Administration and Education

1. Intravenous (IV) Infusion and Subcutaneous Injection: Omvoh is administered in two phases:
• Initially, patients receive three doses via IV infusion over at least 30 minutes at weeks 0, 4, and 8.
• After the initial IV infusions, patients are transitioned to subcutaneous injections at week 12, then every 4 weeks thereafter.

2. Patient Education: Patients need to understand that Omvoh is a treatment that requires their continued active participation, including proper storage, disposal of used needles, and maintaining medication schedules.

3. Home Administration: Patients may be taught to administer Omvoh at home through subcutaneous injections, but they must be trained on the correct preparation and injection techniques to avoid complications.

Safety Precautions

Allergic Reactions

1. Hypersensitivity Reactions: Omvoh can cause serious allergic reactions that may require hospitalization and be life-threatening. Patients with a history of serious allergic reactions needs to be monitored closely for signs of anaphylaxis.

2. Reaction Symptoms: Giant hives, swelling of the face and eyelids, difficulty breathing, and chest pain are symptoms that require immediate medical attention if they arise.

Infections

1. Immunosuppression: Omvoh can lower the immune system’s ability to fight infections, leading to an increased risk of infections. Patients should report any symptoms such as fever, muscle aches, or cough to their healthcare provider promptly.

2. TB Screening: Patients should be screened for tuberculosis (TB) before starting treatment. Those at risk for TB may require concomitant TB treatment.

Liver Problems

1. Hepatotoxicity: Omvoh may cause liver problems. Blood tests should be conducted to monitor liver enzymes and bilirubin levels before, during, and possibly after treatment.

2. Liver Symptoms: Patients should report signs such as yellowing of the skin or eyes, dark urine, nausea, fatigue, or loss of appetite to their healthcare provider quickly as these indicate potential liver problems.

Adverse Effects

1. Common Side Effects: Common side effects include upper respiratory infections, injection site reactions, arthralgia, rash, headache, and herpes viral infections.

2. Long-term Effects: In clinical trials, less than 2% of patients experienced severe side effects like Stevens-Johnson syndrome or toxic epidermal necrolysis.

Special Considerations

1. Anti-Mirikizumab-Mrkz Antibodies (ADA): There is limited data on the impact of ADA on the efficacy and safety of Omvoh. However, some patients with ADA may have reduced serum trough concentrations of mirikizumab-mrkz, which might affect treatment response.

Storage and Disposal

1. Refrigeration: Store Omvoh in the refrigerator. If needed, it can be stored at room temperature for up to 2 weeks, but not returned to the refrigerator.

2. Needle Disposal: Used needles should be disposed of in a hard, closed container that prevents them from piercing through, keeping them out of reach of children and pets.

Byline and Summary