(adalimumab-afzb)

Prescribing Information
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8 USE IN SPECIFIC POPULATIONS

8 USE IN SPECIFIC POPULATIONS

     

8.1 Pregnancy

Risk Summary

Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab. Registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with RA or CD and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see Data).

Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant (see Clinical Considerations). In an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (MRHD) of 40 mg subcutaneous without methotrexate (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Clinical Considerations

Disease-Associated Maternal and Embryo/Fetal Risk

Published data suggest that the risk of adverse pregnancy outcomes in women with RA or inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.

Fetal/Neonatal Adverse Reactions

Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see Data). Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see Use in Specific Populations (8.4)].

Data

Human Data

A prospective cohort pregnancy exposure registry conducted by OTIS/MotherToBaby in the U.S. and Canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 RA, 152 CD) treated with adalimumab during the first trimester and 106 women (74 RA, 32 CD) not treated with adalimumab.

The proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% RA, 10.5% CD) and 7.5% (6.8% RA, 9.4% CD), respectively. The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. This study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design.

In an independent clinical study conducted in ten pregnant women with IBD treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. The last dose of adalimumab was given between 1 and 56 days prior to delivery. Adalimumab concentrations were 0.16–19.7 mcg/mL in cord blood, 4.28–17.7 mcg/mL in infant serum, and 0–16.1 mcg/mL in maternal serum. In all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. In addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/mL), 7 weeks (1.31 mcg/mL), 8 weeks (0.93 mcg/mL), and 11 weeks (0.53 mcg/mL), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth.

Animal Data

In an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the MRHD without methotrexate (on an AUC basis with maternal IV doses up to 100 mg/kg/week). Adalimumab did not elicit harm to the fetuses or malformations.

8.2 Lactation

Risk Summary

Limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. Published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. However, the effects of local exposure in the gastrointestinal tract are unknown. There are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ABRILADA and any potential adverse effects on the breastfed child from ABRILADA or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of ABRILADA have not been established in pediatric patients with psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis.

The safety and effectiveness of ABRILADA have been established for:

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reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 2 years of age and older.
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the treatment of moderately to severely active Crohn's disease in pediatric patients 6 years of age and older.

Pediatric assessments for ABRILADA demonstrate that ABRILADA is safe and effective for pediatric patients in indications for which Humira (adalimumab) is approved. However, ABRILADA is not approved for such indications due to marketing exclusivity for Humira (adalimumab).

Due to their inhibition of TNFα, adalimumab products administered during pregnancy could affect immune response in the in utero-exposed newborn and infant. Data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see Use in Specific Populations (8.1)]. The clinical significance of elevated adalimumab concentrations in infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

Postmarketing cases of lymphoma, including hepatosplenic T-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blockers including adalimumab products [see Warnings and Precautions (5.2)].

Juvenile Idiopathic Arthritis

The safety and effectiveness of ABRILADA for the treatment of moderately to severely active polyarticular JIA have been established in pediatric patients 2 years of age and older. Use for this indication is supported by evidence from an adequate and well-controlled study (Study JIA-I) of adalimumab in patients 4 to 17 years of age [see Clinical Studies (14.2)] and a safety study (Study JIA-II) of adalimumab in patients 2 to <4 years of age where the safety profile was similar to patients 4 to 17 years of age [see Adverse Reactions (6.1)]. Adalimumab products have not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.

The safety of adalimumab in pediatric patients in the polyarticular JIA trials was generally similar to that observed in adults with certain exceptions [see Adverse Reactions (6.1)].

The safety and effectiveness of ABRILADA have not been established in pediatric patients with JIA less than 2 years of age.

Pediatric Crohn's Disease

The safety and effectiveness of ABRILADA for the treatment of moderately to severely active Crohn's disease have been established in pediatric patients 6 years of age and older. Use of ABRILADA for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see Adverse Reactions (6.1), Clinical Pharmacology (12.2, 12.3), Clinical Studies (14.6)]. The adverse reaction profile in patients 6 years to 17 years of age was similar to adults.

The safety and effectiveness of ABRILADA have not been established in pediatric patients with Crohn's disease less than 6 years of age.

8.5 Geriatric Use

In clinical studies of RA (Studies RA-I, RA-II, RA-III, and RA-IV), a total of 519 subjects 65 years of age and older, including 107 subjects 75 years of age and older, received adalimumab. No overall difference in effectiveness was observed between these subjects and younger adult subjects. The frequency of serious infection and malignancy among adalimumab‑treated subjects 65 years of age and older was higher than for those less than 65 years of age. Consider the benefits and risks of ABRILADA in patients 65 years of age and older. In patients treated with ABRILADA, closely monitor for the development of infection or malignancy [see Warnings and Precautions (5.1, 5.2)].

Medication Guide
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MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration.     Revised: 4/2024

MEDICATION GUIDE
ABRILADA™ (AH brill-ah-dah)
(adalimumab-afzb)
injection, for subcutaneous use

Read the Medication Guide that comes with ABRILADA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about ABRILADA?
ABRILADA is a medicine that affects your immune system. ABRILADA can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.

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Your healthcare provider should test you for TB before starting ABRILADA.
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Your healthcare provider should check you closely for signs and symptoms of TB during treatment with ABRILADA.

You should not start taking ABRILADA if you have any kind of infection unless your healthcare provider says it is okay.
Before starting ABRILADA, tell your healthcare provider if you:

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think you have an infection or have symptoms of infection such as:
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fever, sweats, or chills
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muscle aches
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cough
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shortness of breath
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blood in phlegm
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warm, red, or painful skin or sores on your body
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diarrhea or stomach pain
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burning when you urinate or urinate more often than normal
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feel very tired
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weight loss
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are being treated for an infection.
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get a lot of infections or have infections that keep coming back.
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have diabetes.
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have TB, or have been in close contact with someone with TB.
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were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
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live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use ABRILADA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
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have or have had hepatitis B.
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use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP).
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are scheduled to have major surgery

After starting ABRILADA, call your healthcare provider right away if you have an infection, or any sign of an infection.
ABRILADA can make you more likely to get infections or make any infection that you may have worse.
Cancer

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For children and adults taking tumor necrosis factor (TNF) blockers, including ABRILADA, the chances of getting cancer may increase.
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There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers.
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People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
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If you use TNF blockers including ABRILADA your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your healthcare provider if you have a bump or open sore that does not heal.
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Some people receiving TNF blockers including ABRILADA developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6-MP).

What is ABRILADA?
ABRILADA is a medicine called a tumor necrosis factor (TNF) blocker. ABRILADA is used:

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To reduce the signs and symptoms of:
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moderate to severe RA in adults. ABRILADA can be used alone, with methotrexate, or with certain other medicines.
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moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. ABRILADA can be used alone or with methotrexate.
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psoriatic arthritis (PsA) in adults. ABRILADA can be used alone or with certain other medicines.
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ankylosing spondylitis (AS) in adults.
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moderate to severe hidradenitis suppurativa (HS) in adults.
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To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older.
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To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
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To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
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To treat non-infectious intermediate, posterior, and panuveitis in adults.

What should I tell my healthcare provider before taking ABRILADA?
ABRILADA may not be right for you. Before starting ABRILADA, tell your healthcare provider about all of your medical conditions, including if you:

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have an infection. See "What is the most important information I should know about ABRILADA?"
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have or have had cancer.
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have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
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have or had heart failure.
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have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using ABRILADA. Children should be brought up to date with all vaccines before starting ABRILADA.
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are allergic to ABRILADA or to any of its ingredients. The ABRILADA prefilled syringe and prefilled pen are not made with natural rubber latex. See the end of this Medication Guide for a list of ingredients in ABRILADA.
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are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should take ABRILADA while you are pregnant or breastfeeding.
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have a baby and you were using ABRILADA during your pregnancy. Tell your baby's healthcare provider before your baby receives any vaccines.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you use:

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ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use ABRILADA while you are also using one of these medicines.
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RITUXAN (rituximab). Your healthcare provider may not want to give you ABRILADA if you have received RITUXAN (rituximab) recently.
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IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6-MP).

Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take ABRILADA?

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ABRILADA is given by an injection under the skin. Your healthcare provider will tell you how often to take an injection of ABRILADA. This is based on your condition to be treated. Do not inject ABRILADA more often than you were prescribed.
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See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject ABRILADA.
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Make sure you have been shown how to inject ABRILADA before you do it yourself. You can call your healthcare provider or 1-800-438-1985 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject ABRILADA.
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Do not try to inject ABRILADA yourself until you are shown the right way to give the injections and read and understand the Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of ABRILADA at home, you should receive training on the right way to prepare and inject ABRILADA.
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Do not miss any doses of ABRILADA unless your healthcare provider says it is okay. If you forget to take ABRILADA, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject ABRILADA, call your healthcare provider or pharmacist.
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If you take more ABRILADA than you were told to take, call your healthcare provider.

