Description
Copper histidinate injection is used to treat Menkes disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zycubo® in children. Safety and efficacy have been established.
Geriatric
Use of Zycubo® is not indicated for elderly patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Blood problems or
- Kidney disease or
- Liver disease—Use with caution. May make these conditions worse.
Proper Use
Your child's doctor will prescribe the exact dose and tell you how often it should be given. It is given as a shot under the skin, usually on the upper arms, buttocks, stomach, or thighs.
Copper histidinate injection may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your child's doctor or nurse will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected
Use a different body area each time you give your child an injection. Keep track of where you give each injection to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, hard, or has scars.
This medicine comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
To use:
- Wash your hands with soap and water before and after using this medicine.
- Allow 30 minutes for the vial to warm up to room temperature. Do not warm using heat sources (eg, hot water, microwave).
- Do not mix the medicine with anything other than 0.9% sodium chloride.
- Remove the flip-off cap. Clean the rubber stopper of each vial.
- Pull the needle cover straight off. Do not touch the needle.
- Hold the syringe barrel with one hand. Using your other hand, draw air into the syringe by pulling back on the plunger rod until the top of the plunger lines up with 1 milliliters (mL) on the syringe.
- Insert the needle into the center of sodium chloride vial. Turn it upside down. Slowly push up on the plunger rod to push all the air from the syringe to the vial. Slowly pull down on the plunger rod until the top of the plunger reaches 1 mL mark on the syringe.
- Gently tap the syringe barrel to remove air bubbles. Remove the needle and syringe from the sodium chloride vial.
- Insert the syringe with sodium chloride into the Zycubo® vial stopper. Tilt the vial so the tip of the needle is pointing toward the inside wall of the vial.
- Slowly push the plunger rod all the way down. Remove the needle from the vial. Gently swirl the vial until powder is completely dissolved. Do not shake the vial. Check the liquid in the vial. It should be blue. Do not use it if it is cloudy, or has particles in it.
- Gently pinch the skin. Insert the needle at a 45 degree angle. Push the plunger rod all the way down. Pull the needle and let go of the skin.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (vial):
- For Menkes disease:
- Children 1 to less than 17 years of age—1.45 milligrams (mg) injected under the skin once a day.
- Children younger than 1 year of age—1.45 mg injected under the skin 2 times a day.
- For Menkes disease:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Wait at least 6 hours to give another dose after injecting the missed dose.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Before mixing the medicine: Keep the medicine in the original carton until you are ready to use it.
After mixing the medicine: If you do not use the mixture right away after mixing, you may store in the refrigerator and use it within 24 hours. Throw away unused medicine after 24 hours if stored in the refrigerator. You may also store it at room temperature and use it within 4 hours. Throw away unused medicine after 4 hours if stored at room temperature.
Throw the vial away after use, even if there is medicine left. Do not save for later use.
Throw away used syringes and needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your child's doctor check your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious kidney problems. Check with the doctor right away if your child has bloody or cloudy urine, difficult or painful urination, or sudden decrease in amount of urine.
Check with the doctor right away if your child has pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause anemia. Check with the doctor right way if your child has pale skin, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.
Side Effects
Along with its needed effects, a medicine 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 immediately if any of the following side effects occur:
More common
- Bladder pain
- bleeding gums
- bloody or cloudy urine
- blurred vision
- chest pain, discomfort, or tightness
- cold flu-like symptoms
- confusion
- cough
- coughing up blood
- diarrhea
- difficult, burning, or painful urination
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- fracture
- frequent urge to urinate
- headache
- increased menstrual flow or vaginal bleeding
- lower back or side pain
- nosebleeds
- pale skin
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- sneezing
- sore throat
- sweating
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Incidence not known
- Dark urine
- light-colored stools
- nausea
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008615
