ABRILADA- adalimumab-afzb kit ABRILADA- adalimumab-afzb injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ADALIMUMAB (UNII: FYS6T7F842) (ADALIMUMAB - UNII:FYS6T7F842)

Available from:

Pfizer Laboratories Div Pfizer Inc

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ABRILADA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). ABRILADA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ABRILADA can be used alone or in combination with methotrexate. ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. ABRILADA can be used alone or in combination with non-biologic DMARDs. ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. ABRILADA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7)] . ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5)] . ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. None. 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. 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. The safety and effectiveness of ABRILADA have been established for: 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 In Study JIA-I, adalimumab was shown to reduce signs and symptoms of active polyarticular JIA in patients 4 to 17 years of age [see Clinical Studies (14.2)] . In Study JIA-II, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular JIA [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 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 adalimumab products have not been established in pediatric patients with JIA less than 2 years of age. Pediatric Crohn's Disease The safety and effectiveness of adalimumab products 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 adalimumab products 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 adalimumab products have not been established in pediatric patients with Crohn's disease less than 6 years of age. A total of 519 RA patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies RA-I through IV. No overall difference in effectiveness was observed between these patients and younger patients. The frequency of serious infection and malignancy among adalimumab-treated patients 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)] . ABRILADA (AH brill-ah-dah) (adalimumab-afzb) 40 mg/0.8 mL Single-dose Prefilled Pen Injection, for subcutaneous (under the skin) use Keep this leaflet. These instructions show step by step directions on how to prepare and give an injection. Storage Information: Keep ABRILADA, injection supplies, and all other medicines out of the reach of children. ABRILADA for injection comes in a disposable (throw away) single-use pen that contains a single dose of medicine. ABRILADA for injection can be given by a patient, caregiver or healthcare provider. 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. It is important that you read, understand, and follow these instructions so that you inject ABRILADA the right way. It is important to talk to your healthcare provider to be sure you understand your ABRILADA dosing instructions. To help you remember when to inject ABRILADA, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver have any questions about the right way to inject ABRILADA. Step 1. Supplies you need Step 2. Getting ready   Questions and Answers What should I do with my pen if it has been dropped? Do not use it, even if it looks undamaged. Dispose of your pen in the same way as a used pen. You will need to use a new pen to give your injection. Can I use my pen straight from the refrigerator? Yes, however you may find that using the pen at room temperature reduces stinging or discomfort. If you allow your pen to reach room temperature before use, you must keep it away from direct sunlight as this can damage your medicine. What should I do if I need to travel? When you are traveling, you may store your pen in its carton at room temperature up to 86°F (30°C) for up to 30 days. Is it okay to shake my pen before I use it? No, do not shake your pen. Shaking can damage your medicine. When you check your medicine, gently tilt your pen back and forth while looking carefully into the window. It is normal to see one or more air bubbles. Do I need to remove any air bubbles before using my pen? No, do not attempt to remove air bubbles. Drops of medicine have appeared at the needle tip. Is this okay? Yes, it is normal to see a few drops of medicine at the needle tip when you remove the cap. Can I re-insert the needle if I change my mind where I want to inject? No, you should not re-insert the needle into your skin. If you change your mind, you will need a replacement pen if the needle has already been inserted into the skin. After the injection button has been pressed, you must not lift your pen from the skin until the injection has finished. I pushed my pen against the skin but could not press the button down. What should I do? Take your finger off the injection button and push your pen down more firmly against the skin. Then try pushing the button again. If this does not work, stretching the skin may make the injection site firmer, making pressing the injection button easier. Can I pinch or stretch the skin at the injection area? Yes, pinching or stretching the skin before injection may make the injection site firmer, making it easier to press the injection button. Do I need to keep my finger pressed on the injection button for the whole injection? No, you can stop pressing the button when the injection has started. However, make sure you keep holding the pen firmly against the skin. The pen will continue to deliver your medicine. How long will the injection take? From the time the dose begins until you hear the 2nd click, it usually takes 3 to 10 seconds. After the 2nd click, you should continue to hold your pen in place for at least 5 more seconds to make sure you give the full dose. What should I do if I see more than a small drop of medicine on the skin after giving my injection? Nothing this time, but for your next injection wait a little longer before removing the pen from the skin to make sure all of the medicine went into your skin. What should I do if I have any questions about my ABRILADA pen or medicine? Contact your healthcare provider or pharmacist. This Instructions for Use has been approved by the U.S. Food and Drug Administration. 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-1352-3.0 Revised: 06/2023 ABRILADA (AH brill-ah-dah) (adalimumab-afzb) 10 mg/0.2 mL, 20 mg/0.4 mL, 40 mg/0.8 mL Single-dose Prefilled Syringe Injection, for subcutaneous (under the skin) use only Keep this leaflet. These instructions show step by step directions on how to prepare and give an injection. Storage Information: Keep ABRILADA, injection supplies, and all other medicines out of the reach of children. ABRILADA for injection comes in a disposable (throw away) single use prefilled syringe that contains a single dose of medicine. ABRILADA for injection can be given by a patient, caregiver or healthcare provider. 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. It is important that you read, understand, and follow these instructions so that you inject ABRILADA the right way. It is important to talk to your healthcare provider to be sure you understand your ABRILADA dosing instructions. To help you remember when to inject ABRILADA, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver have any questions about the right way to inject ABRILADA. Step 1. Supplies you need Step 2. Getting ready Wash your hands with soap and water, and dry completely. If you have any questions about your medicine, please contact your healthcare provider or pharmacist.   Questions and Answers What should I do with my prefilled syringe if it has been dropped? Do not use it if it has been dropped or the carton containing your prefilled syringe has been dropped even if it looks undamaged. Dispose of your prefilled syringe in the same way as a used prefilled syringe. You will need to use a new prefilled syringe to give your injection. Can I use my prefilled syringe straight from the refrigerator? Yes, however you may find that using the prefilled syringe at room temperature reduces stinging or discomfort. If you allow your prefilled syringe to reach room temperature before use, you must keep it away from direct sunlight as this can damage your medicine. What should I do if I need to travel? When you are traveling, you may store your prefilled syringe in its carton at room temperature up to 86°F (30°C) for up to 30 days. Is it okay to shake my prefilled syringe before I use it? No, do not shake your prefilled syringe. Shaking can damage your medicine. When you check your medicine, gently tilt your syringe back and forth while looking carefully into the window. It is normal to see one or more bubbles. Do I need to remove any air bubbles before using my prefilled syringe? No, do not attempt to remove air bubbles. Drops of medicine have appeared at the needle tip. Is this okay? Yes, it is normal to see a few drops of medicine at the needle tip when you remove the needle cover. Can I re-insert the needle into my skin? No, you should not re-insert the needle into the skin. You will need a replacement prefilled syringe if the needle has already been inserted into the skin. How long will the injection take? Dose delivery will take approximately 2 to 5 seconds. Remember to hold your prefilled syringe in place for at least 5 seconds after the plunger has been pushed down all the way. What should I do if I have any questions about my prefilled syringe or medicine? Contact your healthcare provider or pharmacist. This Instructions for Use has been approved by the U.S. Food and Drug Administration. 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-1353-3.0 Revised: 06/2023

