Avtozma: Uses, Dosage & Side Effects
A tocilizumab biosimilar – interleukin-6 (IL-6) receptor inhibitor for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis
Avtozma (tocilizumab) is a biologic medicine classified as an interleukin-6 (IL-6) receptor inhibitor. It is a biosimilar to the reference product RoActemra and is approved for the treatment of moderate to severe rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), and polyarticular juvenile idiopathic arthritis (pJIA) in patients aged 12 years and older. Tocilizumab works by blocking the IL-6 receptor, thereby reducing the inflammatory cascade that drives joint destruction, vascular inflammation, and systemic symptoms in these conditions. Avtozma is administered as a subcutaneous injection using a pre-filled pen and can be self-administered at home after appropriate training from a healthcare professional.
Quick Facts: Avtozma
Key Takeaways
- Avtozma (tocilizumab) is a biosimilar IL-6 receptor inhibitor that blocks the inflammatory protein interleukin-6, reducing joint inflammation, pain, and systemic disease activity in rheumatoid arthritis and other autoimmune conditions.
- It is approved for moderate to severe rheumatoid arthritis (alone or with methotrexate), giant cell arteritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis in patients aged 12 years and older.
- Avtozma is given as a weekly subcutaneous injection (162 mg) for adults with RA or GCA, using a pre-filled pen that patients can self-administer at home after proper training.
- Serious infections (including tuberculosis), gastrointestinal perforation, and liver enzyme elevations are important risks; regular blood monitoring is required throughout treatment.
- Do not use Avtozma if you have an active severe infection; women of childbearing potential must use effective contraception during and for at least 3 months after treatment.
What Is Avtozma and What Is It Used For?
Avtozma contains the active substance tocilizumab, which is a recombinant humanized monoclonal antibody produced in specialized immune cells using biotechnology. Tocilizumab specifically targets and binds to both soluble and membrane-bound interleukin-6 receptors (sIL-6R and mIL-6R). Interleukin-6 (IL-6) is a cytokine – a signaling protein – that plays a central role in driving inflammation throughout the body. In autoimmune diseases such as rheumatoid arthritis, IL-6 is produced in excessive amounts, contributing to joint inflammation, cartilage and bone destruction, and systemic symptoms such as fatigue, anemia, and elevated inflammatory markers.
By blocking IL-6 from binding to its receptor, tocilizumab effectively interrupts the inflammatory cascade at a key upstream point. This mechanism is distinct from other biologic therapies that target tumor necrosis factor (TNF) or other cytokines. The blockade of IL-6 signaling leads to reduced production of acute-phase proteins (such as C-reactive protein and serum amyloid A), normalization of hemoglobin levels in patients with anemia of chronic disease, and suppression of the pathological immune response that drives joint destruction. Clinical studies have consistently demonstrated that tocilizumab reduces disease activity scores, improves physical function, and slows radiographic joint damage progression in rheumatoid arthritis.
Avtozma is a biosimilar medicine, meaning it has been developed to be highly similar to the reference product RoActemra (also containing tocilizumab), which has been available in clinical practice since 2009. Biosimilars undergo a rigorous regulatory review process to demonstrate that they have comparable quality, safety, and efficacy to the reference product. The European Medicines Agency (EMA) has approved Avtozma based on comprehensive comparability studies confirming its bioequivalence to RoActemra. Other tocilizumab biosimilars, such as Tyenne, are also available on the market.
Avtozma is approved for the following indications:
- Moderate to severe active rheumatoid arthritis (RA) in adults: Avtozma is used when previous disease-modifying antirheumatic drugs (DMARDs), including methotrexate and other conventional synthetic DMARDs or biologic DMARDs, have not provided sufficient disease control. Avtozma can be given in combination with methotrexate or as monotherapy when methotrexate is not appropriate. It reduces symptoms such as joint pain, swelling, and morning stiffness, and has been shown to slow structural joint damage and improve the ability to perform daily activities.
