What is it and how is it used?
Cimzia contains the active substance certolizumab pegol, a human antibody fragment. Antibodies are proteins that specifically recognise and bind to other proteins. Cimzia binds to a specific protein called tumour necrosis factor α (TNFα). Thereby this TNFα is blocked by Cimzia and this decreases inflammation in rheumatoid arthritis. Medicines that bind to TNFα are also called TNF blockers.
Cimzia is used for the treatment of moderate to severe rheumatoid arthritis in adult patients, when other medicines fail to control your symptoms. Cimzia is usually used together with another medicine called methotrexate. If your doctor determines that methotrexate is inappropriate, Cimzia can be given alone.
What do you have to consider before using it?
Do NOT use Cimzia
Take special care with Cimzia
Tell your doctor before treatment with Cimzia if any of the following applies to you: Allergic reactions
Infections
Heart failure
Cancer
Other disorders
Vaccinations
Operations or dental procedures
Children
Cimzia is not recommended for use in children and adolescents under the age of 18 years.
Taking other medicines
You should NOT take Cimzia if you are using the following medicines used to treat rheumatoid arthritis:
Cimzia can be taken together with:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
There is a lack of experience with Cimzia in pregnant women. Therefore, Cimzia should NOT be used in pregnant women. Women of childbearing potential must use adequate contraception while using Cimzia and for at least 5 months after the last Cimzia treatment.
It is not known whether Cimzia passes into breast milk. You should talk to your doctor before breast-feeding during Cimzia treatment.
Driving and using machines
Cimzia may have a minor influence on your ability to drive and use machines. Dizziness (including room spinning sensation, blurred vision and tiredness) may occur after you take Cimzia.
Important information about some of the ingredients of Cimzia
This medicinal product contains less than 1 mmol sodium (23 mg) per 400 mg, i.e. essentially ‘sodium-free’.
How is it used?
Always use Cimzia exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure of how to use Cimzia.
The starting dose for adults with rheumatoid arthritis is 400 mg given at weeks 0, 2 and 4. This is followed by a maintenance dose of 200 mg every other week starting at week 6. Methotrexate is continued while using Cimzia. If your doctor determines that methotrexate is inappropriate, Cimzia can be given alone.
Cimzia will usually be given to you by a specialist doctor or healthcare professional. You will be given Cimzia as either one (200 mg dose) or two injections (400 mg dose) under the skin (subcutaneous use). It is usually injected into the thigh or tummy.
Instructions for preparing and giving an injection of Cimzia
After suitable training, your doctor may also allow you to inject Cimzia yourself. Please read the instructions at the end of this leaflet on how to inject Cimzia.
If you use more Cimzia than you should
If your doctor has allowed you to self-inject and you accidentally inject Cimzia more frequently than prescribed, you should tell your doctor. Always take the Patient Alert Card and the outer carton from the Cimzia package with you, even if it is empty.
If you forget to use Cimzia
If your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inject the next dose of Cimzia as soon as you remember. Then inject the following doses every 2 weeks as originally instructed.
If you stop using Cimzia
Do not stop using Cimzia without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, Cimzia can cause side effects, although not everybody gets them.
Tell your doctor IMMEDIATELY if you notice any of the following side effects:
Tell your doctor AS SOON AS POSSIBLE if you notice any of the following side effects:
The symptoms described above can be due to some of the side effects listed below, which have been observed with Cimzia:
Side effects may occur with certain frequencies, which are defined as follows:
Common side effects:
Uncommon side effects:
Rare side effects:
Other side effects
When Cimzia has been used to treat other diseases the following uncommon side effects have occurred:
When other TNF blockers have been used to treat rheumatoid arthritis, multiple sclerosis or Guillain-Barré syndrome have occurred. The risk of multiple sclerosis or Guillain-Barré syndrome with Cimzia is not known.
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Cimzia after the expiry date which is stated on the pack and syringe after EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.
