Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kineret

Document Subject

Generated Narrative: MedicinalProductDefinition mpe32af5235bc449e932db46935c53460a

identifier: http://ema.europa.eu/identifier/EU/1/02/203/005 – 1-pack

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e32af5235bc449e932db46935c53460a

identifier: http://ema.europa.eu/identifier/EU/1/02/203/005 – 1-pack

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - kineret

Attesters

What is in this leaflet

1. What Kineret is and what it is used for
2. What you need to know before you use Kineret
3. How to use Kineret
4. Possible side effects
5. How to store Kineret
6. Contents of the pack and other information

Kineret contains the active substance anakinra. This is a type of cytokine (an immunosuppressive agent) that is used to treat:

• Rheumatoid Arthritis (RA)
• COVID-19 in patients who have pneumonia, need extra oxygen and are at risk of lung failure
• Periodic fever syndromes:

Cryopyrin-Associated Periodic Syndromes (CAPS) * Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also called Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA), * Muckle-Wells Syndrome (MWS), * Familial Cold Autoinflammatory Syndrome (FCAS)

Familial Mediterranean Fever (FMF)

• Still s disease including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still s Disease (AOSD)

Cytokines are proteins made by your body that co-ordinate communication between cells and help control cell activity. In RA, CAPS, FMF, Still s disease, and in COVID-19 pneumonia, your body produces too much of a cytokine called interleukin-1. This results in harmful effects leading to inflammation, causing the symptoms of the disease. Normally, your body produces a protein that blocks the harmful effects of interleukin-1. The active substance of Kineret is anakinra, this works in the same way as your natural interleukin-1 blocking protein. Anakinra is produced by DNA technology using the micro-organism E. coli.

For RA, Kineret is used to treat the signs and symptoms of the disease in adults (age 18 years and over) in combination with another medicine called methotrexate. Kineret is for patients whose response to methotrexate on its own is not good enough to control the rheumatoid arthritis.

For COVID-19, Kineret is used to treat the hyperinflammation (stronger than the usual inflammation) associated with the disease in adults (age 18 years and over) who have pneumonia, need extra oxygen to help them breathe (low- or high-flow oxygen) and are at risk of lung failure.

For CAPS, Kineret is used to treat the signs and symptoms of inflammation associated with the disease such as rash, joint pain, fever, headache and fatigue in adults and children (age 8 months and older).

For FMF, Kineret is used to treat the signs and symptoms of inflammation associated with the disease such as recurrent fever, fatigue, abdominal pain, muscle or joint pain and rash. Kineret can be used together with colchicine, if appropriate.

For Still s disease, Kineret is used to treat the signs and symptoms of inflammation associated with the disease such as rash, joint pain and fever.

Do not use Kineret

• if you are allergic to anakinra or any of the other ingredients of this medicine, listed in section 6;
• if you are allergic to other products that are produced by DNA technology using the micro- organism E. coli;
• if you have neutropenia (low white blood cell count) determined after a blood test.

Contact your doctor immediately

• if you get a rash all over your body, shortness of breath, wheezing, fast pulse or sweating after your Kineret injection. These may be signs that you are allergic to Kineret.
• if you have ever developed an atypical, widespread rash or skin peeling after taking Kineret.

Warnings and precautions Talk to your doctor before using Kineret:

• if you have a history of recurring infections, or if you suffer from asthma. Kineret may worsen these conditions;
• if you have cancer. Your doctor will have to decide if you can still be given Kineret;
• if you have a history of increased levels of liver enzymes;
• if you require vaccinations. You must not be given live vaccines while being treated with Kineret.

Still s disease

• In rare cases patients with Still s disease, mainly children, may develop lung disease, also during Kineret treatment. The risk may be increased in patients with Down s syndrome (trisomy 21). Symptoms of lung disease can be e.g. shortness of breath during light exercise, morning cough, and difficulties breathing. If you develop signs of lung disease you should contact your health care provider as soon as possible.
• The serious skin reaction, DRESS (drug reaction with eosinophilia and systemic symptoms), has rarely been reported in association with Kineret treatment, predominantly in patients with systemic juvenile idiopathic arthritis (SJIA). Seek medical attention immediately if you notice an atypical, widespread rash, which may occur in conjunction with high body temperature and enlarged lymph nodes.

