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Cimzia

Generic name: certolizumab [SER-toe-LIZ-oo-mab]
Drug class: TNF-alpha inhibitors

What is Cimzia?

Cimzia can reduce the inflammation caused by a substance that is present in the body. Cimzia can be used to treat the symptoms of Crohn’s disease when other treatments fail. Cimzia can also be used to treat ankylosing spondylitis and plaque psoriasis. Cimzia (certolizumab), an injection that is given under the surface of the skin, is used to reduce the inflammation that causes the symptoms associated with specific autoimmune disorders. When a protein called tumor necrosis factor is released into the body, it can cause or worsen inflammation. Cimzia can block tumor necrosis factors, which reduce inflammation and help relieve symptoms. Cimzia is a member of the drug class inhibitors of TNF-α.

Warnings

Cimzia can affect your immune system. Severe and even fatal infections can occur. You may have a higher risk of infection if: you are diabetic; you have HIV or a weak immune response; you suffer from hepatitis B or chronic infections; you take certain medications; or you live or travel in certain regions. If you experience symptoms like fever, chills, cough, diarrhea, night sweats, flu-like symptoms, or sores on your skin, call your doctor immediately. Cimzia can also increase the risk of certain types of cancer. This includes a rare, fast-growing lymphoma, which is fatal. You should not receive any "live" vaccinations while being treated for Cimzia.

Similar/related drugs

Entyvio, Otezla, Taltz, Soty Ktu, Prednisone, Naproxen, and Dexamethasone

Before you take this drug

Cimzia should not be used if you have an allergy to certolizumab. Cimzia may not work if you are experiencing symptoms of infection, such as fevers, chills, and coughs; skin sores or rashes; shortness of breath; weight loss; diarrhea; or painful urination. Tell your doctor whether you or someone in your family has ever suffered from tuberculosis. Tell your doctor about any recent travels. Travel may have exposed you to fungus and tuberculosis. Cimzia can cause a rare form of lymphoma in the liver, spleen, and bone marrow. This is more common among teenagers and young males with Crohn's or ulcerative colitis. Anyone with an autoimmune disease that is inflammatory may be at a greater risk for lymphoma. Speak to your doctor about the risk you face.

Notify your doctor of any of the following issues:

  • A chronic infection
  • Hepatitis B
  • Cancers such as lymphoma and other cancers;
  • A blood cell disorder;
  • Congestive heart failure
  • A seizure;
  • Allergy to latex
  • Numbness, tingling, or a disorder of the nervous system such as multiple sclerosis
  • If you have received BCG (Bacille Calmette Guerin) recently or are due to receive any vaccinations,

Cimzia is not known to harm unborn babies. Inform your doctor if you are pregnant. You may be asked to sign a registry for pregnant women in order to monitor the effects of Cimzia. You may not be able to breastfeed your baby while taking this medication. You should ask your doctor if there are any risks. Cimzia cannot be used by anyone under the age of 18.

How to take Cimzia?

Your doctor may test you to ensure that you don't have tuberculosis or any other infection. Cimzia can be injected into the skin. You may be taught how to use the medication properly by a healthcare provider. Cimzia can be given between 2 and 4 times per week. It may be necessary to inject more than one injection to receive the full dose. Please follow your doctor's instructions for dosage. Please read and follow all directions included with your medication for use. Cimzia should not be used if you do not understand the instructions. Should you have any queries, don't hesitate to seek the advice of your pharmacist or physician. Be sure to prepare your injection only when ready to give it. If the medicine is cloudy, has changed colour, or contains particles, do not use it. For new medicine, call your pharmacist. Cimzia alters the immune system's function, which can increase your risk of infection or bleeding. Your condition requires multiple medical tests on an ongoing basis. Cimzia should be stored in its original packaging in the fridge. Do not freeze, and protect from light. Before injecting, remove the syringe from the refrigerator and allow it to reach room temperature. Prefilled syringes can be stored at room temperature for up to seven days. Keep them away from heat or light. Prefilled syringes that are not used in 7 days should be thrown away. Don't put it in the fridge. Each prefilled syringe can only be used once. After one use, throw away the syringe, even if it still contains medicine. Once used, needles or syringes should only be stored in puncture-proof "sharps containers." In accordance with local or state law, be sure to dispose of this sharps container properly.Keep the container out of reach of pets and children. Cimzia may cause the virus to be active again or worsen if you have ever had hepatitis B. You may require frequent liver function testing while taking this medication and for a few months after stopping.

Details on dosage

Adult dose for rheumatoid arthritis:

Initial dose: 400 mg subcutaneously (given in two 200 mg subcutaneous injections) at weeks 0, 2, and 4, then 200 mg subcutaneously every alternate week.
Maintenance dose: 400 mg subcutaneously every four weeks can be considered.
Use: To treat adults with moderately active to severely active rheumatoid arthritis (RA).

