Prospecto: information for the user
Kineret100mg/0.67ml injectable solution in pre-filled syringe
Anakinra
Read this prospect carefully before starting to use this medication, as it contains important information for you.
1.What is Kineret and for what it is used
2.What you need to know before starting to use Kineret
3.How to use Kineret
4.Possible adverse effects
5.Storage of Kineret
6.Contents of the package and additional information
Kineret contains the active ingredient anakinra. It is a type of cytokine (an immunosuppressant agent) used to treat:
-Periodic syndromes associated with cryopyrin (CAPS)
Cytokines are proteins produced by our body that coordinate cell communication and help control cellular activity. In RA, CAPS, FMF, Still's disease, and Covid-19 pneumonia, the body produces an excessive amount of a cytokine called interleukin-1. This leads to harmful effects causing inflammation and resulting in disease symptoms. Normally, the body produces a protein that blocks the harmful effects of interleukin-1. The active ingredient in Kineret is anakinra, which acts similarly to the natural protein that blocks interleukin-1. Anakinra is obtained through recombinant DNA technology using the microorganism E. coli.
In RA, Kineret is used to treat disease signs and symptoms in adults (18 years of age and older) in combination with another medication called methotrexate. Kineret is intended for patients whose response to methotrexate alone is not sufficient to control rheumatoid arthritis.
In Covid-19, Kineret is used to treat hyperinflammation associated with the disease in adults (18 years of age and older) who have pneumonia, require supplemental oxygen to help them breathe (low or high oxygen flow), and have a risk of pulmonary insufficiency.
In CAPS, Kineret is used to treat inflammation signs and symptoms associated with this disease, such as rash, joint pain, fever, headache, and fatigue, in both adults and children (8 months of age and older).
In FMF, Kineret is used to treat inflammation signs and symptoms associated with this disease, such as recurrent fever, fatigue, abdominal pain, muscle or joint pain, and rash. Kineret can be used in combination with colchicine, as needed.
In Still's disease, Kineret is used to treat inflammation signs and symptoms associated with this disease, such as rash, joint pain, and fever.
No use Kineret
Contact your doctor immediately
Warnings and precautions
Consult your doctor before starting to use Kineret:
Still's disease
CAPS
Children and adolescents
Other medications and Kineret
Inform your doctor if you are using, have used recently, or may need to use any other medication.
Tumor necrosis factor (TNF‑α) inhibitors, such as etanercept, should not be used with Kineret, as this may increase the risk of infections.
When you start using Kineret, the chronic inflammation in your body will decrease. This may require adjusting the doses of other medications, such as warfarin or phenytoin.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.
Kineret has not been tested in pregnant women. It is not recommended to use Kineret during pregnancy or in women of childbearing age who do not use a contraceptive method. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant. Your doctor will discuss with you the possible risks of taking Kineret during pregnancy.
The excretion of anakinra in breast milk is unknown. Stop breastfeeding if you are using Kineret.
Kineret contains sodium
This medication contains less than1mmol of sodium (23mg) per dose of100mg; this is essentially "sodium-free".
Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Kineret is injected under the skin (subcutaneous injection) daily. You should try to give yourself the injection at the same time every day.
The recommended dose is 20 to 90 mg or 100 mg. Your doctor will tell you the dose you need, or if you need a dose greater than 100 mg.
COVID-19: the recommended dose is 100 mg injected under the skin (subcutaneously) daily for 10 days.
Self-Administration of Kineret
Your doctor may decide that it is more convenient for you to inject Kineret yourself. Your doctor or nurse will teach you how to do it. Do not attempt to inject yourself if you have not been explained how to do it.
For information on how to inject Kineret yourself or inject it into your child, please read the section “Instructions for preparing and administering a Kineret injection” included at the end of this prospectus.
If You Use More Kineret Than You Should
You should not have any serious problems if, accidentally, you use more Kineret than you need. However, you should contact your doctor or pharmacist if this occurs. If you do not feel well, you should contact your doctor immediately.
If You Forget to Use Kineret
If you forget to give yourself a dose of Kineret, you should contact your doctor to discuss when you should give yourself the next dose.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects are similar whether Kineret is used for RA or CAPS, FMF, Still's disease, or COVID-19.-
If any of the following side effects occur, inform your doctor immediately:
-Swelling of the face, tongue, or throat
-Difficulty swallowing or breathing
-Sudden sensation of rapid heartbeat or sweating
-Itching on the skin or rash
Very common side effects(may affect more than 1 in 10people):
Common side effects(may affect up to 1 in 10people):
Rare side effects(may affect up to 1 in 100people):
Side effects of unknown frequency(cannot be estimated from available data):
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the label and on the box after “CAD”. The expiration date is the last day of the month indicated.
Store in the refrigerator (between2°Cand8°C). Do not freeze.
Store in the original box to protect it from light.
Do not use Kineret if you believe it has been frozen. Once a syringe has been removed from the refrigerator and has reached room temperature (up to25°C), it must be used within the72hours following or discard. Do not store it back in the refrigerator if it has been stored at room temperature.
Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
Composition of Kineret
Appearance of the product and contents of the pack
Kineret is a transparent, colourless to slightly white solution presented in a pre-filled syringe ready for use. The solution may contain protein particles with a translucent to white appearance, the presence of which does not affect the quality of the product.
Pack sizes of 1, 7 or 28 (multipack with 4 packs of 7 pre-filled syringes) pre-filled syringes.
Only some pack sizes may be marketed.
Holder of the marketing authorisation and responsible person for manufacture
Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm
Sweden
Last date of revision of the package leaflet: 11/2024
Further information is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
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