Omvoh Dosage

Recommended Evaluations and Immunizations Prior to Treatment Initiation

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

Important Administration Instructions

• The 200 mg/2 mL prefilled pen and prefilled syringe are only for maintenance treatment of Crohn's disease.

Recommended Dosage for Ulcerative Colitis

Recommended Dosage for Crohn's Disease

Preparation and Administration Instructions for Intravenous Infusion

1. OMVOH for intravenous use is intended for administration by a healthcare provider using aseptic technique.
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. ​Prior to intravenous administration, determine the dose needed based on the patient's indication (see Table 1 below). For Crohn's disease, discard 45 mL of the infusion bag prior to adding vial contents. Withdraw the required amount of solution from the vial(s) using a 18 gauge to 21 gauge needle and transfer to an infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection (see Table 1 below). Do not mix with other drugs. Do not dilute or infuse through the same intravenous line with other solutions.

   Table 1: Intravenous Induction Dose and Volume of Diluent Required

   ​Indication	Intravenous Induction Dose	Number of OMVOH 300mg/15mL vials needed	Volume of 0.9% Sodium Chloride or 5% Dextrose Injection
   ​Ulcerative colitis	300 mg	1	50 mL, 100 mL, or 250 mL
   ​Crohn's disease	900 mg	3	100 mL or 250 mL

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. Infuse the diluted solution intravenously over a period of at least 30 minutes for the 300 mg dose; at least 90 minutes for the 900 mg dose. If stored refrigerated, allow the diluted solution in the infusion bag to warm to room temperature prior to the start of the intravenous infusion.
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.

Preparation and Administration Instructions for Subcutaneous Injection

• ​A full maintenance dose will require 2 prefilled pens or 2 prefilled syringes given as two consecutive injections, in any order.
• 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 pens or OMVOH prefilled syringes from the refrigerator and leave at room temperature for 30 minutes if using the carton containing 100 mg/mL + 100 mg/mL or 45 minutes if using the carton containing 200 mg/2 mL + 100 mg/mL.
• ​Do not shake the prefilled pens or prefilled syringes.
• 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, discolored, 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. Administration of OMVOH in the back of upper arm may only be performed by another person.
• 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.