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Certolizumab Injection

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WARNING

A serious or life-threatening infection, such as severe fungal, bacterial, or viral infections that could spread throughout the body, may become more likely if you have a certolizumab injection. This is because it may make it harder for you to fight against infection. Some infections might require hospital treatment, and they might even be fatal. Inform your doctor if you frequently contract any kind of infection or if you already have or suspect you may have any kind of infection. Included in this are mild infections (like little cuts or sores), transient infections (like cold sores), and persistent, chronic infections. Also, let your doctor know if you have previously had diabetes, hepatitis B, HIV, or any other immune-compromising diseases, and if you currently reside in or have ever resided in regions like the Ohio and Mississippi River valleys where severe fungal infections are more prevalent. If you are unsure whether these infections are widespread in your area, consult your doctor. Infliximab (Remicade), methotrexate (Otrexup, Rasuvo, Trexall), natalizumab (Tysabri), rituximab (Rituxan), and steroids such as dexamethasone, methylprednisolone (Medrol), prednisolone (Prelone), prednisone (Rayos), and tocilizumab are examples of medications that slow the (Actemra).

When you are receiving treatment and for a while after, your doctor will keep an eye out for any infections. Call your doctor right away if you encounter any of the following symptoms during or right after your therapy, or if you have any of the following symptoms before you start your treatment: Sore throat, coughing up bloody mucus, coughing up blood, fever, stomach discomfort, diarrhoea, flu-like symptoms, open cuts or sores, weight loss, weakness, sweating, breathing difficulties, frequent, painful, or difficult urination, or other infection-related symptoms.

You might already have hepatitis B (a virus that damages the liver) or tuberculosis (TB; a deadly lung infection), but show no signs of the illnesses. Using certolizumab injection in this situation could make your infection worse and give you symptoms. Your doctor may request a blood test to determine whether you have an inactive hepatitis B infection in addition to performing a skin test to determine whether you have a TB infection. Before you begin using certolizumab, your doctor may prescribe medicine to treat this infection if necessary. If you have or have ever had tuberculosis (TB), if you have ever lived in or visited a country where TB is widespread, or if you have ever been around someone who has TB, let your doctor know. Call your doctor right once if you have any of the following TB symptoms, or if you start to experience any of them while receiving treatment: fever, a cough, a decrease in body weight, or a decline in muscular tone. Call your physician right away if you experience any of the following hepatitis B symptoms, or if any of them appear during or after treatment: extreme fatigue, yellowing of the skin or eyes, appetite loss, nausea, or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

Some youngsters and young adults who underwent treatments resembling certolizumab injection developed serious or fatal malignancies, such as lymphoma (cancer that begins in the cells that fight infection). Certolizumab injection is typically contraindicated in children and teenagers, but in some instances, a doctor may determine that it is the most effective treatment for a child’s disease. If your child is given a prescription for certolizumab injection, you should discuss the advantages and disadvantages of using this drug with your child’s doctor. Call your child’s doctor right away if any of these symptoms appear while they are receiving therapy for your child: unexplained loss of weight, enlarged glands in the neck, underarms, or groyne, as well as simple bleeding or bruises.

The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or pharmacist when you start receiving certolizumab injection treatment and each time your prescription is renewed. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Discuss the dangers of using certolizumab injection with your doctor.

Why is this medication prescribed?

The following autoimmune illnesses, in which the immune system targets healthy body components and results in discomfort, swelling, and damage, can be treated with the help of the injection certolizumab:

  • When different medications have been used to treat Crohn’s disease, which is a disorder in which the body attacks the lining of the digestive tract and causes discomfort, diarrhoea, weight loss, and fever,
  • Arthritis rheumatoid (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function),
  • Ankylosing spondylitis (a condition that causes joint pain and swelling and scales on the skin),
  • X-ray abnormalities indicative of active ankylosing spondylitis (a disorder where the body assaults joints in the spine and other places, resulting in discomfort, swelling, and joint degeneration),
  • Axial spondyloarthritis that is active but non-radiographic (a condition in which the body assaults the joints of the spine and other regions, causing pain and swelling),
  • Those with plaque psoriasis, a skin condition that causes red, scaly patches to appear on certain body parts, may benefit from medication or phototherapy (a treatment that involves exposing the skin to ultraviolet light).

The drug certolizumab injection belongs to the group of drugs known as tumour necrosis factor (TNF) inhibitors. It functions by preventing the body’s production of TNF, a chemical that triggers inflammation.

How should this medicine be used?

