WARNING

Cyltezo (adalimumab-adbm) is a medication used to treat autoimmune conditions like rheumatoid arthritis, psoriasis, and Crohn’s disease. As with any medication, there are potential risks associated with its use:

• Infections: Cyltezo can increase susceptibility to infections, including serious ones like tuberculosis and fungal infections. Patients should be screened for infections before starting treatment.
• Immune System Effects: Since Cyltezo suppresses the immune system, it may increase the risk of certain cancers, such as lymphoma, as well as autoimmune diseases.
• Injection Site Reactions: Common side effects include reactions at the injection site, such as pain, redness, or swelling.
• Allergic Reactions: Some people may experience allergic reactions to Cyltezo, ranging from mild to severe.
• Liver and Blood Problems: Monitoring of liver enzymes and blood counts may be necessary due to potential liver and blood cell abnormalities.
• Neurological Issues: Rarely, neurological problems like multiple sclerosis-like symptoms have been reported.
• Heart Failure: There is a risk of worsening heart failure in people predisposed to this condition.

It’s crucial for patients to discuss these risks with their healthcare provider and weigh them against the benefits of treatment. Close monitoring and adherence to healthcare provider instructions can help mitigate these risks.

Why is this medication prescribed?

Cyltezo (adalimumab-adbm) is prescribed for several autoimmune conditions, including:

• Rheumatoid Arthritis: To reduce signs and symptoms, inhibit structural damage, and improve physical function.
• Psoriatic Arthritis: To alleviate signs and symptoms, inhibit structural damage, and improve physical function.
• Ankylosing Spondylitis: To alleviate signs and symptoms.
• Crohn’s Disease: To induce and maintain clinical remission, and to improve symptoms.
• Ulcerative Colitis: To induce and sustain clinical remission, and to enhance symptoms.
• Plaque Psoriasis: To reduce signs and symptoms, and to achieve and maintain satisfactory skin clearance.

Cyltezo is a biologic medication that targets a protein called tumor necrosis factor (TNF), which plays a role in inflammation. By inhibiting TNF, Cyltezo helps reduce inflammation in autoimmune diseases.

How should this medicine be used?

Cyltezo (adalimumab-adbm) is a medication used to treat various inflammatory conditions. Here’s how it should generally be used:

• Prescription: Cyltezo is a prescription medication, meaning it should only be used under the guidance and prescription of a healthcare provider.
• Administration: It is typically administered as an injection under the skin (subcutaneous injection).
• Dosage: The dosage of Cyltezo can vary depending on the condition being treated and individual patient factors. Your healthcare provider will determine the appropriate dosage for you.
• Frequency: How often you receive Cyltezo injections can also vary. It may be administered once every two weeks or once a month, depending on your condition and response to treatment.
• Storage: Follow specific storage instructions provided by your healthcare provider or pharmacist. Generally, Cyltezo should be stored in the refrigerator until ready for use. Do not freeze it.
• Monitoring: Your healthcare provider may monitor you regularly while you are taking Cyltezo to ensure it is working effectively and to watch for any potential side effects.
• Other medications: Inform your healthcare provider about all other medications you are taking, including over-the-counter drugs and supplements, as they can interact with Cyltezo.
• Side effects: Be aware of potential side effects, which can include injection site reactions, infections, allergic reactions, and others. Contact your healthcare provider if you experience any side effects.

Always follow your healthcare provider’s instructions carefully when using Cyltezo or any prescription medication. If you have any questions or concerns about its use, do not hesitate to discuss them with your healthcare provider.

Other uses for this medicine

• Juvenile Idiopathic Arthritis: Cyltezo may be used in children with certain types of juvenile arthritis.
• Uveitis: Inflammation of the eye, particularly in cases where other treatments have been ineffective.
• Sarcoidosis: A condition causing inflammation in various organs.
• Hidradenitis Suppurativa: A chronic skin condition characterized by painful lumps under the skin.
• Other Autoimmune Disorders: Some cases of systemic lupus erythematosus (SLE), dermatomyositis, and other autoimmune conditions where TNF inhibition is indicated.

What special precautions should I follow?

Special Precautions for Cyltezo:

• Infections: Cyltezo can increase the risk of infections, including serious ones like tuberculosis and fungal infections. Patients should be screened for latent tuberculosis before starting treatment.
• Vaccinations: Live vaccines should not be given to patients receiving Cyltezo due to their immunosuppressive effects. Patients should be up-to-date with all appropriate vaccinations before starting treatment.
• Monitoring: Regular monitoring for signs of infection, including tuberculosis screening, is essential during treatment with Cyltezo. Blood tests to monitor liver function and blood counts may also be necessary.
• Allergic Reactions: Patients should be monitored for allergic reactions, including anaphylaxis, particularly after the first dose.
• Heart Failure: Cyltezo may worsen pre-existing heart failure. It should be used with caution in patients with a history of heart failure and monitored closely.
• Malignancies: There is an increased risk of certain cancers, including lymphomas, while taking Cyltezo. Patients should be monitored for signs and symptoms of cancer.
• Neurological Disorders: Rare neurological disorders, including multiple sclerosis-like symptoms, have been reported in patients receiving Cyltezo.
• Pregnancy and Breastfeeding: The safety of Cyltezo during pregnancy and breastfeeding is not well-established. Healthcare providers should weigh the potential benefits against risks when considering its use in pregnant or breastfeeding women.

