Generic drug: infliximab-axxq
Brand name: Avsola
What is Avsola (infliximab-axxq), and how does it work?
Avsola (infliximab-axxq) is a prescription medicine that is approved for patients with:
- Rheumatoid Arthritis — adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
- Crohn's Disease — children 6 years and older and adults with Crohn's disease who have not responded well to other medicines.
- Ankylosing Spondylitis.
- Psoriatic Arthritis.
- Plaque Psoriasis — adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling.
- Ulcerative Colitis — children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.
Avsola blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha). TNF-alpha ismade by your body's immune system. People with certain diseases have too much TNF-alpha that can cause theimmune system to attack normal healthy parts of the body. Avsola can block the damage caused by too much TNF-alpha.
What are the side effects of Avsola?
SERIOUS INFECTIONS AND MALIGNANCY
Patients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avsola should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Avsola use and during therapy. Treatment for latent infection should be initiated prior to Avsola use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with Avsola should be carefully considered prior to 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 Avsola, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including infliximab products.
Postmarketing cases of hepatosplenic 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 have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males.
Avsola can cause serious side effects, including:
- Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as Avsola. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with Avsola your doctor will treat your infection and may need to stop your Avsola treatment.
- Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving Avsola:
- Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are atrisk for TB, you may be treated with medicine for TB before you begin treatment with Avsola and during treatment with Avsola.
- Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving Avsola. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
- If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with Avsola. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with Avsola and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving Avsola. Your congestive heart failure may get worse while you are receiving Avsola. Be sure to tell your doctor of any new or worse symptoms including:
Treatment with Avsola may need to be stopped if you get new or worse congestive heart failure.
Other Heart Problems
Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of infliximab products. Symptoms may include
- chest discomfort or pain,
- arm pain,
- stomach pain,
- shortness of breath,
- fluttering or pounding in your chest, and/or
- a fast or a slow heartbeat.
Tell your doctor right away if you have any of these symptoms.
Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:
- jaundice (skin and eyes turning yellow)
- dark brown-colored urine
- pain on the right side of your stomach area (right-sided abdominal pain)
- extreme tiredness (severe fatigue)
In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:
- have a fever that does not go away
- look very pale
- bruise or bleed very easily
Nervous System Disorders
Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:
- changes in your vision
- numbness or tingling in any part of your body
- weakness in your arms or legs
Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.
Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your Avsola treatment or shortly afterward. Your doctor may need to stop or pause your treatment with Avsola and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:
- hives (red, raised, itchy patches of skin)
- high or low blood pressure
- difficulty breathing
- chest pain
Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with infliximab products. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Avsola:
- muscle or joint pain
- swelling of the face and hands
- difficulty swallowing
- sore throat
Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with Avsola.
- chest discomfort or pain that does not go away
- joint pain
- shortness of breath
- rash on the cheeks or arms that gets worse in the sun
Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with Avsola.
The most common side effects of infliximab products include:
Infusion reactions can happen up to 2 hours after your infusion of Avsola.
Symptoms of infusion reactions may include:
Children with Crohn's disease showed some differences in side effects compared with adults with Crohn's disease. The side effects that happened more in children were:
- anemia (low red blood cells),
- leukopenia (low white blood cells),
- flushing (redness or blushing),
- viral infections,
- neutropenia (low neutrophils, the white blood cells that fight infection),
- bone fracture,
- bacterial infection and
- allergic reactions of the breathing tract.
Among patients who received infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.
Tell your doctor about any side effect that bothers you or does not go away. These are not all of the side effects with Avsola.
Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Avsola?
- The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn's disease or fistulizing Crohn's disease.
- For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg.
- Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue Avsola in these patients.
Pediatric Crohn's Disease
- The recommended dose of Avsola for pediatric patients 6 years and older with moderately to severely active Crohn's disease is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
- The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients with moderately to severely active ulcerative colitis.
Pediatric Ulcerative Colitis
- The recommended dose of Avsola for pediatric patients 6 years and older with moderately to severely active ulcerative colitis is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.
- The recommended dose of Avsola is 3 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active rheumatoid arthritis. Avsola should be given in combination with methotrexate.
- For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses.
- The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 6 weeks thereafter for the treatment of active ankylosing spondylitis.
- The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of psoriatic arthritis. Avsola can be used with or without methotrexate.
- The recommended dose of Avsola is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of chronic severe (i.e., extensive and/or disabling) plaque psoriasis.
Monitoring To Assess Safety
- Prior to initiating Avsola and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection.
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What drugs interact with Avsola?
Use With Anakinra Or Abatacept
- An increased risk of serious infections was seen in clinical studies of other TNFa-blocking agents used in combination with anakinra or abatacept, with no added clinical benefit.
- Because of the nature of the adverse reactions seen with these combinations with TNF-blocker therapy, similar toxicities may also result from the combination of anakinra or abatacept with other TNFa-blocking agents. Therefore, the combination of Avsola and anakinra or abatacept is not recommended.
Use With Tocilizumab
- The use of tocilizumab in combination with biological DMARDs such as TNF antagonists, including Avsola, should be avoided because of the possibility of increased immunosuppression and increased risk of infection.
Use With Other Biological Therapeutics
- The combination of Avsola with other biological therapeutics used to treat the same conditions as Avsola is not recommended.
Methotrexate (MTX) And Other Concomitant Medications
- Specific drug interaction studies, including interactions with MTX, have not been conducted. The majority of patients in rheumatoid arthritis or Crohn's disease clinical studies received one or more concomitant medications.
- In rheumatoid arthritis, concomitant medications besides MTX were non-steroidal anti-inflammatory agents (NSAIDs), folic acid, corticosteroids and/or narcotics.
- Concomitant Crohn's disease medications were antibiotics, antivirals, corticosteroids, 6-MP/AZA and aminosalicylates.
- In psoriatic arthritis clinical trials, concomitant medications included MTX in approximately half of the patients as well as NSAIDs, folic acid and corticosteroids. Concomitant MTX use may decrease the incidence of anti-drug antibody production and increase infliximab product concentrations.
- Patients with Crohn's disease who received immunosuppressants tended to experience fewer infusion reactions compared to patients on no immunosuppressants.
- Serum infliximab concentrations appeared to be unaffected by baseline use of medications for the treatment of Crohn's disease including corticosteroids, antibiotics (metronidazole or ciprofloxacin) and aminosalicylates.
Cytochrome P450 Substrates
- The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation.
- Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as infliximab products, the formation of CYP450 enzymes could be normalized.
- Upon initiation or discontinuation of Avsola in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.
Live Vaccines/Therapeutic Infectious Agents
- It is recommended that live vaccines not be given concurrently with Avsola. It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab products for at least 6 months following birth.
- It is recommended that therapeutic infectious agents not be given concurrently with Avsola.
Is Avsola safe to use while pregnant or breastfeeding?
- Available data from published literature on the use of infliximab products during pregnancy have not reported a clear association with infliximab products and adverse pregnancy outcomes.
- Infliximab products cross the placenta and infants exposed in utero should not be administered live vaccines for at least 6 months after birth.
- In a development study conducted in mice using an analogous antibody, no evidence of maternal toxicity, embryotoxicity or teratogenicity was observed.
- Available information is insufficient to inform the amount of infliximab products present in human milk, and the effects on the breastfed infant.
- There are no data on the effects of infliximab products on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for an infliximab product and any potential adverse effects on the breastfed infant from infliximab products or from the underlying maternal condition.
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Avsola (infliximab-axxq) is a prescription medicine that is approved for patients with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and ulcerative colitis. Serious side effects of Avsola include serious infections, lymphoma and other malignancies, heart failure and other heart problems, liver injury, blood problems, nervous system disorders, allergic reactions, and others.
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