Version May 2024
Dosage guidance:
Safety: Obtain baseline liver chemistries, administer age-appropriate vaccinations, and screen for tuberculosis infection prior to starting mirikizumab. Therapy should not be initiated or continued in patients with untreated, active infections.
Ulcerative colitis:
Induction: IV: 300 mg at weeks 0, 4, and 8.
Maintenance: SUBQ: 200 mg (given as 2 consecutive 100 mg injections) at week 12, then every 4 weeks thereafter.
Missed dose: If dose is missed, administer as soon as possible and then resume every-4-week dosing.
There are no dosage adjustments provided in the manufacturer's labeling; no clinically significant pharmacokinetic differences were observed in patients with CrCl 30 to 89 mL/minute.
Hepatic impairment prior to treatment initiation: There are no dosage adjustments provided in the manufacturer's labeling.
Acute hepatotoxicity during treatment: If mirikizumab-induced liver injury is suspected, interrupt therapy until diagnosis is excluded.
Criteria for interrupting therapy in the phase 3 clinical trial included: ALT/AST >8 × ULN or ALT/AST >5 × ULN for >2 weeks or ALT/AST >3 × ULN and one of the following: total bilirubin >2 × ULN, INR >1.5, or symptoms present (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, eosinophilia) or alkaline phosphatase (ALP) >3 × ULN or ALP >2.5 × ULN and one of the following: total bilirubin >2 × ULN or symptoms present (eg, fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, eosinophilia) (Ref).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Infection: Infection (15% to 24%)
Respiratory: Upper respiratory tract infection (8% to 14%)
1% to 10%:
Dermatologic: Skin rash (4%)
Infection: Herpes virus infection (2%)
Local: Injection-site reaction (9%; including erythema at injection site, hypersensitivity reaction at injection site, pain at injection site, urticaria at injection site)
Nervous system: Headache (4%)
Neuromuscular & skeletal: Arthralgia (2% to 7%)
<1%: Hepatic: Increased serum alanine aminotransferase (≥5 × ULN), increased serum aspartate aminotransferase (≥5 × ULN)
Frequency not defined:
Hepatic: Increased serum bilirubin
Hypersensitivity: Infusion-related reaction, severe hypersensitivity reaction (including anaphylaxis)
Serious hypersensitivity reaction to mirikizumab or any component of the formulation.
Concerns related to adverse effects:
• Hepatotoxicity: A single case of mirikizumab-induced liver injury was observed in 1 patient who continued induction for longer than recommended. The patient experienced an ALT 18 × ULN, AST 10 × ULN, and total bilirubin 2.4 × ULN. Following discontinuation, transaminases returned to baseline.
• Hypersensitivity reactions: Hypersensitivity, including anaphylaxis, mucocutaneous erythema, and pruritus during the IV infusion, has been reported. Discontinue immediately with signs/symptoms of hypersensitivity reaction and treat appropriately as indicated.
• Infections: May increase the risk for infections and use should be avoided until active infection resolves or is adequately treated.
• Tuberculosis: Do not use in patients with tuberculosis (TB) disease (active TB). Patients should be evaluated for TB infection (latent TB). Treatment of TB infection should be initiated before mirikizumab therapy is used. Consider anti-TB treatment in patients with a history of TB infection or disease if an adequate prior treatment course cannot be confirmed.
Disease-related concerns:
• Preexisting liver cirrhosis: Consider other treatment options.
Other warnings/precautions:
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should be avoided during therapy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Omvoh: Mirikizumab-mrkz 300 mg/15 mL (20 mg/mL) (15 mL) [contains polysorbate 80]
Solution Auto-injector, Subcutaneous:
Omvoh: Mirikizumab-mrkz 100 mg/mL (1 mL) [contains polysorbate 80]
No
Solution (Omvoh Intravenous)
300 mg/15 mL (per mL): $767.46
Solution Auto-injector (Omvoh Subcutaneous)
100 mg/mL (per mL): $6,216.40
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Omvoh: Mirikizumab-mrkz 300 mg/15 mL (20 mg/mL) (15 mL) [contains polysorbate 80]
Solution Auto-injector, Subcutaneous:
Omvoh: Mirikizumab-mrkz 100 mg/mL (1 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Omvoh: 100 mg/mL (1 mL) [contains polysorbate 80]
IV: Administer over at least 30 minutes. Do not mix or infuse with other medications. At the end of the infusion, flush the line with NS or D5W.
SUBQ: Before injection, remove prefilled syringes from the refrigerator and leave at room temperature for 30 minutes. Do not shake. May inject into the abdomen, thigh, or back of the upper arm. Rotate injection sites to complete the dose (eg, administer first injection in the abdomen and second injection in the thigh to complete the full dose). Do not inject into tender, bruised, erythematous, or indurated areas.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Omvoh: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761279s000lbl.pdf#page=15
Ulcerative colitis: Treatment of moderately to severely active ulcerative colitis in adults.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Mirikizumab is a humanized monoclonal antibody (IgG4) variant. Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Data collection to monitor pregnancy and infant outcomes following exposure to mirikizumab is ongoing. Health care providers are encouraged to enroll patients exposed to mirikizumab during pregnancy in the pregnancy registry (800-545-5979).
It is not known if mirikizumab is present in breast milk.
Mirikizumab is a humanized monoclonal antibody (IgG4) variant. Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Prior to initiation: Obtain liver transaminases and bilirubin level, ensure age-appropriate vaccinations have been administered according to current immunization guidelines, and evaluate for tuberculosis (TB) infection.
During therapy: Monitor for hypersensitivity reactions (especially during induction). Evaluate liver transaminases periodically for at least 24 weeks of treatment then as needed; the phase 3 clinical trial used the following monitoring algorithm if abnormalities detected: if ALT ≥3 × ULN, alkaline phosphatase ≥2 × ULN, or total bilirubin ≥2 × ULN, repeat testing within 3 to 5 days and continue monitoring until levels normalize or return to baseline values (Ref); monitor for signs/symptoms of TB disease.
Following therapy: Monitor for signs/symptoms of TB disease.
Mirikizumab 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. IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets and innate immune cell subsets. Mirikizumab inhibits the release of proinflammatory cytokines and chemokines.
Distribution: Vd: 4.83 L.
Metabolism: Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Bioavailability: 44% (SUBQ).
Half-life elimination: 9.3 days.
Time to peak: 5 days (SUBQ).
Excretion: Clearance: 0.0229 L/hour.
Body weight ≥90 kg: In patients with body weight ≥90 kg estimated geometric mean concentration of mirikizumab was 20% lower (after 300 mg IV dose) and 38% lower (after 200 mg SUBQ dose) than subjects weighing <90 kg. Clinical response did not differ between patients weighing <90 kg or ≥90 kg.
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