ZYCUBO Solution for injection Ref.[116175] Active ingredients: Copper

2.1 Recommended Testing Before Initiating ZYCUBO

Before initiating ZYCUBO, obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC) [see Warnings and Precautions (5.1)].

2.2 Recommended Dosage and Administration

The recommended dosage of ZYCUBO in pediatric patients:

• Less than 1 year of age is 1.45 mg administered subcutaneously twice daily (8-12 hours between injections).
• 1 year of age to less than 17 years of age is 1.45 mg administered subcutaneously once daily.

2.3 Dosage and Administration Modifications and Monitoring

Monitor serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC) every 6 weeks for the first 6 months, then every 3 months for 18 months, and then every 6 months thereafter during ZYCUBO treatment. If laboratory abnormalities are detected, consider reducing the frequency of ZYCUBO administration or temporarily withholding or permanently discontinuing ZYCUBO. Return to increased frequency of laboratory evaluation when resuming a dosage as clinically indicated [see Warnings and Precautions (5.1)].

2.4 Preparation Instructions

Preparation:

• Use aseptic technique during preparation. Reconstitute ZYCUBO using a sterile disposable 3 mL syringe and 1 inch needle (between 16 to 22 gauge) (see Instructions for Use).
• Remove 1 ZYCUBO vial from the refrigerator and set aside for approximately 30 minutes to allow the vial to come to room temperature [20°C to 25°C (68°F to 77°F)] before use.
• Reconstitute ZYCUBO by tilting the vial and slowly injecting 1 mL of 0.9% Sodium Chloride Injection, USP down the inside wall of the vial.
• Gently swirl the vial continuously until the powder is completely dissolved. Do not shake the vial. Each vial will yield a concentration of 2.9 mg/mL.
• Visually inspect the reconstituted solution in the vial for particulate matter and discoloration. The solution should be blue. Discard if particles are present or the solution is discolored (not blue) or cloudy.
• Do not mix with other medications.

2.5 Storage of Reconstituted Solution

If the reconstituted ZYCUBO vial is not used immediately, store the vial refrigerated at 2°C to 8°C (36° to 46°F) for up to 24 hours or at controlled room temperature at 20°C to 25°C (68°F to 77°F) for up to 4 hours.

Discard the reconstituted ZYCUBO vial if not used within 24 hours of refrigeration or within 4 hours at room temperature.

2.6 Administration Instructions

A caregiver may administer ZYCUBO to patients after proper training in subcutaneous injection technique if a healthcare provider determines that it is appropriate (see Instructions for Use). Administer ZYCUBO using a sterile disposable 1 mL syringe and ½ inch injection needle (between 23 to 27 gauge).

Slowly withdraw 0.5 mL of reconstituted ZYCUBO solution from the vial and inject subcutaneously.

Administer ZYCUBO by subcutaneous injection at separate sites in the abdominal area (2 inches from the navel), buttocks, and the outer lateral aspect of the upper arm or thigh. Rotate injection sites with each injection to reduce the risk of lipodystrophy. Do not give injections into areas where the skin is scarred, tender, bruised, red, or hard.

Discard unused portion after each single use. Do not administer more than one dose from the vial.

2.7 Missed Dose

If a ZYCUBO dose is missed, administer the missed dose as soon as possible. Administer the next scheduled dose at least 6 hours after the administration of the missed dose.

Store ZYCUBO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton.

Store ZYCUBO reconstituted solution either refrigerated or at controlled room temperature [see Dosage and Administration (2.5)].