AVSOLA (intravenous)

AVSOLA (intravenous)

AVSOLA (Intravenous) Intravenous route (powder for solution)

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue infliximab if a patient experiences a severe infection. Conduct a test for latent tuberculosis; If positive, begin treatment for tuberculosis before starting infliximab. Monitor all patients for active tuberculosis during treatment, even if the initial test for latent tuberculosis is negative. Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenal T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab. Almost all had received azathioprine or 6-mercaptopurine concurrently with a TNF blocker at or before diagnosis. Most infliximab cases have been reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult men.

Intravenous route (powder for solution)

Warning: Serious infections and malignancies

Severe infections

Patients treated with infliximab products are at increased risk of developing serious infections that may result in hospitalization or death. Most patients who experienced these infections were also taking immunosuppressants such as methotrexate or corticosteroids. Infliximab-dyyb should be discontinued if a patient experiences severe infection or sepsis.

Reported infections include: 1) Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis often present with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before using Infliximab-Dyyb and during therapy. Treatment of latent infection should be initiated prior to the use of infliximab-dyyb. Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis often present with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before using Infliximab-Dyyb and during therapy. Treatment of latent infection should be initiated prior to the use of infliximab-dyyb. 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may have disseminated rather than localized disease. Antigen and antibody tests for histoplasmosis may be negative in some patients with active infection. Empirical antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic disease. 3) Bacterial, viral and other infections caused by opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with Infliximab-Dyyb should be carefully considered before initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with infliximab-Dyyb, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection before initiating therapy.

malignancy

Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with TNF blockers, including infliximab products.

Postmarketing cases of hepatosplenal T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases had a very aggressive course of the disease and were fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or before diagnosis. Most reported cases have occurred in patients with Crohn's disease or ulcerative colitis and most have affected adolescent and young adult men.

Intravenous route (powder for solution)

Increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Stop treatment with Infliximab-Abda if a patient develops a serious infection. Conduct a test for latent tuberculosis; If positive, start treatment for tuberculosis before starting Infliximab-Abda. Monitor all patients for active tuberculosis during treatment, even if the initial test for latent tuberculosis is negative. Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Post-marketing cases of fatal hepatosplenal T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concurrently with a TNF blocker at or before diagnosis. Most reported cases occurred in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult men.

Intravenous route (powder for solution)

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue treatment with infliximab-qbtx if a patient experiences a serious infection. Conduct a test for latent tuberculosis; If positive, begin treatment for tuberculosis before starting infliximab-qbtx. Monitor all patients for active tuberculosis during treatment, even if the initial test for latent tuberculosis is negative. Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. Post-marketing cases of fatal hepatosplenal T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concurrently with a TNF blocker at or before diagnosis. Most cases have been reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult men.

Intravenous route (powder for solution)

Increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue treatment with infliximab-axxq if a patient experiences a serious infection. Conduct a test for latent tuberculosis; If positive, begin treatment for tuberculosis before starting infliximab-axxq. Monitor all patients for active tuberculosis during treatment, even if the initial test for latent tuberculosis is negative. Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Post-marketing cases of fatal hepatosplenal T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concurrently with a TNF blocker at or before diagnosis. Most reported cases occurred in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult men.

Possible uses for AVSOLA

Infliximab injection is used alone or with other drugs (e.g. methotrexate) to relieve symptoms and prevent progression of moderate to severe active rheumatoid arthritis, psoriatic arthritis, and active ankylosing spondylitis.

Infliximab injection is also used to treat chronic severe (extensive or disabling) plaque psoriasis, a skin condition with red patches and white scales that don't go away. It is used in patients who cannot be treated with other medicines.

Infliximab is a monoclonal antibody that strengthens and improves the immune system.

This medicine is only available with a doctor's prescription.

Before using AVSOLA

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Studies conducted to date have not shown any pediatric-specific problems that would limit the benefit of infliximab injection for the treatment of Crohn's disease or ulcerative colitis in children aged 6 years and older. However, safety and effectiveness have not been established in children under 6 years of age.

No appropriate studies have been conducted on the association between age and the effects of infliximab injection in children with ankylosing spondylitis, plaque psoriasis or psoriatic arthritis. Safety and effectiveness have not been established.

Studies conducted to date have shown that infliximab injection is not helpful in children with juvenile rheumatoid arthritis. Safety and effectiveness have not been established.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of infliximab injection in the elderly. However, older patients are at higher risk of infections and caution may be necessary in patients receiving this medicine.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are receiving this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Abatacept
• Adalimumab
• Adenovirus-Impfstoff, lebend
• Alefacept
• Anakinra
• Anifrolumab-fnia
• Bacillus of Calmette und Guerin-Impfstoff, lebend
• Baricitinib
• Brodalumab
• Certolizumab Pegol
• Cholera-Impfstoff, lebend
• Cyclosporin
• Tetravalenter Dengue-Impfstoff, lebend
• Ebola-Zaire-Impfstoff, lebend
• Etanercept
• Fosphenytoin
• Golimumab
• Guselkumab
• Influenzavirus-Impfstoff, lebend
• Ixekizumab
• Levoketoconazol
• Masernvirus-Impfstoff, lebend
• Methotrexat
• Mumpsvirus-Impfstoff, lebend
• Natalizumab
• Paclitaxel
• Phenytoin
• Poliovirus-Impfstoff, lebend
• Chinidin
• Rilonacept
• Rituximab
• Rotavirus-Impfstoff, lebend
• Rötelnvirus-Impfstoff, lebend
• Sarilumab
• Sirolimus
• Pocken-Affenpocken-Impfstoff, lebend, nicht replizierend
• Pockenimpfstoff
• Tacrolimus
• Tocilizumab
• Tofacitinib
• Typhus-Impfstoff, lebend
• Ustekinumab
• Varizellenvirus-Impfstoff, lebend
• Vedolizumab
• Warfarin
• Gelbfieber-Impfstoff
• Zoster-Impfstoff, lebend

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Aspergillose (Pilzinfektion), Vorgeschichte von oder
• Blastomykose (Pilzinfektion), Vorgeschichte von oder
• Blut- oder Knochenmarkprobleme (z. B. Panzytopenie) oder Vorgeschichte von oder
• Candidiasis (Pilzinfektion), Vorgeschichte von oder
• Kokzidioidomykose (Pilzinfektion), Vorgeschichte von oder
• Diabetes bzw
• Guillain-Barré-Syndrom (Störung des Nervensystems), Vorgeschichte oder
• Hepatitis B, aktiv oder in der Vorgeschichte oder
• Histoplasmose (Pilzinfektion), Vorgeschichte von oder
• Legionellose (bakterielle Infektion), Vorgeschichte von oder
• Leukopenie oder Neutropenie (niedrige weiße Blutkörperchen) oder
• Listeriose (bakterielle Infektion), Vorgeschichte von oder
• Lebererkrankung bzw
• Multiple Sklerose, Vorgeschichte von oder
• Optikusneuritis (Augenproblem) oder
• Pneumozystose (Pilzinfektion), Vorgeschichte von oder
• Psoriasis (Hauterkrankung) bzw
• Anfälle (Krämpfe), Vorgeschichte von oder
• Thrombozytopenie (niedrige Blutplättchenzahl) – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Krebs, aktiv oder in der Vergangenheit oder
• Chronisch obstruktive Lungenerkrankung (COPD) oder
• Erkrankungen des Herzens oder der Blutgefäße – mit Vorsicht anwenden. Kann das Risiko weiterer Nebenwirkungen erhöhen.

• Herzinsuffizienz, mittelschwer bis schwer – sollte Patienten mit dieser Erkrankung nicht verabreicht werden.

• Tuberkulose, Vorgeschichte – Mit Vorsicht verwenden. Patienten benötigen möglicherweise eine zusätzliche Tuberkulosebehandlung.

Proper use of AVSOLA

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle inserted into one of your veins. Administration must be slow so that the needle must remain in place for at least 2 hours.

This medicine should be accompanied by a medication guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may also be given other medications (e.g. allergy medications, fever medications, steroids) to prevent possible unwanted effects during the injection.

Precautions when using AVSOLA

It is very important that your doctor checks you or your child's progress regularly to make sure this medicine is working properly. Blood and urine tests may be needed to check for adverse effects.

Infliximab can cause an infusion reaction, including heart attack, stroke, changes in blood pressure, or abnormal heart rhythms (e.g. cardiac arrhythmias), while you or your child are receiving it or immediately after the infusion ends. Contact your doctor or nurse immediately if you have chest pain, fever, chills, itching, hives, rash, dizziness, fainting, lightheadedness, headache, joint pain, difficulty swallowing, difficulty breathing, or swelling of the face, tongue, etc. and neck.

Your body's ability to fight an infection may be reduced while you or your child are using infliximab. It is very important that you call your doctor at the first sign of infection. Contact your doctor immediately if you or your child have fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

Serious skin reactions may occur while you or your child are receiving this medicine. Contact your doctor immediately if you experience blistering, peeling or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers or white patches on the mouth, or unusual tiredness or weakness.

This medicine may increase your or your child's risk of getting a lupus-like syndrome or a liver disease called autoimmune hepatitis. Consult your doctor immediately if you or your child have dark brown urine, fever or chills, a general malaise, feeling sick or weak, joint pain, light-colored stools, nausea, vomiting, a rash on the cheeks or arms that worsens under the sun, severe fatigue, pain in the upper right abdomen, or yellow eyes and skin.

A small number of people (including children and teenagers) who have taken this medicine have developed certain types of cancer. This is more common in patients with lung diseases (e.g. emphysema, COPD) or heavy smokers, as well as in psoriasis patients who have received phototherapy for a long time. Phototherapy treatment consists of ultraviolet light or sunlight combined with oral medications to make your skin sensitive to light. Some teenagers and young adults with Crohn's disease or ulcerative colitis also developed a rare type of cancer called hepatosplenic T-cell lymphoma. Talk to your doctor if you have unusual bleeding, bruising or weakness, swollen lymph nodes in the neck, armpits, or groin, unexplained weight loss, or red, scaly patches or raised bumps with pus on the skin.

Taking this medicine may increase your risk of developing skin cancer (e.g. melanoma, Merkel cell carcinoma) or cervical cancer. If you notice any changes or growths on your skin, abnormal vaginal bleeding, or abdominal pain, tell your doctor immediately.

Do not take any vaccinations (vaccinations) during treatment with infliximab without your doctor's approval. Live vaccines should not be administered concomitantly with infliximab. Your child must be up to date on vaccinations before receiving infliximab. Talk to your child's doctor if you have any questions.

Women: If you have a child while being treated with infliximab, make sure the child's doctor knows that you are receiving this medicine. You must wait a few months before giving your baby certain vaccines. Talk to the baby's doctor if you have any questions.

Before you start taking this medicine, a skin test for tuberculosis must be done. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

It is important to have your heart checked closely if you are receiving infliximab. Call your doctor immediately if you have trouble breathing, swelling of your ankles and feet, or sudden weight gain.

Do not take any other medicines unless you have discussed this with your doctor. These include abatacept (Orencia®), anakinra (Kineret®), tocilizumab (Actemra®) or other medicines called biologics that are used to treat the same diseases as infliximab. Taking these drugs together with infliximab may increase the risk of serious adverse effects.

Side effects of AVSOLA

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

More common

• Schwarzer, teeriger Stuhl
• Blasenschmerzen
• blutiger oder trüber Urin
• verschwommene Sicht
• Körperschmerzen oder Schmerzen
• Brustschmerzen
• Schüttelfrost
• Husten
• Husten, der Schleim produziert
• schwieriges, brennendes oder schmerzhaftes Wasserlassen
• Schwierigkeiten beim Atmen
• Schwindel
• Trockenheit oder Schmerzen im Hals
• verstopfte Ohren
• Fieber
• häufiger Harndrang
• Kopfschmerzen
• Heiserkeit
• Nesselsucht, Juckreiz oder Hautausschlag
• Verlust der Stimme
• Schmerzen im unteren Rücken oder an der Seite
• Muskelschmerzen
• Nervosität
• Schmerzen oder Schwellungen in den Armen oder Beinen
• Schmerzen oder Druckempfindlichkeit um die Augen und Wangenknochen
• schmerzhaftes oder schwieriges Wasserlassen
• blasse Haut
• in den Ohren hämmern
• laufende oder verstopfte Nase
• langsamer oder schneller Herzschlag
• niesen
• Halsentzündung
• Wunden, Geschwüre oder weiße Flecken auf den Lippen oder im Mund
• Magenschmerzen
• empfindliche, geschwollene Drüsen im Nacken
• Engegefühl in der Brust
• Atembeschwerden
• Schluckbeschwerden
• ungewöhnliche Blutungen oder Blutergüsse
• ungewöhnliche Müdigkeit oder Schwäche
• Stimme verändert sich

Rarely

• Zahnfleischbluten
• Blut im Stuhl
• blaue Lippen und Fingernägel
• Veränderungen der Hautfarbe oder Empfindlichkeit des Fußes oder Beins
• Beschwerden in der Brust
• Verwirrung
• Husten, der manchmal einen rosafarbenen, schaumigen Auswurf erzeugt
• dunkler Urin
• vermindertes Wasserlassen
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• trockener Mund
• schnelles oder lautes Atmen
• Gefühl des Unbehagens
• allgemeines Krankheitsgefühl
• allgemeine Müdigkeit und Schwäche
• hohes Fieber
• Nesselsucht
• vermehrtes Schwitzen
• unregelmäßiger oder pochender Herzschlag
• heller Stuhlgang
• Muskelkater
• Brechreiz
• Punktgenaue rote Flecken auf der Haut
• Schwellungen oder Schwellungen der Augenlider oder um die Augen, das Gesicht, die Lippen oder die Zunge
• schnelles, flaches Atmen
• Schwellung der Gelenke
• eingefallene Augen
• Durst
• Schmerzen im oberen rechten Bauch oder Magen
• Erbrechen
• ungewöhnlicher Gewichtsverlust
• faltige Haut
• gelbe Haut und Augen

Incident not known

• Rückenschmerzen, plötzlich und heftig
• Blasenbildung, Abschälen, Ablösung der Haut
• blutige Nase
• Brennen, Kribbeln, Taubheitsgefühl oder Schmerzen in den Händen, Armen, Füßen oder Beinen
• Veränderung des Geisteszustandes
• lehmfarbener Stuhlgang
• dunkler oder blutiger Urin
• Durchfall
• Schwierigkeiten beim Sprechen
• erweiterte Halsvenen
• Doppeltsehen
• stärkere Menstruationsperioden
• Unfähigkeit, Arme, Beine oder Gesichtsmuskeln zu bewegen
• Unfähigkeit zu sprechen
• Appetitverlust
• Muskelschwäche, plötzlich und fortschreitend
• rote, gereizte Augen
• rote Hautläsionen, oft mit violettem Zentrum
• Anfälle
• Gefühl von Kribbeln und Kribbeln
• langsame oder unregelmäßige Atmung
• langsame Rede
• stechender Schmerz
• vorübergehender Sehverlust
• Erbrechen von Blut

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Aufstoßen
• Schwierigkeiten beim Bewegen
• Gefühl von Wärme
• Sodbrennen
• Verdauungsstörungen
• Muskelsteifheit
• Rötung des Gesichts, des Halses, der Arme und gelegentlich der oberen Brust

Less common

• Verstopfung, schwerwiegend

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• AVSOLA
• Inflectra
• Ixifi
• Remicade
• Renflexis

Available dosage forms:

• Pulver zur Lösung

Therapeutic class: Immunological agent

Pharmacological class: Tumor necrosis factor inhibitor

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