- Severe, active, and progressive rheumatoid arthritis in adults not previously treated with methotrexate: Avtozma can also be used as a first-line biologic therapy in patients with aggressive disease who have not yet received methotrexate, particularly when rapid disease control is needed.
- Giant cell arteritis (GCA) in adults: GCA is an inflammatory condition affecting the large arteries, particularly the temporal arteries and the aorta. Symptoms include severe headache, scalp tenderness, jaw claudication (pain when chewing), visual disturbances, and fatigue. Without treatment, GCA can lead to permanent vision loss or stroke. Avtozma reduces inflammation in the affected arteries and allows corticosteroid doses to be tapered more rapidly, reducing the significant side effects associated with long-term high-dose corticosteroid use. The landmark GiACTA trial demonstrated that tocilizumab plus a corticosteroid taper achieved sustained remission in a significantly higher proportion of patients compared with corticosteroid taper alone.
- Active systemic juvenile idiopathic arthritis (sJIA) in patients aged 12 years and older: sJIA is a severe inflammatory condition affecting children and adolescents, characterized by arthritis, high spiking fevers, and a characteristic salmon-colored rash. It can also cause inflammation in internal organs. Avtozma is used to improve symptoms and can be given alone or in combination with methotrexate.
- Active polyarticular juvenile idiopathic arthritis (pJIA) in patients aged 12 years and older: pJIA affects five or more joints and can cause significant disability if not adequately treated. Avtozma helps reduce joint inflammation, pain, and swelling, and can be used as monotherapy or in combination with methotrexate.
Interleukin-6 is one of the most important pro-inflammatory cytokines in autoimmune conditions. It stimulates the production of acute-phase reactants by the liver, promotes the differentiation of B cells into antibody-producing plasma cells, drives T helper 17 (Th17) cell differentiation, and contributes to bone resorption through activation of osteoclasts. By targeting IL-6 signaling, Avtozma addresses multiple pathological mechanisms simultaneously, which explains its broad clinical efficacy in diverse autoimmune conditions.
What Should You Know Before Taking Avtozma?
Contraindications
There are specific situations in which Avtozma must not be used. Understanding these contraindications is essential for safe treatment.
- Hypersensitivity: Do not use Avtozma if you are allergic to tocilizumab or any of the other ingredients in the product, including polysorbate 80. Signs of an allergic reaction may include chest tightness, wheezing, severe dizziness, swelling of the lips, tongue, or face, itching, hives, or rash.
- Active severe infection: Avtozma must not be started if you currently have an active, severe infection of any kind. Treatment with tocilizumab can impair the body’s ability to fight infections and may worsen an existing infection or increase the risk of developing new infections.
Warnings and Precautions
Tocilizumab suppresses the immune system and may increase the risk of serious infections, including tuberculosis, bacterial, viral, and fungal infections. Some infections can be life-threatening. Your doctor will screen you for tuberculosis and other infections before starting treatment. Contact your doctor immediately if you develop fever, chills, persistent cough, weight loss, or any signs of infection during treatment.
Before and during treatment with Avtozma, inform your doctor if any of the following apply to you:
- Allergic reactions: If you experience any allergic reaction during or after injection – such as chest tightness, wheezing, severe dizziness, swelling of the lips, tongue, or face, itching, hives, or rash – contact your doctor immediately. Do not take the next dose until your doctor has confirmed it is safe to continue.
- Infections: If you have any type of infection, whether short-term or long-term, or if you are prone to frequent infections, tell your doctor. Tocilizumab can reduce the body’s natural defenses against infections. Your doctor will monitor you closely and may need to pause or stop treatment if a serious infection develops.
- Tuberculosis (TB): If you have a history of tuberculosis, inform your doctor. Your doctor will test for TB before starting Avtozma. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, low-grade fever) or any other infection appear during or after treatment, contact your doctor immediately.
- Gastrointestinal perforation: If you have a history of intestinal ulcers or diverticulitis (inflamed pouches in the intestinal wall), tell your doctor. There have been reports of gastrointestinal perforation in patients treated with tocilizumab, most commonly as a complication of diverticulitis. Symptoms may include sudden abdominal pain and unexplained changes in bowel habits, sometimes accompanied by fever.