Patients should communicate openly with their healthcare providers about any existing medical conditions, medications, or concerns before starting treatment with Cyltezo. This helps ensure the safest and most effective use of the medication.

What special dietary instructions should I follow?

• As Soon as Possible: Take the missed dose as soon as you remember, if it is within a few days of your scheduled injection time.
• Schedule Adjustment: If it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
• Do Not Double Dose: Do not take a double dose to make up for a missed one.
• Notify Your Doctor: If you consistently have trouble remembering doses or if you miss several doses, contact your healthcare provider for guidance.

What should I do if I forget a dose?

If you miss a dose of Cymbalta, take it as soon as you remember, unless it is close to the time of your next scheduled dose. In that case, skip the missed dose and take your next dose at the regular time. Do not double up on doses to make up for a missed one.

What side effects can this medication cause?

Cyltezo (adalimumab-adbm), like other medications, can cause side effects. These side effects can vary in severity and occurrence among individuals. Common side effects of Cyltezo include:

• Injection Site Reactions: Such as pain, redness, itching, or swelling at the injection site. These reactions are usually mild and may improve with time.
• Upper Respiratory Tract Infections: Such as sinus infections and sore throat.
• Headache: Mild to moderate headaches are reported by some patients.
• Nausea: Feeling sick to the stomach, occasionally leading to vomiting.
• Serious Infections: While less common, Cyltezo can increase the risk of serious infections such as tuberculosis, bacterial infections, and fungal infections. Patients are usually tested for latent tuberculosis before beginning treatment with Cyltezo.
• Allergic Reactions: Rarely, allergic reactions may occur, potentially causing rash, itching, swelling, dizziness, or difficulty breathing.
• Liver Problems: There have been reports of abnormal liver function tests in some patients.
• Blood Disorders: Rarely, Cyltezo can affect blood cells, potentially leading to low white blood cell count (neutropenia) or low platelet count (thrombocytopenia).
• Neurological Symptoms: Rare cases of neurological disorders, including multiple sclerosis-like symptoms, have been reported.
• Heart Failure: In patients with pre-existing heart conditions, Cyltezo may exacerbate heart failure symptoms.
• Malignancies: There is an increased risk of certain cancers, including lymphomas, while taking Cyltezo.
• Autoimmune Disorders: In some cases, Cyltezo can lead to the development of new autoimmune disorders.

It’s essential for patients to be aware of these potential side effects and to promptly report any unusual symptoms or reactions to their healthcare provider. Close monitoring and adherence to regular check-ups can help manage and mitigate these risks effectively.

What should I know about storage and disposal of this medication?

Storage of Cyltezo:

• Refrigeration: Cyltezo should be stored in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
• Protection from Light: Keep the Cyltezo prefilled syringe or pen in its original carton to protect it from light.
• Do Not Shake: Avoid shaking the prefilled syringe or pen.
• Unused Product: If you have unopened prefilled syringes or pens, keep them in the refrigerator until use. Do not use Cyltezo if it has been frozen.
• Expiration: Check the expiration date on the prefilled syringe or pen. Do not use Cyltezo after the expiration date.

Disposal of Cyltezo:

• Needles and Syringes: After use, dispose of needles and syringes in a puncture-resistant container. Follow local regulations for disposal of medical waste.
• Unused Medication: If you have unused or expired Cyltezo, consult your healthcare provider or pharmacist for proper disposal instructions. Do not dispose of it in household trash or flush it down the toilet.

In case of emergency/overdose

• Symptoms: In case of an overdose or serious reaction, symptoms may include severe allergic reactions, severe infections, or other serious medical conditions.
• Seek Medical Help: If you suspect an overdose or experience severe symptoms after taking Cyltezo, seek immediate medical attention or contact your local poison control center.

What other information should I know?

• Monitoring: Regular monitoring by your healthcare provider is important while taking Cyltezo. This includes monitoring for infections, liver function tests, and other potential side effects.
• Medical Alerts: Inform all healthcare providers (including dentists and specialists) about your use of Cyltezo before undergoing any surgical procedures or receiving any vaccines.
• Patient Support: Many pharmaceutical companies offer patient support programs that can provide information about medication, assistance with insurance coverage, and access to nurse support lines for questions.
• Compliance: Follow your prescribed dosing schedule and instructions carefully to maximize the effectiveness of Cyltezo in managing your condition.
• Travel: If you need to travel with Cyltezo, ensure proper storage in a cooler with ice packs during transport. Avoid exposing it to extreme temperatures or direct sunlight.

Always consult your healthcare provider or pharmacist if you have any questions or concerns about the storage, disposal, emergency procedures, or any other aspect of using Cyltezo. They can provide personalized guidance based on your specific health needs.