Avtozma 162 mg solution for injection in pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Avtozma 162 mg, injection solution in a pre-filled pen
tocilizumab
This medicinal product is subject to additional monitoring, which will facilitate the rapid identification of new safety information. You can help by reporting any side effects you may experience. Section 4 includes information on how to report side effects.
Read this entire leaflet carefully before starting to use this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to refer to it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
- If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
In addition to this leaflet, you will be given a patient information card containing important safety information that you should know before receiving Avtozma and during treatment with Avtozma.
Contents of this leaflet:
- What Avtozma is and what it is used for
- What you need to know before using Avtozma
- How to use Avtozma
- Possible side effects
- How to store Avtozma
- Contents of the pack and other information
- Instructions for use
1. What Avtozma is and what it is used for
Avtozma contains an active substance called tocilizumab, which is a protein derived from specific immune cells (monoclonal antibody) that blocks the action of a specific type of protein (cytokine) called interleukin-6. This protein is involved in inflammatory processes in the body, and by blocking it, inflammation can be reduced. Avtozma is indicated for the treatment of:
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adults with moderate to severe active rheumatoid arthritis (RA), which is an autoimmune disease, when previous treatments have not worked well.
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adults with severe, active and progressive rheumatoid arthritis (RA) who have not previously been treated with methotrexate.
Avtozma helps reduce the symptoms of RA, such as pain and swelling in the joints, and may also improve your ability to perform daily tasks. Avtozma has been shown to reduce the progression of cartilage and bone damage in the joints caused by the disease and to improve your ability to carry out daily activities.
Avtozma is usually used in combination with another RA medication called methotrexate. However, Avtozma may be given alone if your doctor determines that methotrexate is not suitable.
- adults with a blood vessel disease called giant cell arteritis (GCA), caused by inflammation of the larger arteries in the body, especially those supplying blood to the head and neck. Symptoms may include headache, fatigue, and jaw pain. Consequences may include strokes and blindness.
Avtozma can reduce pain and swelling in the arteries and veins of the head, neck, and arms.
GCA is often treated with medications called steroids. These are usually effective, but may cause side effects if used at high doses for long periods. Reducing the steroid dose may also lead to a flare-up of GCA. Adding Avtozma to treatment allows for a shorter duration of steroid use while still maintaining control of GCA.
- children and adolescents, aged 12 years and older, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints, as well as fever and skin rash.
Avtozma is used to improve the symptoms of sJIA. It may be administered in combination with methotrexate or alone.
- children and adolescents, aged 12 years and older, with active polyarticular juvenile idiopathic arthritis (pJIA). This is an inflammatory disease that causes pain and swelling in one or more joints.
Avtozma is used to improve the symptoms of pJIA. It may be administered in combination with methotrexate or alone.
2. What you need to know before starting to use Avtozma
You must not be given Avtozma
- If you or the pediatric patient you are caring for is allergic to tocilizumab or to any of the other components of this medicine (listed in section 6). (See special warnings at the end of this section under the subtitle “Avtozma contains polysorbate”).
- If you or the pediatric patient you are caring for has a serious active infection.
If any of these apply to you, consult your doctor. Do not use Avtozma.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting treatment with Avtozma.
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If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, tongue, face, or skin rash, hives, or itching during or after injection, inform your doctor immediately.
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If you have experienced any symptoms of an allergic reaction after receiving Avtozma, do not take the next dose until you have informed your doctor and your doctor has instructed you to continue.
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If you have any type of infection, whether short-term or long-term, or if you frequently get infections, inform your doctor immediately if you feel unwell. Avtozma may reduce your body's ability to respond to infections and may worsen an existing infection or increase the risk of acquiring a new infection.
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If you have had tuberculosis, inform your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting treatment with Avtozma. Inform your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection occur during or after treatment.
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If you have had intestinal ulcers or diverticulitis, inform your doctor. Symptoms may include abdominal pain and unexplained changes in bowel habits with fever.
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If you have liver disease, inform your doctor. Before using Avtozma, your doctor will perform a blood test to assess your liver function.
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If any patient has recently been vaccinated, or plans to be vaccinated, inform your doctor. All patients should be up to date with their vaccination schedule before starting treatment with Avtozma. Certain types of vaccines should not be administered while receiving Avtozma.
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If you have cancer, inform your doctor. Your doctor will need to decide whether you can continue treatment with Avtozma.
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If you have cardiovascular risk factors, such as high blood pressure or high cholesterol levels, inform your doctor. These factors need to be managed while you are receiving Avtozma.
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If you have moderate to severe kidney problems, your doctor will monitor you.
