WARNING

Certolizumab injection is a medication used to treat various inflammatory conditions such as rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, and ankylosing spondylitis. Like all medications, it carries certain risks, which can include:

• Increased Risk of Infections: Certolizumab can suppress the immune system, making individuals more susceptible to infections. Serious infections, including tuberculosis and fungal infections, have been reported.
• Allergic Reactions: Some people may experience allergic reactions to certolizumab, which can range from mild to severe.
• Autoimmune Reactions: In rare cases, certolizumab can trigger autoimmune reactions, where the immune system attacks healthy tissues.
• Injection Site Reactions: Common side effects include redness, swelling, or pain at the injection site.
• Liver Problems: Certolizumab may cause liver enzyme abnormalities in some individuals.
• Blood Disorders: Rarely, certolizumab can affect blood cell counts.
• Heart Failure: There is a small risk of worsening heart failure symptoms in individuals with pre-existing heart conditions.
• Neurological Issues: Certolizumab may rarely cause neurological problems such as seizures or multiple sclerosis-like symptoms.

It’s important for individuals taking certolizumab to be monitored closely by their healthcare provider for any signs of these potential risks and to report any new symptoms promptly.

Why is this medication prescribed?

Certolizumab injection is prescribed to treat several autoimmune and inflammatory conditions. It is typically used for:

• Rheumatoid Arthritis: Certolizumab is used to reduce signs and symptoms of moderate to severe rheumatoid arthritis, including joint pain, swelling, and damage.
• Crohn’s Disease: It is used to manage symptoms and maintain remission in adult patients with moderate to severe Crohn’s disease.
• Psoriatic Arthritis: Certolizumab helps reduce symptoms of psoriatic arthritis, including joint pain, swelling, and stiffness.
• Ankylosing Spondylitis: It is used to improve symptoms of ankylosing spondylitis, a type of arthritis that affects the spine.

Certolizumab belongs to a class of medications called TNF blockers (tumor necrosis factor blockers), which work by reducing inflammation in the body.

How should this medicine be used?

Here’s how Certolizumab injection should typically be used:

• Certolizumab is administered as a subcutaneous injection (under the skin).
• The dosage and frequency of injections will depend on the specific condition being treated.
• It is typically given once every 2 to 4 weeks after an initial loading dose.
• The injection should be administered by a healthcare provider initially, but some patients may be trained to self-inject at home.
• It’s important to follow the dosing schedule prescribed by the healthcare provider and not to miss doses.
• Certolizumab injections should be stored according to the manufacturer’s instructions and should not be used if the solution is discolored or contains particles.

Patients should also be monitored for any signs of infection or other adverse reactions while on certolizumab therapy, and regular check-ups with healthcare providers are typically recommended to ensure the medication is effective and well-tolerated.

Other uses for this medicine

• Ulcerative Colitis: Certolizumab may be considered in the treatment of moderate to severe ulcerative colitis, particularly in cases where other treatments have not been effective.
• Juvenile Idiopathic Arthritis: In certain cases, certolizumab may be used in children with juvenile idiopathic arthritis who have not responded adequately to other treatments.
• Uveitis: Certolizumab has shown promise in treating uveitis, which is inflammation of the eye’s middle layer (uvea).

What special precautions should I follow?

Special Precautions for Certolizumab Injection:

• Infections: Certolizumab can increase the risk of serious infections, including tuberculosis and fungal infections. Patients should be screened for latent tuberculosis before starting treatment.
• Vaccinations: Live vaccines should generally be avoided during treatment with certolizumab due to the immunosuppressive effects. Non-live vaccines may have reduced efficacy, so vaccination schedules should be discussed with healthcare providers.
• Monitoring: Patients should be monitored closely for signs of infections during treatment. Regular blood tests and monitoring for signs of worsening heart failure (in patients with pre-existing heart conditions) may also be recommended.
• Hepatitis B Reactivation: Certolizumab can cause reactivation of hepatitis B virus in patients who are carriers of the virus. Screening for hepatitis B should be done before starting treatment.
• Neurological Effects: Rarely, certolizumab may cause neurological symptoms such as seizures or multiple sclerosis-like symptoms. Patients should report any new or worsening neurological symptoms to their healthcare provider.
• Pregnancy and Breastfeeding: The safety of certolizumab during pregnancy and breastfeeding is not well-established. Healthcare providers should weigh the risks and benefits when considering its use in pregnant or breastfeeding women.
• Allergic Reactions: Patients should be monitored for signs of allergic reactions during and after the infusion of certolizumab.

