Cyltezo

What is Cyltezo?

Cyltezo (adalimumab-adbm) is an interchangeable biosimilar to Humira and is an TNF-alpha inhibitor that is used to ease inflammation, pain, and skin manifestations in autoimmune disorders. Cyltezo is used for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, ulcerative colitis, as well as hidradenitis suppurativa and uveitis.

Cyltezo can be described as the first biosimilar that can be interchanged with Humira. Biosimilars are biological medicines that are a close replica of the original, produced by a different company. A biosimilar that is interchangeable is subject to another interchangeability study, which means that patients can trust the safety and efficacy of the biosimilar that is interchangeable the same way they would with the FDA-approved original drug for this particular instance, Humira. As a biosimilar that is interchangeable, Cyltezo is able to be automatically substituted by a pharmacist in place of Humira, with state-specific regulations governing the manner in which and how doctors will be informed.

Cyltezo can be used to treat chronic autoimmune disorders. In normal circumstances, your immune system protects your body from illness by battling harmful viruses or bacteria. In autoimmune diseases that affect the immune system, it gets overactive, begins attacking the tissues on its own, and causes signs of an autoimmune disorder. TNF, or tumor necrosis factor (TNF), is an important protein involved in the process of causing inflammation. Cyltezo is an TNF blocker that blocks TNF, which helps reduce inflammation, pain, and skin-related issues.

What is Cyltezo?

Cyltezo is an FDA-approved drug that can be used to treat:

• Rheumatoid arthritis (moderate up to extreme) in adults to decrease the symptoms and signs that RA slow the progress of structural damage and to improve physical functioning.
• Juvenile idiopathic arthritis (moderate or severe polyarticular) for children aged 2 years or older in order to lessen the symptoms and signs of moderately active to severe polyarticular JIA.
• Psoriatic arthritis in adults is utilized to lessen the symptoms and signs of psoriatic joints, slow the progress of structural injuries, and improve physical performance.
• Ankylosing spondylitis in adults can lessen symptoms and signs.
• The condition is known as hidradenitis supurativa (moderate or severe) among adults.
• Crohn's disease (moderate up to serious) for adults and children six years old and up
• Ulcerative colitis (moderate to severe) in adults It isn't clear whether Cyltezo products are effective for those who stop responding to or are unable to take TNF-blocker medications.
• Plaque psoriasis (chronic and severe) for adults who suffer from the condition in a variety of parts of their bodies and who could benefit from having injections or pills (systemic treatment) and phototherapy (treatment by using light therapy with ultraviolet or in combination with pills).
• Uveitis (UV), which is a non-infectious posterior, intermediate, and panuveitis for adult patients,

Side effects

Common Cyltezo side effects

Common adverse consequences of Cyltezo could be:

• Headache;
• Signs of a cold, like sinus pain, a stuffy nose, and sneezing. Sore throat;
• It can be a rash or
• Itching, redness, bruises, or swelling in the area where the injection was administered

See a doctor immediately. If you experience any of the following symptoms or warnings of an allergic reaction, Cyltezo: hives, breathing problems, or swelling of your lips, face, and tongue

Side effects of Serious Cyltezo

Contact your doctor immediately. If you notice any signs of lymphoma,

• Fever, swollen glands, night sweats, and a general feeling of illness;
• Joint and muscle discomfort, skin rash, and easy bruising bleeding;
• Skin that is pale and lightheaded, as if you're short of breath, frigid hands as well as feet
• Discomfort in your stomach, which may then be transferred to your shoulder or
• Loss of appetite feeling fuller after eating one or two bites, weight loss

Contact your doctor at anytime if you suffer from:

• New or worsening psoriasis that is getting worse or not as bad (raised with white flaking on the face);
• An itch or bump in your face that doesn't heal;
• Symptoms of sepsis: chills, confusion, sleepiness, rapid heartbeats, quick breathing, and feeling extremely sick;
• Liver problems: bodyaches, tiredness, and stomach pain. Right-sided nausea, upper stomach pain, hunger loss, dark urine, black stool, and jaundice (yellowing of the eyes or skin)
• Lupus-like condition: joint discomfort or swelling in the chest and shortness of breath. The skin's color changes when exposed to sunlight.
• Nerve disorders: numbness nerve problems: tingling, dizziness, vision issues, weakness in your legs or arms,
• Symptoms of tuberculosis: the cough that continues to recur and the loss of weight (fat or muscular).

Adults who are older might be more likely to get cancer or infection during treatment with Cyltezo. This is not a comprehensive list of all side effects. Other effects may also be present. Contact your doctor to seek medical advice on the effects. You can report any symptoms to the FDA at 1-800-FDA-1088.

Warnings

Cyltezo influences your immune system. You could contract infections more frequently, and even deadly or life-threatening infections. Prior to or during treatment with Cyltezo, inform your physician whether you are showing indications of an infection like fever, chills, aches, fatigue, cough, skin sores, diarrhea, or burning when you go to the bathroom. Your doctor should check you for tuberculosis (TB) prior to beginning Cyltezo and should also be watching closely for any signs or symptoms of TB while you are taking treatment.

The risk of developing cancer is higher in adults and children who are taking TNF-blockers. Do not use Cyltezo in the event that you are allergic to the active ingredient, adalimumab, or any inactive ingredient. Here is an inventory of Cyltezo's ingredients. The latex allergy alert The needle cap on the prefilled pen and prefilled syringe is made of natural latex from rubber.

Prior to use this drug

Before you begin using Cyltezo, consult your physician when you show signs of infection, such as chills, fever, muscle aches, tiredness, and coughing. Also, you may experience skin sores, bloody mucus or diarrhea, burning sensations when you urinate, or feel always exhausted.

Cyltezo is recommended to only be used within the age ranges for particular conditions. Cyltezo is FDA-approved for treating Children taking Cyltezo must be current on all vaccines given to them prior to beginning treatment.

Speak to your doctor if you were ever diagnosed with:

• Tuberculosis (or the case that someone in your family has tuberculosis);
• An ongoing infection;
• Cancer;
• Hepatitis B (Cyltezo could cause hepatitis B to return or worsen);
• Diabetes;
• Heart failure;
• Any sensation of numbness or the sensation of tingling, or a neuromuscle disorder like the condition known as multiple sclerosis and Guillain-Barre syndrome;
• An allergy to latex rubber
• If you are scheduled to undergo an important surgery or
• If you've recently had or are due to be given any vaccination,

Inform your doctor about where you live and whether you have recently traveled or are planning to travel. You could be at risk of contracting illnesses that are common in some regions of the world.

Cyltezo can cause a rare form of lymphoma (cancer) of the spleen, liver, and bone marrow, which could be fatal. It is most common among young people and teens suffering from Crohn's disease and ulcerative colitis. However, those suffering from an autoimmune disease that is inflammatory might have a higher chance of developing cancerous lymphoma. Consult your physician regarding your risk.

Pregnancy

It isn't known if Cyltezo could harm a pre-born baby. Discuss with your doctor if you are planning or expecting an unplanned pregnancy. Check with any doctor caring for your baby's needs to know whether you took Cyltezo during your pregnancy and, especially, prior to your baby's first vaccines.

Breastfeeding

It might not be safe to breastfeed your baby when you are taking Cyltezo. Consult your physician about any concerns and the best method to feed your child when taking this medication.

How to take Cyltezo?

Utilize Cyltezo precisely as directed by your physician. Follow the instructions on the prescription label and go through all medication guides and instructions. Make sure you use the medicine exactly as prescribed.

Cyltezo is injected underneath the skin (subcutaneously) by using a prefilled pen or syringe.

The dosage plan for Cyltezo will be based on the severity and health condition you're treating. Follow the instructions of your doctor for dosage extremely carefully.

A medical professional will show you how to use Cyltezo on your own. Don't use this medication when you do not know the proper instructions for usage. Talk to your pharmacist or doctor if you have any concerns.

Don't take this medication. If you show any signs of infection, Consult your physician for advice.

You should prepare your injection when it is time to administer it. Don't use it if the medication appears unclear, has changed color, or has particles. Contact your pharmacist to request the latest medication.

Place the pen that has been prefilled or syringe prefilled at room temperature of 68°F to 77% (20°C between 25°F and 30°C) for 15–30 minutes for it to warm up. Don't warm the prefilled syringe with heat sources like hot water or the microwave.

Select an injection location. You can inject into the sides of your thighs or your abdomen, with the exception of 2 inches (5 centimeters) around your stomach button (navel). Make sure to rotate the injection site every time you inject. Every new injection site must be at least 1 millimeter (3 centimeters) away from the site that you have used before.

Do not inject into the skin that is swollen, red, soft, tender, broken, bruised, or scarred. Also, do not inject through your clothing.

Cyltezo can affect your immune system, and it is possible to contract infections more quickly, including deadly or life-threatening infections. Your doctor should test your health frequently.

Use a needle or the syringe only once and put them in a punctureproof "sharps" container. Be sure to follow the laws of your state or city regarding how to dispose of the container. Keep it out of the reach of pets and children.

Details on dosage

The dosage and frequency of Cyltezo will vary based on the severity, age, and condition the patient is treating. For more information about specific dose schedules, visit here for a link.

Cyltezo is sold in the following formats:

• 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)

What happens if I miss the dose?

If you do not remember to take your dose, you can inject an injection immediately after you remember. Next, you should make sure to take your next dose at your regular time. This will get you back in line. If you're uncertain about the best time to inject your medication, call your physician or pharmacist.

What happens if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help Line toll-free at 1-800-222-1222.

What should be avoided?

Avoid injecting into the skin that is injured, red, tender, or hard. Avoid being around those who are sick or suffer from infections. Inform your doctor immediately when you begin to show symptoms of an infection. Do not get any "live" vaccines while using Cyltezo. The vaccine might not function at the same level during this time, and it may not be able to fully protect you from diseases. Live vaccines comprise measles and mumps, rubella (MMR), typhoid, polio, and rotavirus yellow fever, varicella (chickenpox), or shingles.

Interaction with other drugs

Certain medications should not be taken with Cyltezo. Discuss with your doctor the medicines you are taking as well as the medicines you begin or stop taking in the course of treatment with Cyltezo, specifically:

• Abatacept, etanercept;
• Anakinra;
• Azathioprine, 6-mercaptopurine, or
• Certolizumab, golimumab, infliximab, and rituximab.

Do not use live vaccines.

This list isn't comprehensive. Other medications may be incompatible with Cyltezo, including prescription and over-the-counter medicines as well as vitamins and herbs. Not all interactions are included.