Cimzia

Certolizumab injection is used for Crohn disease in adult patients who have not been helped by other medicines. It is also used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Certolizumab works on the immune system to decrease inflammation.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Solution
• Powder for Solution

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population

Appropriate studies have not been performed on the relationship of age to the effects of certolizumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric Population

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of certolizumab injection in the elderly. However, this medicine may cause more serious infections in the elderly, which may require caution in patients receiving certolizumab.

Pregnancy

All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Anakinra
• Bacillus of Calmette and Guerin Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems or
• Congestive heart failure or
• Guillain-Barré syndrome (nervous system disorder), history of or
• Leukopenia (low white blood cells) or
• Multiple sclerosis, history of or
• Optic neuritis (eye problem) or
• Pancytopenia (bone marrow problem) or
• Peripheral neuropathy (nerve problem) or
• Seizures, history of or
• Thrombocytopenia (low platelet count)—Use with caution. May make these conditions worse.
• Cancer, or history of or
• Hepatitis B, or history of or
• Tuberculosis, history of—Use with caution. May cause side effects to become worse.
• Infection (eg, bacteria, fungus, virus) or
• Tuberculosis, active—Should not be used in patients with these conditions.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually on the abdomen (stomach) or upper thighs.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Certolizumab may also be given at home. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

To use the prefilled syringe

• Gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.

• Remove the carton with the syringe from the refrigerator and place it on the clean cloth.

• Allow 30 minutes for the syringe to warm up to room temperature. Do not warm this medicine in any other way.

• Wash your hands with soap and water before and after using this medicine.

• Choose an injection site on your body. Use a different body area for each shot. Keep track of where you give each shot so you can rotate body areas.

• Clean the injection site with an alcohol swab, and do not touch the area until you are ready for injection.

• Remove the needle cover when you are ready to inject.

• Hold the syringe with one hand between the thumb and index fingers. Do not to touch the needle or let it touch any surface.

• Use your free hand to pinch and hold the skin at the injection site.

• Inject the medicine in a dart-like motion into the pinched skin at a 45-degree angle.

• Use your thumb to push the plunger and inject the full dose of the medicine. Pull the needle out of the skin.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form (prefilled syringe):

For ankylosing spondylitis:

• Adults—At first, 400 milligrams (mg) given as 2 doses of 200 mg injected under the skin. This dose is repeated after 2 weeks and 4 weeks. Your doctor may continue the dose as 200 mg every 2 weeks or 400 mg every 4 weeks.
• Children—Use and dose must be determined by your doctor.

For Crohn disease:

• Adults—At first, 400 milligrams (mg) given as 2 doses of 200 mg injected under the skin. This dose is repeated after 2 weeks and 4 weeks. Your doctor may continue the dose as 400 mg every 4 weeks.
• Children—Use and dose must be determined by your doctor.

For psoriatic arthritis:

• Adults—At first, 400 milligrams (mg) given as 2 doses of 200 mg injected under the skin. This dose is repeated after 2 weeks and 4 weeks. Your doctor may continue the dose as 200 mg every other week or 400 mg every 4 weeks.
• Children—Use and dose must be determined by your doctor.

For rheumatoid arthritis:

• Adults—At first, 400 milligrams (mg) given as 2 doses of 200 mg injected under the skin. This dose is repeated after 2 weeks and 4 weeks. Your doctor may continue the dose as 200 mg every other week or 400 mg every 4 weeks.
• Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from direct light. Keep your medicine in the original package until you are ready to use it.

Throw away used syringes in a hard, closed container (puncture-resistant) that the needles cannot poke through. Keep this container away from children and pets.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Certolizumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Stop using this medicine and check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

• Avoid contact sports or other situations where bruising or injury could occur.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

While you are being treated with certolizumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Certolizumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include

• measles,
• mumps,
• influenza (nasal flu vaccine),
• poliovirus (oral form),
• rotavirus,
• rubella.

Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Check with your doctor right away if you have symptoms of liver problems such as

• yellow skin or eyes,
• dark brown-colored urine,
• right-sided stomach pain,
• fever,
• severe tiredness.

This medicine may cause other unwanted effects that may not occur until months or years after this medicine is used. A small number of people (including children and teenagers) who have used this type of medicine have developed certain types of cancer (eg, leukemia, skin cancer). Some patients developed a rare type of cancer called lymphoma.

Talk with your doctor if you have

• unusual bleeding,
• bruising,
• weakness,
• swollen lymph nodes in the neck, underarms, or groin,
• unexplained weight loss.

Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

Check with your doctor right away if you have more than one of these symptoms

• chest pain,
• decreased urine output,
• dilated neck veins,
• extreme fatigue,
• irregular breathing,
• irregular heartbeat,
• shortness of breath,
• swelling of the face, fingers, feet, or lower legs,
• tightness in the chest,
• trouble breathing,
• weight gain,
• wheezing.

These may be symptoms of a heart condition called congestive heart failure.

Certolizumab may cause serious allergic reactions.

Check with your doctor right away if you have

• a rash,
• itching,
• dizziness,
• fainting,
• lightheadedness,
• swelling of the face, throat, legs, or feet,
• troubled breathing

after you receive the medicine.

Some people using this medicine developed lupus-like symptoms. Make sure your doctor knows if you start having chest pain, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur

More common

• Bladder pain
• bloody or cloudy urine
• body aches or pain
• chills
• cough or hoarseness
• difficult, burning, or painful urination
• difficulty with breathing
• ear congestion
• fever
• frequent urge to urinate
• headache
• loss of voice
• lower back or side pain
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest pain
• colds or flu-like symptoms
• frequent urination
• pain in the ankles or knees
• pain in the arms or legs
• painful, red lumps under the skin, mostly on the legs
• rapid weight gain
• stomach pain
• tingling of the hands or feet
• tightness in the chest
• unusual weight gain or loss

Rare

• Blurred vision
• confusion
• coughing or spitting up blood
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• feeling of warmth
• general feeling of discomfort, illness, or weakness
• inflammation of the joints
• itching
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle aches
• nausea
• night sweats
• redness of the face, neck, arms, and occasionally, upper chest
• skin rash
• sudden high fever or low-grade fever for months
• sweating
• swelling of the lymph glands
• weakness

Incidence not known

• Blistering, peeling, or loosening of the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• red, scaling, or crusted skin
• sores, ulcers, or white spots in the mouth or on the lips

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty with moving
• muscle pain or stiffness

Less common

• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.