- Liver disease: If you have any liver problems, tell your doctor. Your doctor will perform liver function blood tests before and during treatment with Avtozma. Tocilizumab can cause elevations in liver enzymes, and dose adjustments or treatment interruption may be necessary.
- Vaccinations: If you have been recently vaccinated or plan to receive a vaccination, talk to your doctor. All recommended vaccinations should ideally be completed before starting Avtozma. Certain types of vaccines (live vaccines) must not be given during treatment because the immune suppression caused by tocilizumab may increase the risk of vaccine-strain infection.
- Cancer: If you have cancer, tell your doctor. Your doctor will need to determine whether treatment with Avtozma is appropriate for you, as immunosuppressive therapies may theoretically affect cancer surveillance.
- Cardiovascular risk factors: If you have high blood pressure, elevated cholesterol, or other cardiovascular risk factors, tell your doctor. Tocilizumab has been associated with increases in blood lipid (cholesterol and triglyceride) levels, which require monitoring and may need treatment.
- Kidney function: If you have moderate to severe kidney impairment, your doctor will monitor your kidney function during treatment.
- Persistent headaches: Report persistent or severe headaches to your doctor, as these may require further investigation.
Your doctor will perform blood tests before and at regular intervals during treatment to check your white blood cell counts, platelet counts, liver enzyme levels, and lipid profile. These tests are essential to ensure that treatment remains safe and to detect potential complications early.
Children and Adolescents
The Avtozma pre-filled pen is not recommended for children under 12 years of age. Avtozma should not be given to children with sJIA who weigh less than 10 kg. If a child has previously experienced macrophage activation syndrome (MAS) – a serious condition involving uncontrolled activation of certain immune cells – the doctor must carefully evaluate whether treatment with tocilizumab is appropriate.
Pregnancy and Breastfeeding
Avtozma should not be used during pregnancy unless absolutely necessary and the potential benefit clearly justifies the risk to the unborn child. There are limited data on the use of tocilizumab in pregnant women. Animal studies have shown potential reproductive toxicity at high doses. If you are pregnant, think you may be pregnant, or are planning to become pregnant, discuss the risks and benefits with your doctor before starting or continuing treatment.
Women of childbearing potential must use effective contraception during treatment with Avtozma and for at least 3 months after the last dose. If you discover that you are pregnant during treatment, inform your doctor immediately.
It is not known whether tocilizumab passes into human breast milk. You should stop breastfeeding if you need to start Avtozma treatment, and you should wait at least 3 months after your last dose before resuming breastfeeding. Discuss the options with your doctor.
Driving and Operating Machinery
Avtozma may cause dizziness as a side effect. If you experience dizziness, do not drive or operate machinery until the symptom has resolved. This is particularly important at the start of treatment or when the dose is changed.
Important Information About Ingredients
Each Avtozma pre-filled pen contains 0.2 mg of polysorbate 80. Polysorbate is an excipient that can cause allergic reactions in some individuals. Inform your doctor if you have any known allergies to polysorbate or if you have previously experienced allergic reactions to injectable medicines.
How Does Avtozma Interact with Other Drugs?
