Consumer medicine information

YUFLYMA®


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


1. Why am I using Yuflyma?

Yuflyma contains the active ingredient adalimumab. Yuflyma is used to treat various inflammatory conditions. For more information, see Section 1. Why am I using Yuflyma? in the full CMI.

2. What should I know before I use Yuflyma?

Check the list of ingredients at the end of the CMI. Do not use Yuflyma if you have ever had an allergic reaction to any of them.

Talk to your doctor before taking this medicine if you are not aware that you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Yuflyma? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Yuflyma and affect how it works, or Yuflyma may interfere with other medicines and affect how they work.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Yuflyma?

Yuflyma is injected under the skin (subcutaneous).

More instructions can be found in Section 4. How do I use Yuflyma? in the full CMI.

5. What should I know while using Yuflyma?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Yuflyma.
  • Keep all your appointments, including for blood tests.
  • Tell your doctor if you develop an infection or you notice new or changed spots on your skin.
  • Tell your doctor if you are scheduled for any vaccines.
Things you should not do
  • Do not stop using this medicine or change the dose unless your doctor tells you to.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Yuflyma affects you. The effects on your ability to drive or use machines whilst taking Yuflyma are not known.
Drinking alcohol
  • There is no information on the effects of taking Yuflyma with alcohol.
Looking after your medicine
  • Store Yuflyma in the refrigerator (2°C to 8°C). Do not freeze.
  • Keep pens or syringes in the pack to protect your medicine from light.

For more information, see Section 5. What should I know while using Yuflyma? in the full CMI.

6. Are there any side effects?

Side effects that require urgent medical attention include: Signs of an allergic reaction, such as chest tightness, difficulty breathing,swelling of face lips and tongue, rash; signs of heart failure, such as shortness of breath on exertion or lying down, swelling of the feet; signs suggesting a blood disorder, such as persistent fever, bruising, bleeding, paleness.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

YUFLYMA®(yue-flai-mah)

Active ingredient: adalimumab (rch) (a-da-li-mue-mab)


Consumer Medicine Information (CMI)

This leaflet provides important information about using Yuflyma. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Yuflyma.

Where to find information in this leaflet:

1. Why am I using Yuflyma?
2. What should I know before I use Yuflyma?
3. What if I am taking other medicines?
4. How do I use Yuflyma?
5. What should I know while using Yuflyma?
6. Are there any side effects?
7. Product details

1. Why am I using Yuflyma?

Yuflyma contains the active ingredient adalimumab.

Yuflyma is used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease in adults and children aged 6 years and over, ulcerative colitis, psoriasis in adults and children aged 4 years and over, hidradenitis suppurativa in adults and adolescents aged 12 years and over, and Uveitis.

2. What should I know before I use Yuflyma?

Warnings

Do not use Yuflyma if:

  1. you are allergic to adalimumab, or any of the ingredients listed at the end of this document
  2. you have a severe infection such as sepsis (a serious infection of the blood) or tuberculosis (a serious infection of the lungs caused by bacteria), or other severe infection caused by a virus, fungus, parasite or bacteria
  3. you have heart failure considered by your doctor to be moderate or severe

Check with your doctor if you:

  • have or have had an infection that does not go away or keeps coming back, this can include leg ulcers
  • you have ever had tuberculosis, or you have been in close contact with someone who has tuberculosis. Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
  • you currently have active hepatitis B, have ever had hepatitis B, are a carrier of the hepatitis B virus or you think you may be at risk of contracting hepatitis B
  • you have or have had an infection caused by a fungus, or you have lived or travelled in countries where fungal infections are common
  • you have or have had uveitis, where the middle layer of the eyeball is inflamed
  • you have or have had allergic reactions such as chest tightness, wheezing, dizziness, welling or rash
  • you have a disease that affects the insulating layer of the nerves, e.g. multiple sclerosis (MS)
  • you have or have had a blood disorder
  • you have or have had low resistance to disease
  • you have or have had a heart condition
  • you have or have had cancer or autoimmune disease
  • you have a lung disease called chronic obstructive pulmonary disease (COPD)
  • you have or have had kidney or liver problems
  • you have any vaccinations scheduled
  • you have or have had psoriasis (a skin disease that produces patches of thickened, scaly skin that is not contagious)
  • you have had phototherapy, also known as light therapy, for psoriasis
  • you have any surgery planned
  • you take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Make sure your doctor is aware that you are pregnant or plan to become pregnant. Yuflyma should only be used in pregnancy if clearly needed.

