OMVOH

Generic Name/API: mirikizumab-mrkz

Manufacturer: Eli Lilly and Company

Dosage Forms & Strength & Pack Size:
Intravenous Infusion
Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial
Subcutaneous Injection:
Injection: 100 mg/mL solution in a single-dose prefilled pen 2 x 1ml

Storage:
Storage and Handling
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.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
Omvoh™ (ahm-VOH) is a medicine used to treat adults with moderately to severely active ulcerative colitis.
It is not known if Omvoh is safe and effective in children under 18 years of age.

Warnings – Omvoh can cause serious side effects including:

Serious allergic reactions: Omvoh may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. Do not use Omvoh if you have had a serious allergic reaction to mirikizumab-mrkz or any of the ingredients in Omvoh. See the Medication Guide that comes with Omvoh for a list of ingredients. Stop using Omvoh and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

fainting, dizziness, feeling lightheaded
swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing
trouble breathing, throat tightening, or wheezing
chest tightness
fast heartbeat or tightening in your chest
severe itching, hives, or redness all over your body
sweating
Infections: Omvoh may lower the ability of your immune system to fight infections and may increase your risk of infections. If you have an infection, your healthcare provider should not start treatment with Omvoh until your infection is gone. After starting Omvoh, tell your healthcare provider right away if you have any symptoms of an infection, such as:

fever, sweating, or chills
muscle aches and pain
cough or shortness of breath
blood in your mucus
flu-like symptoms
headache
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
weight loss
nausea or vomiting
pain during urination
Before starting treatment with Omvoh, your healthcare provider should test you for tuberculosis (TB). If you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Omvoh. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with Omvoh and after treatment.

Liver Problems: Omvoh may cause liver problems. Your healthcare provider will do blood tests to check your liver enzyme and bilirubin levels before treatment, for at least 24 weeks during treatment, and possibly after treatment with Omvoh. Your healthcare provider may hold or stop treatment if needed. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:

unexplained rash
nausea
vomiting
abdominal pain
feeling tired
loss of appetite
yellowing of the skin or the whites of your eyes
dark urine
Common side effects

The most common side effects of Omvoh include:

Upper respiratory infections
Joint pain
Injection site reaction
Headache
Rash
Herpes viral infections
These are not all the possible side effects of Omvoh.
Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before you use Omvoh, review these questions with your doctor:

Are you being treated for an infection?
Do you have an infection that does not go away or keeps coming back?
Do you have TB or have you been in close contact with someone with TB?
Do you have any possible symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, or pain during urination?
Tell your doctor about all your medical conditions, including if:

You have a history of serious allergic reaction to Omvoh, any infections or liver problems.
You need any vaccines or have had one recently. Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines.
You are pregnant, or plan to become pregnant. It is not known if Omvoh will harm your unborn baby. There will be a pregnancy registry to collect information about women who are exposed to Omvoh during pregnancy. If you become pregnant while taking Omvoh, you are encouraged to report your pregnancy to Eli Lilly and Company at 1-800-545-5979.
You are breastfeeding or plan to breastfeed. It is not known if Omvoh passes into your breastmilk.
You take prescription or over-the-counter medicines, vitamins, and herbal supplements.
How to take

Use Omvoh exactly as your healthcare provider tells you to. You will first receive Omvoh through a vein in the arm (intravenous infusion) given by a healthcare provider. You will then continue to receive Omvoh as an injection under the skin (subcutaneous injection). Omvoh is intended for use under the guidance and supervision of your doctor. If your doctor decides that you or a caregiver may give your injections at home, you should receive training on the correct way to prepare and inject Omvoh. Read the detailed Instructions for Use that come with the Omvoh prefilled pen for information about how to use Omvoh the correct way.

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