Drug interactions with Avtozma arise primarily from its effect on the cytochrome P450 (CYP450) enzyme system. In patients with chronic inflammatory conditions like rheumatoid arthritis, elevated levels of IL-6 suppress the expression of CYP450 enzymes in the liver. When tocilizumab blocks IL-6 signaling, CYP450 enzyme activity returns toward normal levels. This normalization can accelerate the metabolism of drugs processed by these enzymes, potentially reducing their blood levels and therapeutic effectiveness. Your doctor may need to adjust the doses of your other medications when you start or stop Avtozma.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Other biologic DMARDs (TNF inhibitors, abatacept, etc.) | Additive immunosuppression, significantly increased infection risk | Do not combine – no clinical experience and unacceptable risk |
| Live vaccines (MMR, varicella, BCG, live influenza) | Risk of vaccine-strain infection due to immunosuppression | Avoid during treatment; complete all vaccinations before starting |
| Warfarin / Phenprocoumone (anticoagulants) | Increased CYP metabolism may reduce anticoagulant effect; INR may decrease | Monitor INR closely when starting or stopping Avtozma; dose adjustment likely needed |
| Cyclosporine (immunosuppressant) | Increased CYP3A4 metabolism may reduce cyclosporine levels | Monitor cyclosporine levels closely; dose increase may be needed |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Methylprednisolone / Dexamethasone | Restored CYP3A4 activity may increase corticosteroid metabolism | Monitor clinical response; corticosteroid dose adjustment may be needed |
| Simvastatin / Atorvastatin (statins) | Increased CYP3A4 metabolism may reduce statin blood levels | Monitor lipid levels; statin dose may need increase |
| Amlodipine and other calcium channel blockers | Increased CYP3A4 metabolism may reduce antihypertensive effect | Monitor blood pressure; dose adjustment possible |
| Theophylline | Increased CYP1A2 metabolism may reduce theophylline levels | Monitor theophylline levels if used concurrently |
| Phenytoin (antiepileptic) | Increased CYP metabolism may reduce phenytoin levels | Monitor seizure control and drug levels |
| Benzodiazepines (e.g., temazepam) | Increased CYP3A4 metabolism may reduce benzodiazepine effect | Monitor for reduced anxiolytic efficacy |
Avtozma is commonly used in combination with methotrexate for rheumatoid arthritis. This combination is well-established and supported by clinical trial data. However, tocilizumab must not be combined with other biologic DMARDs (such as TNF inhibitors, abatacept, rituximab, or other IL-6 inhibitors), as there is no clinical experience with such combinations and the risk of excessive immunosuppression and serious infections is considered unacceptable.
The interaction mechanism of tocilizumab is unique among biologic medicines. Rather than directly inhibiting or inducing drug-metabolizing enzymes, tocilizumab restores the normal function of CYP450 enzymes that was previously suppressed by elevated IL-6 levels. This means that when you start tocilizumab, your body may process other medications more efficiently than before, potentially requiring dose adjustments. Conversely, if tocilizumab is stopped, CYP450 suppression may return, and doses of affected medications may need to be reduced.
What Is the Correct Dosage of Avtozma?
Always use Avtozma exactly as your doctor, pharmacist, or nurse has told you. Your treatment will be prescribed and initiated by a healthcare professional experienced in the diagnosis and management of rheumatoid arthritis, giant cell arteritis, or juvenile idiopathic arthritis. Your doctor will determine the most appropriate dosing regimen based on your condition and individual circumstances.
Adults – Rheumatoid Arthritis and Giant Cell Arteritis
Standard Adult Dose (RA and GCA)
Dose: 162 mg (the contents of one pre-filled pen)
Route: Subcutaneous injection
Frequency: Once a week
Administration: Initially, your doctor or nurse may administer the injection. Once you have received proper training, you may self-administer at home. Parents and caregivers can also be trained to administer injections for patients who cannot do so themselves.
Avtozma is injected under the skin (subcutaneously). Suitable injection sites include the front of the thigh, the abdomen (avoiding a 5 cm area around the navel), and the outer upper arm (only if given by a caregiver or healthcare professional – do not inject into your own upper arm). Rotate the injection site each time, choosing a location at least 2.5 cm from the previous injection site. Do not inject into moles, scars, bruises, or areas where the skin is tender, red, or hard.
Children and Adolescents – Systemic JIA (12 Years and Older)
sJIA Dosing by Body Weight
Body weight less than 30 kg: 162 mg (one pre-filled pen) once every 2 weeks
Body weight 30 kg or more: 162 mg (one pre-filled pen) once every week
The pre-filled pen should not be used in children under 12 years of age.
Children and Adolescents – Polyarticular JIA (12 Years and Older)
pJIA Dosing by Body Weight
Body weight less than 30 kg: 162 mg (one pre-filled pen) once every 3 weeks
Body weight 30 kg or more: 162 mg (one pre-filled pen) once every 2 weeks
The pre-filled pen should not be used in children under 12 years of age.
Dosage Overview Table
| Indication | Patient Group | Dose | Frequency |
|---|---|---|---|
| Rheumatoid Arthritis | Adults | 162 mg SC | Once weekly |
| Giant Cell Arteritis | Adults | 162 mg SC | Once weekly |
| Systemic JIA | ≥12 years, <30 kg | 162 mg SC | Every 2 weeks |
| Systemic JIA | ≥12 years, ≥30 kg | 162 mg SC | Once weekly |
| Polyarticular JIA | ≥12 years, <30 kg | 162 mg SC | Every 3 weeks |
| Polyarticular JIA | ≥12 years, ≥30 kg | 162 mg SC | Every 2 weeks |
Missed Dose
It is very important to use Avtozma exactly as prescribed by your doctor. Keep track of when your next dose is due.
- Adults with RA or GCA (weekly dosing): If you miss your weekly dose and it has been no more than 7 days, take the dose on the next scheduled day. If more than 7 days have passed, contact your doctor or pharmacist for advice.
- Children/adolescents with sJIA (every-2-weeks dosing): If you miss a dose and it has been no more than 7 days, inject as soon as you remember and take the next dose on the regular scheduled day. If more than 7 days have passed, contact your doctor.
- Children/adolescents with pJIA: If a dose is missed within 7 days of the scheduled date, inject as soon as you remember and give the next dose on the regular scheduled day. If more than 7 days have passed, contact your doctor.
Overdose
Since Avtozma is given using a pre-filled pen containing a single fixed dose, overdose is unlikely. However, if you are concerned that too much has been administered, contact your doctor, pharmacist, or nurse for advice.
Stopping Treatment
Do not stop using Avtozma without first discussing it with your doctor. Stopping treatment abruptly may cause your disease to flare. Your doctor will advise you on how to manage any transition in your treatment.
What Are the Side Effects of Avtozma?
Like all medicines, Avtozma can cause side effects, although not everyone experiences them. Side effects can occur up to at least 3 months after your last dose of Avtozma. It is important to recognize the signs of potentially serious side effects and report them to your doctor promptly.
Potentially Serious Side Effects – Seek Immediate Medical Attention
If you experience difficulty breathing, chest tightness, dizziness, rash, itching, hives, or swelling of the lips, tongue, or face during or after injection, contact your doctor immediately. Also seek urgent medical attention for fever with chills, mouth or skin blisters, or severe abdominal pain, as these may indicate a serious infection.
Very Common
May affect more than 1 in 10 people
- Upper respiratory tract infection (cough, nasal congestion, runny nose, sore throat, headache)
- Elevated blood cholesterol levels
- Injection site reactions (redness, swelling, pain, or itching at the injection site)
Common
May affect up to 1 in 10 people
- Pneumonia (lung infection)
- Shingles (herpes zoster)
- Cold sores (oral herpes simplex)
- Skin infection (cellulitis), sometimes with fever and chills
- Rash and itching, hives
- Allergic (hypersensitivity) reactions
- Eye infection (conjunctivitis)
- Headache and dizziness
- High blood pressure (hypertension)
- Mouth sores and stomach pain
- Fluid retention (edema) in lower legs, weight gain
- Cough and shortness of breath
- Low white blood cell count (neutropenia, leukopenia)
- Abnormal liver function tests (elevated transaminases)
- Elevated bilirubin
- Decreased fibrinogen levels (a protein involved in blood clotting)
Uncommon
May affect up to 1 in 100 people
- Diverticulitis (inflammation of pouches in the intestine, causing fever, nausea, diarrhea, constipation, abdominal pain)
- Red and swollen areas in the mouth (oral mucositis)
- Elevated triglycerides
- Gastric ulcer
- Kidney stones
- Underactive thyroid (hypothyroidism)
Rare
May affect up to 1 in 1,000 people
- Stevens-Johnson syndrome (severe skin rash that may lead to blistering and skin peeling)
- Fatal allergic reactions (anaphylaxis)
- Hepatitis (inflammation of the liver), jaundice
Very Rare
May affect up to 1 in 10,000 people
- Pancytopenia – low counts of white blood cells, red blood cells, and platelets (shown in blood tests)
- Liver failure
Signs and Symptoms of Liver Toxicity
Liver toxicity can occur in up to 1 in 1,000 patients. Symptoms may include fatigue, abdominal pain, and jaundice (yellowing of the skin and eyes). If you notice any of these symptoms, contact your doctor as soon as possible. Your doctor will monitor your liver function through regular blood tests throughout treatment.
Side Effects in Children and Adolescents
Side effects in children and adolescents with sJIA or pJIA are generally similar to those seen in adults. However, some side effects occur more frequently in younger patients, including inflammation of the nose and throat (nasopharyngitis), headache, nausea, and lower white blood cell counts. Your doctor will monitor your child closely for these and other potential side effects.
It is important to report suspected side effects after a medicine has been approved, as this enables ongoing monitoring of the medicine’s benefit-risk profile. You can report suspected side effects to your national pharmacovigilance authority (e.g., the EMA in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom).
How Should You Store Avtozma?
Keep this medicine out of the sight and reach of children. Do not use after the expiry date stated on the pre-filled pen label and carton (EXP). The expiry date refers to the last day of the stated month.
- Refrigeration: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze the pre-filled pen. If frozen, do not use it.
- Room temperature storage: The pre-filled pen can be stored at room temperature (up to 30°C / 86°F) for up to 3 weeks after removal from the refrigerator. If needed, it can be returned to the refrigerator once within this 3-week period and stored there until the expiry date. Avtozma must be discarded if not used within the 3-week room temperature period.
- Light and moisture protection: Keep the pre-filled pens in the original outer carton to protect from light and moisture.
- Inspection before use: Do not use if the solution is cloudy, contains particles, or has any color other than clear to yellow. Do not use if any part of the pre-filled pen appears damaged.
- After cap removal: Once the cap is removed, injection must begin within 3 minutes to prevent the medicine from drying and blocking the needle. If the pen is not used within 3 minutes, discard it in a sharps container and use a new one.
- Do not shake: The pre-filled pen must not be shaken before use.
If the orange indicator does not move after pressing the needle guard, discard the pre-filled pen in a sharps container. Do not attempt to reuse it. Do not retry the injection with a new pen without consulting your doctor for assistance.
After use, immediately place the pre-filled pen in a puncture-resistant sharps disposal container. Do not dispose of used pens in household waste. Keep the sharps container out of reach of children. Follow your local guidelines for proper disposal, or ask your pharmacist for advice.
What Does Avtozma Contain?
Active Substance
The active substance is tocilizumab. Each pre-filled pen contains 162 mg of tocilizumab in 0.9 mL of solution for injection. Tocilizumab is a recombinant humanized monoclonal antibody of the IgG1 subclass directed against both soluble and membrane-bound human interleukin-6 receptors.
Inactive Ingredients (Excipients)
- L-histidine
- L-histidine monohydrochloride monohydrate
- L-threonine
- L-methionine
- Polysorbate 80 (0.2 mg per pen)
- Water for injections
Appearance and Pack Sizes
Avtozma is a solution for injection that is colorless to yellow in appearance. It is supplied as a 0.9 mL pre-filled pen containing 162 mg of tocilizumab. The pre-filled pens are available in the following pack sizes:
- 1 pre-filled pen
- 2 pre-filled pens
- 4 pre-filled pens
- 12 pre-filled pens (3 packs of 4) (multipack)
Not all pack sizes may be marketed in all countries.
Manufacturer
Avtozma is manufactured by Nuvisan France SARL (Biot, France), Midas Pharma GmbH (Ingelheim, Germany), and KYMOS S.L. (Cerdanyola del Vallès, Barcelona, Spain). The marketing authorization holder is Celltrion Healthcare Hungary Kft., Budapest, Hungary.