If you use Yuflyma during pregnancy your baby may have a higher risk of getting an infection.

You should consider the use of effective contraception to prevent pregnancy and continue its use for at least 5 months after the last Yuflyma injection.

Tell your baby’s doctors if you have taken Yuflyma while you are pregnant, especially before your baby receives any vaccinations.

Make sure your doctor is aware that you are breastfeeding, or you plan to do so.

Use in children

  • Wherever possible, it is recommended that children are up to date with all vaccinations, according to current immunisation guidelines, before they are started on Yuflyma treatment.
  • Treatment of Crohn’s disease in children should be supported by good nutrition to allow appropriate growth.
  • The long-term effects of Yuflyma on the growth and development of children is not known.

Use in the elderly

If you are over 65, you may be more likely to get an infection while taking Yuflyma.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Yuflyma and affect how it works while Yuflyma may affect how other medicines work.

Do not take Yuflyma if you are taking the following medicine:

  • Anakinra, a medicine used to treat rheumatoid arthritis, juvenile idiopathic arthritis and conditions associated with a defect in a protein call cryoprin.

Medicines that may increase the risk of infection when taken with Yuflyma include:

  • anakinra, a medicine used to treat rheumatoid arthritis, juvenile idiopathic arthritis and conditions associated with a defect in a protein called cryoprin
  • abatacept, a medicine used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis
  • azathioprine, a medicine used for suppressing the immune system to treat various conditions
  • 6-mercaptopurine, a medicine used to treat certain types of leukaemia, a blood disorder.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Yuflyma.

4. How do I use Yuflyma?

Always use YUFLYMA® exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

YUFLYMA® is injected under the skin (subcutaneous use). It is only available as 40 mg/0.4 mL and 80 mg/0.8mL strengths. Thus, it is not possible to use YUFLYMA® for children who require less than a full 40 mg dose. If such a dose is required, other adalimumab medicines should be used.

How much to use

  • Rheumatoid arthritis in adults
    Inject one 40 mg dose every fortnight.
    If you are not taking methotrexate, your doctor may change this dose to 40 mg every week, or 80 mg every fortnight, (given as one 80 mg injection or two 40 mg injections) depending on your response.
  • Psoriatic arthritis and ankylosing spondylitis in adults
    Inject one 40 mg dose every fortnight.
  • Crohn’s disease and ulcerative colitis in adults
    Inject 160 mg on day 1 (given as two 80 mg injections or four 40 mg injections), followed by 80 mg on day 15 (given as one 80 mg injection or two 40 mg injections) and 40 mg on day 29. Then, continue to inject 40 mg every fortnight (maintenance dose).
    Your doctor may change this maintenance dose to 40 mg every week, or 80 mg every fortnight (given as one 80 mg injection or two 40 mg injections), depending on your response.
    (See Special dosing instructions at the end of this section.)
  • Psoriasis in adults
    Inject 80 mg on day 1, followed by 40 mg on day 8 and 40 mg on day 22. Then, continue to inject 40 mg every fortnight (maintenance dose).
    Your doctor may change this maintenance dose to 40 mg every week, or 80 mg every fortnight (given as two 40 mg injections), depending on your response.
    (See Special dosing instructions at the end of this section.)
  • Uveitis in adults
    Inject 80 mg on day 1 (given as one 80 mg injection or two 40 mg injections), followed by 40 mg on day 8 and 40 mg on day 22. Then continue to inject 40 mg every fortnight (maintenance dose).
    (See Special dosing instructions at the end of this section.)
  • Hidradenitis suppurativa in adults
    Inject 160 mg on day 1 (given as two 80 mg injections in one day, one 80 mg injection per day for two consecutive days, or four 40 mg injections), followed by 80 mg on day 15 (given as one 80 mg injection or two 40 mg injections). Then continue to inject 40 mg every week or 80 mg every fortnight from day 29 (maintenance dose).
    (See Special dosing instructions at the end of this section.)
  • Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
    If the patient’s body weight is at least 30 kg, inject one 40 mg dose every fortnight.
  • Crohn’s disease in children
    If the patient’s body weight is at least 40 kg, inject 160 mg on day 1 (given as two 80 mg injections in one day, one 80 mg injection per day for two consecutive days, orfour 40 mg injections), followed by 80 mg on day 15 (given as one 80 mg injection ortwo 40 mg injections) and 40 mg on day 29. Then, continue to inject 40 mg every fortnight (maintenance dose).
    Your doctor may change this maintenance dose to 40 mg every week, or 80 mg every fortnight, depending on your response.
    (See Special dosing instructions at the end of this section.)
  • Psoriasis in children
    If the patient’s body weight is at least 40 kg, inject 40 mg on day 1, followed by 40 mg on day 8 and 40 mg on day 22. Then continue to inject 40 mg every fortnight (maintenance dose).
  • Hidradenitis suppurativa (HS) in adolescents
    Inject 80 mg on day 1 (given as one 80 mg injection or two 40 mg injections), followed by 40 mg on day 8, and 40 mg on day 22. Then continue to inject 40 mg every fortnight (maintenance dose) Your doctor may change this maintenance dose to 40 mg every week, or 80 mg every fortnight depending on your response.
    (See Special dosing instructions at the end of this section.)
    Use an antiseptic face wash on the affected areas.

