Cyltezo

Generic name: Adalimumab-adbm
Drug class: TNF alfa inhibitors

Usage of Cyltezo

Cyltezo (adalimumab-adbm) is an interchangeable biosimilar of Humira; it is a TNF alfa inhibitors used to reduce pain, inflammation, and skin symptoms in autoimmune conditions. Cyltezo Is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Cyltezo is the first interchangeable biosimilar to Humira. Biosimilars are biologic medicines that are a very close copy to the original product made by another company. An interchangeable biosimilar has undergone an additional Interchangeability Study, meaning that patients can be confident in the safety and effectiveness of the interchangeable biosimilar product, just as they would be for the FDA-approved original product, in this case, Humira. Being an interchangeable biosimilar means Cyltezo can automatically be substituted by a pharmacist for Humira, with individual state laws controlling how and whether physicians will be notified.

Cyltezo is used to treat chronic autoimmune conditions. Normally, your immune system defends your body against diseases by fighting harmful bacteria or viruses. However, in autoimmune disorders, the immune system becomes hyperactive and mistakenly attacks its own tissues, leading to symptoms of the autoimmune condition. Tumor necrosis factor (TNF) is a protein that is involved in causing inflammation. Cyltezo is a TNF blocker that inhibits TNF, helping to reduce pain, inflammation, and skin symptoms.

Cyltezo side effects

Common Cyltezo side effects

Common side effects of Cyltezo may include:

headache;

cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;

rash; or

redness, bruising, itching, or swelling where the injection was given.

Get emergency medical help if you have any of these signs of an allergic reaction to Cyltezo: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious Cyltezo side effects

Call your doctor right away if you have any symptoms of lymphoma:

fever, swollen glands, night sweats, general feeling of illness;

joint and muscle pain, skin rash, easy bruising or bleeding;

pale skin, feeling light-headed or short of breath, cold hands and feet;

pain in your upper stomach that may spread to your shoulder; or

loss of appetite, feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

new or worsening psoriasis (raised, silvery flaking of the skin);

a sore or bump on your skin that does not heal;

symptoms of sepsis - confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;

liver problems - body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

lupus-like syndrome - joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;

nerve problems - numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or

signs of tuberculosis - fever with ongoing cough, weight loss (fat or muscle).

Older adults may be more likely to develop infections or cancer while using Cyltezo.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Before taking Cyltezo

Before you start using Cyltezo, tell your doctor if you have signs of infection - fever, chills, sweats, muscle aches, tiredness, cough, bloody mucus, skin sores, diarrhea, burning when you urinate, or feeling constantly tired.

Cyltezo should only be used in age groups for the specific conditions that Cyltezo is FDA-approved to treat. Children using Cyltezo should be current on all childhood immunizations before starting treatment.

Tell your doctor if you have ever had:

tuberculosis (or if anyone in your household has tuberculosis);

a chronic infection;

cancer;

hepatitis B (Cyltezo can cause hepatitis B to come back or get worse);

diabetes;

heart failure;

any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;

an allergy to latex rubber;

if you are scheduled to have major surgery; or

if you have recently received or are scheduled to receive any vaccine.

Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common in certain areas of the world.

Cyltezo may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Pregnancy

It is not known whether Cyltezo will harm an unborn baby. Tell your doctor if you are pregnant or planning a pregnancy. Make sure any doctor caring for your newborn baby knows if you used Cyltezo while you were pregnant, and especially before your baby receives any vaccines.

Breastfeeding

It may not be safe to breastfeed a baby while you are using Cyltezo. Ask your doctor about any risks and the best way to feed your baby while on this medicine.

Relate drugs

How to use Cyltezo

The dose and frequency of Cyltezo given is dependent on age, severity, and condition treated. For more information on specific dosing schedules click the link below.

Cyltezo is available as:

Cyltezo Pen (40 mg/0.8 mL)

Cyltezo Prefilled Syringe Injection (40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL)

Warnings

Cyltezo affects your immune system. You may get infections more easily, even serious or fatal infections.

Before or during treatment with Cyltezo, tell your doctor if you have signs of infection such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

Your doctor should test you for tuberculosis (TB) before starting to take Cyltezo and also monitor you closely for signs and symptoms of TB during treatment.

The chances of getting cancer may be increased for children and adults taking TNF-blockers.

Do not take Cyltezo if are allergic to the active ingredient adalimumab or to any of the inactive ingredients. Click here for a list of Cyltezo ingredients

Latex allergy warning. The needle cap of the Prefilled Pen and Prefilled Syringe contains natural rubber latex

What other drugs will affect Cyltezo

Some drugs should not be used together with Cyltezo. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Cyltezo especially:

abatacept, etanercept;

anakinra;

azathioprine, 6-mercaptopurine; or

certolizumab, golimumab, infliximab, rituximab.

Avoid the use of live vaccines.

This list is not complete. Other drugs may interact with Cyltezo including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.