Frequently Asked Questions About Avtozma
Avtozma (tocilizumab) is used to treat moderate to severe active rheumatoid arthritis in adults when previous treatments have not worked well enough, severe progressive rheumatoid arthritis in adults not previously treated with methotrexate, giant cell arteritis (GCA) in adults, systemic juvenile idiopathic arthritis (sJIA) in patients aged 12 years and older, and polyarticular juvenile idiopathic arthritis (pJIA) in patients aged 12 years and older. It works by blocking interleukin-6, a key inflammatory protein involved in these conditions.
After receiving training from your healthcare professional, you can self-inject Avtozma at home using the pre-filled pen. Choose an injection site (front of thigh or abdomen, avoiding the navel area), clean the area with an alcohol wipe, remove the pen cap, place the pen at a 90-degree angle against your skin, press firmly to start the injection, wait for two clicks and count slowly to 5, then lift the pen straight up. The needle guard will automatically cover the needle. Dispose of the used pen in a sharps container immediately. Allow the pen to reach room temperature (45 minutes out of the refrigerator) before injecting.
Yes, Avtozma is commonly prescribed in combination with methotrexate for the treatment of rheumatoid arthritis. This combination is one of the standard treatment approaches recommended by international guidelines (EULAR and ACR). Clinical trials have shown that tocilizumab combined with methotrexate provides greater improvement in disease activity compared with either drug alone. However, if methotrexate is not suitable for you (due to intolerance or contraindications), Avtozma can also be used as monotherapy.
Avtozma is a biosimilar medicine to RoActemra. Both contain the same active substance (tocilizumab) and work by the same mechanism – blocking the interleukin-6 receptor. Avtozma has been approved by the EMA after comprehensive comparability studies demonstrating equivalent quality, safety, and efficacy to RoActemra. Biosimilars are rigorously tested and must meet the same pharmaceutical standards as the reference product. The main difference may be in price, as biosimilars typically offer a more affordable option. Your doctor may prescribe either product based on availability and formulary guidelines.
Some patients notice improvement in symptoms such as joint pain, stiffness, and swelling within the first few weeks of treatment with Avtozma. Laboratory markers of inflammation (such as C-reactive protein and erythrocyte sedimentation rate) typically improve rapidly, often within the first week. However, the full therapeutic benefit, including improvement in physical function and slowing of joint damage, usually develops over several weeks to months. Most clinical trials assess response at 12–24 weeks. Your doctor will evaluate your response and adjust treatment as needed.
You should ideally complete all recommended vaccinations before starting Avtozma. During treatment, live vaccines (such as MMR, varicella, BCG, and live influenza vaccine) must not be given because the immunosuppression from tocilizumab may increase the risk of infection from the vaccine strain. Inactivated vaccines (such as influenza shot, pneumococcal, COVID-19, and hepatitis B) can generally be given during treatment, although the immune response may be reduced. Discuss your vaccination schedule with your doctor before starting Avtozma.
References
- European Medicines Agency (EMA). Avtozma (tocilizumab) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- European Medicines Agency (EMA). RoActemra (tocilizumab) – Summary of Product Characteristics. Available from: EMA EPAR.
- Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3–18. doi:10.1136/ard-2022-223356.
- Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res. 2021;73(7):924–939. doi:10.1002/acr.24596.
- Stone JH, Tuckwell K, Dimonaco S, et al. Trial of tocilizumab in giant-cell arteritis (GiACTA). N Engl J Med. 2017;377(4):317–328. doi:10.1056/NEJMoa1613849.
- Hellmich B, Agueda AF, Monti S, et al. 2024 update of the EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2024;83(5):583–594.
- Burmester GR, Rubbert-Roth A, Cantagrel A, et al. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016;75(1):68–74. doi:10.1136/annrheumdis-2015-207281.
- De Benedetti F, Brunner HI, Ruperto N, et al. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis (TENDER). N Engl J Med. 2012;367(25):2385–2395. doi:10.1056/NEJMoa1112802.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- U.S. Food and Drug Administration (FDA). Actemra (tocilizumab) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
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This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in rheumatology, immunology, and clinical pharmacology.
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