Frequently asked questions about CYLTEZO

CYLTEZO, an interchangeable* biosimilar to Humira^®, may treat or reduce the signs and symptoms of certain autoimmune conditions. See Important Safety Information about CYLTEZO.

*Interchangeability of CYLTEZO has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its full Prescribing Information.

CYLTEZO is an interchangeable biosimilar to Humira. Both are adalimumab products, and CYLTEZO has been tested to make sure it is as effective and safe as Humira. Learn more about why interchangeable biosimilars matter here.

No, CYLTEZO is not a generic version of Humira. CYLTEZO is a biosimilar to Humira, and is as effective and safe as Humira. You can learn more about biosimilars and interchangeable biosimilars here.

Yes, CYLTEZO and Adalimumab-adbm are the exact same medicine with the same effectiveness and safety.

CYLTEZO and Adalimumab-adbm are the exact same medicine with the same effectiveness and safety. Whether you receive CYLTEZO or Adalimumab-adbm depends on which product is covered by your insurance plan. A specialty pharmacy may have worked with your healthcare provider and insurance company for you to receive Adalimumab-adbm.

The amount you pay for CYLTEZO is determined by your insurance coverage. If you are underinsured or uninsured, the BI Solutions Plus^® team can help you apply for the CYLTEZO Copay Program to see if you're eligible. Find out if you’re eligible. BI Solutions Plus can also provide information about third-party financial support resources.

How much you pay for CYLTEZO will depend on your insurance coverage. If you are commercially insured, including through a health insurance exchange, federal employee plan, or state employee plan you may be eligible for the CYLTEZO Copay Program, in which you pay as little as $0 per fill of CYLTEZO. Terms and Conditions apply and may change without notice. Find out if you’re eligible.

If you are underinsured or uninsured and not eligible for the CYLTEZO Copay Program, you can contact our BI Solutions Plus team, who can provide information about independent third-party organizations that may offer assistance. Contact BI Solutions Plus at 1-833-CYLTEZO to learn more.

If your insurance plan did not accept your CYLTEZO copay-assistance information, or if you paid your copay because you were not enrolled in BI Solutions Plus, we may be able to reimburse you for certain out-of-pocket costs. Terms and Conditions apply and may change without notice. Contact BI Solutions Plus at 1-833-CYLTEZO to learn more.

Your doctor may have recommended that you switch to CYLTEZO because CYLTEZO is an interchangeable* biosimilar to Humira. A specialty pharmacy may also work with your healthcare provider and insurance company to coordinate the coverage and delivery of the medication. Interchangeable biosimilars are carefully evaluated to ensure they are as safe and effective as the original medication in any given patient.

*Interchangeability of CYLTEZO has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its full Prescribing Information.

Yes. A range of clinical studies with adalimumab showed the medication to be effective and safe in the treatment of rheumatoid arthritis, Crohn’s disease, plaque psoriasis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, and uveitis.

The FDA designated CYLTEZO as an interchangeable* biosimilar to Humira, based on an additional study in which patients were switched back and forth from Humira to CYLTEZO, with no change in effectiveness or safety in any given patient. The FDA only gives the interchangeable designation based on additional information. This is generally from one or more studies that confirm the biosimilar's effectiveness and safety are the same as the original branded product in any given patient.

*Interchangeability of CYLTEZO has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its full Prescribing Information.

CYLTEZO is a medicine that affects your immune system. CYLTEZO can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.

Your doctor should test you for TB before starting CYLTEZO. Your doctor should check you closely for signs and symptoms of TB during treatment with CYLTEZO.

You should not start taking CYLTEZO if you have any kind of infection unless your doctor says it is okay.

The FDA approved CYLTEZO as a biosimilar and additionally designated CYLTEZO as an interchangeable biosimilar to Humira. This designation was based, in part, on data from an additional study, in which patients were switched back and forth from Humira to CYLTEZO, with no meaningful difference in effectiveness or safety compared to patients who remained on Humira.

The most common side effects of CYLTEZO include injection site reactions: redness, rash, swelling, itching, or bruising. These are not all the possible side effects with CYLTEZO. Tell your doctor if you have any side effect that bothers you or that does not go away. Additional side effects include upper respiratory infections (including sinus infections), headaches, and rash.

