Healthcare professionals prescribe Cyltezo injections to treat a variety of moderate to severe inflammatory conditions.
Injections are self-administered every other week, but some people may be given weekly doses.
The initial injections may be high, but the standard dosage is 40 mg biweekly.
Because Cyltezo weakens the immune system, there’s an increased risk of infections and cancer.
Cyltezo is a brand-name prescription drug that treats a wide range of autoimmune diseases, including inflammatory arthritis, psoriasis, inflammatory bowel disease, and other conditions. Its active ingredient, an antibody called adalimumab-adbm, is nearly identical to the active ingredient in Humira (adalimumab). As a biosimilar to Humira, it works the same way and has the same side effects and drug interactions. Its use and dosages are the same.
Cyltezo is a citrate-free injectable medicine. It’s given as a subcutaneous injection and is available in two dosage forms:
Single-dose prefilled pen: 40 mg/0.8 mL, 40 mg/0.4 mL
Single-dose prefilled syringe: 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.4 mL, 10 mg/0.2 mL
Cyltezo is approved by the U.S. Food and Drug Administration (FDA) to reduce signs and symptoms of a variety of inflammatory conditions, including active rheumatoid arthritis, ankylosing spondylitis (arthritis of the spine), juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, noninfectious uveitis (an inflammatory eye disease), and hidradenitis suppurativa (an inflammatory skin condition).
Cyltezo is a tumor necrosis factor (TNF) inhibitor, which works to reduce the body’s inflammatory and immune response. Cyltezo has no contraindicated medical conditions that forbid its use. However, it should not be started in people with an active infection because it weakens the immune system.
Cyltezo adult dosage chart |
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|---|---|---|
| Indication | Starting dosage | Standard dosage |
| Rheumatoid arthritis | 40 mg injection every other week | 40 mg injection every other week OR 40 mg injection every week or 80 mg injection every other week |
| Psoriatic arthritis | 40 mg injection every other week | 40 mg injection every other week OR 40 mg injection every week or 80 mg injection every other week |
| Ankylosing spondylitis (spinal arthritis) | 40 mg injection every other week | 40 mg injection every other week OR 40 mg injection every week or 80 mg injection every other week |
| Moderate to severe plaque psoriasis | 80 mg injection on day 1 and then 40 mg on day 8 | 40 mg once every 2 weeks |
| Moderate to severe Crohn’s disease | 160 mg injection on day 1 (or 80 mg on days 1 and 2) and then 80 mg on day 15 followed by 40 mg on day 29 | 40 mg once every 2 weeks |
| Moderate to severe ulcerative colitis | 160 mg injection on day 1 (or 80 mg on days 1 and 2) and then 80 mg on day 15 followed by 40 mg on day 29 | 40 mg once every 2 weeks |
| Non-infectious intermediate or posterior uveitis or panuveitis | 80 mg injection on day 1 and then 40 mg on day 8 | 40 mg once every 2 weeks |
| Moderate to severe hidradenitis suppurativa | 160 mg injection on day 1 (or 80 mg on days 1 and 2) and then 80 mg on day 15 followed by 40 mg on day 29 | 40 mg once per week OR 80 mg once every 2 weeks |
Cyltezo treats three types of inflammatory arthritis: moderately to severely active rheumatoid arthritis (RA), ankylosing spondylitis, and psoriatic arthritis (PSA). Cyltezo works by blocking TNF, a protein that provokes an immune response.
Standard Cyltezo dosage for rheumatoid arthritis: 40 mg every other week OR 40 mg every week (or 80 mg once every two weeks) for patients not taking methotrexate (MTX)
Standard Cyltezo dosage for ankylosing spondylitis or psoriatic arthritis: 40 mg once every two weeks
Inflammatory bowel disease is the term used to refer to Crohn’s disease and ulcerative colitis, which are two chronic inflammatory diseases of the gastrointestinal tract. Cyltezo reduces the signs and symptoms of moderately to severely active Crohn’s disease and ulcerative colitis. Ulcerative colitis is limited to the colon lining, while Crohn’s disease can occur anywhere from the mouth to the anus a. The initial dose is very high (160 mg) but can be divided into two doses over the first two days.
