WARNING

Cimzia (certolizumab pegol) is a medication used to treat autoimmune conditions like rheumatoid arthritis, Crohn’s disease, and psoriatic arthritis. Like any medication, it carries certain risks and side effects. Here are some potential risks associated with taking Cimzia:

• Serious Infections: Cimzia can lower your body’s ability to fight infections. This increases the risk of developing serious infections, including tuberculosis (TB), bacterial sepsis, and fungal infections.
• Allergic Reactions: Some people may experience allergic reactions to Cimzia, which can range from mild to severe. Symptoms may include rash, itching, swelling, severe dizziness, or trouble breathing.
• Liver Problems: Cimzia may cause liver problems, which can lead to jaundice (yellowing of the skin and eyes), dark urine, and fatigue.
• Heart Failure: In rare cases, Cimzia may worsen heart failure or lead to new onset heart failure. Symptoms may include shortness of breath, swelling of the ankles/feet, or sudden weight gain.
• Blood Disorders: Cimzia may affect your blood cells, leading to problems such as low white blood cell count (increasing susceptibility to infections), low platelet count (increasing risk of bleeding), or anemia.
• Neurological Reactions: Some people may experience neurological reactions such as seizures or multiple sclerosis-like symptoms.
• Malignancies: There is a slightly increased risk of certain cancers, including lymphoma, associated with the use of Cimzia.
• Injection Site Reactions: Common side effects include reactions at the injection site, such as pain, redness, itching, or swelling.

It’s important to discuss these risks with your healthcare provider before starting Cimzia. They can help weigh the potential benefits against the risks and monitor you for any adverse effects during treatment.

Why is this medication prescribed?

Cimzia (certolizumab pegol) is prescribed primarily for the treatment of several autoimmune conditions, including:

• Rheumatoid Arthritis: Cimzia is used to reduce signs and symptoms of moderate to severe rheumatoid arthritis in adults.
• Psoriatic Arthritis: It is also prescribed to treat active psoriatic arthritis in adults.
• Ankylosing Spondylitis: Cimzia helps to improve signs and symptoms of ankylosing spondylitis in adults.
• Crohn’s Disease: Cimzia is used to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapies.
• Plaque Psoriasis: In some cases, Cimzia may be used to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

How should this medicine be used?

Cimzia is typically administered as a subcutaneous injection. Here are some general guidelines for its use:

• Dosage: The dosage of Cimzia can vary based on the condition being treated. It is usually given as an initial loading dose followed by maintenance doses at regular intervals.
• Administration: Cimzia is injected under the skin (subcutaneously). It can be administered by a healthcare provider or self-administered if instructed properly.
• Injection Sites: The recommended injection sites include the thigh or abdomen (avoiding the area around the navel). Rotating injection sites can help minimize injection site reactions.
• Frequency: The frequency of injections depends on the condition being treated and the response to therapy. For some conditions, injections may be given every 2 to 4 weeks after the initial loading dose.
• Monitoring: Regular monitoring by healthcare providers is important to assess the response to treatment and to watch for any potential side effects or complications.
• Storage: Cimzia should be stored refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light. Before use, it should be allowed to reach room temperature for about 30 minutes.

Always follow your healthcare provider’s instructions regarding the use of Cimzia. They will tailor the dosage and frequency to your specific condition and medical history to achieve the best therapeutic outcome while minimizing risks.

Other uses for this medicine

Besides the primary uses mentioned earlier (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and plaque psoriasis), Cimzia (certolizumab pegol) is not widely prescribed for other conditions due to its specific mechanism of action and indications approved by regulatory agencies.

What special precautions should I follow?

When using Cimzia, it’s crucial to follow certain precautions to ensure safe and effective treatment. Here are some important precautions:

• Infections: Cimzia can increase the risk of infections, including serious and sometimes fatal infections. Before starting treatment, healthcare providers should evaluate for tuberculosis (TB) and other infections. Patients should be monitored closely for signs of infection during treatment, and Cimzia should not be used in patients with active infections.
• Immunizations: Patients should be up to date with all immunizations before starting Cimzia. Live vaccines should generally not be given concurrently with Cimzia or within a certain period after stopping treatment due to the risk of infection.
• Hepatitis B Virus Reactivation: Patients with a history of hepatitis B virus infection should be monitored closely for reactivation during treatment with Cimzia.
• Malignancies: There is a slightly increased risk of certain cancers, including lymphoma, with the use of Cimzia. Patients should be monitored for signs and symptoms of malignancies during treatment.
• Heart Failure: Cimzia may worsen heart failure or lead to new onset heart failure. Patients with a history of heart failure should be monitored closely during treatment.
• Hypersensitivity Reactions: Patients should be monitored for allergic reactions, including anaphylaxis, during and after administration of Cimzia.
• Neurological Reactions: Rare cases of central nervous system demyelinating disorders, such as multiple sclerosis, have been reported with Cimzia. Patients should be monitored for neurological symptoms.
• Pregnancy and Breastfeeding: The safety of Cimzia in pregnant women has not been established. It should be used during pregnancy only if clearly needed. It is not known if Cimzia passes into breast milk; breastfeeding should be avoided during treatment.
• Monitoring: Regular monitoring by healthcare providers is essential to assess the response to treatment, monitor for side effects, and adjust therapy as needed.

