Important Safety Information

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. For direct links to the HUMIRA Pen and Humira Pre-filled syringe CMI, see the links 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, 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. It is important to tell your doctor if you get symptoms of infections such as fever, wounds, feeling tired or dental problems. 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.

HUMIRA may increase the risk of getting lymphoma or other cancers. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death.

There have been very rare cases of two types of skin cancer (basal cell and squamous cell) in people treated with HUMIRA. These types are generally not life-threatening if treated.

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
  • you have 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
  • 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
  • allergy to rubber or latex
  • 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.

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. Since the effects of HUMIRA in pregnancy are not known, the use of HUMIRA in pregnant women is not recommended. Tell your doctor if you are breastfeeding, or plan to breastfeed. Your doctor may advise you to stop breastfeeding while you are using HUMIRA.

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 ORENCIA® (abatacept), KINERET® (anakinra), 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:

  • severe rash, hives or other signs of allergic reaction
  • swollen face, hands, feet
  • trouble breathing, swallowing
  • 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 rare.

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

  • 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 most common side effects of the medicine are listed below and usually mild and short lived:

  • respiratory tract infections – upper (eg. cold, sinus infection, sore throat), lower (eg. bronchitis, pneumonia)
  • other infections – skin (eg. cellulitis), ear, mouth (inflammation or ulcers), urinary tract, fungal (eg. thrush) and viral infections (eg. 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 (leucopaenia)
  • 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.

Other information you should know while you are taking HUMIRA:

  • if you starting any new medicine, tell your doctor you are taking HUMIRA
  • 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.

NZ-HUM-0113 TAPS PP9594 Prepared May 2017