Hulio (adalimumab-fkjp) for Inflammatory Diseases

HULIO is a tumor necrosis factor (TNF) blocker indicated for the treatment of:

• Rheumatoid Arthritis: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.

• Juvenile Idiopathic Arthritis: Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older.

• Psoriatic Arthritis: Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

• Ankylosing Spondylitis: Reducing signs and symptoms in adult patients with active AS.

• Adult Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderate to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products.

• Ulcerative Colitis: Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as azathioprine, corticosteroids, or 6-mercaptopurine (6-MP). The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.

• Plaque Psoriasis: The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

HULIO may not be right for you. Before starting HULIO, 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 HULIO or to any of its ingredients.

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

• breastfeeding or planning to breastfeed. HULIO 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 HULIO while you are also using one of these medicines.
  • RITUXAN (rituximab). Your doctor may not give you HULIO if you have received RITUXAN (rituximab) recently.
  • PURINETHOL (6–mercaptopurine, 6-MP) or IMURAN(azathioprine)

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

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

• Inject HULIO 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 HULIO at home, you should receive training on the right way to prepare and inject HULIO.

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

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

HULIO is administered by subcutaneous injection.

• 40 mg every other week.
• Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.

• 15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week
• ≥ 30 kg (66 lbs): 40 mg every other week

• Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days)
• Second dose two weeks later (Day 15): 80 mg
  • Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week.

• Only continue HULIO in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.

• 80 mg initial dose, followed by 40 mg every other week starting one week after the initial dose.

The most common side effects of HULIO include:

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

HULIO 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 HULIO and during treatment with HULIO. Tell your doctor if you have any of the following symptoms while taking or after taking HULIO:
  • 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 HULIO. Your doctor should do blood tests before you start treatment, while you are using HULIO, and for several months after you stop treatment with HULIO. 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
  • stomach discomfort
  • little or no appetite
  • skin rash
  • vomiting

• Allergic reactions: Allergic reactions can happen in people who use HULIO. 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 HULIO, 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 HULIO.

• 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 HULIO.

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

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

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

• Do not use the medicine after the expiration date.

• When you are traveling, you can store HULIO 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 HULIO 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 HULIO from the refrigerator in the spaces provided on the carton and dose tray.

• Do not store HULIO 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 HULIO. The prefilled syringe is a glass

Active ingredient: adalimumab-fkjp
Inactive ingredients: methionine, polysorbate 80, monosodium glutamate, sorbitol, and Water for Injection, USP. Hydrochloric acid is added as necessary to adjust pH.