Mirikizumab-mrkz

Mirikizumab-mrkz
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rithish Nimmagadda,MBBS.[2]

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Overview

Mirikizumab-mrkz is a interleukin-23 antagonist that is FDA approved for the treatment of moderately to severely active ulcerative colitis in adults. Common adverse reactions include Most common adverse reactions (≥2%) in the induction study: upper respiratory tract infections and arthralgia.

Most common adverse reactions (≥2%) in the maintenance study: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Prior to treatment initiation, evaluate patients for tuberculosis (TB) infection, obtain appropriate tests (i.e., liver enzymes, bilirubin levels), and complete all age-appropriate vaccinations according to current immunization guidelines.

The recommended induction dosage is 300 mg administered by IV infusion over at least 30 minutes at Weeks 0, 4, and 8.

The recommended maintenance dosage is 200 mg administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter.

See the full prescribing information for preparation, administration, and storage information for IV infusion and subcutaneous injection

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Mirikizumab-mrkz FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

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

Warnings

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis during IV infusion, have been reported with mirikizumab administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue mirikizumab immediately and initiate appropriate treatment.

Infections

Mirikizumab may increase the risk of infection.

Do not initiate treatment with mirikizumab in patients with a clinically important active infection until the infection resolves or is adequately treated. [ref]

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing mirikizumab. [ref] Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. [ref] If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer mirikizumab until the infection resolves. [ref]

Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with mirikizumab.

Do not administer mirikizumab to patients with active TB infection. Initiate treatment of latent TB prior to administering mirikizumab. Consider anti-TB therapy prior to initiation of mirikizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after mirikizumab treatment.

In clinical trials, subjects were excluded if they had evidence of active TB, a past history of active TB, or were diagnosed with latent TB at screening.

Hepatotoxicity

A case of drug-induced liver injury (alanine aminotransferase [ALT] 18 times the upper limit of normal (ULN), aspartate aminotransferase [AST] 10 times the ULN, and total bilirubin 2.4 times the ULN) in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. [ref] Mirikizumab was discontinued. Liver test abnormalities eventually returned to baseline.

Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. [ref] Monitor thereafter according to routine patient management.

Consider other treatment options in patients with evidence of liver cirrhosis. [ref] Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

Immunizations

Avoid use of live vaccines in patients treated with mirikizumab. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with mirikizumab, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with mirikizumab.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Mirikizumab-mrkz Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Mirikizumab-mrkz Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Mirikizumab-mrkz Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Mirikizumab-mrkz in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mirikizumab-mrkz in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Mirikizumab-mrkz during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Mirikizumab-mrkz in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Mirikizumab-mrkz in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Mirikizumab-mrkz in geriatric settings.

Gender

There is no FDA guidance on the use of Mirikizumab-mrkz with respect to specific gender populations.

Race

There is no FDA guidance on the use of Mirikizumab-mrkz with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Mirikizumab-mrkz in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Mirikizumab-mrkz in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Mirikizumab-mrkz in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Mirikizumab-mrkz in patients who are immunocompromised.

Administration and Monitoring

Administration

Prior to treatment initiation, evaluate patients for tuberculosis (TB) infection, obtain appropriate tests (i.e., liver enzymes, bilirubin levels), and complete all age-appropriate vaccinations according to current immunization guidelines.

The recommended induction dosage is 300 mg administered by IV infusion over at least 30 minutes at Weeks 0, 4, and 8.

The recommended maintenance dosage is 200 mg administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter.

See the full prescribing information for preparation, administration, and storage information for IV infusion and subcutaneous injection.

Monitoring

There is limited information regarding Mirikizumab-mrkz Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Mirikizumab-mrkz and IV administrations.

Overdosage

There is limited information regarding Mirikizumab-mrkz overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Mirikizumab-mrkz Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Mirikizumab-mrkz Mechanism of Action in the drug label.

Structure

There is limited information regarding Mirikizumab-mrkz Structure in the drug label.

Pharmacodynamics

There is limited information regarding Mirikizumab-mrkz Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Mirikizumab-mrkz Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Mirikizumab-mrkz Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Mirikizumab-mrkz Clinical Studies in the drug label.

How Supplied

There is limited information regarding Mirikizumab-mrkz How Supplied in the drug label.

Storage

There is limited information regarding Mirikizumab-mrkz Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Mirikizumab-mrkz Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Mirikizumab-mrkz interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

Omvoh®

Look-Alike Drug Names

There is limited information regarding Mirikizumab-mrkz Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.