HUMIRA pre-filled pen instructions

Humira is injected under the skin. It can be self-administered after proper training in injection technique, or given by your doctor or their assistant. Many people feel nervous the first time they give themselves an injection. That’s why it’s ok to ask a friend or relative for help, once they have been trained. Our support staff can also help by talking to you through the injection steps. Call us on 0800 848 243 or visit www.abbviecare.co.nz

 

 

Instructions for preparing and giving an injection of HUMIRA using the pre-filled pen.

 

Read through these instructions before handling the pen. Note that you can only use the HUMIRA pen once. The pen comes preloaded with the exact dose of medicine inside, ready for you to inject. It also has its own built-in needle. 

Read these instructions carefully and follow them step by step. 

These instructions explain how to self-inject this medicine. Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.

Your doctor or his/her assistant will also show you best how to self-inject. 

Keep HUMIRA out of the sight of children.

1. What should I do before I give myself a HUMIRA injection

                                                       

  • Take one dose tray containing a pre-filled pen of HUMIRA from the refrigerator.
  • Do not shake or drop the pre-filled pen.
  • Leave HUMIRA at room temperature for 15 to 30 minutes before injecting.

Do not remove the grey cap or plum cap while allowing HUMIRA to reach room temperature.

Do not warm HUMIRA in any other way. For example, do not warm it in a microwave or in hot water. Do not use if the solution has been frozen.

  • Check the expiry date on the pre-filled pen label. Do not use the product after the month and year shown.
  • Hold the pre-filled Pen with the grey cap (labelled ‘1’) pointing up. Check the appearance of the HUMIRA solution through the windows on the sides of the pre-filled pen.

It must be clear and colourless. If it is cloudy or has particles in it, you must not use it.

Do not remove either the grey cap or the plum cap, until immediately before the injection.

  • Set up the following items on a clean surface:
    • One HUMIRA pre-filled pen
    • One alcohol pad.

  • Wash your hands thoroughly.

 

2. Where should I give my injections?

  • Choose a site on your thigh or stomach, at least 5 cm from your navel (belly button). Please see the shaded area above.
  • Change the place that you inject each time so that you do not become sore in one area. Each new injection should be given at least 3 cm from the last injection site.

Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques.

3. How do I give my injection?

  • Wipe your skin by using the enclosed alcohol pad, using a circular motion.

                                                                                                        

  • Only remove  both the grey cap and the plum cap immediately before injection.
  • Hold the grey body of the pre-filled pen with one hand by placing this hand in the middle of the pen so that neither the grey cap nor the plum cap is covered. Hold the pre-filled pen with the grey cap pointing up.
  • With your other hand, pull the grey cap straight off and discard cap.
  • Check that the small grey needle cover of the syringe has been removed with the cap. If a few small drops of liquid come out of the needle, that is okay. The white needle sleeve will now be exposed.
  • Do not try to touch the needle housed in the barrel.
  • DO NOT RECAP the pen as you may damage the needle inside.
  • Pull the plum safety cap (labelled ‘2’) straight off to expose the plum coloured activation button.
  • The pre-filled pen is now ready to use. Do not press the plum activation button until properly positioned as this will result in discharge of medication.                                                                                 

DO NOT RECAP as this could cause the unit to discharge and could potentially cause needle stick injury

  • Do not place the pen down as this could cause the unit to discharge.

 

4. Give the injection

  • With your free hand, gently grasp or pinch a sizable area of the cleaned skin at the injection site and hold firmly for the entire injection procedure.
  • Position the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that you can see the window. The presence of one or more bubbles in the window is normal.
  • Holding the barrel of the pre-filled pen, press down slightly onto the injection site (holding in place without moving), but do not press plum end until ready for injection.
  • With your index finger or your thumb, press the plum coloured button on top once you are ready to begin the injection. You will hear a loud ‘click’ as the needle is released, and you will feel a small prick as the needle advances.

  OR   

  • Keep pressing and continue to hold the pen with steady pressure for about 10 seconds to ensure a complete injection. Do not remove the pen while the injection is being given.
  • You will see a yellow indicator move into the window during the injection. The injection is complete when the yellow indicator stops moving.

  • Lift the pen straight up from the injection site. The white needle sleeve will move down over the needle and lock into place over the needle tip. Do not try to touch the needle. The white needle sleeve is there to protect you from touching the needle.

  • You may notice a spot of blood at the injection site. You can press a cotton ball or a piece of gauze over the injection site for 10 seconds.
  • Do NOT rub the injection site.

5. Throwing away supplies

  • Only use each pen for one injection. Do not put either of the caps back on the pen.
  • After injecting HUMIRA, immediately throw away the used pen in a special ‘sharps’ container as instructed by your doctor, nurse or pharmacist.
  • Keep this container out of reach and sight of children.

Please review the full instructions provided with your HUMIRA pre-filled pen for complete directions.

Please also review the Consumer Medicine Information at http://www.medsafe.govt.nz/consumers/cmi/h/humirapen.pdf.

You can also speak to your Healthcare Professional for further information.

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What is the most important safety information I should know about HUMIRA?

You should discuss the potential benefits and risks of HUMIRA with your doctor, even though not everyone will experience side effects.

Because of the way HUMIRA works on your immune system, you may become more likely to develop infections. It is important to tell your doctor if you get symptoms of infections such as fever, wounds, feeling tired, dental problems, or burining on urination. 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 patients 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.

You should also not receive some types of vaccines (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.

For more information on what you need to tell your doctor before starting HUMIRA and other safety information, please refer to the safety information and what information you should share with your doctor before starting HUMIRA (see FAQ below).

Also refer to Consumer Medicine Information (CMI) which is available at Medsafe New Zealand and in the link at the bottom of this page.

Refer to your doctor for more information or to discuss any concerns.

Who shouldn’t use HUMIRA?
  • If you have an allergy to any medicine containing HUMIRA (adalimumab) or any of the product’s ingredients
  • If you currently have a severe active infection for example, tuberculosis
  • If you are already using anakinra (Kineret®) or other biologic DMARDs or TNF-inhibitors such as abatacept (Orencia®), etanercept (Enbrel®) or infliximab (Remicade®)
  • If you have moderate to severe heart failure

If you have any questions about any of this information, ask your doctor.

Speak to your doctor before starting Humira if you are pregnant or breastfeeding, or plan to become pregnant or to breastfeed.

Orencia is a registered trade mark registered to Bristol-Myers Squibb. Kineret is a registered trade mark licensed by Swedish Orphan Biovitrum. Enbrel is a registered trade mark registered to Pfizer New Zealand. Remicade is a registered trade mark registered to Janssen Cilag.

What information should I share with my 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
  • tuberculosis, or if you have been in close contact with someone who has had tuberculosis
  • hepatitis B virus, or you suspect you may be infected
  • a fungal infection
  • multiple sclerosis and other demyelinating disease
  • allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash
  • blood disorders
  • a suppressed immune system or if you are taking any medicines that can lower your immune system
  • heart conditions including congestive heart failure, heart attack or worsening of existing heart conditions
  • cancer or autoimmune disease
  • a lung disease called chronic obstructive pulmonary disease (COPD)
  • kidney or liver problems

As cases of tuberculosis have been reported in patients treated with HUMIRA, your doctor will check you for signs and symptoms of tuberculosis before starting this medicine. 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 patients be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating HUMIRA therapy. Patients 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 are a psoriasis sufferer who has undergone phototherapy.

You should tell your doctor if you are pregnant, become pregnant, or are thinking about becoming pregnant. Tell your doctor if you are breastfeeding, or plan to breastfeed.

If you have any questions about any of this information, ask your doctor, and refer to the Consumer Medicine Information available from the link at the bottom of this page.

What are the most common side effects with HUMIRA?

All medicines have risks and benefits. It is important to be aware of side effects, even though not everyone will experience them. If you have any questions about any of this information, ask your specialist, GP or pharmacist.

There are other possible side-effects with Humira, some serious, so you should review the Consumer Medicines Information (see below) for the full list. Remember to tell your doctor if you experience these or any other side-effects.

The most common side effects with HUMIRA are listed below:

  • Respiratory tract infections – upper (such as cold, sinus infection, sore throat) or 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

For more information refer to the Consumer Medicine Information (CMI) which is available in the link at the bottom of this page, and review the safety information section of this website.

How will I know if I’m allergic to HUMIRA?

Symptoms of an allergic reaction may include:

  • chest tightness
  • shortness of breath, wheezing or difficulty breathing or swallowing
  • swelling of the face, lips, tongue or other parts of the body, eg hands or feet
  • hives, itching or skin rash.

If you experience any of these symptoms you should seek urgent medical attention.

How often and for how long will I have to use HUMIRA?

The recommended dose of HUMIRA depends on the conditions being treated, and in the case of children, their age and weight.

You should talk to your specialist about the dosage and frequency of your injections. Do not inject HUMIRA more often than prescribed.

HUMIRA is available in either a pre-filled single-use syringe or, a pre-filled single-use pen. Both the syringe and pen come preloaded with the exact dose of medicine inside, ready for you to inject.

The duration of treatment with HUMIRA will depend on many factors. If you stop taking HUMIRA your immune system may, once again, become over-active and cause inflammation so it is important that you continue to use HUMIRA for as long as your specialist tells you to. If you need to stop HUMIRA for a medical reason, you should tell your specialist as soon as possible.

Can I use HUMIRA if I’m taking other medicines?

You can take other medicines if your doctor has told you it’s okay to take them while you’re using HUMIRA. You can still take some other types of medicines for your condition at the same time as HUMIRA, for example, methotrexate, steroids, non-steroidal anti- inflammatories and painkillers; this is something your specialist will advise you on.

However, you should not take HUMIRA if you are taking anakinra (Kineret®), or if you are taking any other biologic DMARDs or Anti-TNFs such as abatacept (Orencia®), etanercept (Enbrel®) or infliximab (Remicade®) as taking the two medicines together may increase the risk of infection.

You should not receive some types of vaccines (live vaccines) whilst taking HUMIRA. Tell your healthcare professional that you are taking HUMIRA before you are scheduled to have any vaccinations.

HUMIRA is supplied in a single-use, pre-filled syringe or single-use, pre-filled pen. It should NOT be mixed with any other medicine (such as insulin), nor should any other medicines be added to the syringe or pen.

Make sure to tell your specialist about all medicines you are taking including other prescription medicines, any medicines purchased from a pharmacy or supermarket, painkillers, herbal medicines, and vitamin and mineral supplements you are taking. If you have any questions, you should ask your specialist.

Orencia is a registered trade mark registered to Bristol-Myers Squibb. Kineret is a registered trade mark licensed by Swedish Orphan Biovitrum. Enbrel is a registered trade mark registered to Pfizer New Zealand. Remicade is a registered trade mark registered to Janssen Cilag.

Are there any foods that interact with HUMIRA?

Since HUMIRA is injected under the skin (subcutaneously), rather than taken by mouth, food and drink should not affect HUMIRA. If you have questions, talk to your doctor.

Can I drink alcohol when using HUMIRA?

There is insufficient information on the effects of alcohol on HUMIRA. If you have questions, talk to your doctor.

Should I get a flu vaccination (“flu shot”) if I am taking HUMIRA?

Tell your doctor if you are scheduled for any vaccines. It is recommended that patients be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating HUMIRA therapy.

Your specialist or GP may encourage you to have vaccinations for flu annually and pneumonia to help protect you, or to try to reduce the severity of these infections.

Patients receiving HUMIRA should not receive live vaccines. Check with your doctor about which ones are ‘live’ vaccines.

If you have any questions about any of this information, ask your doctor.

Can I use HUMIRA if I’m pregnant or breastfeeding?

Tell your doctor if you are pregnant or planning to become pregnant. If you become pregnant while using HUMIRA, tell your doctor immediately.

If you use HUMIRA during pregnancy, your baby may have a higher risk of getting an infection. It is important that you 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. 

If you have any questions about any of this information, ask your doctor.