IMRALDI- adalimumab injection, solution 
Samsung Bioepis Co., Ltd.

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This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: MM/YYYY


MEDICATION GUIDE
IMRALDI (Im-RAL-di)
(adalimumab-xxxx)
injection
Read the Medication Guide that comes with IMRALDI before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about IMRALDI?
IMRALDI is a medicine that affects your immune system. IMRALDI can lower the ability of your immune system to fight infections. Serious infections have happened in people taking TNF blockers including adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.

  • Your doctor should test you for TB before starting IMRALDI.
  • Your doctor should check you closely for signs and symptoms of TB during treatment with IMRALDI.
You should not start taking IMRALDI if you have any kind of infection unless your doctor says it is okay.
Before starting IMRALDI, tell your doctor if you:
  • think you have an infection or have symptoms of infection such as:
  • fever, sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feel very tired
  • weight loss

  • are being treated for an infection
  • get a lot of infections or have infections that keep coming back
  • have diabetes
  • have TB, or have been in close contact with someone with TB
  • were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
  • live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use IMRALDI. Ask your doctor if you do not know if you have lived in an area where these infections are common.
  • have or have had hepatitis B
  • use the medicine ORENCIA® (abatacept), KINERET® (anakinra), RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (6–mercaptopurine, 6-MP).
  • are scheduled to have major surgery
After starting IMRALDI, call your doctor right away if you have an infection, or any sign of an infection.
IMRALDI can make you more likely to get infections or make any infection that you may have worse.
Cancer
  • For children and adults taking TNF-blockers, including adalimumab products, the chances of getting cancer may increase.
  • There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers.
  • People with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
  • If you use TNF blockers including adalimumab product your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that doesn't heal.
  • Some people receiving TNF blockers including adalimumab products developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN® (azathioprine) or PURINETHOL® (6-mercaptopurine, 6–MP).
What is IMRALDI?
IMRALDI is a medicine called a Tumor Necrosis Factor (TNF) blocker. IMRALDI is used:
  • To reduce the signs and symptoms of:
    • moderate to severe rheumatoid arthritis (RA) in adults. IMRALDI can be used alone, with methotrexate, or with certain other medicines.
    • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children from 4 years of age and ≥ 30 kg (66 lbs). IMRALDI can be used alone, with methotrexate, or with certain other medicines.
    • psoriatic arthritis (PsA) in adults. IMRALDI can be used alone or with certain other medicines.
    • ankylosing spondylitis (AS) in adults.
    • moderate to severe Crohn's disease (CD) in adults when other treatments have not worked well enough.
  • In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if IMRALDI is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
  • To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
What should I tell my doctor before taking IMRALDI?
IMRALDI may not be right for you. Before starting IMRALDI, tell your doctor about all of your health conditions, including if you:
  • have an infection. See What is the most important information I should know about IMRALDI?
  • have or have had cancer.
  • have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
  • have or had heart failure.
  • have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using IMRALDI. Children should be brought up to date with all vaccines before starting IMRALDI.
  • are allergic to IMRALDI or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in IMRALDI.
  • are pregnant or plan to become pregnant. It is not known if IMRALDI will harm your unborn baby. IMRALDI should only be used during a pregnancy if needed.
  • have a baby and you were using IMRALDI during your pregnancy. Tell your baby's doctor before your baby receives any vaccines.
  • breastfeeding or plan to breastfeed. You and your doctor should decide if you will breastfeed or use IMRALDI. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your doctor if you use:
  • ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol) or SIMPONI® (golimumab), because you should not use IMRALDI while you are also using one of these medicines.
  • RITUXAN® (rituximab). Your doctor may not want to give you IMRALDI if you have received RITUXAN® (rituximab) recently.
  • IMURAN® (azathioprine) or PURINETHOL® (6–mercaptopurine, 6-MP).
Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take IMRALDI?
  • IMRALDI is given by an injection under the skin. Your doctor will tell you how often to take an injection of IMRALDI. This is based on your condition to be treated. Do not inject IMRALDI more often than you were prescribed.
  • See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject IMRALDI.
