Omvoh (mirikizumab-mrkz)

No dosing information is available for this tab.

Mirikizumab-mrkz is sterile and preservative free. Discard any unused portion.

Store mirikizumab-mrkz refrigerated at 2 to 8degreesC. Do not freeze; do not use mirikizumab-mrkz if it has been frozen. Keep mirikizumab-mrkz in the original carton to protect from light until ready to use.

No dosing information is available for this tab.

There have been no drug-drug interaction studies conducted in patients with ulcerative colitis at the recommended dosage.

Because mirikizumab-mrkz is a monoclonal antibody expected to be metabolized by proteolytic degradation to peptides and amino acids, it is not likely to have any direct effect on drug-metabolizing enzymes.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Immunosuppressive Agents/Live Vaccines; Live Bcg

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Igg Antibodies And Derivatives/Rozanolixizumab-Noli

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

*History of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

• Active tuberculosis

• Hepatic cirrhosis
• Inactive tuberculosis
• Infection

There are no moderate contraindications for this drug.

Induction in ulcerative colitis: The most common adverse effects of mirikizumab-mrkz (>=2% of patients) reported in clinical studies include upper respiratory tract infections and arthralgia.

Maintenance in ulcerative colitis: The most common adverse effects of mirikizumab-mrkz (>=2% of patients) reported in clinical studies include upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.

The most common adverse effects of mirikizumab-mrkz (>=5% of patients) reported in clinical studies of Crohn's disease include upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.

Less Frequent

• Herpes simplex infection
• Infection

Rare or Very Rare

• Increased alanine transaminase
• Increased aspartate transaminase

More Frequent

• Arthralgia
• Injection site sequelae
• Upper respiratory infection

Less Frequent

• Herpes zoster
• Skin rash
• Urticaria

Rare or Very Rare

• Headache disorder

No enhanced messaging available.

Safety and effectiveness of mirikizumab-mrkz in pediatric patients have not been established.

There is insufficient evidence with mirikizumab-mrkz in pregnant females to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks of adverse pregnancy outcomes associated with increased disease activity in females with inflammatory bowel disease. Adverse pregnancy outcomes associated with increased disease activity include preterm delivery (before 37 weeks' gestation), low birth weight (less than 2500 grams), and small for gestational age at birth.

An enhanced pre- and post-natal development study conducted in pregnant monkeys during organogenesis to parturition at a dose 69 times the maximum recommended human dose revealed no adverse developmental effects to the developing fetus or harm to infant monkeys from birth through 6 months of age. No mirikizumab-mrkz-related effects on morphological, function, or immunological development were observed. The incidence of embryo/fetal loss was higher in the treated groups compared to controls but were within the range of historical control data. Following delivery, most adult female monkeys and all infants from the mirikizumab-mrkz-treated group had measurable serum concentrations up to 28 days postpartum. In the infant monkeys, mean serum concentrations were approximately 4.8 times the respective mean maternal concentrations.

Although there are no data on mirikizumab-mrkz, monoclonal antibodies can be actively transported across the placenta, and mirikizumab-mrkz may cause immunosuppression in the in utero-exposed infant. Transport of endogenous immunoglobulin G (IgG) antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester. Because mirikizumab-mrkz may interfere with the immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to mirikizumab-mrkz in utero. There are no data regarding infant serum levels of mirikizumab-mrkz at birth and the duration of persistence of mirikizumab-mrkz in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 2 months after birth should be considered because of the half-life of the product.

There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to mirikizumab-mrkz during pregnancy. Pregnant females exposed to mirikizumab-mrkz and clinicians are encouraged to contact the manufacturer at 1-800-545-5979.

There are no data on the presence of mirikizumab-mrkz in human milk, the effects on the breast-fed infant, or the effects on milk production. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk. The effects of local GI exposure and limited systemic exposure in the breast-fed infant to mirikizumab-mrkz are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mirikizumab-mrkz and any potential adverse effects on the breast-fed child from mirikizumab-mrkz or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Of the 795 mirikizumab-mrkz-treated patients in two ulcerative colitis clinical trials, 64 patients (8%) were 65 years of age and older, while 10 patients (1%) were 75 years of age and older. Of the 715 mirikizumab-mrkz-treated patients in a Crohn's disease clinical trial, 22 patients (3%) were 65 years of age and older, while 6 patients (1%) were 75 years of age and older. These clinical studies did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. No clinical meaningful differences in the pharmacokinetics of mirikizumab-mrkz were observed in patients 65 years of age and older compared to younger adult patients.