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If you have persistent headaches.
Your doctor will perform blood tests before you receive Avtozma to determine whether you have low levels of white blood cells, low platelet counts, or elevated liver enzymes.
Children and adolescents
The use of the Avtozma pre-filled pen is not recommended in children under 12 years of age. Avtozma must not be administered to children with pJIA weighing less than 10 kg.
If the child has a history of macrophage activation syndrome (uncontrolled activation and proliferation of a specific type of blood cell), inform your doctor. Your doctor will decide whether Avtozma can continue to be administered.
Other medicines and Avtozma
Inform your doctor if you are taking any other medicines, or have recently taken any. This is because Avtozma may affect how some medicines work, and a dose adjustment may be needed. Inform your doctor if you have recently used medicines containing any of the following active substances:
- methylprednisolone, dexamethasone, used to reduce inflammation
- simvastatin or atorvastatin, used to reduce cholesterol levels
- calcium channel blockers, such as amlodipine, used to treat high blood pressure
- theophylline, used in the treatment of asthma
- warfarin or phenprocoumon, used as anticoagulants
- phenytoin, used to treat seizures
- cyclosporine, used as an immunosuppressant in organ transplantation
- benzodiazepines, such as temazepam, used to relieve anxiety.
Due to lack of clinical experience, the use of tocilizumab with other biological medicines used to treat RA, pJIA, sJIA, or GCA is not recommended.
Pregnancy, breastfeeding, and fertility
Avtozma must not be used during pregnancy, unless clearly necessary. Speak with your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant.
Women of childbearing potential must use effective contraception during treatment and for at least 3 months after stopping treatment.
Interrupt breastfeeding if you start treatment with Avtozma, and consult your doctor. Breastfeeding should not be resumed until at least 3 months after your last dose of Avtozma. It is unknown whether Avtozma passes into breast milk.
Driving and use of machines
This medicine may cause dizziness. If you feel dizzy, do not drive or operate machinery.
Avtozma contains polysorbate
This medicine contains 0.2 mg of polysorbate 80 in each pre-filled pen. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
3. How to use Avtozma
Follow exactly the instructions for administration of this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.
Treatment should be initiated by a healthcare professional experienced in the diagnosis and treatment of RA, JIA, JIAp, or GCA.
Recommended dose
The dose for all adults with RA or GCA is 162 mg (the content of one pre-filled pen) administered once weekly.
Adolescents with JIA (12 years of age and older)
The usual dose of Avtozma depends on the patient's weight.
- If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled pen), once every 2 weeks
- If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled pen), once every week.
The pre-filled pen must not be used to treat children under 12 years of age.
Adolescents with JIAp (12 years of age and older)
The usual dose of Avtozma depends on the patient's weight.
- If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled pen), once every 3 weeks
- If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled pen), once every 2 weeks.
The pre-filled pen must not be used to treat children under 12 years of age.
Avtozma is administered by injection under the skin (subcutaneously). At the beginning, your doctor or nurse may administer Avtozma to you. However, your doctor may decide that you can self-inject Avtozma. In this case, you will receive instructions on how to self-inject Avtozma. Parents and caregivers will be trained on how to inject Avtozma for patients who cannot self-inject.
Speak with your doctor if you have any questions about how you or an adolescent you care for can self-administer an injection. Detailed “administration instructions” can be found at the end of this leaflet.
If you are given more Avtozma than you should
Since Avtozma is administered in a pre-filled pen, it is unlikely that you will be given too much. However, if you are concerned, speak with your doctor, pharmacist, or nurse.
If an adult with RA or GCA or an adolescent with JIA missed or forgot a dose of Avtozma
It is very important to use Avtozma exactly as prescribed by your doctor. Keep track of your next dose.
- If you miss your weekly dose within 7 days, take your dose on the next scheduled day.
- If you miss your dose every two weeks within 7 days, inject a dose as soon as you remember and take your next dose according to your original schedule.
- If you miss your weekly or every two-week dose for more than 7 days, or are unsure when to inject Avtozma, contact your doctor or pharmacist.
If an adolescent with JIAp missed or forgot a dose
It is very important to use Avtozma exactly as prescribed by the doctor. Keep track of the next dose.
- If a dose is missed within 7 days, inject a dose as soon as you remember and administer the next dose according to your original schedule.
- If a dose is missed for 7 days or more, or you are unsure when to inject Avtozma, contact the doctor or pharmacist.
If you interrupt treatment with Avtozma
You must not stop treatment with Avtozma without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Adverse effects may occur up to at least 3 months after your last dose of Avtozma.
Possible serious adverse effects: consult your doctor immediately.