Special dosing instructions

  • When a dose of 160 mg is required, this can be given as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days, or asfour 40 mg injections in one day, or two 40 mg injections per day over two consecutive days.
  • When a dose of 80 mg is required, this can be given as one 80 mg injection or two 40 mg injections in one day.

In some instances, Yuflyma needs to be taken with other medicines. Your doctor will let you know which medicines, how to take them and how long to take them.

Follow all instructions given to you and use Yuflyma until your doctor tells you to stop.

How to use Yuflyma

  • Yuflyma is injected under the skin (sub-cutaneous injection).
  • It can be injected by the patient, or by someone else, such as a family member, friend or carer.
  • An injection should not be attempted until proper training has been received on the correct injection technique.
  • Do not mix the injection with any other medicine.
  • Read the instructions for preparing and giving a Yuflyma injection that are supplied with the product. These instructions are also available via the following hyperlinks:
    Yuflyma syringe: [hyperlink to be included]
    Yuflyma 80 mg/0.8 mL pen: [hyperlink to be included]

If you forget to take Yuflyma

It is important that you use your medicine as prescribed by your doctor.

If you miss your dose at the usual time, inject Yuflyma as soon as you remember, and continue injecting the next dose at the usual time on your scheduled day.

Do not take a double dose to make up for the dose you missed.

If you inject too much Yuflyma

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Yuflyma?

Things you should do

  • Keep all your doctor’s appointments so your progress can be tracked.
  • Keep your appointments for blood tests. Some side effects are seen in blood results before you have any symptoms.
  • Remind any doctor, dentist or pharmacist you visit that you are using Yuflyma, especially if you are scheduled for surgery or to receive any live vaccines (e.g. Bacille Calmette-Guerin or oral polio vaccine).

Call your doctor straight away if you:

  • get symptoms of an infection, such as a fever, skin sores, feeling tired, any problems with your teeth or gums or pain when passing urine or blood in your urine.
  • become pregnant while using Yuflyma.
  • notice new skin lesions (skin spots or sores), or if existing lesions change appearance.

Things you should not do

  • Do not stop using this medicine or change the dose without checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Yuflyma affects you.

Drinking alcohol

There is no information on the use of alcohol with Yuflyma.

Looking after your medicine

Follow the instructions on the carton on how to take care of your medicine properly.

  • Keep Yuflyma in the carton protected from light.
  • Keep Yuflyma in a refrigerator (at 2°C to 8°C). Do not freeze.

Keep it where young children cannot reach it.

