Drug Guide
Mirikizumab-mrkz
Classification
Therapeutic: Antirheumatic, Disease-Modifying Antirheumatic Drug (DMARD)
Pharmacological: Monoclonal antibody (IL-23 inhibitor)
FDA Approved Indications
- Ulcerative colitis
Mechanism of Action
Mirikizumab is a monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23), inhibiting its interaction with the IL-23 receptor and consequently reducing inflammation associated with ulcerative colitis.
Dosage and Administration
Adult: The recommended dose is 180 mg administered as an intravenous infusion at weeks 0, 4, and then every 8 weeks thereafter.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dosage adjustments required; monitor elderly patients closely due to potential for increased susceptibility to infections.
Renal Impairment: No specific adjustments recommended.
Hepatic Impairment: No specific adjustments recommended.
Pharmacokinetics
Absorption: Administered via IV infusion; systemic absorption details are not applicable.
Distribution: Limited data, but as a monoclonal antibody, it primarily remains in the vascular and extracellular spaces.
Metabolism: Metabolized via proteolytic catabolism into peptides and amino acids.
Excretion: Excreted through normal proteolytic pathways; no renal or hepatic clearance data suggest significant elimination via these routes.
Half Life: Approximately 15 to 20 days.
Contraindications
- Hypersensitivity to mirikizumab or any excipients.
- Active infections.
Precautions
- Monitor for infections during therapy.
- Consider risk of immunosuppression; assess for latent infections before initiation.
Adverse Reactions - Common
- Upper respiratory infections (Frequent)
- Headache (Frequent)
- Injection site reactions (Common)
Adverse Reactions - Serious
- Serious infections (Uncommon)
- Hypersensitivity reactions (Rare)
- Malignancies (Rare)
Drug-Drug Interactions
- Other immunosuppressants or biologics—monitor for increased risk of infection or immunosuppression.
Drug-Food Interactions
- No specific interactions identified.
Drug-Herb Interactions
- Limited data; use caution with herbal supplements that affect immunity.
Nursing Implications
Assessment: Monitor for signs of infection, allergic reactions, and response to therapy.
Diagnoses:
- Risk for infection
- Impaired skin integrity at injection site
Implementation: Administer as prescribed; monitor patient closely after infusion for adverse reactions; educate patient on infection signs.
Evaluation: Assess effectiveness via symptom reduction, monitor for adverse effects.
Patient/Family Teaching
- Report any signs of infection immediately.
- Keep all follow-up appointments.
- Inform about possible side effects, including signs of allergic reactions or infections.
Special Considerations
Black Box Warnings:
- Serious infections, including tuberculosis and invasive fungal infections, have been reported with IL-23 inhibitors.
Genetic Factors: No specific genetic markers required for use.
Lab Test Interference: No known interference with routine lab tests.
Overdose Management
Signs/Symptoms: Unknown; monitor for adverse reactions and manage supportively.
Treatment: Supportive care, no specific antidote.
Storage and Handling
Storage: Store vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.
Stability: Stable for the duration of the labeled shelf life when stored properly.