These are common: may affect up to 1 in 10 patients
Allergic reactions during or after injection:
- difficulty breathing, chest tightness, or dizziness
- skin rash, itching, hives, swelling of the lips, tongue, or face
If you experience any of these symptoms, speak to your doctor immediately.
Signs of serious infections:
- fever and chills
- blisters in the mouth or on the skin
- stomach pain
Signs and symptoms of liver toxicity
May affect up to 1 in 1,000 patients
- fatigue
- abdominal pain
- jaundice (yellowing of the skin or eyes)
If you notice any of these symptoms, inform your doctor immediately.
Very common adverse effects:
May affect more than 1 in 10 patients
- upper respiratory tract infections, with typical symptoms such as cough, nasal congestion, runny nose, sore throat, and headache
- high levels of fat in the blood (cholesterol)
- injection site reactions
Common adverse effects:
May affect up to 1 in 10 patients
- lung infection (pneumonia)
- shingles (herpes zoster)
- cold sores (oral herpes simplex), blisters
- skin infections (cellulitis), sometimes with fever and chills
- rash and itching, urticaria
- allergic reactions (hypersensitivity)
- eye infection (conjunctivitis)
- headache, dizziness, hypertension
- mouth ulcers, stomach pain
- fluid retention (edema) in the lower legs, weight gain
- cough, shortness of breath
- low white blood cell counts in blood tests (neutropenia, leucopenia)
- abnormal liver function tests (elevated transaminases)
- increased bilirubin measured by blood test
- low levels of fibrinogen in the blood (a protein involved in blood clotting)
Uncommon adverse effects:
May affect up to 1 in 100 patients
- diverticulitis (fever, nausea, diarrhea, constipation, stomach pain)
- swollen and red areas in the mouth
- elevated blood fats (triglycerides)
- stomach ulcers
- kidney stones
- hypothyroidism
Rare adverse effects:
May affect up to 1 in 1,000 patients
- Stevens-Johnson syndrome (skin rash, which may lead to blistering and severe skin peeling)
- life-threatening allergic reactions (Anaphylaxis [fatal])
- liver inflammation (hepatitis), jaundice
Very rare adverse effects:
May affect up to 1 in 10,000 patients
- low counts of white blood cells, red blood cells, and platelets in blood tests
- liver failure
Adverse effects in children and adolescents with JIA or pJIA
Adverse effects in children and adolescents with JIA or pJIA are generally similar to those in adults. Some adverse effects observed more frequently in children and adolescents are: inflammation of the nose and throat, headache, nausea, and decreased white blood cell count.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Avtozma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the pre-filled pen and on the carton (EXP). The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C). Do not freeze. After removal from the refrigerator, the pre-filled pen may be kept for up to 3 weeks at a temperature not exceeding 30°C. If necessary, Avtozma may be returned to the refrigerator once during these 3 weeks and kept refrigerated until the expiry date. Avtozma must be discarded if not used within this 3-week period.
Keep pre-filled pens in their outer packaging to protect from light and moisture.
Do not use this medicine if it appears cloudy or contains particles, if it is any colour other than colourless or yellow, or if any part of the pre-filled pen appears damaged.
Do not shake the pen. After removing the needle cap, the injection should be administered within 3 minutes to prevent the medicine from drying and blocking the needle. If the pre-filled pen is not used within 3 minutes after removing the needle cap, it must be disposed of in a sharps container and a new pre-filled pen must be used.
If, after pressing the needle guard, the orange indicator does not move, the pre-filled pen must be disposed of in a sharps container. Do not attempt to reuse the pre-filled pen. If reused, the pre-filled pen will lock and the needle will be covered by the needle guard. Do not repeat the injection with another pre-filled pen. If you have any questions or encounter any problems, consult your healthcare professional.
6. Contents of the pack and other information
Composition of Avtozma
- The active substance is tocilizumab.
Each pre-filled pen contains 162 mg of tocilizumab in 0.9 ml.
- The other components are L-histidine, L-histidine monohydrochloride monohydrate, L-threonine, L-methionine, polysorbate 80, and water for injections.
Appearance of the product and contents of the pack
Avtozma is a solution for injection. The solution is colourless to yellow.
Avtozma is supplied in 0.9 ml pre-filled pens containing 162 mg of tocilizumab solution for injection.
The Avtozma pre-filled pen for patient use is available in packs containing:
- 1 pre-filled pen
- 2 pre-filled pens
- 4 pre-filled pens
- 12 (3 packs of 4) pre-filled pens (multiple packs)
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer Responsible
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary
Manufacturer Responsible
Nuvisan France SARL
2400, Route des Colles,
06410, Biot,
France
Midas Pharma GmbH
Rheinstr. 49,
55218 Ingelheim,
Germany
KYMOS S.L.