Patients should discuss any existing medical conditions, medications, and concerns with their healthcare provider before starting Cimzia. It’s important to adhere to prescribed dosages and follow-up appointments to optimize treatment outcomes and minimize risks.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Cimzia. However, maintaining a healthy and balanced diet is generally recommended to support overall health and well-being.

What should I do if I forget a dose?

• As Soon as You Remember: If it is within a day or two of your scheduled dose, take the missed dose as soon as you remember.
• Skip the Dose: If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double up on doses to make up for a missed one.
• Notify Your Healthcare Provider: If you frequently forget doses or have questions about your dosing schedule, contact your healthcare provider for guidance.

What side effects can this medication cause?

Cimzia (certolizumab pegol) can cause a range of side effects, some of which can be serious. It’s important to discuss these potential side effects with your healthcare provider before starting treatment. Here are some common and serious side effects associated with Cimzia:

Common Side Effects:

• Injection site reactions (pain, redness, itching, swelling)
• Upper respiratory tract infections (such as sinus infections)
• Headache
• Rash
• Urinary tract infections
• Hypertension (high blood pressure)
• Liver enzyme elevations
• Nausea

Serious Side Effects:

• Serious infections: Cimzia can increase the risk of serious infections, including tuberculosis (TB), bacterial sepsis, and fungal infections. Symptoms may include fever, chills, cough, and unusual tiredness.
• Allergic reactions: Some people may experience allergic reactions to Cimzia, which can range from mild (rash, itching) to severe (anaphylaxis). Seek immediate medical attention if you experience symptoms such as difficulty breathing, swelling of the face/throat, or severe dizziness.
• Liver problems: Cimzia may cause liver enzyme elevations and, rarely, serious liver problems. Symptoms may include jaundice (yellowing of the skin and eyes), dark urine, and persistent nausea or vomiting.
• Heart failure: Cimzia may worsen heart failure or lead to new onset heart failure. Symptoms may include shortness of breath, swelling of the ankles/feet, or sudden weight gain.
• Blood disorders: Cimzia can affect blood cells, leading to problems such as low white blood cell count (increasing susceptibility to infections), low platelet count (increasing risk of bleeding), or anemia.
• Neurological reactions: Rare cases of central nervous system demyelinating disorders, such as multiple sclerosis-like symptoms, have been reported with Cimzia.
• Malignancies: There is a slightly increased risk of certain cancers, including lymphoma, associated with the use of Cimzia.
• Injection site reactions: Although common, injection site reactions can sometimes be severe. Symptoms may include severe pain, swelling, or persistent irritation at the injection site.

It’s important to report any side effects or concerns to your healthcare provider promptly. They can help monitor your condition, adjust treatment if necessary, and provide guidance on managing side effects.

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

Storage of Cimzia:

• Refrigeration: Cimzia should be stored in the refrigerator at a temperature of 2°C to 8°C (36°F to 46°F). Do not freeze.
• Protection from Light: Keep Cimzia in the original carton to protect it from light.
• Room Temperature: Before use, Cimzia can be left at room temperature (up to 25°C or 77°F) for up to 7 days. Once removed from the refrigerator and allowed to warm to room temperature, do not put it back into the refrigerator.
• Unused Product: Unused Cimzia syringes or autoinjectors should be discarded if they have been kept at room temperature for more than 7 days.
• Do Not Shake: Avoid shaking Cimzia. Gently swirl the syringe or autoinjector to mix the medication if needed, as shaking can damage the medication.
• Expiration: Check the expiration date on the packaging. Do not use Cimzia if it has expired.

Disposal of Cimzia:

• Unused Medication: Dispose of any unused or expired Cimzia according to local regulations. Do not flush it down the toilet or pour it into a drain unless instructed to do so.
• Sharps Disposal: Used syringes or autoinjectors should be disposed of in a puncture-resistant container designed for sharps disposal. Follow local regulations for proper disposal of sharps containers.

In case of emergency/overdose

• Seek Immediate Medical Attention: Call emergency services or go to the nearest emergency room.
• Symptom Management: If possible, inform medical personnel about the medication you have taken (Cimzia), the dosage, and the time it was taken.
• Treatment: Treatment for an overdose or severe reaction will depend on the specific symptoms and their severity. Medical professionals will provide appropriate supportive care and treatment as necessary.

What other information should I know?

• Regular Monitoring: Attend all scheduled appointments with your healthcare provider for monitoring of your condition and response to Cimzia treatment. This helps to ensure the medication is working effectively and to detect any potential side effects early.
• Patient Education: Understand the signs and symptoms of serious side effects, such as infections, allergic reactions, liver problems, and heart failure. Promptly report any unusual symptoms to your healthcare provider.
• Pregnancy and Breastfeeding: Discuss with your healthcare provider the risks and benefits of using Cimzia if you are pregnant, planning to become pregnant, or breastfeeding. The safety of Cimzia during pregnancy and breastfeeding has not been established.
• Immunizations: Before starting Cimzia, ensure you are up to date with all recommended vaccinations. However, live vaccines should generally not be given during treatment with Cimzia or for a certain period after stopping treatment due to the risk of infection.
• Storage and Handling: Handle Cimzia with care to avoid damage to the syringe or autoinjector. Store it out of reach of children and pets.

Always follow your healthcare provider’s instructions and guidelines for the safe and effective use of Cimzia. If you have any questions or concerns about Cimzia or its use, discuss them with your healthcare provider for clarification and guidance.