Certolizumab injection is available as a pre-filled syringe that you can inject subcutaneously at home or as a powder that must be combined with sterile water and administered by a doctor or nurse in a medical office. Certolizumab injection is typically administered every two weeks for the first three doses, and then every four weeks for the duration of the course of treatment, to treat Crohn’s disease. Certolizumab injection is typically administered every two weeks for the first three doses and then every two or four weeks going forward as long as treatment is being administered for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis. Certolizumab injection is typically administered every two weeks to treat plaque psoriasis. If you are administering certolizumab injection on your own, carefully follow the instructions on the prescription label. Never provide more or less certolizumab than your doctor has advised.

Ask your doctor to demonstrate how to inject the drug if you plan to administer certolizumab injection on your own at home or have a friend or family member administer it on your behalf. The written directions for use that are provided with the drug should be read by both you and the person who will be injecting it.

When you open the package holding your medication, make sure it is not ripped, the tamper-evident seals are intact and not broken on the top and bottom of the packaging, and the expiration date is still current. Examine the liquid in the syringe carefully once you’ve opened the packaging. The liquid shouldn’t have any noticeable coloured particles and should be clear or pale yellow in hue. If there are any issues with the container or the syringe, contact your pharmacist. Avoid injecting the medicine.

Except for the navel and the two inches around it, you can inject certolizumab injection anyplace on your stomach or thighs. The drug should not be injected into skin that is brittle, bruised, red, or hard, or that has scars or stretch marks. Never administer the drug again in the same location. Each time you inject the drug, choose a different location at least 1 inch away from the last location you utilised. If your doctor instructed you to administer certolizumab twice, use a different location for each injection.

Reusing or capping pre-filled syringes with certolizumab is not advised. Put used syringes in a container that won’t puncture. Find out from your pharmacist how to throw away the container.

The injection of certolizumab might help you manage your symptoms, but it won’t make your disease go away. Without consulting your doctor, do not stop using certolizumab injection.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using certolizumab injection,

  • If you have any allergies, including to latex, rubber, or any of the substances in certolizumab injection, notify your doctor and pharmacist right away. For a list of the ingredients, consult the prescription guide or ask your pharmacist. If you plan to use the prefilled syringe, be sure to let your doctor know if you or the person administering the injection has a latex allergy.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention all of the drugs that are listed in the IMPORTANT CAUTION section. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have or have had had a condition that affects your neurological system, such as multiple sclerosis, let your doctor know (MS; a disease in which the nerves do not function properly causing weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control) Numbness, burning, or tingling in any part of your body; seizures; heart failure; any form of cancer; bleeding issues; or blood-related illnesses. Guillain-Barré syndrome (weakness, tingling, and potentially paralysis due to sudden nerve damage) or optic neuritis (inflammation of the nerve that transmits messages from the eye to the brain).
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while receiving certolizumab injection.
  • Inform the surgeon or dentist that you are using certolizumab injection if you are having surgery, including dental surgery.
  • Avoid getting any shots without first consulting your doctor.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, administer it as soon as you remember. Skip the missed dose and carry on with your regular dosing plan if it is almost time for your next dose. To make up for a missing dose, do not provide a second injection.

What side effects can this medication cause?

The injection of certolizumab may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • At the injection site, look for any redness, itchiness, pain, or swelling
  • Headache
  • Back ache

Some adverse effects may be severe. Get emergency medical assistance or call your doctor right away if you develop any of the following symptoms or any of those in the IMPORTANT WARNING section:

  • Edoema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Hoarseness
  • Breathing difficulty
  • Breathing or swallowing challenges
  • Chest ache
  • Unexpected weight gain
  • Hives
  • Hot flash
  • Nausea or fainting
  • Rash that gets worse in the sun, especially on the arms or cheeks
  • Significant bruising or bleeding
  • Light skin
  • Blemished skin
  • Extreme fatigue
  • Feeling numb or tingly
  • Difficulties with eyesight
  • Weakened back or legs
  • Joints hurt
  • Reduced appetite
  • Pus-filled lumps or red, scaly spots on the skin

People who get certolizumab injection might have a higher risk of getting skin cancer, lymphoma, and other cancers than adults who don’t get the injection. You should discuss the dangers of using this drug with your doctor.

Further adverse effects from the injection of certolizumab are possible. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

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

To protect them from light and to keep them out of the reach of children, keep the vials and prefilled syringes in the original box they arrived in. Do not freeze or keep certolizumab injection outside of the refrigerator.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the certolizumab injection, your doctor will request specific lab tests.

Inform the lab staff and your doctor that you are using certolizumab injection prior to any laboratory test.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Cimzia®
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