Hadlima (adalimumab-bwwd) for Inflammatory Diseases

HADLIMA is a Tumor Necrosis Factor (TNF) blocker that is used:

• to reduce the signs and symptoms of:
  • Moderate to severe Rheumatoid arthritis in adults: HADLIMA can be used alone, with methotrexate, or with certain other medicines.
  • Moderate to severe polyarticular juvenile idiopathic arthritis: in children 4 years and older. HADLIMA can be used alone, with methotrexate, or with certain other medicines.
  • Psoriatic arthritis in adults: HADLIMA can be used alone or with certain other medicines.
  • Ankylosing spondylitis in adults.

• Moderate to severe Crohn’s disease: in adults when other treatments have not worked well enough. in adults, to help get moderate to severe ulcerative colitis under control and keep it under control when certain other medicines have not worked well enough. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

• 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.

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

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

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

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

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

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

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

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

ABRILADA 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.

• ≥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 HADLIMA 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 HADLIMA 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 HADLIMA and during treatment with HADLIMA. Tell your doctor if you have any of the following symptoms while taking or after taking HADLIMA:
  • 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 HADLIMA. Your doctor should do blood tests before you start treatment, while you are using HADLIMA, and for several months after you stop treatment with HADLIMA. 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 HADLIMA. 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 HADLIMA, 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 HADLIMA.

• 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 HADLIMA.

• Cancer: For children and adults taking (TNF)-blockers, including HADLIMA, 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 HADLIMA, 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 HADLIMA 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 HADLIMA in the refrigerator at (2ºC to 8ºC). Store YUSIMRY in the original carton until use to protect it from light.

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

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

• Do not use the medicine after the expiration date.

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

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

Active ingredient: adalimumab-bwwd
Inactive ingredients: citric acid monohydrate, sodium citrate dihydrate, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20, sorbitol, and Water for Injection, USP.