Cyltezo

Cyltezo is a prescription medication used to relieve the symptoms of some autoimmune disorders. It is used to treat certain types of arthritis, Crohn's disease, ulcerative colitis, and plaque psoriasis. 

Cyltezo belongs to a group of drugs called tumor necrosis factor (TNF) inhibitors. These work by decreasing TNF action in the body which decreases inflammation in the body. Cyltezo is a biosimilar (closely related) product to Humira (adalimumab).

This medication comes in an injectable form in prefilled syringes. Cyltezo is injected just under the skin usually once every other week.

Common side effects of Cyltezo include infection, reaction at the site of injection, and headache.

Cyltez is a prescription medication used to:

• Reduce the signs and symptoms of:
  • moderate to severe rheumatoid arthritis (RA) in adults. Cyltezo can be used alone, with methotrexate, or with certain other medicines for RA.
  • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years and older. Humira can be used alone or with methotrexate. 
  • psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines.
  • ankylosing spondylitis (AS) in adults.
  • moderate to severe Crohn’s disease (CD) in adults who did not respond to other treatment.
  • moderate to severe ulcerative colitis (UC) who did not respond to other treatments.
• Treat moderate to severe chronic plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• Treat moderate to severe ulcerative colitis (UC) in adults who have not been helped by corticosteroids and other immunosuppressant medicines.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Cyltezo. See the “Cyltezo Precautions” section.

Common side effects of Cyltezo include the following:

• infections such as upper respiratory infection or sinus infection
• reaction at the site of injection
• headache
• rash
• low blood cell counts

This is not a complete list of Cyltezo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Orencia (abatacept)
• Enbrel (etanercept)
• Kineret (anakinra)
• Rituxan (rituximab)
• Remicade (infliximab)
• Cimzia (certolizumab pegol)
• Simponi (golimumab)
• Imuran (azathioprine)
• Purinethol (mercaptopurine, 6-MP)

This is not a complete list of Cyltezo drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Cyltezo including the following:

• serious infections. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, ongoing cough and congestion, or other signs of infection
• tuberculosis (TB). Your doctor will examine you for TB and perform a test to see if you have TB. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Cyltezo. While taking or after taking Cyltezo, tell your doctor if you have any of the symptoms of TB including a cough that does not go away, a low grade fever, weight loss, and loss of body fat and muscle (wasting).
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity including chest pain, swelling of the face or mouth, difficulty breathing or swallowing, and rash.
• hepatits B infection in persons that carry the hepatitis B virus. Your doctor may do blood tests before you start treatment with Cyltezo and while you are using Cyltezo. Tell your doctor if you have any of the following symptoms of a hepatitis B infection including muscle aches, feeling tired, dark urine, skin or eyes look yellow, little or no appetite, vomiting. clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash
• congestive heart failure (CHF). Tell your healthcare provider right away if you experience any of the symptoms of CHF including sudden weight gain, worsening shortness of breath, increased swelling of your feet or legs or abdomen, needing to use more pillows to go to sleep or sleeping in a recliner, waking from sleep to catch your breath, a cough that does not go away, or new or increasing irregularities in your heart rate.
• lowered blood count. This may cause certain symptoms and may increase the risk that you will develop a serious or life-threatening infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; bloody or black, tarry stools; bloody vomit; or vomiting blood or brown material that resembles coffee grounds.

Do not take Cyltezo if you are allergic to Cyltezo or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cyltezo, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Cyltezo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Cyltezo or to any of its ingredients.
• have an allergy to latex or rubber. The prefilled syringe cap contains latex and rubber.
• have an infection.
• have hepatitis B.
• have tuberculosis (TB) or been around someone with TB.
• have any disease that can cause any numbness or tingling usch as multiple sclerosis or Guillain-Barré syndrome.
• have recently received or are scheduled to receive a vaccine.
• have heart problems.
• have or have had cancer.
• have diabetes.
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are limited studies that have been done in humans with Cyltezo. Cyltezo can cross to an unborn baby, especially in the third trimester. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. You and your healthcare provider can discuss if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Cyltezo has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Cyltezo, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Cyltezo exactly as prescribed.

Cyltezo is given by an injection under the skin. Your doctor will tell you how often to take an injection of Cyltezo. This is based on your condition to be treated. Do not inject Cyltezo more often than you were prescribed. See the Patient Instructions for Use inside the carton for complete instructions for the right way to inject Humira.

Make sure you have been shown how to inject Cyltezo before you do it yourself. You can call your doctor or 1-800-542-6257 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after he/she has been shown how to prepare and inject Cyltezo. Do not try to inject Cyltezo yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of Cyltezo at home, you should receive training on the right way to prepare and inject Cyltezo.

Do not miss a dose 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 regular scheduled time. Do not take two doses of Cyltezo at the same time. This will put you back on schedule. In case you are not sure when to inject Cyltezo, call your doctor or pharmacist.

Take adalimumab exactly as it is prescribed by your doctor. Your doctor will determine the best dose for you.

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

The recommended dose of adalimumab for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg given every other week. Methotrexate (MTX), other non-biologic disease modifying anti-rheumatic drugs (DMARDs), glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with adalimumab. In the treatment of RA, some patients not taking MTX may receive additional benefit from increasing the dosing frequency of Cyltezo to 40 mg every week.

Juvenile Idiopathic Arthritis

The recommended dose of Cyltezo for pediatric patients 4 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight. For patients ≥ 30 kg (66 lbs), the recommended dose is 40 mg every other week. There is no dosage form available of Cyltezo for patients < 30 kg (66 lbs).

Crohn's Disease and Ulcerative Colitis

The recommended Cyltezo dose regimen for adult patients with Crohn’s disease is 160 mg initially on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week.

For patients with Ulcerative Colitis only: Only continue this medication in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy. 

Aminosalicylates and/or corticosteroids may be continued during treatment with Cyltezo. Azathioprine, 6-mercaptopurine (6-MP) or MTX may be continued during treatment with Cyltezo if necessary. The use of Cyltezo products in Crohn’s disease beyond one year has not been evaluated in controlled clinical studies.

Plaque Psoriasis

The recommended dose of adalimumab for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of Cyltezo products in moderate to severe chronic plaque psoriasis beyond one year has not been evaluated in controlled clinical studies.

If you take too much Cyltezo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Cyltezo in the refrigerator in the original carton to protect it from light.
• If you are going to be traveling, Cyltezo may be stored at room temperature for up to 14 days. Throw away Cyltezo if it has been at room temperature and not been used within 14 days.
• Do not use a prefilled syringe if the liquid is cloudy, discolored, or has flakes in it.

SERIOUS INFECTIONS 

• Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.  
• Discontinue Cyltezo if a patient develops a serious infection or sepsis during treatment.  
• Perform test for latent TB; if positive, start treatment for TB prior to starting Cyltezo.
• Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

MALIGNANCY

• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.  
• Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.