Patients should discuss their medical history and any current medications or conditions with their healthcare provider before starting certolizumab treatment to ensure it is safe and appropriate for them.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with certolizumab injection. However, maintaining a healthy and balanced diet is important for overall health and may support your immune system. If you have any specific dietary concerns or conditions (e.g., diabetes or high blood pressure), discuss them with your healthcare provider or a registered dietitian.

What should I do if I forget a dose?

• As soon as you remember: If you remember shortly after the missed dose and it is still within a few days of your scheduled injection, take the missed dose as soon as possible.
• If it’s close to your next scheduled dose: If it’s almost time for your next injection, skip the missed dose and continue with your regular dosing schedule.
• Do not double dose: Do not take extra medicine to make up for a missed dose. Taking more than the prescribed dose can increase your risk of side effects.

What side effects can this medication cause?

Certolizumab injection, like any medication, can cause side effects. Some of the common and serious side effects include:

Common Side Effects:

• Injection site reactions: Pain, redness, swelling, or itching at the injection site.
• Upper respiratory tract infections: Such as sinus infections, colds, or flu-like symptoms.
• Headache.
• Rash or itching.

Serious Side Effects:

• Infections: Certolizumab can increase the risk of serious infections, including tuberculosis, bacterial infections, and fungal infections. Symptoms may include fever, chills, cough, or persistent sore throat.
• Allergic Reactions: Rarely, certolizumab can cause severe allergic reactions (anaphylaxis) with symptoms such as difficulty breathing, swelling of the face, throat, or tongue, and itching or rash.
• Autoimmune Reactions: Certolizumab may trigger autoimmune reactions, which can cause symptoms resembling lupus or other autoimmune diseases.
• Liver Problems: Some people may experience liver enzyme abnormalities.
• Heart Failure: Worsening of heart failure symptoms in individuals with pre-existing heart conditions has been reported.
• Blood Disorders: Rarely, certolizumab can affect blood cell counts.
• Neurological Effects: Certolizumab may rarely cause neurological symptoms such as seizures or multiple sclerosis-like symptoms.

It’s important to report any new or worsening symptoms to your healthcare provider promptly, as early detection and management can help minimize the impact of these potential side effects. Your healthcare provider will monitor you closely while you are receiving certolizumab to mitigate risks and ensure the medication is appropriate for you.

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

Storage of Certolizumab Injection:

• Certolizumab injections should be stored in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F).
• Do not freeze Certolizumab. If frozen, do not use and contact your healthcare provider or pharmacist.
• Keep Certolizumab injections in the original carton to protect from light.
• Do not shake the vial or syringe.

Disposal of Certolizumab Injection:

• Dispose of used syringes and needles in a puncture-resistant container.
• Follow local regulations or guidelines for proper disposal of medical waste.
• Do not dispose of Certolizumab injections in household trash or recycling.

In case of emergency/overdose

• In case of an emergency or overdose, seek medical attention immediately.
• Symptoms of overdose with Certolizumab may include increased risk of infections or worsening side effects.
• There is no specific antidote for Certolizumab overdose; treatment would typically involve supportive care and monitoring of symptoms.

What other information should I know?

• Monitoring: Regular monitoring by your healthcare provider is important while taking Certolizumab to check for effectiveness and detect any potential side effects early.
• Medical Conditions: Inform your healthcare provider about all your medical conditions, including infections, liver disease, heart conditions, and neurological disorders.
• Pregnancy and Breastfeeding: Discuss with your healthcare provider the risks and benefits of Certolizumab if you are pregnant, planning to become pregnant, or breastfeeding.
• Immunizations: Avoid live vaccines while taking Certolizumab due to the risk of infection. Non-live vaccines may have reduced effectiveness.
• Travel: If you are traveling with Certolizumab, ensure you have enough medication for the duration of your trip. Properly pack and store Certolizumab injections according to the manufacturer’s instructions.
• Medical Alert: Consider wearing a medical alert bracelet or carrying a card that indicates you are taking Certolizumab in case of emergency.

It’s important to follow your healthcare provider’s instructions and advice regarding Certolizumab treatment. They can provide specific guidance tailored to your individual needs and circumstances.