Omvoh

— THERAPEUTIC CATEGORIES —
  • Colorectal disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Omvoh Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Mirikizumab-mrkz 20mg/mL (soln for IV infusion after dilution); 100mg/mL (soln for SC inj); preservative-free.

    Pharmacological Class

    Interleukin-23 antagonist.

    How Supplied

    Single-dose vial (15mL)—1; single-dose prefilled pen (1mL)—2

    Storage

    Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use Omvoh if it has been frozen. Do not shake. 

    Keep Omvoh in the original carton to protect from light until the time of use. Omvoh is sterile and preservative-free. Discard any unused portion.

    If needed, the prefilled pen may be stored at room temperature up to 30°C (86°F) for up to 2 weeks in the original carton to protect from light. Once Omvoh has been stored at room temperature, do not return to the
    refrigerator. If these conditions are exceeded, Omvoh must be discarded.

    The vial and prefilled pen are not made with dry natural rubber latex. 

    Manufacturer

    Eli Lilly and Company

    Generic Availability

    NO

    Mechanism of Action

    Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. By blocking its interaction with the IL-23 receptor, mirikizumab inhibits the release of pro-inflammatory cytokines and chemokines.

    Omvoh Indications

    Indications

    Moderately to severely active ulcerative colitis.

    Omvoh Dosage and Administration

    Prior to Treatment Evaluations

    Evaluate for tuberculosis (TB) infection prior to initiation.

    Obtain liver enzymes and bilirubin levels prior to initiation.

    Complete all age-appropriate vaccinations according to current immunization guidelines.

    Adult

    Induction: 300mg given by IV infusion over at least 30mins at Week 0, Week 4, and Week 8. Maintenance: 200mg (two inj of 100mg each; use different inj sites every time) given by SC inj into abdomen, thigh, and back of the upper arm at Week 12, and every 4 weeks thereafter.

    Children

    Not established.

    Administration

    • A full maintenance dose requires 2 prefilled pens. 
    • Omvoh should be administered under the supervision of a health care professional. Patients may self-inject after training.
    • Prior to injection, remove Omvoh prefilled pen from the refrigerator and leave at room temperature for 30 minutes. 
    • Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. The solution should be a clear to opalescent, colorless to slightly yellow to slighly brown solution. Do not use if it is cloudy or there are visible particles.
    • Inject into abdomen, thigh, and back of the upper arm. Rotate injection sites.
    • Avoid injection sites where the skin is tender, bruised, erythematous, or indurated.
    • Omvoh is preservative-free.

    Omvoh Contraindications

    Not Applicable

    Omvoh Boxed Warnings

    Not Applicable

    Omvoh Warnings/Precautions

    Warnings/Precautions

    Discontinue if serious hypersensitivity reaction occurs; treat appropriately. May increase risk of infections. Active infection: do not initiate until resolves or treated. Chronic or history of recurrent infection: consider the risks/benefits. If a serious infection develops or is not responding to standard therapy, monitor closely and discontinue until resolves. Evaluate for tuberculosis (TB) infection prior to initiating. History of latent or active TB (without confirmed adequate treatment); consider anti-TB therapy prior to initiation. Monitor for active TB during and after therapy. Patients with active TB infection: do not initiate. Obtain liver enzymes, bilirubin at baseline and for at least 24 weeks of treatment. Interrupt therapy if drug-induced liver injury is suspected. Consider alternative treatment in those with evidence of liver cirrhosis. Complete all age-appropriate immunizations according to current guidelines prior to initiation. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • Pregnant women exposed to Omvoh and health care providers are encourages to call Eli Lilly and Company at 1-800-Lilly-Rx (1-800-545-5979).

    Risk Summary

    • Available data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
    • While there are no data on mirikizumab-mrkz, monoclonal antibodies can be actively transported across the placenta, and may cause immunosuppression in the in utero-exposed infant.

    Clinical Considerations

    • Disease-associated maternal and embryo/fetal risk: Published data suggest that the risk of adverse pregnancy outcomes in women with IBD is associated with increased disease activity. Adverse outcomes include preterm delivery, low birth weight infants, and small for gestational age at birth.
    • Fetal/Neonatal Adverse Reactions: Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Consider the risks and benefits of mirikizumab-mrkz prior to administering live vaccines to infants exposed to Omvoh in utero. A minimum of 2 months should be considered as a timeframe to delay live virus immunizations in infants exposed in utero.

    Nursing Mother Considerations

    Risk Summary

    • No available data on the presence of mirikizumab-mrkz in human milk, the effects on the breastfed infant, or the effects on milk production.
    • Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. 
    • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Omvoh and any potential adverse effects on the breastfed infant from Omvoh or from the underlying maternal condition.

    Pediatric Considerations

    Safety and efficacy have not been established in pediatric patients.

    Geriatric Considerations

    No clinically meaningful differences in the pharmacokinetics of mirikizumab-mrkz were observed in subjects 65 years of age and older compared to younger adult subjects.

    Omvoh Pharmacokinetics

    Absorption

    Median Tmax: 5 days (range, 3.08–6.75). Geometric mean (CV%) absolute bioavailability: 44% (34%).

    Distribution

    Geometric mean (CV%) total volume of distribution: 4.83 L (21%).

    Metabolism

    Catabolic pathways.

    Elimination

    Half-life: 9.3 days. Geometric mean (CV%) clearance: 0.0229 L/hours (34%). 

    Omvoh Interactions

    Interactions

    Avoid use of live vaccines.

    Omvoh Adverse Reactions

    Adverse Reactions

    Upper respiratory tract infections, arthralgia, inj site reactions, rash, headache, herpes viral infection; hypersensitivity reactions, hepatotoxicity.

    Omvoh Clinical Trials

    Clinical Trials

    The approval was based on 2 randomized, double-blind, placebo-controlled studies, the LUCENT-1 induction study (ClinicalTrials.gov Identifier: NCT03518086) and the LUCENT-2 maintenance study (ClinicalTrials.gov Identifier: NCT03524092). The 12-week intravenous (IV) induction study was followed by the 40-week subcutaneous (SC) randomized withdrawal maintenance study. The clinical trial program included adult patients with moderately to severely active UC who had an inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, 6-mercaptopurine, azathioprine, biologic therapy (TNF blocker, vedolizumab), or tofacitinib.

    In the induction study, 1062 patients were randomly assigned to receive mirikizumab (n=795) or placebo (n=267) by IV infusion at week 0, 4 and 8. The primary endpoint was clinical remission at week 12 (defined as stool frequency subscore = 0 or 1, rectal bleeding subscore = 0, and centrally read endoscopy subscore = 0 or 1 [excluding friability]).

    Results showed a significantly greater proportion of patients treated with mirikizumab achieved clinical remission compared with placebo (24% vs 15%; treatment difference, 10%; P <.001). The trial also met key secondary endpoints including clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement with mirikizumab vs placebo (all P <.001).

     

    Omvoh Note

    Not Applicable

    Omvoh Patient Counseling

    Patient Counseling

    Hypersensitivity Reactions

    • Discontinue Omvoh and seek immediate medical attention if patients experience any symptoms of serious hypersensitivity reactions.

    Infections

    • Use of Omvoh may lower the ability of the immune system to fight infections. Contact your health care provider immediatley if symptoms of infection develop.

    Tuberculosis

    • Contact your health care provider if symptoms suggestive of TB develop (eg, unexplained fever, cough, or difficulty breathing).

    Hepatotoxicity

    • Use of Omvoh may cause liver injury. Seek medical attention if symptoms suggestive of liver dysfunction develop (eg, unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine).

    Immunizations

    • Live vaccines are not recommended during Omvoh treatment and immediately prior to or after Omvoh treatment.

    Pregnancy

    • Contact Eli Lilly and Company if exposed to Omvoh during pregnancy.

    Cost Savings Program

    Omvoh Savings Program

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