Important safety information to know about HUMIRA

Safety information on this website includes some of the more important information to know about HUMIRA. Additional information is also available in the Consumer Medicine Information (CMI) which is available on the Medsafe New Zealand website. Find links to the HUMIRA Pen and HUMIRA Prefilled syringe CMI at the bottom of this page.

Information on this website should be discussed with your doctor, and does not replace a doctor’s advice.

 

What you should know about HUMIRA

Because of the way HUMIRA works on your immune system, you may become more likely to develop infections. Usually these infections are mild – like a cold or a sinus infection, but occasionally they can be very serious, even life-threatening, for example tuberculosis (TB) or hepatitis B. That’s why doctors monitor people carefully for serious infections while they are taking HUMIRA and why your specialist and general practitioner (GP) may encourage you to get treatment early for any infection, even a minor one, like a cold or a graze, so they don’t become serious infections. It is important to tell your doctor if you get symptoms of infections such as fever, feeling tired, persistent cough, wounds, dental problems or burning on urination.

You should also not receive some types of vaccinations (live vaccines) whilst taking HUMIRA. Speak to your doctor about vaccines whilst taking HUMIRA.

There have been cases of certain kinds of cancer (such as lymphoma, leukaemia, and some others) in patients taking Humira. If you take Humira your risk may increase. On rare occasions, a specific and severe (life-threatening) type of lymphoma, hepatosplenic T-cell lymphoma, has been observed in patients taking Humira. In addition cases of skin cancer have been observed in patients taking Humira. If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor as soon as possible. Speak to your doctor for more information on your specific situation.

A small number of patients may have an allergic reaction to HUMIRA.

HUMIRA may increase the chance of diseases that affect the nervous system such as multiple sclerosis.

There have been cases of psoriasis and worsening of existing psoriasis.

Do not use HUMIRA if you have:

  • an allergy to any medicine containing adalimumab or any of the ingredients listed in the CMI that are part of HUMIRA
  • a severe infection including infection of the bloodstream, active tuberculosis and other infections that can occur when the body’s natural defenses are lowered
  • moderate to severe heart failure.

Information you should share with your doctor before starting HUMIRA

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

  • an infection, including a long-term or localised infection (for example, leg ulcer)
  • a history of recurrent infections or other conditions that increase the risk of infections
  • you are a carrier of or you suspect you may be infected with the hepatitis B virus
  • 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)
  • multiple sclerosis and other demyelinating disease
  • heart conditions including congestive heart failure, heart attack or worsening of existing heart condition
  • kidney or liver problems
  • you experience allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash
  • a suppressed immune system or if you are taking any medicines that can lower your immune system
  • blood disorders.

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 history, 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 temporary discontinuation of HUMIRA. Also tell your doctor if you live(d) or have travelled to countries where there is more risk for certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may develop or become more severe if you take HUMIRA.

Tell your doctor if you have psoriasis and have undergone phototherapy.

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 about all the medicines you take, including any that you get without a prescription from your pharmacy, supermarket or health food store. You should not take HUMIRA with KINERET® (anakinra), or other biologic DMARDs or TNF-inhibitors such as ORENCIA® (abatacept), REMICADE® (infliximab), ENBREL® (etanercept).

The possible side effects 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
  • shortness of breath with exertion or upon lying down or swelling of the feet
  • signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.

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

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, malaise, wounds, dental problems, burning on urination
  • signs of nervous system disorders such as numbness or tingling throughout your body, arm or leg weakness, double vision
  • a bump or open sore that doesn’t heal.

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

The most common side effects with HUMIRA are listed below:

  • respiratory tract infections – upper (such as cold, sinus infection, sore throat), and lower (such as bronchitis, pneumonia)
  • other infections – skin (such as cellulitis), ear, mouth (inflammation or ulcers), bacterial (such as urinary tract infection), fungal (such as thrush) and viral infections (such as influenza, cold sore blisters, chicken pox, shingles)
  • injection site reactions
  • headache
  • nausea, diarrhoea and /or abdominal pain
  • muscle ache
  • rash
  • lower than normal number of white blood cells (leukopaenia)
  • lower than normal number of red blood cells (anaemia)
  • increased lipids
  • higher than normal liver enzymes
  • fatigue.

Tell your doctor if you have any side effect that bothers you or that does not go away, even if its not listed above.

Other information you should know while you are taking HUMIRA:

  • tell all doctors, dentists, and pharmacists who are treating you that you are using HUMIRA
  • if you’re about to start any new medicine, or if you are scheduled to receive a vaccine tell your doctor or other healthcare professional that you are taking HUMIRA
  • if you become pregnant, tell your doctor immediately
  • if you are going to have surgery, tell your surgeon or anaesthetist you are taking HUMIRA
  • do not stop taking HUMIRA without checking with your doctor
  • be careful driving or operating machinery until you know how HUMIRA will affect you.