Description
Certolizumab injection is used to reduce the signs and symptoms of moderate to severe active Crohn disease in patients who have received other medicines or treatments that did not work well.
Certolizumab injection is also used to treat moderate to severe active rheumatoid arthritis. It is used in children 2 years of age and older to treat active polyarticular juvenile idiopathic arthritis.
Certolizumab injection is also used to treat active psoriatic arthritis, which is a type of arthritis that causes pain and swelling in the joints along with patches of scaly skin on some areas of the body. This medicine is also used to treat active ankylosing spondylitis and active non-radiographic axial spondyloarthritis (a type of arthritis in the spine) with objective signs of swelling.
Certolizumab injection is also used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- Powder for Solution
Before Using
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
Appropriate studies have not been performed on the relationship of age to the effects of certolizumab injection for thetreatment of polyarticular juvenile idiopathic arthritis in children younger than 2 years of age and for the treatment of other conditions in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of certolizumab injection in the elderly. However, elderly patients are more likely to have serious infections, which may require caution in patients receiving certolizumab.
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.
- Abatacept
- Adalimumab
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anakinra
- Anifrolumab-fnia
- Bacillus of Calmette and Guerin Vaccine, Live
- Baricitinib
- Dengue Tetravalent Vaccine, Live
- Infliximab
- 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, Live
- Varicella Virus Vaccine, Live
- Vedolizumab
- Yellow Fever Vaccine
- Zoster Vaccine, Live
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 problems (eg, aplastic anemia, pancytopenia, thrombocytopenia) or
- Congestive heart failure or
- Guillain-Barré syndrome (nervous system disorder), history of or
- Infections (fungal, bacterial), history of or
- Leukopenia (low white blood cells) or
- Multiple sclerosis, history of or
- Optic neuritis (eye problem) or
- Peripheral neuropathy (nerve problem) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Cancer, active or history of or
- Diabetes 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), active or
- Tuberculosis, active—Should not be used in patients with these conditions.
Proper Use
This medicine is available in 2 forms. A vial and prefilled syringe.
Vial: A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under the skin of your stomach or upper thigh.
Prefilled syringe: You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach or thigh.
This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, hard, or have scars or stretch marks.
The needle shield inside the cap of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before using this medicine.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Allow 30 minutes for the prefilled syringe to warm up to room temperature. Do not warm this medicine in any other way.
- Check the liquid in the prefilled syringe. It should be clear and colorless or yellow. Do not use the medicine if it is cloudy, discolored, or has particles in it.
- Remove the plastic ring needle cap by pulling straight up. Do not touch the needle.
- Gently pinch the skin. With a quick dart-like motion, insert the needle into your skin at about a 45 degree angle. Slowly push the plunger all the way down until the syringe is empty.
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 or non-radiographic axial spondyloarthritis::
- Adults—At first, 400 milligrams (mg) injected under the skin given as two shots (200 mg each) at Weeks 0, 2, and, 4. This initial dose is followed by 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) injected under the skin given as two shots (200 mg each) at Weeks 0, 2, and, 4. A maintenance dose of 400 mg every 4 weeks is given.
- Children—Use and dose must be determined by your doctor.
- For plaque psoriasis:
- Adults weighing more than 90 kilograms (kg)—At first, 400 milligrams (mg) injected under the skin given as two shots (200 mg each) every other week.
- Adults weighing 90 kg or less—At first, 400 milligrams (mg) injected under the skin given as two shots (200 mg each) at Weeks 0, 2, and 4. Followed by 200 mg every other week.
- Children—Use and dose must be determined by your doctor.
- For polyarticular juvenile idiopathic arthritis:
- Children 2 years of age and older weighing 40 kilograms (kg) or more—At first, 400 milligrams (mg) injected under the skin at Weeks 0, 2, and 4. A maintenance dose of 200 mg every 2 weeks starting at Week 6 is given.
- Children 2 years of age and older weighing 20 kg to less than 40 kg—At first, 200 mg injected under the skin at Weeks 0, 2, and 4. A maintenance dose of 100 mg every 2 weeks starting at Week 6 is given.
- Children 2 years of age and older weighing 10 kg to less than 20 kg—At first, 100 mg injected under the skin at Weeks 0, 2, and 4. A maintenance dose of 50 mg every 2 weeks starting at Week 6 is given.
- Children younger than 2 years of age or weighing less than 10 kg—Use and dose must be determined by your doctor.
- For psoriatic arthritis or rheumatoid arthritis:
- Adults—At first, 400 milligrams (mg) injected under the skin given as two shots (200 mg each) at Weeks 0, 2, and 4. Followed by 200 mg every other week. A maintenance dose of 400 mg every 4 weeks may be given instead.
- Children—Use and dose must be determined by your doctor.
- For ankylosing spondylitis or non-radiographic axial spondyloarthritis::
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 its original package until you are ready to use it.
You may also store the prefilled syringe at room temperature for up to 7 days. Do not put it back in the refrigerator once stored at room temperature. Throw away any unused medicine after 7 days.
Throw away used syringes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine 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. 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, and 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, including yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or 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, lymphoma, leukemia, skin cancer). Some patients developed a rare type of cancer called lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or 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 or your child have swelling of the face, fingers, feet, or lower legs, sudden weight gain, or trouble breathing. These may be signs of a heart condition called congestive heart failure (CHF).
Certolizumab injection may cause serious allergic reactions (eg, anaphylaxis, angioedema), which can be life threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, dizziness, fainting, or lightheadedness, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, swelling of the face, throat, legs, or feet, or trouble breathing after you use the medicine.
Some people who have used this medicine developed lupus-like symptoms during treatment and got better after the medicine was stopped. Check with your doctor right away if you or your child start having chest pains, joint pain, trouble breathing, 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.
Side Effects
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
- difficult, burning, or painful urination
- difficulty with breathing
- ear congestion
- fever
- frequent urge to urinate
- headache
- hoarseness
- 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 or tightness
- frequent urination
- pain in the arms, ankles, knees, or legs
- painful, red lumps under the skin, mostly on the legs
- rapid weight gain
- stomach pain
- tingling of the hands or feet
- 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
- itching, skin rash
- joint pain or swelling
- 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
- 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.
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