Indications
AVSOLA® is indicated for: Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an... Read more
AVSOLA® is indicated for: Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an... Read more
Call Amgen® SupportPlus at
866-264-2778
Monday - Friday,
9:00am to 8:00pm ET Or visit
AmgenSupportPlus.com
to learn how Amgen can help.
We're right here, right when you need us.
We're right here, right when you need us.
Call Amgen® SupportPlus at
866-264-2778
Monday - Friday,
9:00am to 8:00pm ET Or visit
AmgenSupportPlus.com
to learn how Amgen can help.
BENEFIT VERIFICATIONS VIA AMGEN SUPPORTPLUS CUSTOMER PORTAL
A tool for managing patient benefits verification and more. Submit, store, and retrieve benefit verifications electronically.
FINANCIAL SUPPORT
We know every patient has unique needs. And we’re here to provide financial support information and resources, regardless of current financial situation or type of insurance.
AMGEN® SUPPORTPLUS REPRESENTATIVES
Our Amgen® SupportPlus Representatives can assist with issues around patient coverage, prior authorizations, co-pay programs, and more
AMGEN® SUPPORTPLUS CO-PAY PROGRAM
The Amgen SupportPlus Co-Pay Program may help eligible patients with private or commercial insurance lower their out-of-pocket costs.
*Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/copay for full Terms and Conditions.
*Eligibility Criteria: Subject to program limitations and terms and conditions, the AVSOLA® Co-Pay Card is open to patients who have been prescribed AVSOLA® and who have commercial or private insurance, including plans available through state and federal healthcare exchanges. This program helps eligible patients cover out-of-pocket medication costs related to AVSOLA®, up to program limits. The AVSOLA® Co-Pay Card does not cover any other costs related to office visits or administration of AVSOLA®. There is no income requirement to participate in this program.
This offer is not valid for patients whose AVSOLA® prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state healthcare program. It is not valid for cash-paying patients or where prohibited by law. A patient is considered cash-paying where the patient has no insurance coverage for AVSOLA® or where the patient has commercial or private insurance but Amgen in its sole discretion determines the patient is effectively uninsured because such coverage does not provide a material level of financial assistance for the cost of an AVSOLA® prescription.
The AVSOLA® Co-Pay Card does not cover out-of-pocket costs for any patient whose selected coverage option under their commercial insurance plan does not apply AVSOLA® Co-Pay Card payments to satisfy the patient’s co-payment, deductible, or co-insurance for AVSOLA®. Patients with these plan limitations are not eligible for the AVSOLA® Co-Pay Card but may be eligible for other needs-based assistance provided by Amgen. These programs are often referred to as accumulator adjustment programs. If you believe your commercial insurance plan may have such limitations, please contact AVSOLA® Support at 1-866-264-2778.
The AVSOLA® Co-Pay Card also may provide a reduced benefit amount, unilaterally determined by Amgen in its sole discretion, to satisfy the out-of-pocket cost sharing requirement for any patient whose plan or plan agent (including, but not limited to, a Pharmacy Benefit Manager (PBM)) requires enrollment in the AVSOLA® Co-Pay Card as a condition of the plan or PBM waiving some or all of an otherwise applicable patient out-of-pocket cost sharing amount. These programs are often referred to as co-pay maximizer programs. If you believe your commercial insurance plan may have such limitations, please contact AVSOLA® Support at 1-866-264-2778. Health plans, Specialty pharmacies, and Pharmacy Benefit Managers (individually and collectively “Plan Administrators”) are prohibited from enrolling patients in the AVSOLA® Co-Pay Card. Plan Administrators are prohibited from assisting patients with enrollment in the AVSOLA® Co-Pay Card. The patient, or his/her legal representative, must personally enroll in the AVSOLA® Co-Pay Card in order to be eligible for program benefits.
If at any time a patient begins receiving coverage for medications under any federal, state, or government healthcare program (including but not limited to Medicare, Medicaid, TRICARE, Department of Defense, or Veteran Affairs programs), the patient will no longer be able to use this card and you must contact AVSOLA® Support at 1-866-264-2778 (Monday through Friday, from 9:00 am to 8:00 pm ET) to stop your participation in this program.
Patients may not seek reimbursement for the value received from the AVSOLA® Co-Pay Card from any third-party payers, including a flexible spending account or healthcare savings account. Participating in this program means that you are ensuring you comply with any required disclosure regarding your participation in the AVSOLA® Co-Pay Card of your insurance carrier or pharmacy benefit manager. Restrictions may apply. Offer subject to change or discontinuation without notice. This is not health insurance.
For all eligible patients the AVSOLA® Co-Pay Card offers:
Maximum Program Benefit, Patient Total Program Benefit, Benefits May Change, End or Vary: The program provides up to a Maximum Program Benefit of assistance to reduce a patient’s out-of-pocket medication costs that Amgen will provide per patient for each calendar year, which must be applied to the AVSOLA® patient’s out-of-pocket costs (co-pay, deductible, or co-insurance). Patient Total Program Benefit amounts are unilaterally determined by Amgen in its sole discretion and will not exceed the Maximum Program Benefit. The Patient Total Program Benefit may be less than the Maximum Program Benefit, depending on the terms of a patient’s plan, and may vary among individual patients covered by different plans, based on factors determined solely by Amgen, to ensure all programs funds are used for the benefit of the patient. Each patient is responsible for costs above the Patient Total Program Benefit amounts. Please ask your AVSOLA® Support Representative to help you understand whether your particular insurance coverage is likely to result in your reaching the Maximum Program Benefit or your Patient Total Program Benefit amount by calling 1-866-264-2778. Participating patients are solely responsible for updating Amgen with changes to their insurance including, but not limited to, initiation of insurance provided by the government, the addition of any coverage terms that do not apply AVSOLA® Co-Pay Card benefits to reduce a patient’s out-of-pocket costs, such as accumulator adjustment benefit design or a co-pay maximization program. Participating patients are responsible for providing Amgen with accurate information necessary to determine program eligibility. By accepting payments from Amgen made on behalf of participating patients, participating PBMs and Plans likewise are responsible for providing Amgen with accurate information regarding patient eligibility.
Patients may use the card every time they receive a treatment with AVSOLA®. Benefits reset each calendar year. Enrollment in the program is for 12 months. Patients may participate in the program for 12 months, or continue in the program after that, provided s/he continues to meet all of the program’s eligibility requirements during participation in the program, and with program enrollment renewal every 12 months. Patients can enroll/reenroll by calling 1-866-264-2778.
Amgen Safety Net Foundation is a nonprofit patient assistance program sponsored by Amgen that helps qualifying patients access Amgen medicines at no cost.
RESOURCES FOR YOUR OFFICE
BENEFIT
VERIFICATION FORM
Obtain patient insurance coverage and cost information
OFFICE
ATTESTATION FORM
Allows access specialist to provide case specific support
BILLING AND
CODING GUIDE
Refer to this guide for billing and coding information
AVSOLA® SUPPORT
SERVICES BROCHURE
Learn about dedicated support for your patients and resources for your office
SAMPLE LETTER OF
MEDICAL NECESSITY
Sample letter template that can be used to demonstrate medical necessity
SAMPLE LETTER OF
APPEAL
Sample letter template that can be used if appealing a PA denial
AVSOLA® INFUSION
PROTOCOL BROCHURE
Educates nurses and office staff about preparing,
administering, and infusing AVSOLA®
RESOURCES FOR YOUR PATIENTS
SWITCHING TO AVSOLA®
PATIENT BROCHURE
Your patient's guide to switching to AVSOLA® from Remicade®
BIOSIMILAR
PATIENT BROCHURE
Simple educational content to help patients feel confident about receiving a biosimilar (based on FDA guidance)
AVSOLA®
PATIENT BROCHURE
Your patient's guide to understanding and starting treatment with AVSOLA®
AVSOLA® PATIENT BROCHURE
IN SPANISH
Your patient's guide to understanding and starting treatment with AVSOLA®
FDA = Food and Drug Administration.
SERIOUS INFECTIONS: 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. Discontinue AVSOLA® if a patient develops a serious infection or sepsis.
Reported infections include:
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 TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.
Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab products included pneumonia, cellulitis, abscess, and skin ulceration.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
Postmarketing cases of hepatosplenic T-cell lymphoma, 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. 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. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with AVSOLA®, especially in these patient types.
In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including infliximab products, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with infliximab products was similar to that expected in the general population, whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between infliximab products and cervical cancer cannot be excluded. Periodic screening should continue in women treated with AVSOLA®.
The use of AVSOLA® at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure. AVSOLA® is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of AVSOLA® or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness).
TNF inhibitors, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating AVSOLA®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing AVSOLA® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with AVSOLA®. Discontinue AVSOLA® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of TNF-blocker therapy and monitor patients closely.
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving infliximab products postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥ 5 times the upper limit of normal) develop, AVSOLA® should be discontinued, and a thorough investigation of the abnormality should be undertaken.
In a randomized, placebo-controlled study in patients with moderate or severe heart failure (NYHA Functional Class III/IV), higher mortality rates and a higher risk of hospitalization were observed at Week 28 at a dose of 10 mg/kg and higher rates of cardiovascular events were observed at both 5 mg/kg and 10 mg/kg. There have been postmarketing reports of new onset and worsening heart failure, with and without identifiable precipitating factors. Patients with moderate or severe heart failure taking infliximab (≤5 mg/kg) or patients with mild heart failure should be closely monitored and treatment should be discontinued if new or worsening symptoms appear.
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported in patients receiving infliximab products. The causal relationship to infliximab product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of AVSOLA® in patients who develop significant hematologic abnormalities.
Infliximab products have been associated with hypersensitivity reactions that differ in their time of onset. Anaphylaxis, urticaria, dyspnea, and hypotension have occurred in association with infusions of infliximab products. Medications for the treatment of hypersensitivity reactions should be available.
Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of infliximab product infusion. Cases of transient visual loss have been reported during or within 2 hours of infusion of infliximab. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.
Agents that inhibit TNF have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering AVSOLA® in patients with these disorders and consider discontinuation if these disorders develop.
Concomitant use of AVSOLA® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as AVSOLA® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.
Treatment with infliximab products may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue treatment with AVSOLA® if symptoms of a lupus-like syndrome develop.
Bring patients up to date with all vaccinations prior to initiating AVSOLA®. Live vaccines or therapeutic infectious agents should not be given with AVSOLA® due to the possibility of clinical infections, including disseminated infections.
At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to infliximab products.
In clinical trials with infliximab products, the most common adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
AVSOLA® is indicated for:
Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. AVSOLA® is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease.
Pediatric Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
Ulcerative Colitis: 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 who have had an inadequate response to conventional therapy.
Pediatric Ulcerative Colitis: Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
Rheumatoid Arthritis in combination with methotrexate: Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Ankylosing Spondylitis: Reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Psoriatic Arthritis: Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis.
Plaque Psoriasis: The treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. AVSOLA® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Please see full Prescribing Information.
AVSOLA® is a registered trademark of Amgen, Inc.
Important Safety Information
SERIOUS INFECTIONS:
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. Discontinue AVSOLA® if a patient develops a serious infection or sepsis.
Reported infections include:
