The delayed reactions occurred 3 to 12 days after receiving treatment with infliximab products. Improvement was observed as early as Week 2. At Week 30, a significantly greater proportion of these patients in the 5 mg/kg and 10 mg/kg maintenance groups achieved clinical remission compared to patients in the placebo maintenance group (Table 3). March 30, 2022 Deana Ferreri, PhD An article reviewed the totality of evidence leading to the approval of Amgen's infliximab biosimilar ABP 710 (Avsola), which is currently approved in the US and Canada for all the indications of the originator (Remicade). In a multidose trial (ACCENT I [Study Crohns I]), 545 adult patients received 5 mg/kg at Week 0 and were then randomized to one of three treatment groups; the placebo maintenance group received placebo at Weeks 2 and 6, and then every 8 weeks; the 5 mg/kg maintenance group received 5 mg/kg at Weeks 2 and 6, and then every 8 weeks; and the 10 mg/kg maintenance group received 5 mg/kg at Weeks 2 and 6, and then 10 mg/kg every 8 weeks. These patients were randomized to receive either placebo or infliximab at doses of 3 mg/kg or 5 mg/kg at Weeks 0, 2, and 6. agents. In the placebo-controlled portion of the Ps studies, 7 of 1123 patients who received infliximab at any dose were diagnosed with at least one NMSC compared to 0 of 334 patients who received placebo. Monitor patients during infusion and if serious reaction occurs, discontinue infusion. AVSOLA may cause serious side effects, including: 1. Cells expressing transmembrane TNF bound by infliximab products can be lysed in vitro or in vivo. The AVSOLA infusion should begin within 3 hours of reconstitution and dilution. Sitagliptin prolongs the action of GLP-1 and GIP. loss of voice. Tell your doctor if you are pregnant or plan to become pregnant. infliximab concentrations appeared to be unaffected by baseline use of Do not use if the lyophilized powder has not fully dissolved or if opaque particles, discoloration, or other foreign particles are present. Patients who did not respond to infliximab at Week 8 received no further infliximab and returned for safety follow-up. Unopened Avsola vials may also be stored at temperatures up to a maximum of 30C (86F) for a single period of up to 6 months but not exceeding the original expiration date. It may harm them. The safety and effectiveness of infliximab products have been established for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy. Advise the patient or their caregiver to read the FDA-approved patient labeling (Medication Guide). In the controlled and open-label portions of infliximab clinical trials, 5 patients developed lymphomas among 5707 patients treated with infliximab (median duration of follow-up 1.0 years) vs. 0 lymphomas in 1600 control patients (median duration of follow-up 0.4 years). Compared to placebo, treatment with infliximab resulted in improvements in the components of the ACR response criteria, as well as in dactylitis and enthesopathy (Table 11). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Agents that inhibit TNF have been associated with CNS manifestation of systemic vasculitis, seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barr syndrome. The mechanism of enzyme action depends upon the two factors, namely enzyme's specificity and transition state of the reactants or substrates. In a shorter (22-week) placebo-controlled study of 1082 RA patients randomized to receive placebo, 3 mg/kg or 10 mg/kg infliximab infusions at 0, 2, and 6 weeks, followed by every 8 weeks with MTX, serious infections were more frequent in the 10 mg/kg infliximab group (5.3%) than the 3 mg/kg or placebo groups (1.7% in both). Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Patients with guttate, pustular, or erythrodermic psoriasis were excluded from these studies. If you received AVSOLA while you were pregnant, your baby may be at higher risk for getting an infection. (infliximab-axxq) for injection, for intravenous use. The EIA method is subject to interference by serum infliximab, possibly resulting in an underestimation of the rate of patient antibody formation. Do not shake this medication. Figure 4: Proportion of Adult Ps Patients Who Achieved 75% Improvement in PASI from Baseline through Week 50 (patients randomized at Week 14). American Thoracic Society, Centers for Disease Control and Prevention. Because of the nature of the adverse reactions seen with these See the end of thisMedication Guide for a complete list of ingredients in AVSOLA. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. Terms of Use. People with certain diseases have too much TNF-alpha that can cause the immune system to attack normal healthy parts of the body. Learn how to store and discard medical supplies safely. For storage conditions of the reconstituted and diluted product, see DOSAGE AND ADMINISTRATION. Tell your doctor about all of your medical conditions, including if you: If you have a baby and you were receiving AVSOLA during your pregnancy, it is important to tell your babys doctorand other health care professionals about your AVSOLA use so they can decide when your baby should receive anyvaccine. Compare TNF blockers. Please contact Medicare.gov or 1-800-MEDICARE to get information on all of your options. The enzyme's specificity is due to its active site, which seems like a small aperture or opening. Inflectra, Renflexis, and Avsola are used to treat the same conditions as Remicade, including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. Of the total number of infliximab-treated patients in CD, UC, AS, and PsA clinical studies, 76 (3.2%) were 65 years old and over, while 9 (0.4%) were 75 years old and over. skin rash on your cheeks or arms (worsens in sunlight). Avoid prolonged or vigorous agitation. AVSOLA can make you more likely to get infections or make any infection that you have worse. Of the total number of infliximab-treated patients in RA and Ps clinical studies, 256 (9.6%) were 65 years old and over, while 17 (0.6%) were 75 years old and over. The most common serious adverse reactions observed in clinical trials were infections [see ADVERSE REACTIONS]. The anal area has ulcers and stricture. Patients have frequently presented with disseminated rather than localized disease. This method is 60-fold more sensitive than the original EIA. Greater than 90% of the patients had received previous immunosuppressive and antibiotic therapy. The following adverse reactions were reported more commonly in 103 randomized pediatric CD patients administered 5 mg/kg infliximab through 54 weeks than in 385 adult CD patients receiving a similar treatment regimen: anemia (11%), leukopenia (9%), flushing (9%), viral infection (8%), neutropenia (7%), bone fracture (7%), bacterial infection (6%), and respiratory tract allergic reaction (6%). TNF-alpha is made by your body's immune system. This is especially true for people with very active disease. Consult your doctor for more details. Patients who are carriers of HBV and require treatment with TNF blockers should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. The effectiveness of infliximab in inducing and maintaining mucosal healing in pediatric UC was not established. Available for Android and iOS devices. However, the safety and effectiveness of infliximab products in pediatric patients <6 years of age with CD or UC have not been established. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, difficulty swallowing. Signs of an allergic reaction can include: Some patients treated with infliximab products have had delayed allergic reactions. It is not known if Avsola harms your unborn baby. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products [see ADVERSE REACTIONS]. In addition, 75% of patients had a BSA >20%. Your doctor will determine the right dose of Avsola for you and how often you should receive it. 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. Biosimilars are usually sold at significantly lower prices. Tell your health care professional that you are using infliximab before having any immunizations/vaccinations. In PsA, treatment with infliximab products resulted in a reduction in the number of T-cells and blood vessels in the synovium and psoriatic skin lesions as well as a reduction of macrophages in the synovium. Closure of all fistulas was achieved in 52% of infliximab-treated patients compared with 13% of placebo-treated patients (P<0.001). The most common side effects of infliximab products include: Infusion reactions can happen up to 2 hours after your infusion of Avsola. What is the most important information I should know about AVSOLA? A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Avsola is also indicated to treat rheumatoid arthritis in combination with methotrexate, as well as psoriatic arthritis. In this study, the majority of serious infusion reactions occurred during the second infusion at Week 2. Children should have all of their vaccines brought up to date before starting treatment with Avsola. 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. FDA approval was based on comparative analytical, nonclinical and clinical data that demonstrated Avsola to be highly similar to Remicade with no clinically meaningful differences. Pericardial effusion, systemic and cutaneous vasculitis. At Week 54, 8 of 21 patients in the every 8-week maintenance group and 4 of 22 patients in the every 12-week maintenance group achieved remission as measured by the PUCAI score. Of these infliximab-treated patients, 9 developed a malignancy, including 1 lymphoma, for a rate of 7.67 cases per 100 patient-years of follow-up (median duration of follow-up 0.8 years; 95% CI 3.51 -14.56). The biosimilar was approved to treat Crohn disease (CD), pediatric CD, ulcerative colitis (UC), pediatric UC, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Following an initial dose of infliximab, repeated infusions at 2 and 6 weeks resulted in predictable concentration-time profiles following each treatment. Common side effects include upper respiratory infections, sinusitis, infusion-related reactions, headache, and abdominal pain. Carcinogenesis, Mutagenesis, Impairment of Fertility . This Medication Guide has been approved by the U.S. Food and Drug Administration. Patients enrolled had a median age of 51 years with a median disease duration of 0.6 years, median swollen and tender joint count of 19 and 31, respectively, and >80% of patients had baseline joint erosions. Analyses of fetal samples on GD 14 indicated placental transfer of the antibody and exposure of the fetuses during organogenesis. AVSOLA is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. In Study Peds Crohn's, 18% of randomized patients experienced 1 or more infusion reactions, with no notable difference between treatment groups. shortness of breath with swelling of your ankles or feet. It is approved in the USA and Canada for all the same indications as infliximab RP. Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. People who have been treated for rheumatoid arthritis, Crohns disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis for a long time may be more likely to develop lymphoma. Antibody development was lower among RA and CD patients receiving immunosuppressant therapies such as 6-MP/AZA or MTX. The FDA has approved Amgen's infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade. Signs of anallergic reaction can include: Some patients treated with infliximab products have had delayed allergic reactions. Proposed Proprietary Name1 Avsola Pharmacologic Class tumor necrosis factor (TNF) blocker Applicant Amgen Inc. Allow the reconstituted solution to stand for 5 minutes. Avsola may cause serious side effects including: hives, difficulty breathing, swelling of your face, lips, tongue, or throat, dizziness, nausea, lightheadedness, itching, tingling, shortness of breath, headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, trouble swallowing during the injection, ABP 710 (AVSOLA ) is a biosimilar to infliximab reference product (RP), a monoclonal antibody targeting tumor necrosis factor alpha (TNF). 2) High Certainty: US Patents for AVSOLA Derived from Company Disclosures . Tuberculosis should be strongly considered in patients who develop a new infection during AVSOLA treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis. There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor (TNF)-blocker medicines, such as Avsola. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]. Published literature show that infliximab is present at low levels in human milk. Your doctor may do certain tests while you are receiving AVSOLA to monitor you for side effectsand to see how well you respond to the treatment. Symptoms of infusion reactions may include: Children with Crohns disease showed some differences in side effects compared with adults with Crohns disease. Because infliximab products do not cross-react with TNF in species other than humans and chimpanzees, animal reproduction studies have not been conducted with infliximab products. heart failure, unless your doctor has examined you and decided that you are able to receive Avsola. Discontinue infliximab-axxq if a patient develops a serious infection. The majority of patients in RA or CD clinical studies received one or more concomitant medications. ABP 710 (AVSOLA ) is a biosimilar to infliximab reference product (RP), a monoclonal antibody targeting tumor necrosis factor alpha (TNF). Clinical response at Week 8 was defined as a decrease from baseline in the Mayo score by 30% and 3 points, including a decrease in the rectal bleeding subscore by 1 points or achievement of a rectal bleeding subscore of 0 or 1. At Week 8, 45 patients were randomized to a maintenance regimen of 5 mg/kg infliximab given either every 8 weeks through Week 46 or every 12 weeks through Week 42. Tests for latent tuberculosis infection may also be falsely negative while on therapy with AVSOLA. Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period. AVSOLA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of AVSOLA or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Patients received either placebo + MTX or one of 4 doses/schedules of infliximab + MTX: 3 mg/kg or 10 mg/kg of infliximab by IV infusion at Weeks 0, 2 and 6 followed by additional infusions every 4 or 8 weeks in combination with MTX. with MTX, have not been conducted. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. #1. 13 NONCLINICAL TOXICOLOGY . You may have a higher chance of getting skin cancer while receiving AVSOLA. Infliximab products are known to cross the placenta and have been detected up to 6 months following birth. Keep all medical and lab appointments. Concurrent use of stable doses of folic acid, oral corticosteroids (10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted. Patients were randomized at week 0 to receive either placebo, 5 mg/kg infliximab or 10 mg/kg infliximab at Weeks 0, 2, 6, and every 8 weeks thereafter through Week 46 in Study UC I, and at Weeks 0, 2, 6, and every 8 weeks thereafter through Week 22 in Study UC II. Avsola is a medicine that affects your immune system. For other types of vaccines, talk with your doctor. Risk of infection. The potential role of TNF blockers in the development of malignancies is not known [see ADVERSE REACTIONS]. (Avsola, Inflectra or Renflexis) that is not expect ed with Remicade, or contraindication to all (Avsola, Inflectra or Renflexis) Covered Doses . AVSOLA can cause serious side effects, including: See What is the most important information I should know about AVSOLA?. All patients received 5 mg/kg infliximab at Weeks 0, 2 and 6. It has a molecular weight of approximately 149.1 kilodaltons. Enter your address. While the proportion of patients with infections was also higher in the younger age group (60% vs. 49%), for serious infections, the proportions were similar in the two age groups (13% in the 6-to 11-year age group vs. 11% in the 12-to 17-year age group). In Study RA I, all doses/schedules of infliximab + MTX showed significantly greater improvement from baseline in HAQ-DI and SF-36 physical component summary score averaged over time through Week 54 compared to placebo + MTX, and no worsening in the SF-36 mental component summary score. Study RA I was a placebo-controlled study of 428 patients with active RA despite treatment with MTX. Instruct patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever) while on AVSOLA [see WARNINGS AND PRECAUTIONS]. get a lot of infections or have infections that keep coming back. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Elevations of ALT up to 3 times the upper limit of normal (ULN) were seen in 18% of pediatric patients in CD clinical trials; 4% had ALT elevations 3 x ULN, and 1% had elevations 5 x ULN. regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients Population pharmacokinetic analysis showed that in pediatric patients with JRA with a body weight of up to 35 kg receiving 6 mg/kg infliximab and pediatric patients with JRA with body weight greater than 35 kg up to adult body weight receiving 3 mg/kg infliximab, the steady state area under the concentration curve (AUCss) was similar to that observed in adults receiving 3 mg/kg of infliximab. An increased risk of serious infections was seen in clinical studies of other TNF blockers used in combination with anakinra or abatacept, with no added clinical benefit. Data on use of infliximab products without concurrent MTX are limited [see ADVERSE REACTIONS]. Safety and efficacy of infliximab were assessed in a multicenter, double-blind, placebo-controlled study in 200 adult patients with active PsA despite DMARD or NSAID therapy (5 swollen joints and 5 tender joints) with 1 or more of the following subtypes: arthritis involving DIP joints (n=49), arthritis mutilans (n=3), asymmetric peripheral arthritis (n=40), polyarticular arthritis (n=100), and spondylitis with peripheral arthritis (n=8). Prolia targets and binds RANK Ligand, inhibiting osteoclast formation, function, and survival 1. Blood tests, imaging tests and more are used to diagnose musculoskeletal disorders. Most of these people were male teenagers or young men. Key observations in the study included a high placebo response rate and a higher rate of immunogenicity than what has been observed in adults. Dilute the total volume of the reconstituted AVSOLA solution to 250 mL* with sterile 0.9% Sodium Chloride Injection, USP, (do not dilute with any other diluent) as follows: Withdraw a volume from the 0.9% Sodium Chloride Injection, USP, 250 mL bottle or bag equal to the total volume of reconstituted AVSOLA required for a dose. have or have had a condition that affects your nervous system such as: multiple sclerosis, or Guillain-Barr syndrome, or, if you experience any numbness or tingling, or. In addition, 75% of patients had a BSA >20%. Patients who completed the study continued to receive open-label treatment with infliximab for up to 2 years in a companion extension study. Adults and children receiving Avsola should not receive live vaccines (for example, the Bacille Calmette-Gurin [BCG] vaccine) or treatment with a weakened bacteria (such as BCG for bladder cancer). Inotuzumab ozogamicin is a CD22-directed antibody-drug conjugate (ADC). Patients treated with infliximab products are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Your doctor should test you for TB before starting Avsola. The groups that received a maintenance dose every 8 weeks appear to have a greater percentage of patients maintaining a PASI 75 through Week 50 as compared to patients who received the as needed or PRN doses, and the best response was maintained with the 5 mg/kg every 8-week dose. Call your doctor for medical advice about side effects. In the controlled portions of clinical trials of all the TNF blockers, more cases of lymphoma have been observed among patients receiving a TNF blocker compared with control patients. intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance Some patients receiving infliximab products have developed serious liver problems. 1. Use of TNF blockers, including infliximab products, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Serious infections have happened in patients receiving Avsola. Although 105 patients were tested for antibodies to infliximab, 81 patients were classified as inconclusive because they could not be ruled as negative due to assay interference by the presence of infliximab in the sample. Serious infections were reported in 12% (7/60) of all treated patients. Similar responses were seen in patients with each of the subtypes of PsA, although few patients were enrolled with the arthritis mutilans and spondylitis with peripheral arthritis subtypes. Pharmacokinetic results for single doses of 3 mg/kg to 10 mg/kg in RA, 5 mg/kg in CD, and 3 mg/kg to 5 mg/kg in Ps indicate that the median terminal half-life of infliximab is 7.7 to 9.5 days. The inactive ingredients in AVSOLA include: dibasic sodium phosphate anhydrous, monobasic sodium phosphatemonohydrate, polysorbate 80, and sucrose. Among patients who were not in response at Week 2, 59% (92/157) of infliximab maintenance patients responded by Week 14 compared to 51% (39/77) of placebo maintenance patients. swelling of your face, lips, tongue, or throat. AVSOLA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see BOXED WARNING and WARNINGS AND PRECAUTIONS]. If yourbaby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. Patients enrolled had a median age of 54 years, median disease duration of 8.4 years, median swollen and tender joint count of 20 and 31 respectively, and were on a median dose of 15 mg/wk of MTX. intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance Transient visual loss have been reported in association with infliximab products during or within 2 hours of infusion. In all the clinical studies, approximately 20% of infliximab-treated patients experienced an infusion reaction compared with 10% of placebo-treated patients. Headache, stomach pain, or nausea may occur. Hidradenitis suppurativa . are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. At least a six-month waiting period following birth is recommended before the administration of live vaccines (e.g. with underlying conditions that may predispose them to infection. For patients who have an incomplete response, consideration may be given to adjusting the dosage up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses per infusion or more frequent dosing [see ADVERSE REACTIONS]. TNF-alpha ismade by your bodys immune system. Psoriasis is a common skin condition characterized by red, scaly, itchy and thickened areas of skin. Infliximab-axxq is produced in a recombinant Chinese Hamster Ovary (CHO) cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever) while on AVSOLA. Of the enrolled patients, 114 (46%) received the Week 26 additional dose. Avsolamay cause serious side effects including: Get medical help right away, if you have any of the symptoms listed above. These serious infections include TB and infections caused by viruses, fungi, orbacteria that have spread throughout the body or cause infections in certain areas (such as skin). As with all therapeutic proteins, there is potential for immunogenicity. Avsola will be given to you over a period of about 2 hours. (2) The physiologic or biochemical processes within the body that are affected by a drug's action, producing a given response. This document does not contain all possible drug interactions. Patients who do not respond by Week 14 are Of the 112 patients in Study Peds Crohn's, there were no serious infusion reactions, and 2 patients had non-serious anaphylactoid reactions. People with certain diseases have too much TNF-alpha that can cause the immune system to attack normal healthy parts of the body. Despite the increase in antibody formation, the infusion reaction rates in Studies I and II in patients treated with 5 mg/kg induction followed by every 8-week maintenance for 1 year and in Study III in patients treated with 5 mg/kg induction (14.1%-23.0%) and serious infusion reaction rates (<1%) were similar to those observed in other study populations. There was no change in the SF-36 mental component summary score in either the infliximab group or the placebo group. chronic inflammation. The inhibition of progression of structural damage was observed at 54 weeks (Table 9) and maintained through 102 weeks. Pneumonia was reported for 3 patients, (2 in the every 8-week and 1 in the every 12-week maintenance treatment groups). Infliximab infusions beyond the initial infusion were not associated with a higher incidence of reactions. Among patients who did not respond by Week 14, additional therapy did not result in significantly more responses [see DOSAGE AND ADMINISTRATION]. The majority of antibody-positive patients had low titers. Inhibition of progression of structural damage was observed at Weeks 30 and 54 (Table 9) in the infliximab + MTX groups compared to MTX alone. Treatment success, defined as clear or excellent, consisted of some residual pinkness or pigmentation to marked improvement (nearly normal skin texture; some erythema may be present). Paclitaxel has an unusual chemical structure--it is a complex diterpene having a taxane ring with a four-membered oxetane ring and an ester side chain at position C-13--and a unique mechanism of action. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. AVSOLA Savings, Coupons and Information. At Week 10, 103 patients were randomized to a maintenance regimen of 5 mg/kg of infliximab given either every 8 weeks or every 12 weeks. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Avsola: Some patients have developed symptoms that are like the symptoms of Lupus.
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