Mirikizumab

Mirikizumab is a prescription medication indicated for the treatment of moderately to severely active ulcerative colitis in adults.

• Mirikizumab is available under the following different brand names: Omvoh, mirikizumab-mrkz

Common side effects of Mirikizumab include:

• upper respiratory tract infections (nose and throat infections)
• headache
• rash and reactions at the site of injection (when given by injection under the skin)

Serious side effects of Mirikizumab include:

• serious allergic reactions include - fainting, dizziness, feeling lightheaded (low blood pressure)
• trouble breathing, throat tightening or wheezing
• fast heartbeat or pounding in your chest (tachycardia)
• swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing
• chest tightness
• severe itching, hives, or redness all over the body
• sweating
• infections include- fever, sweating, or chills, flu-like symptoms, diarrhea, or stomach pain, muscle aches and pain, headache, weight loss, cough or shortness of breath, warm, red, or painful skin or nausea or vomiting, blood in the mucus (phlegm) sores on the body, pain during urination
• liver problems

Rare side effects of Mirikizumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution for IV

• 20 mg/mL (300 mg/15 mL single-dose vial)

Injectable SC solution

• 100 mg/mL single-dose prefilled pen

Ulcerative colitis

Adult dosage

• IV induction dose: 300 mg IV infusion over 30 minutes at weeks 0, 4, and 8
• SC maintenance dose: 200 mg SC (ie, 2 consecutive 100-mg injections) at week 12, and every 4 weeks thereafter

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Mirikizumab has no noted severe interactions with any other drugs
• Mirikizumab has no noted serious interactions with any other drugs
• Mirikizumab has no noted moderate interactions with any other drugs
• Mirikizumab has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity reaction to Mirikizumab or any of its excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Mirikizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Mirikizumab?”

Cautions

• Hypersensitivity reactions
• Serious hypersensitivity reactions, including anaphylaxis during IV infusion, reported
• Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction
• If a severe hypersensitivity reaction occurs, discontinue immediately and initiate appropriate treatment
• Infections
  • May increase the risk of infection
  • Do not initiate in patients with a clinically important active infection until the infection resolves or is adequately treated
  • In patients with chronic infection or a history of recurrent infection, consider risks and benefits before prescribing mirikizumab
  • Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur
  • If a serious infection develops or is nonresponsive to standard therapy, monitor closely and do not administer until the infection resolves
• Tuberculosis (TB) infection
  • Evaluate for TB infection before initiating
  • Do not administer to patients with active TB infection
  • Initiate treatment of latent TB before administering
  • Consider anti-TB therapy before initiation in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed
  • Monitor for signs and symptoms of active TB during and after treatment
• Hepatotoxicity
  • A case of drug-induced liver injury (ALT 18* ULN; AST 10* ULN; total bilirubin 2.4* ULN) in conjunction with pruritus was reported in a clinical trial subject following a longer-than-recommended induction regimen
  • In the trial, mirikizumab was discontinued, and liver test abnormalities eventually returned to baseline
  • Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment
  • Monitor thereafter according to routine patient management
  • Consider other treatment options in patients with evidence of liver cirrhosis
  • 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 the use of live vaccines in patients treated with mirikizumab
• Medications that interact with the immune system may increase the risk of infection following the administration of live vaccines
• Before initiating, complete all age-appropriate vaccinations according to current immunization guidelines
• No data are available on response to live or non-live vaccines in mirikizumab-treated patients

Pregnancy and Lactation

• Available data from case reports of mirikizumab use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• However, monoclonal antibodies can be actively transported across the placenta, and Mirikizumab may cause immunosuppression the in utero-exposed infant
• Pregnancy registry
  • Monitor pregnancy outcomes in women exposed to mirikizumab during pregnancy
  • Patients and healthcare providers are encouraged to call Eli Lilly and Company at 1-800-Lilly-Rx (1-800-545-5979)
• Clinical considerations
  • Disease-associated maternal and embryo/fetal risk
  • Risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity
  • Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (under 2,500 g) 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
  • Because mirikizumab may interfere with the immune response to infections, consider risks and benefits before administering live vaccines to infants exposed to mirikizumab in utero
  • There are no data regarding infant serum levels of mirikizumab at birth and the duration of persistence of mirikizumab in infant serum after birth
  • Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, consider a minimum of 2 months after birth because of the half-life of the product
• Lactation
  • There are no data on the presence of mirikizumab in human milk, its effects on breastfed infants, or milk production
  • Endogenous maternal IgG and monoclonal antibodies are transferred in human milk
  • Effects of local GI exposure and limited systemic exposure in breastfed infants are unknown