Important safety information to know about HUMIRA

Tell your doctor if you have, or have had, any of the following:

• an infection, including a long-term infection in one part of the body (for example, leg ulcer)
• infections which keep coming back or other conditions that increase the risk of infections
• you are a carrier of the hepatitis B virus (HBV) or you have active HBV or you think you might be at risk of contracting HBV
• tuberculosis, or if you have been in close contact with someone who has had tuberculosis
• a fungal infection
• cancer or autoimmune disease
• a lung disease called chronic obstructive pulmonary disease (COPD)
• you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis)
• a serious heart condition
• kidney or liver problems
• you experience allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash
• low resistance to disease
• blood disorders
• uveitis. Your doctor may check for signs and symptoms of neurologic disease before starting this
  medicine.

As cases of tuberculosis have been reported in people treated with HUMIRA, your doctor will check you for signs and symptoms of tuberculosis before starting treatment. This will include a thorough medical examination, including your medical history and appropriate screening tests (for example a chest x-ray and tuberculin test).

HUMIRA can cause reactivation of hepatitis B in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of hepatitis B virus can be life-threatening.

Tell your doctor if you are scheduled for any vaccines. It is recommended that people be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating HUMIRA therapy. People receiving HUMIRA should not receive live vaccines. Check with your doctor about which ones are ‘live’ vaccines.

Tell your doctor if you are currently taking or have previously taken any medication that lowers the body’s resistance to disease. You might get infections more easily while you are receiving HUMIRA treatment. These infections may be serious and include tuberculosis, infections caused by viruses, fungi or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life threatening.

If you get an infection your doctor may recommend you discontinue HUMIRA. Also tell your doctor if you have or have had a fungal infection or have lived or travelled in countries where some fungal infections are common. These infections may develop or become more severe if you take HUMIRA.

Tell your doctor if you have psoriasis and have undergone phototherapy, also known as light therapy.

You should tell your doctor if you are pregnant, become pregnant, or are thinking about becoming pregnant. If you use HUMIRA during pregnancy your baby may have a higher risk of getting an infection. Tell your baby’s doctors and other healthcare professionals about your HUMIRA use during your pregnancy before the baby receives any vaccine. Tell your doctor if you are breastfeeding, or plan to breastfeed. 

Also tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket, naturopath or health food shop. Tell your doctor or pharmacist if you are taking anakinra (Kineret) or abatacept (Orencia). Taking either of these two medicines together with HUMIRA may increase the risk of infection. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with HUMIRA.

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• Signs of an allergic reaction such as:
  • chest tightness
  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • hives, itching or skin rash.
• Signs and symptoms suggestive of heart failure, such as shortness of breath with exertion or upon lying down, or swelling of the feet
• Signs and symptoms suggestive of a blood disorder such as persistent fever, bruising, bleeding very easily, paleness.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor as soon as possible if you notice any of the following:

• Signs of tuberculosis such as persistent cough, weight loss, listlessness, fever
• Signs of infection such as fever, lack of energy, skin sores, problems with your teeth or gums, burning when you pass urine
• Signs of nervous system disorders such as numbness or tingling throughout your body, arm or leg weakness, double vision
• Signs of soft tissue infection, such as a bump or open sore that doesn’t heal.
• Signs suggesting a blood clot, such as swelling, tenderness, redness and a warm feeling of an area of the arm or leg.

The above list includes serious side effects. You may need urgent medical attention.

The more common side effects with HUMIRA are listed below. Tell your doctor if you notice any of the following and they worry you:

• Pain, swelling, redness or itching at the site of injection
• Cold, runny nose, sinus infection, sore throat, cough, congestion on the chest, asthma or a worsening of asthma symptoms
• Lower respiratory tract infections (such as bronchitis, pneumonia)
• Pain in the ear which could suggest an ear infection
• Pain or inflammation of the eye or eye lid or changes to your vision
• Mouth ulcers, pain or excessive bleeding from the gums
• Burning or pain when passing urine, or blood in the urine
• Skin bumps or sores that don’t heal
• Headache or migraine, dizziness, vertigo
• Muscle weakness or numbness, difficulty balancing
• Fever, flushing, increased sweating
• Nausea, vomiting, abdominal pain
• Reflux or heartburn
• Chest pain
• Rash, itching, redness or scaly patches
• Problems with your finger or toe nails
• Hair loss
• Fatigue, tiredness, lack of energy
• Muscle, joint or bone pain
• Bleeding or bruising more easily than usual
• Feeling overwhelmed or sad, or lacking motivation (depression)
• Feeling anxious, especially fearful or worried (anxiety)
• Increased heart rate
• Viral infections (including the flu, cold sore blisters, chicken pox and shingles)
• Bacterial infections (including urinary tract infection)
• Fungal infections

Tell your doctor as soon as possible if you do not feel well while using HUMIRA or if you have any problems using it. Do this even if you do not think the problems are connected to the medicine or are not listed in the CMI.

Download your patient reminder cards here:

Adult patient reminder card (PDF)

Paed patient reminder card (PDF)