Standard Cyltezo dosage for ulcerative colitis or Crohn’s disease: 160 mg on day one (or split into two 80 mg doses on the first two consecutive days), 80 mg on day 15, and then 40 mg once every two weeks starting on day 29
Standard Cyltezo dosage for Crohn’s disease: 160 mg on day one (or split into two 80 mg doses on the first two consecutive days), 80 mg on day 15, and then 40 mg once every two weeks starting on day 29
Cyltezo is used to treat moderate to severe chronic plaque psoriasis in adults.
Standard Cyltezo dosage for plaque psoriasis: 80 mg starting dose on day one and then a 40 mg maintenance dose injected once every two weeks beginning on day eight
Uveitis is the swelling of the inner layers of the eyes. It can be caused by infections or by the immune system. Cyltezo treats uveitis caused by the immune system but only when the condition affects the middle or back area of the eyes (intermediate uveitis or posterior uveitis) or the entire eye (panuveitis).
Standard Cyltezo dosage for uveitis: 80 mg on day one and then 40 mg once every two weeks starting on day eight
Hidradenitis suppurativa is an autoimmune condition that affects sweat glands in the skin. Flare-ups cause sweat glands to swell into lumps, which can then develop into pus-filled and painful sores.
Standard Cyltezo standard dosage for moderate to severe hidradenitis suppurativa: 160 mg on day one (can be split into two 80 mg doses on the first two consecutive days), 80 mg on day 15, and then 40 mg once per week or 80 mg once every two weeks starting on day 29.
Healthcare professionals use Cyltezo to treat juvenile idiopathic arthritis (JIA) in children two years of age and older, as well as Crohn’s disease in children six and older. Dosages for children are smaller than for adults and are based on body weight. Like adults, children receive biweekly injections of Cyltezo.
Cyltezo pediatric dosage chart |
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|---|---|---|---|---|
| Indication | Age | Weight | Starting dosage | Standard dosage |
| Juvenile idiopathic arthritis | Two years and older | 10–14 kilograms (kg) (22–32 lbs.) | 10 mg | 10 mg once every two weeks |
| 15–29 kg (33–65 lbs.) | 20 mg | 20 mg once every two weeks | ||
| ≥30 kg (≥66 lbs.) | 40 mg | 40 mg once every two weeks | ||
| Moderate to severe Crohn’s disease | Six years and older | 17–39 kg (37-87 lbs.) | 80 mg on day 1 and then 40 mg on day 15 | 20 mg once every two weeks starting on day 29 |
| ≥40 kg (≥88 lbs) | 160 mg on day 1 (or 80 mg on days 1 and 2) and then 80 mg on day 15 | 40 mg once every two weeks starting on day 29 |
Cyltezo has not been studied in patients less than 2 years of age or in patients with a weight below 10 kg (22 pounds).
Cyltezo can cause problems and may require doctors to monitor patients closely. As an immune suppressant, Cyltezo increases the risk of serious infections. For this reason, healthcare professionals will not start the drug in people with an active bacterial, viral, or fungal infection. They use it cautiously in people with malignancies, lymphoma, skin cancer, chronic infections, latent tuberculosis (TB), hepatitis B infection, or any medical condition that makes them more vulnerable to infections.
Cyltezo can cause worsening of multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
Doctors will immediately stop Cyltezo treatment in anyone who has a serious allergic reaction to the drug or symptoms of lupus-like syndrome, such as muscle/joint pain, rash, or fever.
A healthcare provider may administer the first one or two injections. After that, injections are done at home.
Take Cyltezo as directed by a healthcare professional.
A healthcare provider will demonstrate the proper injection technique. A step-by-step video tutorial is also available on the Cyltezo website.
Injections can be made on the sides of the abdomen or upper thighs.
Use a different body area each time an injection is given.
Do not inject the medicine into red, bruised, tender, or hard skin or into psoriasis plaques or lesions.
Read the Medication Guide and the Instructions for Use that come with this medicine.
How to store Cyltezo:
Store Cyltezo in its original package until it’s time for an injection.