Adult dose for psoriatic arthritis:

Initial dose: 400 mg subcutaneously (given in two 200mg subcutaneous injections) at weeks 0, 2, and 4, then 200 mg subcutaneously every alternate week.
Use: To treat adult patients with active psoriatic arthritis (psa).

Adult dose for ankylosing spondylitis:

Initial dose: 400mg subcutaneously (given in two 200mg subcutaneous injections) at weeks 0, 2, and 4. Then 200mg subcutaneously every 2 weeks, or 400mg subcutaneously once every 4 weeks.
Adults with active ankylosing spondylitis

Adult dose for Crohn's disease—Maintenance:

Initial dose: 400mg subcutaneously (given in two 200mg subcutaneous injections) at weeks 0, 2, and 4.
Maintenance dose: 400mg subcutaneously every four weeks
Use: To reduce signs and symptoms and maintain clinical response among adult patients with moderately active to severely active Crohn's who have not responded to conventional therapy.

Usual Adult Dose for Plaque Psoriasis:

Initial dose:
Every other week, 400 mg subcutaneously (given in 2 subcutaneous injections of 200 mg or as two subcutaneous injections).
For certain patients with a body weight of 90 kg, 400 mg (given in 2 subcutaneous injections at 200 mg each) can be given to them during weeks 0, 2, 4, and then 200 mg every alternate week.
Use: To treat adults with moderate to severe plaque psoriasis who are not candidates for phototherapy or systemic therapy.

Adult dose for non-radiographic axial spondyloarthritis

Initial dose: 400mg subcutaneously (given in two 200mg subcutaneous injections) at weeks 0, 2, and 4. Then 200mg subcutaneously every 2 weeks, or 400mg subcutaneously once every 4 weeks.
Use: To treat adults with non-radiographic axial spondyloarthritis with objective signs and symptoms of inflammation.

Comments:
-Rotate injection sites.
Never inject into skin that is tender, bruised, red, or hard.
When a 400-mg dose is required (given in 2 subcutaneous 200-mg injections), the injections must be given at different sites on either the thigh or abdomen.
This drug can be used as monotherapy or in conjunction with other non-biological disease-modifying anti-rheumatic medications (dmards).
It is not recommended to use this drug with other tumour necrosis factor (TNF)-blocking therapies or biological dmards.

What happens if I miss the dose?

If you missed a dose, call your doctor to get instructions.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Avoid injecting Cimzia into scars, stretch marks, or skin that is swollen or red. Consult your doctor prior to receiving any vaccination while being treated for Cimzia. Avoid people who are sick. Avoid any activity that could increase your chances of injury or bleeding. Take extra precautions to avoid bleeding when shaving or brushing your teeth.

Side effects of Cimzia

In case of any of the following symptoms of allergic reaction: hives, difficulty breathing and swelling to lips, face, tongue or throat - seek emergency medical assistance immediately. It is possible to develop serious and even fatal infections during treatment with Cimzia. These include: fever, chills (chills), coughing, sweating, muscle pain, sores on your skin, unusual fatigue, a feeling of shortness of breath, painful or bloody urination or diarrhoea, or weight loss.

If you notice any of the following symptoms of lymphoma, seek medical help as soon as possible:

  • Chest pain, coughing, feeling of shortness of breath
  • This swelling can come and go.
  • Feeling tired, having a fever, experiencing night sweats, or itchiness;
  • Feeling full after eating a small portion
  • Pain in the upper abdomen that can spread to your shoulder or back.

If you experience any of the following symptoms, stop using Cimzia immediately and contact your doctor.

  • Rapid weight gain, swelling (even when mildly exerted), and shortness of breath
  • Pale skin is prone to bleeding or bruising.
  • A new growth (which may be red or violet) or a change in size or colour of any mole, freckle, or bump;
  • Nerve disorders and vision problems dizziness: numbness, tingling, or weakness in the arms or legs
  • Liver disorders: fatigue, nausea, pain in the right side of the stomach, jaundice (yellowing skin or eyes);
  • New or worsening lupus symptoms: joint pain and a skin reaction on your arms or cheeks that gets worse in the sun.

Cimzia can cause a variety of side effects.

  • Pain or burning after urinating;
  • Rash;
  • Cold symptoms often include stuffy nose and sneezing.

There may be other side effects. Call your physician if experiencing side effects; to report side effects contact the FDA at 1-800-FDA-1088.

Interaction with other drug

Inform your physician of any medications taken other than those listed here, including:

  • Abatacept;
  • Adalimumab;
  • Anakinra;
  • Etanercept;
  • Golimumab;
  • Infliximab;
  • Natalizumab;
  • Rituximab.

This list is incomplete. Cerolizumab may interact with other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal remedies. This list does not include all drug interactions.

 

DRUG STATUS

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Prescription only

Pregnancy & Lactation

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