Children and adolescents

• RA: Use of Kineret in children and adolescents with Rheumatoid Arthritis has not been fully investigated and therefore cannot be recommended.
• COVID-19: Use of Kineret in children and adolescents with COVID-19 has not been investigated and therefore cannot be recommended.
• CAPS, FMF, Still s disease: Kineret is not recommended for children younger than 8 months of age because there is no data in this age group.

Other medicines and Kineret Tell your doctor if you are taking, have recently taken or might take any other medicines.

Medicines called tumour necrosis factor (TNF- ) inhibitors, such as etanercept should not be used with Kineret because this may increase the risk of infections.

When you start taking Kineret the chronic inflammation in your body will decrease. This could mean that the doses of some other medicines, e.g. warfarin or phenytoin, have to be adjusted.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Kineret has not been tested in pregnant women. Use of Kineret is not recommended during pregnancy and in women of childbearing potential not using contraception. It is important to tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby. Your doctor will discuss with you the potential risks of taking Kineret during pregnancy.

It is not known whether anakinra is excreted in human milk. You must not breast-feed if you use Kineret.

Kineret contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially sodium-free .

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Kineret must be injected under your skin (subcutaneous) daily. You should try to have the injection at the same time each day.

The recommended dose is either 20 to 90 mg or 100 mg. Your doctor will tell you the dose that you need or whether you need a dose higher than 100 mg.

COVID-19: The recommended dose is 100 mg injected under your skin (subcutaneous) daily for 10 days.

Injecting Kineret yourself Your doctor may decide that it would be more convenient for you to inject Kineret yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.

For instructions on how to inject yourself or your child with Kineret, please read the Instructions for preparing and giving an injection of Kineret section at the end of this leaflet.

If you use more Kineret than you should You should have no serious problems if you accidentally take more Kineret than you need. However, you should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell in any way you should contact your doctor or nurse immediately.

If you forget to use Kineret If you have forgotten to take a dose of Kineret, you should contact your doctor to discuss when you should take the next dose.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are similar regardless if you are treated with Kineret for RA, CAPS, FMF, Still s disease, or COVID-19. If any of the following happen, tell your doctor immediately:

• Serious infections such as pneumonia (a chest infection) or infections of the skin can occur during Kineret treatment. Symptoms might be persistent high fever, shivers, cough, headache, and redness and tenderness of the skin. Also persistent low-grade fever, weight loss, and persistent cough can be signs of an infection.

• Serious allergic reactions are uncommon. However, any of the following symptoms may indicate an allergic reaction to Kineret, so you should seek immediate medical attention. Do not inject more Kineret.

• Swelling of the face, tongue or throat

• Trouble swallowing or breathing

• Suddenly feeling fast pulse or sweating

• Itchy skin or rash

Very common side effects (may affect more than 1 in 10 people):

• Redness, swelling, bruising or itching at the injection site. These symptoms are generally mild to moderate and are more common at the start of your treatment.
• Headaches.
• Increased total blood cholesterol levels.

Common side effects (may affect up to 1 in 10 people):

• Neutropenia (low white blood cell count) determined after a blood test. This might increase the risk of you getting an infection. Symptoms of infection might include a fever or a sore throat.
• Serious infections such as pneumonia (a chest infection) or infections of the skin.
• Thrombocytopenia (low level of blood platelets).

Uncommon side effects (may affect up to 1 in 100 people):

• Serious allergic reactions including swelling of the face, tongue or throat, trouble swallowing or breathing, suddenly feeling fast pulse or sweating and itchy skin or rash.
• Elevated levels of liver enzymes determined after a blood test.

Side effects with frequency not known (frequency cannot be estimated from the available data):

• Signs of liver disorders such as yellow skin and eyes, nausea, loss of appetite, dark-coloured urine and light-coloured stools.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C to 8 C). Do not freeze. Store in original carton in order to protect from light.

Do not use Kineret if you think it has been frozen. Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25 C) it must either be used within 72 hours or discarded. Do not place it back in the refrigerator if it has been stored at room temperature.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Kineret contains

• The active substance is anakinra. Each graduated pre-filled syringe contains 100 mg of anakinra.
• The other ingredients are anhydrous citric acid, sodium chloride, disodium edetate dihydrate, polysorbate 80 and sodium hydroxide and water for injections.

What Kineret looks like and contents of the pack Kineret is a clear, colourless-to-white solution for injection and is supplied ready for use in a pre-filled syringe. It may contain some translucent-to-white particles of protein. The presence of these particles does not affect the quality of the product.

Pack sizes of 1, 7 or 28 (multipack containing 4 packs of 7 pre-filled syringes) pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: