Important Safety Instructions

Important Safety Instructions About Exemptia^TM (Adalimumab)

What is the most important information that I should know about Exemptia?

The potential benefits and risks of Exemptia should be discussed by you with your doctor. Exemptia is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking Exemptia if you have any kind of infection unless your doctor says it is okay.

• Serious infections have happened in people taking adalimumab. 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 Exemptia and check you closely for signs and symptoms of TB during treatment with Exemptia. If your doctor feels you are at risk, you may be treated with medicine for TB.
• Cancer. For children and adults taking TNF blockers, including Exemptia, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers and young adults using TNF blockers. Some people taking adalimumab have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including Exemptia, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore (skin lesion) that doesn’t heal.

What should I tell my doctor BEFORE starting Exemptia?

Tell your doctor about all of your health conditions, whether you:

• Have an infection, are being treated for infection or have symptoms of an infection
• Get a lot of infections or infections that keep coming back
• Have diabetes
• Have TB or have been in close contact with someone with TB or were born in, lived in or travelled where there is more risk for getting TB
• Live or have lived in an area where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis
• Have or have had hepatitis B
• Are scheduled for major surgery
• Have or have had cancer
• Have numbness or tingling (lack of sensation) or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
• Have or had heart failure
• Have recently received or are scheduled to receive a vaccine. Exemptia patients may receive vaccines, except for live vaccines
• Are allergic to any of the Exemptia ingredients
• Are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed

Also tell your doctor about all the medicines you take. You should not take Exemptia with abatacept, anakinra, infliximab, etanercept, certolizumab pegol or golimumab. Tell your doctor if you have ever used rituximab, azathioprine or mercaptopurine (6-MP).

What should I watch for AFTER starting Exemptia?

Exemptia can cause serious side effects, including:

• Serious infections. These include TB and infections caused by viruses, fungi or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss or loss of body fat and muscle.
• Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort and skin rash.
• Allergic reactions. Symptoms of serious allergic reactions include hives (urticaria), trouble during breathing and swelling of your face, eyes, lips or mouth.
• Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs and dizziness.
• Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily or looking very pale.
• Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet and sudden weight gain.
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain or rash on your cheeks or arms that gets worse in the sun.
• Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting and pain on the right side of your stomach (abdomen).
• Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care immediately if you develop any of the above mentioned symptoms.

Common side effects of adalimumab include injection site reactions (redness, rash, swelling, itching or bruisi
ng), upper respiratory infections (sinus infections), headache, rash and nausea. These are not all of the possible side effects with Exemptia. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor immediately if you have an infection or symptoms of an infection, including:

• Fever, sweats or chills
• Muscle aches
• Cough
• Shortness of breath
• Blood in phlegm
• Weight loss
• Warm, red or painful skin or sores on your body
• Diarrhea or stomach pain
• Burning when you urinate
• Urinating more often than normal
• Feeling very tired

Exemptia is given by injection under the skin.

Above mentioned information is the most important that you should know about Exemptia. For more information, talk to your doctor.

Uses

Exemptia^TM is indicated for:

Rheumatoid Arthritis (RA) (in adults)

• Moderate to severe, active RA
• Severe, active and progressive RA

Juvenile Idiopathic Arthritis (JIA)

• Moderate to severe active polyarticular JIA in pediatric patients of 2 years of age and older.
• Active enthesitis related arthritis in patients of 6 years of age and older

Psoriatic Arthritis (PsA)

• Active and progressive PsA in adults.

Ankylosing Spondylitis (AS) and axial spondyloarthritis without radiographic evidence of AS

• Active AS and axial spondyloarthritis without radiographic evidence of AS in adults.

Plaque Psoriasis (PsO)

• Moderate to severe plaque psoriasis in adult patients who are candidates for the systemic therapy or phototherapy.

Hidradenitis Suppurativa (HS)

• Recalcitrant hidradenitis suppurativa (HS).

Crohn’s disease (CD) and Ulcerative Colitis (UC)

• Moderate or Severe Crohn’s Disease (CD), Paediatric CD and Ulcerative Colitis (UC).