Store Cyltezo in the refrigerator (36°F to 46°F). Do not freeze.
The Cyltezo pen injector or pre-filled syringe can be removed from the refrigerator 15 to 30 minutes before the injection to allow the medicine to come to room temperature.
Cyltezo can be stored at room temperature for up to 14 days if traveling. Do not expose it to excessive heat.
How to use Cyltezo prefilled pen injectors:
Remove the pen from the carton and inspect it. Follow the Instructions for Use.
Wash your hands.
Clean the injection area with an alcohol swab.
Remove the cap from the pen injector. Once removed, the cap should not be placed back on the needle.
Gently squeeze together the skin at the injection site. Hold it squeezed together during the injection.
Holding the pen by the green grip, place the pen tip at a 90˚angle to the skin.
Press the gray injector button and hold it down.
Count to 10. Do not move the pen during the count.
At 10, inspect the pen to see if the plunger is all the way down. If it doesn’t reach the bottom, call the doctor.
Remove the pen.
Throw the pen away in a sharps container.
How to use Cyltezo prefilled syringes:
Always hold the syringe by the barrel (the middle glass section).
Remove the syringe from the carton and inspect it. Follow the Instructions for Use when inspecting the syringe.
Wash your hands.
Clean the injection area with an alcohol swab.
Remove the cap from the syringe. Once removed, the cap should not be placed back on the needle.
Gently squeeze together the skin at the injection site. Hold it squeezed together during the injection.
Holding the syringe by the barrel, insert the needle into the skin at a 45˚angle.
Slowly push the plunger down until it reaches the bottom of the syringe.
Remove the needle. Do not touch the needle.
Throw the empty syringe away in a sharps container.
Clinical trials have shown that, depending on the condition being treated, people can notice a significant improvement in their symptoms in as little as four weeks (Crohn’s disease) or as long as six months (rheumatoid arthritis).
On average, it takes the body about 300 hours (two weeks
) to eliminate half a dose of adalimumab. At that rate, the body should take about two to three months to completely clear a dose, but it could be much longer.
Take a missed dose as soon as it’s remembered. Take the next dose as scheduled.
If you inject more than the prescribed amount of Cyltezo, call the prescribing doctor.
Cyltezo suppresses the immune system, so healthcare providers will avoid prescribing it with other biologic TNF blockers such as Orencia (abatacept), Enbrel (etanercept), Remicade (infliximab), or other adalimumab products. Doctors also avoid using it with powerful immune suppressants such as Kineret (anakinra). People on corticosteroids should also be cautious because of the increased risk of infections.
Live vaccines cannot be given with Cyltezo because of the risk of serious infections. Other types of immunizations are permissible.
There is no evidence that Cyltezo increases the risk of birth defects or miscarriage. However, adalimumab may affect a baby in the third trimester. Women should ask their doctors for medical advice about taking Cyltezo during their pregnancy. It is safe to take Cyltezo while breastfeeding.
Studies have shown women can safely take Cyltezo while breastfeeding. Adalimumab is present in breast milk, but the baby’s digestive system will break it apart.
Adalimumab,Drugs and Lactation Database (LactMed®)
Adalimumab, Mother To Baby
Adalimumab, StatPearls
Adalimumab (40 mg subcutaneous administration), U.S. Food and Drug Administration
Cyltezo, Boehringer Ingelheim
Cyltezo prescribing information, DailyMed (U.S. National Library of Medicine)
Cyltezo, U.S. Food and Drug Administration
Madeline Remelius, Pharm.D., BCPS, graduated with her Doctor of Pharmacy degree from St. Louis College of Pharmacy at the University of Health Sciences and Pharmacy in St. Louis in 2021, then went on to complete a PGY1 Pharmacy Practice Residency at Sarasota Memorial Hospital in Sarasota, Florida. Dr. Remelius currently works as a clinical pharmacist in Sarasota, Florida, caring for both adult and pediatric patients. Dr. Remelius has developed a true passion for ensuring the well-being of patients through the safe and effective use of medications and providing evidence-based recommendations and guidance to healthcare teams, ultimately improving patient outcomes and promoting medication safety.
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