Adalicip

Adalicip

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

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Adalicip. 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 Adalicip.

Where to find information in this leaflet:

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

1. Why am I using Adalicip?

Adalicip contains the active ingredient adalimumab.

Adalicip 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 Adalicip?

Warnings

Do not use Adalicip if:

• you are allergic to adalimumab, or any of the ingredients listed at the end of this document.
• 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
• 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, swelling 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. Adalimumab should only be used in pregnancy if clearly needed.

If you use adalimumab 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 adalimumab injection.

Tell your baby’s doctors if you have taken Adalicip 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 Adalicip treatment.
• Treatment of Crohn’s disease in children should be supported by good nutrition to allow appropriate growth.
• The long-term effects of adalimumab 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 adalimumab.

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 adalimumab and affect how it works, while adalimumab may affect how other medicines work.

Do not take Adalicip 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 called cryoprin.

Medicines that may increase the risk of infection when taken with adalimumab 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 Adalicip.

4. How do I use Adalicip?

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

Adalicip is only available in 40 mg/0.4 mL and 80 mg/0.8 mL strengths. Thus, it is not possible to use Adalicip for children with juvenile idiopathic arthritis weighing less than 30 kg, children with paediatric Crohn’s Disease (6 to 17 years) weighing less than 40 kg or for children with paediatric plaque psoriasis weighing less than 40 kg. If a dose lower than 40 mg is required, speak to your doctor or pharmacist about other adalimumab products which may be suitable as other adalimumab products 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, 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, followed by 80 mg on day 15 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 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, depending on your response.
  (See Special dosing instructions at the end of this section.)
• Uveitis 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).
  (See Special dosing instructions at the end of this section.)
• Hidradenitis suppurativa in adults
  Inject 160 mg on day 1, followed by 80 mg on day 15. 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.
  There is no available dosage form of Adalicip that allows dosage of less than 40 mg. If a dose lower than 40 mg is required, speak to your doctor or pharmacist.
• Crohn’s disease in children
  If the patient’s body weight is at least 40 kg, inject 160 mg on day 1, followed by 80 mg on day 15 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.)
  There is no available dosage form of Adalicip that allows dosage of less than 40 mg. If a dose lower than 40 mg is required, speak to your doctor or pharmacist.
• 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).
  There is no available dosage form of Adalicip that allows dosage of less than 40 mg. If a dose lower than
  40 mg is required, speak to your doctor or pharmacist.
• Hidradenitis suppurativa (HS) in adolescents
  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 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 OR four 40 mg injections in one day, or one 80 mg 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, Adalicip 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 Adalicip until your doctor tells you to stop.

How to use Adalicip

• Adalicip 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 Adalicip injection that are supplied with the product.

If you forget to inject Adalicip

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

If you miss your dose at the usual time, inject Adalicip 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 Adalicip

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 appear to be no signs of discomfort or poisoning.

5. What should I know while using Adalicip?

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 Adalicip, 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 Adalicip.
• 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 adalimumab affects you.

Drinking alcohol

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

Looking after your medicine

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

• Keep Adalicip in the carton protected from light.
• Keep Adalicip 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

• Product is for single use in one patient only. Discard any residue.
• When necessary, a single Adalicip pen or syringe may be stored at room temperature (25°C) for a maximum of 14 days, protected from light.
• Once removed from the refrigerator, the pen or syringe must be used within 14 days or discarded, even if it has been returned to the refrigerator.
• After injecting Adalicip, 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 worsening asthma 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 effects

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 Adalicip contains

Adalicip 80 mg in 0.8mL; 40 mg in 0.4 mL

Adalicip is a clear, colourless, sterile preservative-free solution containing:

• 80 mg adalimumab in 0.8 mL solution in a prefilled syringe
• 40 mg adalimumab in 0.4 mL solution in a prefilled pen
• 40 mg adalimumab in 0.4 mL solution in a prefilled syringe

Active ingredient (main ingredient)	adalimumab
Other ingredients (inactive ingredients)	Polysorbate 80 Sodium chloride Sucrose Water for injections

What Adalicip looks like

40 mg per 0.4 mL prefilled pens and prefilled syringes are available for patient use in packs of 1,2 or 6 units with alcohol pads.

80 mg prefilled syringes is available for patient use in pack of 1 unit with alcohol pads.

Who distributes Adalicip?

Adalicip is distributed in Australia by:

Cipla Australia Pty Ltd
Level 1 / 132-136 Albert road,
SOUTH MELBOURNE VIC 3205.
drugsafety@cipla.com
Phone: 1800-569-074

This leaflet was prepared in August 2023.