When to discard your medicine

  • When necessary, a single Yuflyma pen or syringe may be stored at room temperature (≤25°C) for a maximum of 30 days, protected from light.
  • Once removed from the refrigerator, the pen or syringe must be used within 30 days or discarded, even if it has been returned to the refrigerator.
  • After injecting Yuflyma, immediately throw away the used pen or syringe in a special sharps container as instructed by your doctor, nurse or pharmacist.

Getting rid of any unwanted medicine

If your doctor advises that you no longer need to use this medicine or it is out of date, follow local guidelines for safe disposal.

6. Are there any side effects?

All medicines can have side effects. Most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects What to do
Injection site:

  • pain
  • swelling
  • redness
  • itching

Lungs and upper airways

  • cold
  • flu
  • runny nose
  • cough
  • sore throat
  • sinus infection
  • asthma or asthma worsening
  • bronchitis or pneumonia (congestions on the chest)

Ears, eyes and mouth

  • pain in the ear
  • pain, redness or swelling of the eye or eye lid
  • changes to vision
  • mouth ulcers
  • pain in the gums
  • excessive bleeding from the gums

Brain and nerves

  • headache or migraine
  • dizziness
  • muscle weakness
  • muscle, bone or joint pain
  • numbness
  • difficulty balancing

Gut and digestion

  • nausea
  • vomiting
  • tummy pain
  • reflux or heartburn

Skin and nails

  • rash
  • itching
  • redness
  • scaly skin patches
  • problems with your fingernails or toenails
  • hair loss
  • cold sore blisters
  • chicken pox

Blood

  • bleeding
  • bruising more easily than usual

Body as a whole

  • tiredness
  • chest pain
  • lack of energy
  • increased heart rate
  • feeling overwhelmed or sad, lacking motivation (depression)
  • feeling especially fearful or worried (anxiety)
Speak to your doctor if you have any of these side effects and they worry you.

Serious Side effect

Serious side effects What to do
Signs of tuberculosis, such as:

  • persistent cough
  • weight loss
  • listlessness
  • fever

Signs of an infection, such as:

  • fever
  • lack of energy
  • skin bump or sore that doesn’t heal
  • problems with your teeth or gums
  • pain when passing urine or blood in the urine

Signs of problems with your nervous system, such as:

  • numbness
  • tingling throughout your body
  • arm or leg weakness
  • double or blurred vision.

Signs suggesting a blood clot, such as:

  • swelling, tenderness, redness and a warm feeling of an area of the arm or leg
Speak to your doctor as soon as possible if you have any of these side effects.

Very serious side effects

Very serious side effects What to do
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 of heart failure, such as:

  • shortness of breath on exertion or lying down
  • swelling of the feet

Signs suggesting a blood disorder, such as:

  • persistent fever
  • bruising
  • bleeding very easily
  • paleness
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Yuflyma contains

Active ingredient
(main ingredient)
adalimumab
Other ingredients
(inactive ingredients)
acetic acid
sodium acetate trihydrate
glycine
polysorbate 80
water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What Yuflyma looks like

Yuflyma is a clear to slightly opalescent, colourless to pale brown solution containing 40 mg/0.4 mL and 80 mg/ 0.8 mL(100 mg/mL).

Yuflyma is available in the following presentations:

  • 40 mg adalimumab in 0.4 mL solution in a prefilled syringe (AUST R 358350)
  • 40 mg adalimumab in 0.4 mL solution in a prefilled syringe with safety guard (AUST R367770)
  • 40 mg adalimumab in 0.4 mL solution in a prefilled pen (AUST R 367771)

Yuflyma is a clear to slightly opalescent, colourless to pale brown solution containing 80 mg/0.8 mL (100 mg/mL).

  • 80 mg adalimumab in 0.8 mL solution in a prefilled syringe (AUST R 396990)
  • 80 mg adalimumab in 0.8 mL solution in a prefilled syringe with safety guard (AUST R 396991)
  • 80 mg adalimumab in 0.8 mL solution in a prefilled pen (AUST R 396992)

Who distributes Yuflyma

Celltrion Healthcare Australia Pty Ltd
Suite 13-03 31 Market Street,
Sydney NSW 2000, Australia

Phone: 1800 325 228

This leaflet was prepared in May 2023.

Published by MIMS August 2023