Tell your doctor if you have any side effect that bothers you or that does not go away. Tell your doctor if you think you have an infection or have symptoms of an infection, such as fever, sweats, or chills; muscle aches; cough; shortness of breath; blood in phlegm; warm, red or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal; feel very tired; and/or weight loss. CYLTEZO can make you more likely to get infections or make any infection that you may have worse.

For full details, please see the Medication Guide.

You can expect the same results that you experienced with Humira. Learn why results are the same between CYLTEZO and Humira here.

Your doctor can provide guidance on the efficacy of CYLTEZO for your condition. If you have any questions regarding the use of CYLTEZO or if you experience any side effects, please contact your doctor right away. If you are starting treatment with adalimumab, please follow your doctor's prescription. You can refer to the full Prescribing Information for more information about CYLTEZO. If you don't notice any improvement or experience worsening of symptoms after several weeks, consult with your doctor to determine if CYLTEZO is the appropriate medication for you.

For patients switched from Humira to CYLTEZO, you can expect the same clinical results as Humira immediately. Because you already had the required starting dose with Humira, you will start CYLTEZO by continuing to take maintenance doses with CYLTEZO. To learn more about switching from Humira, click here.

The appropriate dosage of CYLTEZO is prescribed by your doctor, based on your condition. Please follow the dosing instructions provided by your doctor.

Do not miss any doses of CYLTEZO unless your doctor says it is okay. If you forget to take CYLTEZO, inject a dose as soon as you remember. Then, take your next dose at your scheduled time. This will put you back on schedule. In case you are not sure when to inject CYLTEZO, call your doctor or pharmacist.

If you take more CYLTEZO than you were told to take, call your doctor.

Although some patients may experience positive results, others may not. Therefore, it's essential that you discuss with your doctor the efficacy of CYLTEZO for your condition. If you have questions regarding the use of CYLTEZO, please don't hesitate to speak with your doctor.

Before starting CYLTEZO, you should tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bringing a list of medicines that you are currently taking to show your doctor and pharmacist is often helpful when you are getting a new medicine.

Especially tell your doctor if you use ORENCIA^® (abatacept), KINERET^® (anakinra), REMICADE^® (infliximab), ENBREL^® (etanercept), CIMZIA^® (certolizumab pegol), or SIMPONI^® (golimumab), because you should not use CYLTEZO while you are also using one of these medicines: Your doctor may not want to give you CYLTEZO if you have received RITUXAN (rituximab) recently, IMURAN^® (azathioprine), or PURINETHOL (6-mercaptopurine, 6-MP).

Talk to your doctor about which vaccines are right for you. You may receive vaccines, except for live vaccines, while using CYLTEZO. It is recommended that pediatric patients, if possible, be up to date with all immunizations that follow current immunization guidelines before starting CYLTEZO. Please speak with your child's doctor.

CYLTEZO is injected under the skin using either a CYLTEZO Pen or a prefilled syringe. Both were designed to be used at home so that you can inject on a set schedule, using the right dose prescribed by your doctor. Speak to your doctor before starting injections on your own to ensure that you have the proper injection training. You can find information about how to inject CYLTEZO here.

The CYLTEZO Pen has been certified by the Arthritis Foundation as an Ease of Use product. The Arthritis Foundation recognizes products proven to make life easier for people with arthritis and other physical limitations. Ease of Use is proven through independent testing. Do not use a CYLTEZO Pen until you have been shown the right way to inject by your doctor or nurse and have read and understood the Instructions for Use. If you need a refresher, watch this video on how to inject with the CYLTEZO Pen.

Your CYLTEZO prescription and shipment frequency will be determined by your doctor and your insurance coverage.

Reach out to 1-833-CYLTEZO or contact your specialty pharmacy with questions or issues regarding refills.

If one or more of your CYLTEZO Pens meet at least one of the following criteria, do not use it, and call to request a replacement at 1-833-CYLTEZO (1-833-295-8396).

