject within 2 inches of the navel, or areas where the skin is tender, hard, red, bruised, or has scars. Do not inject into the same place two times in a row.

Your child's blood will need to be tested before and during treatment with copper histidinate. The next dose may be reduced, delayed, or permanently discontinued based on the results.

Your child may be given other medications to help prevent certain serious side effects. Keep taking these medicines for as long as your doctor has prescribed.

Store this medicine in the original carton in the refrigerator, do not freeze.

Take the vial out of the refrigerator and let it reach room temperature for 30 minutes before mixing with a diluent. Do not warm the medicine with hot water, sunlight, or a microwave.

You may save the mixture for later use at room temperature or refrigerated. If the vial is stored in the refrigerator, let it reach room temperature for 30 minutes before using.

Throw away the mixture if not used within 4 hours at room temperature or within 24 hours if refrigerated.

Do not reuse a needle, syringe, or vial. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Copper histidinate may cause copper to accumulate in the body, which can lead to serious problems in the liver, kidney, or blood. Contact the doctor if your child has swelling, is urinating less, has dark urine, jaundice (yellowing of the skin or eyes), unusual tiredness, pale skin, or shortness of breath.

Inform the doctor if your child has or has ever had:

• a blood cell disorder;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium); or
• liver or kidney disease.

Let the doctor know if your child has any health conditions or is taking other medications.

Get emergency medical help if you notice signs of an allergic reaction: hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Call the doctor immediately if the child has:

• kidney problems—swelling, urinating less, feeling tired or short of breath;
• signs of an electrolyte imbalance—increased thirst or urination, constipation, muscle weakness, leg cramps, numbness or tingling, feeling jittery, fluttering in your chest;
• signs of metabolic acidosis—confusion, vomiting, lack of energy, irregular heartbeats;
• liver problems—loss of appetite, nausea, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)—pale skin, feeling light-headed, cold hands and feet.

Common side effects of copper histidinate may include:

• fever, infection;
• trouble breathing or shortness of breath;
• seizure;
• bleeding;
• fast heart rate, feeling like you might pass out;
• vomiting, diarrhea, dehydration;
• abnormal liver function tests;
• bone fractures;
• low red blood cells (anemia); or
• pain, bruising, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Pediatric Dose for Menkes Kinky Hair Syndrome:

Less than 1 year: 1.45 mg subcutaneously 2 times a day1 year to less than 17 years: 1.45 mg subcutaneously once a dayComments:-Limitations of use: This drug is not indicated for the treatment of occipital horn syndrome.-Before starting therapy, obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count. Monitor every 6 weeks for the first 6 months, then every 3 months for the next 18 months, and every 6 months thereafter during treatment.Use: For the treatment of Menkes disease

Use the medicine as soon as you can, then wait at least 6 hours before taking the next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect copper histidinate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines your child uses.