Omvoh Dosage

Recommended Evaluations and Immunizations Prior to Treatment Initiation

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with OMVOH [see Warnings and Precautions (5.3)].
• Obtain liver enzymes and bilirubin levels prior to initiating treatment with OMVOH [see Warnings and Precautions (5.4)].
• Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.5)].

Recommended Dosage

Preparation and Administration of OMVOH for Intravenous Infusion

1. OMVOH for intravenous use is intended for administration by a healthcare provider using aseptic technique. Each vial is for single use only.
2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be a clear to opalescent, colorless to slightly yellow to slightly brown solution, and free of visible particles. Do not use OMVOH if it is cloudy or there are visible particles.
3. Using an 18 to 21 gauge needle withdraw 15 mL of OMVOH solution from the vial and transfer to an infusion bag ranging in size from 50 mL to 250 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection. Do not mix with other drugs. Do not dilute or infuse through the same intravenous line with solutions other than 0.9% Sodium Chloride or 5% Dextrose Injection.
4. Gently invert the infusion bag to mix the contents. Do not shake the prepared infusion bag.
5. Connect the intravenous administration set (infusion line) to the prepared infusion bag and prime the line.
6. Administer the infusion over at least 30 minutes.
7. At the end of the infusion, flush the line with 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
   • Administer the flush at the same infusion rate as used for OMVOH administration.
   • The time required to flush OMVOH solution from the infusion line is in addition to the minimum 30-minute infusion time.

Storage of Diluted Solution

• Start the infusion immediately after preparation. If not used immediately, store the diluted infusion solution in the refrigerator at 2°C to 8°C (36°F to 46°F). Use the diluted infusion solution within 48 total hours, of which not more than 5 hours are permitted at non-refrigerated temperatures not to exceed 25°C (77°F), starting from the time of vial puncture.
• Keep drug product away from direct heat or light. Do not freeze the diluted solution in the prepared infusion bag.

Preparation and Administration of OMVOH for Subcutaneous Injection

• A full maintenance dose will require 2 prefilled pens.
• OMVOH is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject OMVOH after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of OMVOH according to the “Instructions for Use”, included with the packaged product.
• Before injection, remove OMVOH prefilled pen from the refrigerator and leave at room temperature for 30 minutes. Do not shake the prefilled pens.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be a clear to opalescent, colorless to slightly yellow to slightly brown solution, and free of visible particles. Do not use OMVOH if it is cloudy or there are visible particles.
• Sites for injection include the abdomen, thigh, and back of the upper arm. Instruct patients to inject in a different location every time. For example, if the first injection was in the abdomen, administer the second injection (to complete a full dose) in another area of the abdomen, or upper arm, or thigh.
• Do not inject into areas where the skin is tender, bruised, erythematous, or indurated.
• OMVOH does not contain preservatives; therefore, discard any unused product. Do not reuse.
• If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing every 4 weeks.