Avtozma 162 mg solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Avtozma 162 mg, solution for injection in a pre-filled syringe
tocilizumab
This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may 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 (a 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:
-
Adults with moderate to severe active rheumatoid arthritis (RA), which is an autoimmune disease, when previous treatments have not worked well.
-
Adults with severe, active, and progressive rheumatoid arthritis (RA) who have not been previously 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 joint cartilage and bone damage caused by the disease and to improve your ability to carry out daily activities.
Avtozma is usually used in combination with another rheumatoid arthritis 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 body's larger arteries, especially those supplying blood to the head and neck. Symptoms may include headache, fatigue, and jaw pain. Complications 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 steroid doses may also lead to GCA flares. Adding Avtozma to treatment allows for a shorter duration of steroid use while still maintaining control of GCA.
- Children and adolescents, aged 1 year 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 2 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 Avtozma
Do not use Avtozma if:
- You or a child (if the child is the patient you are caring for) are allergic to tocilizumab or to any of the other ingredients of this medicine (listed in section 6). (See special warnings at the end of this section under the subtitle “Avtozma contains polysorbate”).
- You or a child (if the child is the patient you are caring for) have 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 Avtozma.
-
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 the injection, contact your doctor immediately.
-
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.
-
If you have any type of infection, whether short-term or long-term, or if you frequently get infections, contact 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.
-
If you have had tuberculosis, inform your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting treatment with Avtozma. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection appear during or after treatment.
-
If you have had intestinal ulcer or diverticulitis, inform your doctor. Symptoms may include abdominal pain and unexplained changes in bowel habits accompanied by fever.
-
If you have liver disease, inform your doctor. Before using Avtozma, your doctor will perform a blood test to assess your liver function.
-
If any patient has recently been vaccinated or is scheduled 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.
-
If you have cancer, inform your doctor. Your doctor will need to decide whether you can continue treatment with Avtozma.
-
If you have cardiovascular risk factors, such as high blood pressure or elevated cholesterol levels, inform your doctor. These factors need to be managed while receiving Avtozma.
-
If you have moderate to severe kidney problems, your doctor will monitor you.
-
If you have persistent headaches.
Your doctor will perform blood tests before you receive Avtozma to determine whether you have low white blood cell count, low platelet count, or elevated liver enzymes.
Children and adolescents
Subcutaneous injection of Avtozma is not recommended in children under 1 year of age. Avtozma should not be administered to children with JIA who weigh less than 10 kg.
If a child has a history of macrophage activation syndrome (uncontrolled activation and proliferation of specific blood cells), inform your doctor. Your doctor will need to decide whether Avtozma can still 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 in organ transplantation as an immunosuppressant
- benzodiazepines, such as temazepam, used to treat anxiety.
Due to lack of clinical experience, the use of tocilizumab with other biological medicines used to treat RA, JIA, SJIA, or GCA is not recommended.
Pregnancy, breastfeeding, and fertility
Avtozma must not be used during pregnancy unless clearly necessary. Talk to your doctor if you are pregnant, think you may 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.
Breastfeeding must be discontinued if you start treatment with Avtozma, and you should consult your doctor. Breastfeeding may be resumed only after at least 3 months have passed since your last dose of Avtozma. It is unknown whether Avtozma passes into breast milk.
Driving and using 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 syringe. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
3. How to use Avtozma
Follow exactly the instructions for using this medicine as 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, pJIA, or GPA.
Recommended dose
The dose for adults with RA and GPA is 162 mg (the contents of one pre-filled syringe) administered once weekly.
Children and adolescents with JIA (from 1 year of age onwards)
The usual dose of Avtozma depends on the patient's body weight.
- If the patient weighs less than 30 kg: the dose is 162 mg (the contents of one pre-filled syringe), once every 2 weeks
- If the patient weighs 30 kg or more: the dose is 162 mg (the contents of one pre-filled syringe), once every week.
Children and adolescents with pJIA (from 2 years of age onwards)
The usual dose of Avtozma depends on the patient's body weight.
- If the patient weighs less than 30 kg: the dose is 162 mg (the contents of one pre-filled syringe), once every 3 weeks
- If the patient weighs 30 kg or more: the dose is 162 mg (the contents of one pre-filled syringe), once every 2 weeks.
Avtozma is administered by injection under the skin (subcutaneously). Initially, 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 information on how to self-inject Avtozma. Parents and caregivers will be given instructions on how to inject Avtozma to patients who cannot self-inject, such as children.
Talk to your doctor if you have any questions about self-injecting the medicine or about injecting it to the child in your care. Detailed “instructions for administration” 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 syringe, it is unlikely that you will receive too much. However, if you are concerned, speak with your doctor, pharmacist, or nurse.
If an adult with RA and GPA or a child or adolescent with JIA misses or forgets a dose
It is very important to use Avtozma exactly as prescribed by your doctor. Keep track of when your next dose is due.
- If you miss your weekly dose within 7 days, take your dose on the next scheduled day.
- If you miss your dose due every two weeks within 7 days, inject a dose as soon as you remember and administer your next dose according to your original schedule.
- If you miss a dose for 7 days or more, or are unsure when to inject Avtozma, contact your doctor or pharmacist.
If a child or adolescent with pJIA misses or forgets a dose
It is very important to use Avtozma exactly as prescribed by the doctor. Keep track of the next dose.
- If you miss a dose within 7 days, inject a dose as soon as you remember and administer the next dose according to your original schedule.
- If you miss a dose for 7 days or more, or are unsure when to inject Avtozma, contact the doctor or pharmacist.
If you stop 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 can cause adverse effects, although not everyone will experience 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 as soon as possible.
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, hives
- 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 levels 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 fats in the blood (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])
- inflammation of the liver (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
In children and adolescents with JIA or pJIA, adverse effects are generally similar to those in adults. Some adverse effects are observed more frequently in children and adolescents: inflammation of the nose and throat, headache, nausea, and decreased white blood cell count.
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.
Reporting of adverse effects
If you experience any 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. Avtozma Storage
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pre-filled syringe label and 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. Once removed from the refrigerator, the pre-filled syringe can 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 stored under refrigeration until the expiry date. Avtozma must be discarded if not used within this 3-week period.
Keep pre-filled syringes in the outer packaging to protect from light and moisture.
Do not use this medicine if it appears cloudy or contains particles, if it is a different colour than colourless to yellow, or if any part of the pre-filled syringe appears damaged.
Do not shake the syringe. After removing the needle cap, the injection should be administered within 5 minutes to prevent the medicine from drying and blocking the needle. If the pre-filled syringe is not used within 5 minutes after removing the needle cap, it must be disposed of in a sharps container and a new pre-filled syringe must be used.
If, after inserting the needle, the plunger of the syringe cannot be pushed, the pre-filled syringe must be discarded in a special sharps container and a new syringe must be used.
6. Contents of the pack and other information
Composition of Avtozma
- The active substance is tocilizumab.
Each pre-filled syringe 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 container
Avtozma is an injection solution. The solution is colourless to yellow.
Avtozma is supplied in 0.9 ml pre-filled syringes containing 162 mg of tocilizumab solution for injection.
The Avtozma pre-filled syringe for patient use is available in packs containing:
- 1 pre-filled syringe
- 2 pre-filled syringes
- 4 pre-filled syringes
- 12 (3 packs of 4) pre-filled syringes (multiple packs)
Only certain pack sizes may be marketed.
Marketing Authorisation 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
More information about this medicinal product is available upon request from the local representative of the Marketing Authorisation 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/Suomi 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. Talr.: +36 1 231 0493 |
Date of the most recent review of this leaflet
Other sources of information
Detailed information on this medicine 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 Medical Devices (AEMPS): http://www.aemps.gob.es.
- Instructions for use
Read and follow the instructions for use provided with the Avtozma pre-filled syringe 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 syringe until you are ready to administer the Avtozma injection.
- Do not ever attempt to disassemble the pre-filled syringe.
- Do not reuse the same syringe.
- Do not shake the pre-filled syringe.
- Do not use the pre-filled syringe if it has been dropped or is damaged.
- Information for patients about hypersensitivity (or anaphylactic) reactions: 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 a feeling of dizziness or fainting, at any time during or after an injection, even if not at a medical facility, you must seek immediate emergency medical attention.
How to store Avtozma
- Store the unused pre-filled syringe 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 these 3 weeks. Avtozma must be discarded if not used within this 3-week period.
- Keep the pre-filled syringe protected from direct sunlight.
- Do not remove the pre-filled syringe from its original carton during storage.
- Do not leave the pre-filled syringe unattended.
- Keep the pre-filled syringe out of the reach of children. It contains small parts.
Components of the pre-filled syringe (see Figure A).
Preparation for injection
|
Not included in the box:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
With the other hand, carefully pull the cap straight off horizontally (see Figure J). Note: If you cannot remove the cap, ask a caregiver for help or contact your healthcare professional.
|
|
|
|
|
|
|
After injection
| |
|
Note: If someone else administers the injection to you, that person should also handle and dispose of the prefilled syringe carefully to avoid accidental needlestick injuries and infections.
Dispose of a full container as instructed by your healthcare professional or pharmacist. If a sharps container is not available, you may use a puncture-resistant, tightly sealed household waste container. Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations. |
|
