outcomes in women exposed to the drug during pregnancy; MotherToBaby pregnancy studies conducted by the Organization of Teratology Information Specialists (OTIS); OTIS AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/ Due to its inhibition of TNFalpha, certolizumab pegol administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant; clinical significance of low levels is unknown for in utero-exposed infants; additional data available from one exposed infant suggest that may be eliminated at a slower rate in infants than in adults Limited data from ongoing pregnancy registry on use of drug in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes Contraception Consider adequate contraception for women of childbearing potential For women planning pregnancy, consider adequate contraception for 5 months after last dose due to its elimination rate Lactation In a clinical study, minimal transfer of certolizumab pegol from plasma to breast milk was observed Percentage of maternal certolizumab pegol dose that was reaching an infant during a 24 hr period was estimated to 0.04-0.3% In addition, since certolizumab pegol is a protein that is degraded in gastrointestinal tract after oral administration, absolute bioavailability is expected to be very low in a breastfed infant; can be used during breastfeedingPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Recombinant humanized antihuman TNF-alpha neutralizing antibody Binds to human TNFα with a KD of 90pM; TNF-alpha is a key pro-inflammatory cytokine with a central role in inflammatory processes Selectively neutralizes TNF-alpha; cross-reacts poorly with TNF from rodents and rabbits, therefore in vivo efficacy was evaluated using animal models in which human TNF-alpha was the physiologically active molecule Absorption Peak plasma concentration: 43-49 mcg/mL (RA patients) Peak plasma time: 54-171 hr Bioavailability: ~80% Distribution Vd: 4.7-8 L Metabolism Not studied in humans Data from animals indicate that once cleaved from the Fab' fragment the PEG moiety is mainly excreted in urine without further metabolism Excretion Half-life: 14 days Clearance: 17 mL/hr (Crohn disease); 21 mL/hr (RA) SC Preparation Vials Remove from refrigerator and allow the vial(s) to sit at room temperature for 30 min before reconstituting; do not warm vial in any other way Reconstitute 200 mg vial(s) with 1 mL of sterile water for injection, using the 20-gauge needle provided; water should be directed at vial wall rather than directly to contents Gently swirl each vial for about one min without shaking, assuring that all of powder comes in contact with sterile water; avoid creating a foaming effect Continue swirling every 5 min as long as non-dissolved particles observed; full reconstitution may take as long as 30 min; final reconstituted solution contains 200 mg/mL and should be clear to opalescent, colorless to pale yellow liquid essentially free from particulates Reconstitute each 200 mg vial with 1 mL sterile water for injection, swirl to dissolve; leave vials undisturbed for up to 30 minutes to fully reconstitute Syringe Prefilled syringe contains a derivative of natural rubber latex and use caution by latex-sensitive individuals SC Administration Inject full contents of each syringe SC into separate sites on abdomen or thigh Storage Unopened vial Refrigerate intact carton between 2-8°C (36-46°F) Do not freeze Do not separate contents of carton prior to use Protect solution from light Prefilled syringe Refrigerate intact carton between 2-8°C (36-46°F) Store at room temperature up to 25°C (77°F) in the original carton for a single period of up to 7 days Do not place back in refrigerator; write the date removed from the refrigerator in the space provided on the carton and discard if not used within the 7-day period Do not freeze Do not separate contents of carton prior to use Protect solution from light Reconstituted vial Do not leave reconstituted solution at room temperature >2 hr May be stored for up to 24 hr at 2-8°C (36-46°F) prior to injection Do not freeze BRAND FORM. UNIT PRICE PILL IMAGE Cimzia Powder for Reconstitution subcutaneous- 400 mg (200 mg x 2 vials) kitCimzia Starter Kit subcutaneous- 400 mg/2 mL (200 mg/mL x 2) syringeCimzia subcutaneous- 400 mg/2 mL (200 mg/mL x 2) syringeCopyright © 2010 First DataBank, Inc.Print Patient Educationcertolizumab pegol subcutaneous CERTOLIZUMAB - INJECTION (SER-toe-LIZ-oo-mab) COMMON BRAND NAME(S): Cimzia WARNING: This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). You should have a tuberculosis (TB) skin test before and during treatment with this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Tell your doctor right away if you develop signs of an infection while using this drug, such as sore throat or cough that doesn't go away, fever, chills, night sweats, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).If you are diagnosed with TB, you must first be treated for it before you start certolizumab to prevent a serious TB infection.Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as fever that doesn't go away, unusual lumps/growths, skin changes, swollen glands, swollen or painful abdomen, unexplained weight loss, or night sweats. USES: This medication is used to reduce pain and swelling due to certain inflammatory conditions (such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis). Some brands may also be used to treat a certain type of spine condition (axial spondyloarthritis) or a certain bowel condition (Crohn's disease). Certolizumab belongs to a class of drugs known as tumor necrosis factor (TNF) blockers. It works by blocking TNF, a substance made by the body that causes inflammation. HOW TO USE: Read the Medication Guide and, if available, the Instructions for Use provided by your pharmacist before you start using certolizumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is given by injection under the skin in the stomach or thigh area as directed by your doctor. Do not inject into any areas of skin that are sore, bruised, red, scaly, or hard. The dosage is based on your medical condition and response to treatment.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. If stored in the refrigerator, remove this medication from the refrigerator and leave at room temperature for 30 minutes before injecting. Do not warm up this medication in any other way such as heating in the microwave or placing in hot water. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Use this medication regularly to get the most benefit from it. To help you remember, mark the days on a calendar when you need to receive the medication.Tell your doctor if your condition does not improve or if it gets worse. SIDE EFFECTS: See also Warning section.Cough, sore throat, stuffy/runny nose, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, swollen joints, rash on nose and cheeks, eye pain, vision changes, dizziness, numbness/tingling of arms/legs, seizures, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).Certolizumab may rarely cause serious (possibly fatal) liver disease in people exposed to hepatitis B virus. Your doctor may order blood tests and watch for symptoms during treatment and for several months after your last treatment. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, stomach/abdominal pain, dark urine, yellowing eyes/skin.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before using certolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the rubber syringe cap of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: any current/recent infection (such as HIV, hepatitis B, tuberculosis), any infection that keeps coming back, cuts or open sores, cancer, diabetes, heart failure, blood/bone marrow disorders, history of cancer (such as lymphoma), brain/nervous system disorders (such as multiple sclerosis, seizures).Certolizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using certolizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults are more sensitive to the effects of this drug, especially the risk of infections.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: abatacept, anakinra, other drugs that weaken the immune system (such as azathioprine, cancer chemotherapy, cyclosporine).This medication may interfere with certain laboratory tests (including aPTT tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete