Indications

AVSOLA® is indicated for: Moderate to Severe Crohn’s Disease: Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t... Read more

Prescribing Information Indications Medication Guide Visit AmgenBiosimilars.com

FOR PATIENTS

DEDICATED SUPPORT & RESOURCES

 

FIND HELP FROM AMGEN WHEN STARTING AVSOLA®

Amgen ASSIST<sup>®</sup>

If you’ve been prescribed AVSOLA®, you may have questions about your co-pay, insurance, or your options if you do not have insurance.* Your Amgen® SupportPlus Representatives is here to help.

866-264-2778

Monday to Friday,
9:00 am to 8:00 pm ET

Amgen® SupportPlus Representatives can help you understand:

INSURANCE COVERAGE

CO-PAY COSTS

DEDUCTIBLE COSTS

*Co-pay support available for commercially eligible patients only; additional resources may be available for independent patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits’ criteria. Amgen has no control over these programs and provides information as a courtesy only.

CO-PAY PROGRAM

The Amgen® SupportPlus Co-Pay Program may help patients with private or commercial insurance lower their out-of-pocket costs

  • Pay as little as $0* out-of-pocket for each dose
  • Can be applied to deductible, co-insurance, and co-payment*
  • No income eligibility requirement

For co-pay support, click here for more information, or call 866-264-2778

*Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/copay for full Terms and Conditions.

AVSOLA® Co-pay Program Terms and Conditions

  1. ELIGIBILITY

    *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.

  2. PROGRAM BENEFITS

    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.

  3. PROGRAM DETAILS

    For all eligible patients the AVSOLA® Co-Pay Card offers:

    • A program benefit that covers the patient’s eligible out-of-pocket medication costs for AVSOLA® (co-pay, deductible, or co-insurance) on behalf of the patient, up to a Maximum Program Benefit determined by the program per calendar year. The AVSOLA® Co-Pay Card does not cover any other costs related to office visits or administration of AVSOLA®.
    • AVSOLA® patients pay $5 out-of-pocket for each treatment, and Amgen will pay on behalf of the patient the remaining eligible out-of-pocket prescription costs (up to the Patient Total Program Benefit described below. AVSOLA® patients are responsible for all amounts that exceed this limit.).
    • Ongoing activation of the AVSOLA® Co-Pay Card is contingent on the submission of the required Explanation of Benefits (EOB) form by the healthcare provider’s office within 180 days of the use of the AVSOLA® Co-Pay Card. Patients will be responsible for reimbursing the program for all amounts paid out if the EOB for the date of service is not received within 180 days.

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.

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HELPFUL RESOURCES

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A nonprofit patient assistance program

Amgen Safety Net Foundation is a nonprofit patient assistance program sponsored by Amgen that helps qualifying patients access Amgen medicines at no cost.

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HELPFUL RESOURCES FOR YOU THROUGHOUT YOUR TREATMENT JOURNEY

Links to these third-party organizations are for your information only. Amgen does not endorse and is not responsible for the content included by these organizations.

Click below to discover websites that can provide you with more information about your inflammatory disease and support groups near you.

The link to this third-party organization is for your information only. Amgen does not endorse and is not responsible for the content included by this organization.

Click below to discover websites that can provide you with more information about your inflammatory disease and support groups near you.

INFLAMMATORY ARTHRITIS DISEASES Chronic inflammation in joints and other tissues

INFLAMMATORY BOWEL DISEASES Chronic inflammation in parts of the digestive tract

Arthritis Foundation Logo

AMERICAN COLLEGE OF RHEUMATOLOGY

NATIONAL PSORIASIS FOUNDATION

Arthritis Foundation Logo

AMERICAN COLLEGE OF RHEUMATOLOGY

Crohn's and Colitis Foundation Logo

American Gastroenterological Association Logo

Crohn's and Colitis Foundation Logo

Important Safety Information

Only your doctor can recommend a course of treatment after checking your health condition. AVSOLA® (infliximab-axxq) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with AVSOLA®.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking infliximab products and azathioprine or 6-mercaptopurine. For children and adults taking TNF-blockers, including AVSOLA®, the chances of getting lymphoma or other cancers may increase.

It is not known if AVSOLA® is safe and effective in children under 6 years of age.

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take AVSOLA®?

You should let your doctor know if you have or ever had any of the following:

  • Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start AVSOLA®.
  • Lived in a region where certain fungal infections like histoplasmosis, coccidioidomycosis or blastomycosis are common.
  • Infections that keep coming back, have diabetes or an immune system problem.
  • Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
  • Heart failure or any heart condition. Many people with heart failure should not take AVSOLA®.
  • Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV. Nervous system disorders (like multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor if you:

  • Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as AVSOLA®.
  • Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using AVSOLA® during your pregnancy. You and your doctor should decide if you should receive AVSOLA® while you are pregnant or breastfeeding. Tell your baby’s doctor about your AVSOLA® use. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death.
  • Recently received or are scheduled to receive a vaccine. Adults and children taking AVSOLA® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking AVSOLA®.
What should I watch for and talk to my doctor about before or while taking AVSOLA®?

The following serious (sometimes fatal) side effects have been reported in people taking AVSOLA®.

You should tell your doctor right away if you have any of the signs listed below:

  • Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. AVSOLA® can make you more likely to get an infection or make any infection that you have worse.
  • Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
  • Lymphoma, or any other cancers in adults and children.
  • Skin cancer—any changes in or growths on your skin.
  • Cervical cancer—your doctor may recommend that you be regularly screened. Some women with rheumatoid arthritis, particularly those over 60, have developed cervical cancer.
  • Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Other heart problems within 24 hours of infusion, including heart attack, low blood flow to the heart, or abnormal heart rhythm—chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat.
  • Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
  • Blood disorders—fever that doesn’t go away, bruising, bleeding or severe paleness.
  • Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
  • Stroke within 24 hours of infusion—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.
  • Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, and fever or chills.
  • Delayed allergic reactions (3 to 12 days after infusion)—fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
  • Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.
  • Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

The most common side effects of infliximab products include respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.

Please read the full Prescribing Information and Medication Guide for AVSOLA® and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATIONS

AVSOLA® is indicated for:

Moderate to Severe Crohn’s Disease: Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn’s disease who haven’t responded well to other therapies

Moderate to Severe Pediatric Crohn’s Disease: Can reduce signs and symptoms, and induce and maintain remission, in children (ages 6-17) with moderately to severely active Crohn’s disease who haven’t responded well to other therapies

Moderate to Severe Ulcerative Colitis (UC): Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active UC who haven’t responded well to other therapies

Moderate to Severe Pediatric Ulcerative Colitis: Can reduce signs and symptoms, and induce and maintain remission, in children (ages 6-17) with moderately to severely active ulcerative colitis who haven’t responded well to other therapies

Moderate to Severe Rheumatoid Arthritis (RA): Can reduce signs and symptoms, help stop further joint damage, and improve physical function in adult patients with moderately to severely active RA, in combination with methotrexate

Psoriatic Arthritis (PsA): Can reduce signs and symptoms of active arthritis, help stop further joint damage, and improve physical function in adult patients with PsA

Ankylosing Spondylitis (AS): Can reduce signs and symptoms in adult patients with active AS

Chronic Severe Plaque Psoriasis: Approved for the treatment of adult patients with severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if AVSOLA® is appropriate considering other available therapies

Please see full Prescribing Information.

AVSOLA® is a registered trademark of Amgen, Inc.

Important Safety Information

Only your doctor can recommend a course of treatment after checking your health condition. AVSOLA® (infliximab-axxq) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with AVSOLA®.