Ronda Can Fatjó, 7B.
08290 Cerdanyola del Vallès,
Barcelona,
Spain
Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Celltrion Healthcare Belgium BVBA Tel/Tel: +32 2 643 71 81 | Lithuania Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493 |
Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493 | Luxembourg/Luxembourg Celltrion Healthcare Belgium BVBA Tel/Tel: +32 2 643 71 81 |
Czech Republic Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 | Hungary Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493 |
Denmark Celltrion Healthcare Hungary Kft. Tlf: +36 1 231 0493 | Malta Mint Health Ltd. Tel: +356 2093 9800 |
Germany Celltrion Healthcare Deutschland GmbH Tel: +49(0)30 346494150 | Netherlands Celltrion Healthcare Netherlands B.V. Tel: +31 20 888 7300 |
Estonia Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 | Norway Celltrion Healthcare Hungary Kft. Tlf: +36 1 231 0493 |
Spain CELLTRION FARMACEUTICA (SPAIN) S.L. Tel: +34 910 498 478 | Austria Astro-Pharma GmbH Tel: +43 1 97 99 860 |
Greece BIANEX S.A. Tel: +30 210 8009111 | Poland Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493 |
France Celltrion Healthcare France SAS Tél.: +33 (0)1 71 25 27 00 | Portugal CELLTRION PORTUGAL, UNIPESSOAL LDA. Tel: +351 21 936 8542 |
Croatia Oktal Pharma d.o.o. Tel: +385 1 6595 777 | Romania Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 |
Ireland Celltrion Healthcare Ireland Limited Tel: +353 1 223 4026 | Slovenia OPH Oktal Pharma d.o.o. Tel.: +386 1 519 29 22 |
Iceland Celltrion Healthcare Hungary Kft. Sími: +36 1 231 0493 | Slovakia Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 |
Italy Celltrion Healthcare Italy S.r.l. Tel: +39 02 47927040 | Finland/Sweden Celltrion Healthcare Finland Oy. Puh/Tel: +358 29 170 7755 |
Cyprus C.A. Papaellinas Ltd Tel: +357 22741741 | Sweden Celltrion Sweden AB |
Latvia Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493 |
Date of the most recent review of this leaflet
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/ and on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es.
- Instructions for use
Read and follow the instructions for use provided with the Avtozma pre-filled pen before starting to use it and each time you receive a new supply. They may contain new information. Before using Avtozma, ensure that your healthcare professional has shown you how to use it correctly.
Important information
- Do not remove the cap from the pre-filled pen until you are ready to inject Avtozma.
- Do not ever attempt to disassemble the pre-filled pen.
- Do not reuse the same pre-filled pen.
- Do not shake the pre-filled pen.
- Do not use the pre-filled pen if it has been dropped or is damaged.
- Patient information on hypersensitivity reactions (or anaphylaxis): If you experience symptoms such as rash, itching, chills, swelling of the face, lips, tongue or throat, chest pain, wheezing, difficulty breathing or swallowing, or feeling dizzy or faint, at any time during or after an injection, even if not at a medical facility, seek immediate emergency medical attention.
How to store Avtozma
- Store the unused pre-filled pen in its original carton in a refrigerator at a temperature between 2 °C and 8 °C. Do not freeze.
- After removal from the refrigerator, Avtozma may be stored for up to 3 weeks at a temperature not exceeding 30 °C. If necessary, Avtozma may be returned to the refrigerator once within the 3-week period. Avtozma must be discarded if not used within the 3-week period.
- Keep the pre-filled pen away from direct sunlight.
- Do not remove the pre-filled pen from its original carton during storage.
- Do not leave the pre-filled pen unattended.
- Keep the pre-filled pen out of the reach of children. It contains small parts.
Components of the Avtozma pre-filled pen (see Figure A).
Preparation for injection
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Not included in the box:
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Note: It is normal to see a small space between the orange cap and the body of the injector. |
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How to administer the injection
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Note: If you are unable to remove the cap, ask a caregiver for help or contact your healthcare professional.
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Note: If the orange indicator does not move, discard the pre-filled pen and use a new one. |
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injection site.
Note: If the orange indicator has not completely covered the viewing window or if medication is still being released, this means the full dose has not been injected. Carefully discard the pre-filled pen into a sharps container and contact your healthcare professional immediately.
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After the injection
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Note: If someone else administers the injection, that person should also handle the pre-filled pen with care when removing and disposing of it to avoid accidental needle-stick injuries and infections.
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