It is cracked, broken, or leaking

It has been frozen

It has been at room temperature for longer than 14 days

It has been exposed to direct light

The medicine has flakes or particles in it

The medicine is milky or discolored

Its expiration date has passed

You may use the CYLTEZO products you have as long as they have not expired. Check the date on the container. If the expiration date has passed, discard the entire CYLTEZO Pen or prefilled syringe in your sharps disposal container, and use a CYLTEZO Pen or prefilled syringe that has not yet expired.

CYLTEZO must be refrigerated between 36° F and 46° F. Do not freeze CYLTEZO. Do not use CYLTEZO if frozen, even if it has been thawed. Do not store CYLTEZO in extreme heat or cold. CYLTEZO must be stored in its original carton until the time of injection to protect it from light.

The storage of CYLTEZO is determined by its expiration date. The expiration date is printed on the carton. Do not use CYLTEZO after its expiration date.

CYLTEZO Pens and prefilled syringes must be disposed of immediately after use, using a sharps disposal container. Sharps disposal containers should be kept safely beyond the reach of children.

Yes. When you are traveling, CYLTEZO may be stored at room temperature up to a maximum of 77° F for a period of up to 14 days, protected from light. If it is not used within that 14-day period, CYLTEZO should be discarded.

No, you should not put CYLTEZO back in the refrigerator after you have let it warm up to room temperature. However, CYLTEZO may be stored at room temperature up to a maximum of 77° F for a period of up to 14 days, protected from light. If it is not used within that 14-day period, CYLTEZO should be discarded.

If you have questions about how long you will have to be on treatment with CYLTEZO, speak with your doctor. Always follow your doctor’s instructions about taking CYLTEZO.

Before starting CYLTEZO, tell your doctor if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. In such cases, CYLTEZO may not be right for you. You and your doctor should decide if you should take CYLTEZO while you are pregnant or breastfeeding.

If you have a baby and you were using CYLTEZO during your pregnancy, tell your baby’s doctor before your baby receives any vaccines.

BI Solutions Plus is a patient support program designed with your needs in mind. Here are some of the ways our team can help you stay on track:

• Understanding your insurance coverage benefits for CYLTEZO and your eligibility for financial support options
• Personalized injection education either online, over the phone, or in person
• Dedicated Patient Navigator to help you get started and answer questions throughout your treatment
• Additional resources, if you need them, to help you inject at home or when traveling (eg sharps container, insulated travel bag)

The CYLTEZO Copay Program helps eligible patients with commercial insurance, including health insurance exchanges, federal employee plans, or state employee plans, pay as little as $0 per fill of CYLTEZO. Terms and Conditions apply and may change without notice.

To enroll, call BI Solutions Plus at 1-833-CYLTEZO Monday-Friday from 8:00 am to 8:00 pm ET.

The CYLTEZO Copay Program may help eligible patients with commercial insurance, including health insurance exchanges, federal employee plans, or state employee plans, pay as little as $0 per fill for CYLTEZO. Terms and Conditions apply and may change without notice. Patients on any state or federally funded insurance programs, including but not limited to Medicare or Medicaid, Medigap, VA, DOD, or Tricare, are not eligible. If you are underinsured or uninsured, the BI Solutions Plus^® team will research your situation and determine eligibility for other potential ways to save. To see if you are eligible, please call BI Solutions Plus at 1-833-CYLTEZO.

If you are eligible, you will receive an email that provides all of your details for the CYLTEZO Copay Program. You'll need to provide that information, including the BIN, PCN, Member ID, and Group ID numbers, to the specialty pharmacy when they call you to set up delivery of CYLTEZO. The pharmacy will apply the card to help lower your out-of-pocket costs and will note the card number in your record for future refills. If you have questions about the CYLTEZO Copay Program, call BI Solutions Plus at 1-833-CYLTEZO (1-833-295-8396).

You'll need to provide the details in your Copay Welcome Email (including BIN, PCN, Member ID, and Group ID numbers) to the specialty pharmacy when they call you to set up delivery of CYLTEZO. The pharmacy will note the card number in your record for future refills. If there are problems applying your savings or you cannot locate your welcome email, please contact BI Solutions Plus at 1-833-CYLTEZO Monday-Friday from 8:00 am to 8:00 pm ET.