YUSIMRY (Adalimumab-aqvh) for Inflammatory Diseases

YUSIMRY is a medicine called a Tumor Necrosis Factor (TNF) blocker. YUSIMRY is used

• To reduce the signs and symptoms of:
  • Moderate to severe Rheumatoid Arthritis in adults: YUSIMRY can be used alone, with methotrexate, or with certain other medicines.
  • Moderate to severe Polyarticular juvenile idiopathic arthritis: in children 2 years and older. YUSIMRY can be used alone or with methotrexate.
  • Psoriatic arthritis in adults: YUSIMRY can be used alone or with certain other medicines.
  • Ankylosing spondylitis in adults.

• To treat moderate to severe Crohn’s disease: in adults and children 6 years of age and older.

• To treat moderate to severe Ulcerative colitis in adults: It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

• To treat moderate to severe Chronic plaque psoriasis: in adults who have the condition in many areas of their body and who may benefit from taking injections or pills or phototherapy.

YUSIMRY may not be right for you. Before starting YUSIMRY, tell your doctor about all of your medical conditions, including if you:

• have an infection.

• have or have had cancer.

• have any numbness, tingling, or have a disease that affects your nervous system such as Guillain-Barré syndrome or multiple sclerosis.

• have or had heart failure.

• have received or are planning to receive a vaccine.

• are allergic to YUSIMRY or to any of its ingredients.

• are pregnant or plan to become pregnant. YUSIMRY may harm your unborn baby.

• breastfeeding or planning to breastfeed. YUSIMRY may pass into your breast milk.

• 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), CIMZIA (certolizumab pegol), KINERET (anakinra), REMICADE (infliximab), SIMPONI (golimumab), or ENBREL (etanercept) because you should not use YUSIMRY while you are also using one of these medicines.
  • RITUXAN (rituximab). Your doctor may not give you YUSIMRY if you have received RITUXAN (rituximab) recently.
  • PURINETHOL (6–mercaptopurine, 6-MP) or IMURAN(azathioprine)

• YUSIMRY is given by an injection under the skin. Your doctor will tell you how often to take an injection of YUSIMRY. This is of course based on what condition of yours is to be treated. Do not inject YUSIMRY more often than you were prescribed.

• Make sure you know how to inject YUSIMRY. Someone you know can also help you with your injection after they have been shown how to prepare and inject YUSIMRY.

• Inject YUSIMRY yourself only if 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 YUSIMRY at home, you should receive training on the right way to prepare and inject YUSIMRY.

• Do not miss any doses of YUSIMRY unless your doctor says it is okay. call your doctor if you miss a dose.

• If you take more YUSIMRY than you were told to take, call your doctor.

The recommended subcutaneous dosage of YUSIMRY for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis is 40 mg administered every other week. Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), Methotrexate (MTX), other non-biologic DMARDS, and/or analgesics may be continued during treatment with YUSIMRY. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of YUSIMRY to 40 mg every week or 80 mg every other week.

The recommended subcutaneous dosage of YUSIMRY for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with YUSIMRY.

30 kg (66 lbs) and greater: the recommended dosage IS 40 mg every other week

There is no dosage form for YUSIMRY for pediatric patients below 30 kg.

Adults: The recommended subcutaneous dosage of YUSIMRY for adult patients with Crohn’s disease (CD) is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin with a dosage of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with YUSIMRY. Azathioprine, 6 mercaptopurine (6-MP), or MTX may be continued during treatment with YUSIMRY if necessary

The recommended dosage of YUSIMRY for pediatric patients 6 years of age and older with Crohn’s disease (CD) is based on body weight as shown below:

The recommended Dosage for Day 1 is 160 mg (single dose or split over two consecutive days) and the recommended dosage for Day 15 is 80 mg

The recommended dosage starting on Day 29 is 40 mg every other week

There is no dosage form for YUSIMRY for pediatric patients below 40 kg.

Adults: The recommended dosage of YUSIMRY for adult patients with ulcerative colitis (UC) is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) continue with a dosage of 40 mg every other week. Discontinue YUSIMRY in adult patients without evidence of clinical remission by eight weeks (Day 57) of therapy. Corticosteroids and/or aminosalicylates may be continued during treatment with YUSIMRY. 6-mercaptopurine (6-MP) and azathioprine may be continued during treatment with YUSIMRY if necessary.

The recommended dosage of YUSIMRY for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of adalimumab products in moderate to severe chronic Plaque Psoriasis beyond one year has not been evaluated in controlled clinical studies.

The most common side effects of YUSIMRY include:

• Injection site reactions
• Upper respiratory infections (including sinus infections).
• Headaches.
• Rash.

YUSIMRY can cause serious side effects, including:

• Serious Infections: Your doctor will examine you for tuberculosis (TB) and perform a test to see if you have TB. If you have TB, you may be treated with medicine for TB before you begin treatment with YUSIMRY and during treatment with YUSIMRY. Tell your doctor if you have any of the following symptoms while taking or after taking YUSIMRY:
  • cough that does not go away
  • weight loss
  • low-grade fever
  • 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, the virus can become active while you use YUSIMRY. Your doctor should do blood tests before you start treatment, while you are using YUSIMRY, and for several months after you stop treatment with YUSIMRY. Tell your doctor if you have any of the following symptoms of a hepatitis B infection:
  • muscle aches
  • clay-colored bowel movements
  • feel very tired
  • fever
  • dark urine
  • chills
  • eyes or skin look yellow o stomach discomfort
  • little or no appetite
  • skin rash
  • vomiting

• Allergic reactions: Allergic reactions can happen in people who use YUSIMRY. Call your doctor right away if you have any of these symptoms of a serious allergic reaction:
  • hives
  • swelling of your face, eyes, lips, or mouth
  • trouble breathing

• Nervous system problems: Signs and symptoms of a nervous system problem include: problems with your vision, weakness in your arms or legs, numbness or tingling, and dizziness.

• Blood problems: Your body may not make enough blood cells that help fight infections or help to stop bleeding. Symptoms include bruising or bleeding very easily, a fever that does not go away, 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 YUSIMRY, including:
  • shortness of breath
  • swelling of your ankles or feet
  • sudden weight gain

• Immune reactions include a lupus-like syndrome: Symptoms include pain that does not go away or chest discomfort, joint pain, shortness of breath, or a rash on your arms or cheeks that gets worse in the sun. Symptoms may improve when you stop YUSIMRY.

• Liver problems: Liver problems can happen in patients 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
  • skin or eyes look yellow
  • poor appetite or vomiting
  • 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 raised bumps or red scaly patches that are filled with pus. Your doctor may decide to stop your treatment with YUSIMRY.

• Cancer: For children and adults taking (TNF)-blockers, including YUSIMRY, the chances of getting cancer may increase. There have been cases of unusual cancers in teenagers, children, and young adults using TNF-blockers. People with rheumatoid arthritis, especially more serious RA, may have a higher chance of getting a kind of cancer called lymphoma. If you use TNF blockers, including YUSIMRY, your chances of getting skin cancer may increase (two skin cancers such as 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 does not heal.

• Rare cancer called Hepatosplenic T-cell lymphoma: some people receiving TNF blockers including YUSIMRY 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 with another medicine called IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6–MP).

• Store YUSIMRY in the refrigerator at (2ºC to 8ºC). Store YUSIMRY in the original carton until use to protect it from light.

• Do not freeze YUSIMRY. Do not use it is frozen.

• Refrigerated YUSIMRY may be used until the expiration date printed on the YUSIMRY carton, prefilled syringe, or dose tray.

• Do not use the medicine after the expiration date.

• When you are traveling, you can store YUSIMRY at room temperature up to 77°F (25°C) for up to 14 days. Store the medicine in the original carton until use to protect it from light.

• Throw away YUSIMRY if it has not been used within 14 days or if it has been kept at room temperature.

• Record the date when you first remove YUSIMRY from the refrigerator in the spaces provided on the carton and dose tray.

• Do not store YUSIMRY in extreme heat or cold.

• Do not use a prefilled syringe if the liquid is discolored, cloudy, or has flakes or particles in it.

• Do not crush or drop YUSIMRY. The prefilled syringe is a glass

Active ingredient: adalimumab-aqvh
Inactive ingredients: glycine, L-histidine, polysorbate 80, L-histidine hydrochloride monohydrate, sodium chloride, and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust the pH.