  • Make sure you have been shown how to inject IMRALDI before you do it yourself. You can call your doctor or 1-877-888-4231 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject IMRALDI.
  • Do not try to inject IMRALDI yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of IMRALDI at home, you should receive training on the right way to prepare and inject IMRALDI.
  • Do not miss any doses of IMRALDI unless your doctor says it is okay. If you forget to take IMRALDI, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject IMRALDI, call your doctor or pharmacist.
  • If you take more IMRALDI than you were told to take, call your doctor.
What are the possible side effects of IMRALDI?
IMRALDI can cause serious side effects, including:
See “What is the most important information I should know about IMRALDI?
  • Serious Infections.
    Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with IMRALDI and during treatment with IMRALDI. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking IMRALDI. People who had a negative TB skin test before receiving adalimumab have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking IMRALDI:
  • cough that does not go away
  • low grade fever
  • weight loss
  • loss of body fat and muscle (wasting)
  • Hepatitis B infection in people who carry the virus in their blood.
    If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use IMRALDI. Your doctor should do blood tests before you start treatment, while you are using IMRALDI, and for several months after you stop treatment with IMRALDI. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:
  • muscle aches
  • feel very tired
  • dark urine
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • clay-colored bowel movements
  • fever
  • chills
  • stomach discomfort
  • skin rash
  • clay-colored bowel movements
  • Allergic reactions. Allergic reactions can happen in people who use adalimumab products. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:
  • hives
  • trouble breathing
  • swelling of your face, eyes, lips or mouth
  • Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
  • New heart failure or worsening of heart failure you already have. Call your doctor right away if you get new worsening symptoms of heart failure while taking IMRALDI, including:
  • shortness of breath
  • sudden weight gain
  • swelling of your ankles or feet
  • Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop IMRALDI.
  • Liver Problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:
  • feel very tired
  • poor appetite or vomiting
  • skin or eyes look yellow
  • pain on the right side of your stomach (abdomen)
  • Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with IMRALDI.
Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with IMRALDI may be stopped. Common side effects with adalimumab products include:
  • injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your doctor right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.
  • upper respiratory infections (including sinus infections)
  • headaches
  • rash
These are not all the possible side effects with IMRALDI. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store IMRALDI?
  • Store IMRALDI in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store IMRALDI in the original carton until use to protect it from light.
  • Do not freeze IMRALDI. Do not use IMRALDI if frozen, even if it has been thawed.
  • Refrigerated IMRALDI may be used until the expiration date printed on the IMRALDI carton, dose pack, pre-filled pen. Do not use IMRALDI after the expiration date.
  • If needed, for example when you are traveling, you may also store IMRALDI at room temperature up to 77°F (25°C) for up to 14 days. Store IMRALDI in the original carton until use to protect it from light.
  • Throw away IMRALDI if it has been kept at room temperature and not been used within 14 days.
  • Record the date you first remove IMRALDI from the refrigerator in the spaces provided on the carton and dose tray.
  • Do not store IMRALDI in extreme heat or cold.
  • Do not use a pre-filled pen if the liquid is cloudy, discolored, or has flakes or particles in it.
  • Do not drop or crush IMRALDI.
Keep IMRALDI, injection supplies, and all other medicines out of the reach of children.
General information about the safe and effective use of IMRALDI
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use IMRALDI for a condition for which it was not prescribed. Do not give IMRALDI to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about IMRALDI. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about IMRALDI that is written for health professionals. For more information go to www.XXXXXXX.com or call Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. at 1-877-888-4231.
What are the ingredients in IMRALDI?
Active ingredient: adalimumab

IMRALDI Pre-filled Pen 40 mg/0.8 mL:

Inactive ingredients: trisodium citrate dihydrate, citric acid monohydrate, histidine, histidine monohydrochloride monohydrate, sorbitol, polysorbate 20, and Water for Injection.

Manufactured by: Samsung Bioepis Co., Ltd., 107, Cheomdan-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ 07033 USA
US License Number 2046
Revised: 1/2018
Samsung Bioepis Co., Ltd.