What are the possible side effects of ABRILADA?
ABRILADA can cause serious side effects, including:
See "What is the most important information I should know about ABRILADA?"

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Serious Infections.
Your healthcare provider will examine you for TB and perform a test to see if you have TB. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with ABRILADA and during treatment with ABRILADA. Even if your TB test is negative your healthcare provider should carefully monitor you for TB infections while you are taking ABRILADA. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your healthcare provider if you have any of the following symptoms while taking or after taking ABRILADA:
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cough that does not go away
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low grade fever
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weight loss
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loss of body fat and muscle (wasting)
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Hepatitis B infection in people who carry the virus in their blood.
If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ABRILADA. Your healthcare provider should do blood tests before you start treatment, while you are using ABRILADA, and for several months after you stop treatment with ABRILADA. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
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muscle aches
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feel very tired
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dark urine
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skin or eyes look yellow
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little or no appetite
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vomiting
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clay-colored bowel movements
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fever
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chills
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stomach discomfort
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skin rash
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Allergic reactions. Allergic reactions can happen in people who use ABRILADA. Call your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction:
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hives
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trouble breathing
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swelling of your face, eyes, lips or mouth
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Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
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Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
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New heart failure or worsening of heart failure you already have. Call your healthcare provider right away if you get new worsening symptoms of heart failure while taking ABRILADA, including:
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shortness of breath
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sudden weight gain
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swelling of your ankles or feet
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Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop ABRILADA.
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Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your healthcare provider right away if you have any of these symptoms:
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feel very tired
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poor appetite or vomiting
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skin or eyes look yellow
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pain on the right side of your stomach (abdomen)
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Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that are filled with pus. Your healthcare provider may decide to stop your treatment with ABRILADA.

Call your healthcare provider or get medical care right away if you develop any of the above symptoms. Your treatment with ABRILADA may be stopped.

The most common side effects of ABRILADA include:

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injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your healthcare provider right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.
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upper respiratory infections (including sinus infections).
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headaches.
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rash.

These are not all of the possible side effects with ABRILADA. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ABRILADA?

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Store ABRILADA in the refrigerator at 36°F to 46°F (2°C to 8°C). Store ABRILADA in the original carton until use to protect it from light.
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Do not freeze ABRILADA. Do not use ABRILADA if frozen, even if it has been thawed.
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Refrigerated ABRILADA may be used until the expiration date printed on the ABRILADA carton, pen or prefilled syringe. Do not use ABRILADA after the expiration date.
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If needed, for example when you are traveling, you may also store ABRILADA at room temperature up to 86°F (30°C) for up to 30 days. Store ABRILADA in the original carton until use to protect it from light.
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Throw away ABRILADA if it has been kept at room temperature and not been used within 30 days.
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Record the date you first remove ABRILADA from the refrigerator in the spaces provided on the ABRILADA pen carton or the prefilled syringe carton.
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Do not store ABRILADA in extreme heat or cold.
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The medicine in ABRILADA should be clear and colorless to very light brown. Do not use a pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.
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Do not drop or crush ABRILADA. The prefilled syringe is glass.

Keep ABRILADA, injection supplies, and all other medicines out of the reach of children.

General information about the safe and effective use of ABRILADA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABRILADA for a condition for which it was not prescribed. Do not give ABRILADA to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about ABRILADA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ABRILADA that is written for health professionals.

What are the ingredients in ABRILADA?

Active ingredient: adalimumab-afzb
ABRILADA pen 40 mg/0.8 mL, ABRILADA 40 mg/0.8 mL prefilled syringe, ABRILADA 20 mg/0.4 mL prefilled syringe, ABRILADA 10 mg/0.2 mL prefilled syringe, and ABRILADA 40 mg/0.8 mL institutional use vial:

Inactive ingredients: edetate disodium dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and Water for Injection.

Pfizer

Manufactured by Pfizer Inc.
New York, NY 10001

Distributed by Pfizer Labs
Division of Pfizer Inc.
New York, NY 10001

US License No. 2001

LAB-1351-6.0

For more information go to www.Pfizer.com.

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