CYLTEZO

CYLTEZO is the brand name for adalimumab-adbm and is available as an injection for subcutaneous use.

CYLTEZO is available in one of the following:

• Single-dose prefilled pen (CYLTEZO Pen): 40 mg/0.8 mL (3)
• Single-dose prefilled glass syringe: 40 mg/0.8 mL, 20 mg/0.4 mL, or 10 mg/0.2 mL

CYLTEZO is a biologic DMARD and is used for the following:

• Rheumatoid arthritis (RA) – adults only
• Juvenile idiopathic arthritis (JIA) – people age 2 and older
• Psoriatic arthritis (PsA) – adults only
• Ankylosing spondylitis (AS) – adults only
• Crohn’s disease (CD) – people age 6 and older
• Ulcerative colitis (UC) – adults only
• Plaque psoriasis – adults only
• Hidradenitis suppurativa (HS) – adults only

CYLTEZO is a biologic disease-modifying antirheumatic drug (DMARD). It blocks tumor necrosis factor (TNF), which is a protein in your body that plays a role in inflammation. By blocking TNF, CYLTEZO lowers inflammation to relieve symptoms in different parts of your body.

CYLTEZO is typically dosed as follows:

Adults:

• Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The typical starting dose is 40 mg injected under the skin every other week
• Crohn’s disease and ulcerative colitis: The typical dose is 160 mg injected under the skin on Day 1, followed by 80 mg on Day 15, then 40 mg every other week starting Day 29
• Plaque psoriasis: The typical dose is 80 mg injected under the skin on Day 1, followed by 40 mg every other week starting 1 week after the first dose
• Hidradenitis suppurativa: The typical dose is 160 mg injected under the skin on Day 1, followed by 80 mg on Day 15, then 40 mg every week OR 80 mg every other week starting Day 29.

Children:

• Juvenile idiopathic arthritis and Crohn’s disease: The dose will be based on your child’s body weight. Typically it will be injected under the skin once every other week.

CYLTEZO is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of CYLTEZO:

• Injection site reaction
• Upper respiratory tract infection
• Headache
• Rash
• Sinus inflammation
• Accidental injury
• Nausea
• Urinary tract infection (UTI) or bladder infection

Serious side effects are rare with CYLTEZO. Contact your healthcare provider immediately if you experience any of the following.

• Serious infection: fever, cough, weight loss, muscle aches, dark urine, chills, vomiting
• Severe allergic reaction: rash, trouble breathing, swelling of your face, eyes, lips, or mouth, hives
• Low blood cell counts: fever that doesn’t go away, easy bruising or bleeding, pale skin
• Heart failure: shortness of breath, swelling in the legs, ankles, or feet, irregular heartbeat, tiredness, sudden weight gain
• Liver problems: feeling tired, vomiting, yellow skin or whites of the eyes, stomach pain

The following medications may interact with CYLTEZO:

• Abatacept: Increased risk of serious infection
• Anakinra: Increased risk of serious infection
• Live vaccines: Avoid use with CYLTEZO

Boehringer Ingelheim Pharmaceuticals, Inc.

It is not known if CYLTEZO may harm your unborn baby. You and your doctor should decide if you should take CYLTEZO while you are pregnant. Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to CYLTEZO products