ADALIMUMAB- adalimumab-fkjp kit

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Mylan Specialty L.P.

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Adalimumab-fkjp 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. Adalimumab-fkjp can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab-fkjp is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-fkjp can be used alone or in combination with methotrexate . Adalimumab-fkjp is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-fkjp can be used alone or in combination with non-biologic DMARDs. Adalimumab-fkjp is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Adalimumab-fkjp is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older . Adalimumab-fkjp 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, 14.8)] . Adalimumab-fkjp 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. Adalimumab-fkjp 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)] . Adalimumab-fkjp is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. HULIO 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 Adalimumab-fkjp and any potential adverse effects on the breastfed child from Adalimumab-fkjp or from the underlying maternal condition. The safety and effectiveness of Adalimumab-fkjp have been established for: Pediatric assessments for Adalimumab-fkjp demonstrate that Adalimumab-fkjp is safe and effective for pediatric patients in indications for which Humira (adalimumab) is approved. However, Adalimumab-fkjp 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. Post-marketing 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 Adalimumab-fkjp in patients 65 years of age and older. In patients treated with Adalimumab-fkjp, closely monitor for the development of infection or malignancy [see Warnings and Precautions (5.1, 5.2)] . Adalimumab-fkjp Pen Injection for subcutaneous use 40 mg/0.8 mL Single-Dose Prefilled Pen For subcutaneous (under the skin) use only Read these instructions carefully before using your Pen. This information does not replace talking to your healthcare provider about your medical condition and your treatment. Do not try to inject Adalimumab-fkjp yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of Adalimumab-fkjp at home, you should receive training on the right way to prepare and inject Adalimumab-fkjp. It is important that you read, understand, and follow these instructions so that you inject Adalimumab-fkjp the right way. It is also important to talk to your healthcare provider to be sure you understand your Adalimumab-fkjp dosing instructions. To help you remember when to inject Adalimumab-fkjp, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver has any questions about the right way to inject Adalimumab-fkjp. For Questions or Assistance, Call Mylan at 1-877-446-3679 (1-877-4-INFO-RX) Caution: Never put your thumb, fingers, or hand over the orange activator after cap is removed. Never press or push the Orange Activator with your thumb, fingers, or hand. The Orange Activator is where the needle comes out. If accidental injection to your fingers or hands occurs, apply first-aid and either call your healthcare provider or go to the nearest hospital emergency room if needed.   Dosage: Adalimumab-fkjp Pen is for single dose (1-time) use only. Important: Do not use Adalimumab-fkjp if frozen, even if it has been thawed. Do not uncap your Adalimumab-fkjp Pen until you are ready to inject and will not be interrupted. Do not recap. Recapping your Adalimumab-fkjp Pen can damage the needle. A loud “click” will occur when the Orange Activator is pressed down to deliver your dose of Adalimumab-fkjp. Parts of the Adalimumab-fkjp Pen Storing and Handling the Adalimumab-fkjp Pen If needed, for example when traveling, Adalimumab-fkjp may be stored at room temperature up to 77°F (25°C) for a period of up to 14 days, with protection from light. Discard (throw away) Adalimumab-fkjp if not used within the 14 day period. Record the date on the carton and dose tray when Adalimumab-fkjp is first removed from the refrigerator. Gather Supplies for Injection Find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive an injection. Supplies you will need: Included in Adalimumab-fkjp carton Not included in Adalimumab-fkjp carton If you do not have all the supplies you need to give yourself an injection, visit or call your local pharmacist. Preparing the Pen Remove the Pen from the refrigerator 30 minutes before using. Check the Viewing Window to make sure: Do not use the Pen if medicine is not near the Fill Marker. Use another Pen or contact your healthcare provider. Do not use the Pen if it is cloudy, discolored, or has particles in it. Choosing and Preparing Injection Site Your healthcare provider should show you proper injection site techniques. Giving the Injection Caution: Injection process must be completed without interruption. Read all steps first before beginning injection. Step 1 Uncap Important: Step 2 Squeeze and Hold Injection Site The thigh injection site is shown here (See Figure F). Perform these steps the same way for abdomen (belly) injection sites. Step 3 Place Pen Step 4 Begin Injection Step 5 Hold Down for 2nd “click”, Orange Indicator and 10 Seconds Continue pushing the body of the Pen down against the injection site until: Caution: Make sure all three of these have occurred to ensure all medicine was delivered. If the needle did not retract or you do not think you received the full dose contact your healthcare provider for assistance. Step 6 End of Injection, Remove Adalimumab-fkjp Pen Dispose of the Adalimumab-fkjp Pen and Cap Put the used Pen and Cap in an FDA-cleared sharps disposal container or puncture resistant container right away to avoid injury (See “How should I throw away (dispose of) the used Adalimumab-fkjp Pen and Cap?” in Step 7). Pen is for single-dose only. Do not reuse the Pen if all of the medicine was not injected. Do not try to recap the Pen as it could lead to a needle stick injury. Step 7 How should I throw away (dispose of) the used Adalimumab-fkjp Pen and cap? If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not recycle your used sharps disposal container. Step 8 Write down the date you received your injection and the injection site used in the injection diary. Injection Diary Date Injection Site Used                     Customer Service For Questions or Assistance, Call Mylan at 1-877-446-3679 (1-877-4-INFO-RX) The brands listed are trademarks of their respective owners. The Logo is a trademark of BGP Products Operations GmbH, a Viatris Company. © 2023 Viatris Inc. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured for: Mylan Specialty L.P. Morgantown, WV 26505 U.S.A. U.S. License No. 2210 Product of Japan This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 06/2023 PCI:ADALUB:IFUP:R2 725787 Adalimumab-fkjp Injection for subcutaneous use 20 mg/0.4 mL and 40 mg/0.8 mL Single-Dose Prefilled Syringe For subcutaneous (under the skin) use only Read these instructions carefully before using your Syringe. This information does not replace talking to your healthcare provider about your medical condition and your treatment. Do not try to inject Adalimumab-fkjp yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of Adalimumab-fkjp at home, you should receive training on the right way to prepare and inject Adalimumab-fkjp. It is important that you read, understand, and follow these instructions so that you inject Adalimumab-fkjp the right way. It is also important to talk to your healthcare provider to be sure you understand your Adalimumab-fkjp dosing instructions. To help you remember when to inject Adalimumab-fkjp, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver has any questions about the right way to inject Adalimumab-fkjp. For Questions or Assistance, Call Mylan at 1-877-446-3679 (1-877-4-INFO-RX) Dosage: Adalimumab-fkjp Prefilled Syringe is for single dose (1-time) use only. Important: Parts of the Adalimumab-fkjp Prefilled Syringe (Syringe) See Figure A Storing and Handling the Syringe If needed, for example when traveling, Adalimumab-fkjp may be stored at room temperature up to 77°F (25°C) for a period of up to 14 days, with protection from light. Discard (throw away) Adalimumab-fkjp if not used within the 14-day period. Record the date on the carton and dose tray when Adalimumab-fkjp is first removed from the refrigerator. Gather Supplies for Injection Find a quiet area with a well-lit, clean and flat work surface and gather all the supplies you will need to give yourself or receive an injection. Supplies you will need: Included in the Adalimumab-fkjp carton (taken from refrigerator 30 minutes prior to intended injection time to allow Syringe to reach room temperature) Not included in Adalimumab-fkjp carton If you do not have all the supplies you need to give yourself an injection, visit or call your local pharmacist. Preparing the Syringe Remove the syringe from the refrigerator 30 minutes before using. Check the Viewing Window to make sure: Do not use the Syringe if medicine is not near the Fill Marker. Use another Syringe or contact your healthcare provider. Do not use the Syringe if it is cloudy, discolored, or has particles in it. Choosing and Preparing Injection Site Your healthcare provider should show you proper injection site techniques. Wait for it to dry on its own, do not fan or blow dry. Giving the Injection Caution: Injection process must be completed without interruption.               Read all steps first before beginning injection. Step 1 Uncap Caution: Step 2 Squeeze and Hold Injection Site The thigh injection site is shown here (See Figure F). Perform these steps the same way for abdomen (belly) injection sites. Step 3 Insert Needle Into Site At a 45° angle to the injection site, with your other hand use a quick dart-like motion to insert the needle into the site (See Figure G). Be careful to insert the needle so that it will not inject into your fingers holding the injection site. Step 4 Inject Medicine After the needle is in, let go of squeezing the injection site. Slowly push the plunger all the way down with your thumb until all the medicine is injected and the Syringe is empty (See Figure H). If the plunger is not pressed all the way down the Needle Safety Feature will not activate afterwards to cover the needle. Do not move, twist, or rotate Syringe during injection. Step 5 End of Injection, Remove Syringe Pull the Syringe away from the injection site, then release your thumb from the plunger. The needle will retract and the Needle Safety Feature will cover the needle (See Figure I). Caution : If the needle did not retract or you do not think you received the full dose, contact your healthcare provider for assistance. If the needle does not retract, carefully place the Syringe into a sharps or puncture resistant container to avoid injury. Dispose of the Adalimumab-fkjp Syringe and Needle Cap Put the used Syringe and Needle Cap in an FDA-cleared sharps disposal container or puncture resistant container right away to avoid injury (See “How should I throw away (dispose of) the used Adalimumab-fkjp Prefilled Syringe and Needle Cap?” in Step 6). Syringe is for single-dose only. Do not reuse the Syringe even if all of the medicine was not injected. Do not try to recap the needle as it could lead to a needle stick injury. Step 6 How should I throw away (dispose of) the used Adalimumab-fkjp Prefilled Syringe and Needle Cap? If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not recycle your used sharps disposal container. Step 7 Write down the date you received your injection and the injection site used in the injection diary. Injection Diary Date Injection Site Used                          Customer Service For Questions or Assistance, Call Mylan at 1-877-446-3679 (1-877-4-INFO-RX) The brands listed are trademarks of their respective owners. The Logo is a trademark of BGP Products Operations GmbH, a Viatris Company. © 2023 Viatris Inc. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured for: Mylan Specialty L.P. Morgantown, WV 26505 U.S.A. U.S. License No. 2210 Product of Japan This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 06/2023 PCI:ADALUB:IFUS:R2 725784

Резиме производа:

Adalimumab-fkjp (injection) is supplied as a preservative-free, sterile, clear to slightly opalescent and colorless to pale brownish-yellow solution for subcutaneous administration. The following packaging configurations are available: Adalimumab-fkjp Prefilled Syringe Carton - 20 mg/0.4 mL Adalimumab-fkjp (injection) is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL pre-filled plastic syringe with a fixed 29 gauge thin wall, ½ inch needle, providing 20 mg/0.4 mL of adalimumab-fkjp. The NDC number is 49502-417-02. Adalimumab-fkjp Prefilled Syringe Carton - 40 mg/0.8 mL Adalimumab-fkjp (injection) is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled plastic syringe with a fixed 29 gauge thin wall, ½ inch needle, providing 40 mg/0.8 mL of adalimumab-fkjp. The NDC number is 49502-418-02. Adalimumab-fkjp Prefilled Pen Carton - 40 mg/0.8 mL Adalimumab-fkjp (injection) is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose pen, containing a 1 mL prefilled plastic syringe with a fixed 29 gauge thin wall, ½ inch needle, providing 40 mg/0.8 mL of adalimumab-fkjp. The NDC number is 49502-416-02. Storage and Stability Do not use beyond the expiration date on the container. Adalimumab-fkjp 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, Adalimumab-fkjp may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light. Adalimumab-fkjp should be discarded if not used within the 14-day period. Record the date when Adalimumab-fkjp is first removed from the refrigerator in the spaces provided on the carton and dose tray. Do not store Adalimumab-fkjp in extreme heat or cold.

Статус ауторизације:

Biologic Licensing Application

Информативни летак

Mylan Specialty L.P.
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MEDICATION GUIDE
Adalimumab (ay″da lim′ue mab)-fkjp
Injection, for subcutaneous use
Read the Medication Guide that comes with Adalimumab-fkjp 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
Adalimumab-fkjp?
Adalimumab-fkjp is a medicine that affects your immune system.
Adalimumab-fkjp 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
Adalimumab-fkjp.
•
Your healthcare provider should check you closely for signs and
symptoms of TB during treatment
with Adalimumab-fkjp.
You should not start taking Adalimumab-fkjp if you have any kind of
infection unless your healthcare
provider says it is okay.
Before starting Adalimumab-fkjp, tell your healthcare provider if you:
•
think you have an infection or have symptoms of an infection such as:
o
fever, sweats, or chills
o
muscle aches cough 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 Mississippi River valleys)

Карактеристике производа

ADALIMUMAB- ADALIMUMAB
MYLAN SPECIALTY L.P.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADALIMUMAB-FKJP
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ADALIMUMAB-FKJP
INJECTION.
ADALIMUMAB-FKJP INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2020
THIS PRODUCT IS HULIO (ADALIMUMAB-FKJP). HULIO 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, Juvenile Idiopathic Arthritis (1.2) 07/2022
Indications and Usage, Crohn’s Disease (1.5) 07/2022
Indications and Usage, Hidradenitis Suppurativa (1.8) 03/2023
Indications and Usage, Uveitis (1.9) 08/2023
Dosage and Administration, Rheumatoid Arthritis, Psoriatic Arthritis,
and Ankylosing Spondylitis
(2.1) 07/2022
Dosage and Administration, Juvenile Idiopathic Arthritis (2.2) 07/2022
Dosage and Administration, Crohn’s Disease (2.3) 07/2022
Dosage and Administration, Hidradenitis Suppurativa (2.6) 03/2023
INDICATIONS AND USAGE
Adalimumab-fkjp 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 ADALIMUMAB-FKJP 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
ADALIMUMAB-FKJP.
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