Product summary:

ABRILADA™ (adalimumab-afzb) is supplied as a preservative-free, sterile, clear and colorless to very light brown solution for subcutaneous administration. The following packaging configurations are available. Storage and Stability Do not use beyond the expiration date on the container. ABRILADA must be refrigerated at 36°F to 46°F (2°C to 8°C). DO NOT FREEZE. Do not use if frozen even if it has been thawed. Store in original carton until time of administration to protect from light. If needed, for example when traveling, ABRILADA may be stored at room temperature up to a maximum of 86°F (30°C) for a period of up to 30 days, with protection from light. ABRILADA should be discarded if not used within the 30-day period. Record the date when ABRILADA is first removed from the refrigerator in the spaces provided on the ABRILADA pen carton or the prefilled syringe carton. Do not store ABRILADA in extreme heat or cold.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

ABRILADA- ADALIMUMAB-AFZB INJECTION, SOLUTION
Pfizer Laboratories Div Pfizer Inc
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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.
•
Your healthcare provider should test you for TB before starting
ABRILADA.
•
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:
•
think you have an infection or have symptoms of infection such as:
o
fever, sweats, or chills
o
muscle aches
o
cough
o
shortness of breath
o
blood in phlegm
o
warm, red, or painful skin or sores on your body
o
diarrhea or stomach pain
o
burning when you urinate or urinate more often
than normal
o
feel very tired
o
weight loss
•
are being treated for an infection.
•
get a lot of infections or have infections that keep coming back.
•
have diabetes.
•
have TB, or have been in close contact with someone with TB.
•
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.
•
live or have lived in certain parts of the country (such as the Ohio
and Mississip

Summary of Product characteristics

ABRILADA- ADALIMUMAB-AFZB
ABRILADA- ADALIMUMAB-AFZB INJECTION, SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABRILADA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABRILADA.
ABRILADA™ (ADALIMUMAB-AFZB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2019
ABRILADA (ADALIMUMAB-AFZB) IS BIOSIMILAR TO HUMIRA (ADALIMUMAB).
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS INFECTIONS (5.1, 6.1):
•
•
•
•
MALIGNANCY (5.2):
•
•
RECENT MAJOR CHANGES
Indications and Usage, Hidradenitis Suppurativa (1.8)
06/2023
Indications and Usage, Uveitis (1.9)
08/2023
Dosage and Administration, Plaque Psoriasis or Adult Uveitis (2.5)
08/2023
Dosage and Administration, Hidradenitis Suppurativa (2.6)
06/2023
Warnings and Precautions, Malignancies (5.2)
08/2023
Warnings and Precautions, Neurologic Reactions (5.5)
08/2023
INDICATIONS AND USAGE
ABRILADA is a tumor necrosis factor (TNF) blocker indicated for:
•
•
•
•
*
INCREASED RISK OF SERIOUS INFECTIONS LEADING TO HOSPITALIZATION OR
DEATH, INCLUDING
TUBERCULOSIS (TB), BACTERIAL SEPSIS, INVASIVE FUNGAL INFECTIONS (SUCH
AS
HISTOPLASMOSIS), AND INFECTIONS DUE TO OTHER OPPORTUNISTIC PATHOGENS.
DISCONTINUE ABRILADA IF A PATIENT DEVELOPS A SERIOUS INFECTION OR
SEPSIS DURING
TREATMENT.
PERFORM TEST FOR LATENT TB; IF POSITIVE, START TREATMENT FOR TB PRIOR
TO STARTING
ABRILADA.
MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT, EVEN IF INITIAL
LATENT TB TEST IS
NEGATIVE.
LYMPHOMA AND OTHER MALIGNANCIES, SOME FATAL, HAVE BEEN REPORTED IN
CHILDREN
AND ADOLESCENT PATIENTS TREATED WITH TNF BLOCKERS INCLUDING ADALIMUMAB
PRODUCTS.
POST-MARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA (HSTCL), A RARE
TYPE OF T-
CELL LYMPHOMA, HAVE OCCURRED IN ADOLESCENT AND YOUNG ADULTS WITH
INFLAMMATORY
BOWEL DISEASE TREATED WITH TNF BLOCKERS INCLUDING ADALIMUMAB PRODUCTS.
RHEUMATOID ARTHRITIS (RA) (1.1