ORENCIA- abatacept injection, powder, lyophilized, for solution ORENCIA- abatacept injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

abatacept (UNII: 7D0YB67S97) (abatacept - UNII:7D0YB67S97)

Saatavilla:

E.R. Squibb & Sons, L.L.C.

INN (Kansainvälinen yleisnimi):

abatacept

Koostumus:

abatacept 250 mg in 15 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

ORENCIA® is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). ORENCIA is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). ORENCIA is indicated for the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). ORENCIA is indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor. The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDs), Janus kinase (JAK) inhibitors] is not recommended. None. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972. The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. However, there are clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero (see Clinical Considerations) . In reproductive toxicology studies in rats and rabbits, no fetal malformations were observed with intravenous administration of ORENCIA during organogenesis at doses that produced exposures approximately 29 times the exposure at the maximum recommended human dose (MRHD) of 10 mg/kg/month on an AUC basis. However, in a pre- and postnatal development study in rats, ORENCIA altered immune function in female rats at 11 times the MRHD on an AUC basis. Infants and Administration of Live Vaccines It is unknown if abatacept can cross the placenta into the fetus when a woman is treated with ORENCIA during pregnancy. Abatacept is an immunomodulatory agent. It is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants [see Warnings and Precautions (5.4)] . There are no adequate and well-controlled studies of ORENCIA use in pregnant women. The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. Intravenous administration of abatacept during organogenesis to mice (10, 55, or 300 mg/kg/day), rats (10, 45, or 200 mg/kg/day), and rabbits (10, 45, or 200 mg/kg every 3 days) produced exposures in rats and rabbits that were approximately 29 times the MRHD on an AUC basis (at maternal doses of 200 mg/kg/day in rats and rabbits), and no embryotoxicity or fetal malformations were observed in any species. In a study of pre- and postnatal development in rats (10, 45, or 200 mg/kg every 3 days from gestation day 6 through lactation day 21), alterations in immune function in female offspring, consisting of a 9-fold increase in T-cell-dependent antibody response relative to controls on postnatal day (PND) 56 and thyroiditis in a single female pup on PND 112, occurred at approximately 11 times the MRHD on an AUC basis (at a maternal dose of 200 mg/kg). No adverse effects were observed at approximately 3 times the MRHD (a maternal dose of 45 mg/kg). It is not known if immunologic perturbations in rats are relevant indicators of a risk for development of autoimmune diseases in humans exposed in utero to abatacept. Exposure to abatacept in the juvenile rat, which may be more representative of the fetal immune system state in the human, resulted in immune system abnormalities including inflammation of the thyroid and pancreas [see Nonclinical Toxicology (13.2)] . There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept. Polyarticular Juvenile Idiopathic Arthritis The safety and effectiveness of ORENCIA for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) have been established (ORENCIA may be used as monotherapy or concomitantly with methotrexate). Use of ORENCIA for this indication is supported by evidence from the following studies: The safety and effectiveness of ORENCIA use in pJIA in pediatric patients less than two years of age have not been established. Acute Graft Versus Host Disease Prophylaxis The safety and effectiveness of ORENCIA for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in pediatric patients aged 2 years of age and older undergoing HSCT from a matched or 1 allele-mismatched unrelated donor have been established. Use of ORENCIA for this indication is supported by evidence from: Furthermore, the course of disease is sufficiently similar in pediatric patients aged 2 years to less than 6 years to that of patients aged 6 years and older to allow extrapolation of data to younger pediatric patients [see Clinical Pharmacology (12.3) and Clinical Studies (14.4)] . No new safety signals were observed in pediatric patients aged 6 years and older in Study GVHD-1. The safety and effectiveness of ORENCIA for this indication have not been established in pediatric patients less than 2 years of age. Psoriatic Arthritis Subcutaneous Administration The safety and effectiveness of subcutaneous ORENCIA have been established for treatment of psoriatic arthritis in pediatric patients 2 to 17 years old. Use of ORENCIA in this age group is supported by evidence from adequate and well-controlled studies of ORENCIA in adults with PsA, pharmacokinetic data from adult patients with RA, adult patients with PsA, and pediatric patients with pJIA, and safety data from clinical studies in pediatric patients 2 to 17 years old with pJIA using the subcutaneous formulation. The observed pre-dose (trough) concentrations are generally comparable between adults with RA and PsA and pediatric patients with JIA with active polyarthritis, and the PK exposure is expected to be comparable between adult PsA and pediatric patients with PsA. [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1, 14.2, 14.3)]. The safety and effectiveness of subcutaneous ORENCIA have not been established in pediatric patients less than 2 years old with psoriatic arthritis. Intravenous Administration The safety and effectiveness of intravenous ORENCIA in pediatric patients with psoriatic arthritis have not been established. A juvenile animal study conducted in rats dosed with abatacept from 4 to 94 days of age (prior to immune system maturity) showed an increase in the incidence of infections leading to death at all doses compared with controls. Altered T-cell subsets including increased T-helper cells and reduced T-regulatory cells were observed. In addition, inhibition of T-cell-dependent antibody responses (TDAR) was observed. Upon following these animals into adulthood, lymphocytic inflammation of the thyroid and pancreatic islets was observed. In contrast, studies in adult mice and monkeys have not demonstrated similar findings. As the immune system of the rat is undeveloped in the first few weeks after birth, the relevance of these results to humans is unknown. Rheumatoid Arthritis A total of 323 patients 65 years of age and older, including 53 patients 75 years and older, received ORENCIA in clinical studies. No overall differences in safety or effectiveness were observed between geriatric patients (patients aged 65 years of age and older) and younger adults, and other reported clinical experience has not identified differences in responses between geriatric patients and younger adults, but greater sensitivity of some geriatric patients cannot be ruled out. The frequency of serious infection and malignancy among ORENCIA-treated patients over age 65 was higher than for those under age 65. Because there is a higher incidence of infections and malignancies in the geriatric population in general, caution should be used when treating geriatric patients. Acute Graft Versus Host Disease Prophylaxis Of the 116 patients in Study GVHD-1 who received ORENCIA at a dose of 10 mg/kg for the prophylaxis of aGVHD, 12 (10%) were 65 years of age and older, and 2 (2%) patients were 75 years of age and older [see Clinical Studies (14.4)]. Clinical studies of ORENCIA for aGVHD did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. ORENCIA ® (oh-REN-see-ah) (abatacept) Prefilled syringe with BD UltraSafe Passive ™ needle guard ORENCIA ® prefilled syringe with BD UltraSafe Passive ™ needle guard (abatacept) Injection Read these instructions before you start using your ORENCIA prefilled syringe and each time you get a refill. There may be new information. Before you use the prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it and decides that you or a caregiver may be able to give your injections of ORENCIA at home. Important: Before you begin: get to know your prefilled syringe There are 3 types of prefilled syringes: The type of prefilled syringe you receive depends on the dose prescribed by your healthcare provider. The 125 mg/mL prefilled syringe is shown below. Before use After use The prefilled syringe has a flange extender that makes it easier to hold and inject, and a needle guard that automatically covers the needle after a complete injection. Go to Step 1 Step 1:  Preparing for an ORENCIA injection Gather and place supplies for your injection on a clean, flat surface. Only the prefilled syringe is included in the package: Let your prefilled syringe warm up. Remove 1 prefilled syringe from the refrigerator and wait 30 minutes to allow it to reach room temperature. Wash your hands well with soap and water. Go to Step 2 Step 2: Examine the prefilled syringe Hold the prefilled syringe by the body with the needle cover pointing down as shown. Check the Liquid. Note : the 50 mg prefilled syringe is shown. Note: It is normal to see an air bubble. Do not attempt to remove it. Go to Step 3 Step 3:  Check the dose on the prefilled syringe Hold the syringe at eye level. Look closely to make sure that the amount of liquid in the prefilled syringe is at or just above the fill line for your prescribed dose: Do not use if your prefilled syringe does not have the correct amount of liquid. Call your pharmacist immediately. Go to Step 4 Step 4: Choose and prepare an injection site Choose your injection site. Choose your injection site in either the stomach (abdomen) , front of the thighs , or outer area of upper arm (only if caregiver administered). Rotate injection site. Gently clean injection site. Remove the needle cover by holding the body of the prefilled syringe with one hand and pulling the cover straight off with your other hand. Do not put the needle cover back on the needle after you remove it. Throw away the needle cover in your household trash. Note : It is normal to see a drop of fluid leaving the needle. Go to Step 5 Step 5: Inject Your Dose of ORENCIA Hold the body of the prefilled syringe in your hand using your thumb and index finger. With your other hand, pinch the area of skin you cleaned. Insert the needle. Gently insert the needle into the pinched skin at a 45° angle. Complete all steps to deliver your full dose of the medicine. Inject: push the plunger with your thumb as far as it will go. Release the needle guard: slowly lift your thumb from the plunger to activate the needle guard. Confirm: after a complete injection, the needle guard will cover the needle and you may hear a click. Remove the prefilled syringe and let go of the pinched skin. Go to Step 6 Step 6: After the injection Care of injection site: Throwing away (disposing of) used prefilled syringes:         See Frequently Asked Questions for additional throwing away (disposal) information. If your injection is administered by a caregiver, this person must also be careful handling the syringe to prevent accidental needle stick injury and possibly spreading infection. Keep the ORENCIA prefilled syringes and the sharps disposal container out of the reach of children. How to store ORENCIA prefilled syringe Go to next page Frequently Asked Questions Q. Why do I need to allow the prefilled syringe to warm up at room temperature for 30 minutes prior to injecting? A. This step is primarily for your comfort. Never try to speed up the warming process in any way, like using the microwave or placing the syringe in warm water. Q. Is it necessary to hold the skin pinch during the entire time I inject the dose? A. You must pinch the skin during needle insertion however, for your comfort you may release the skin pinch as you deliver the injection. Q. What if my prefilled syringe appears to be broken or damaged? A. Do not use the prefilled syringe. Contact your healthcare provider or pharmacist for further instructions. Q. What if I cannot clearly see the liquid inside the syringe? A. Look at the syringe closely by holding at eye level and up to the light. You may tilt the syringe slowly to get a better view of the drug fluid. If you still have trouble, contact your healthcare provider or pharmacist for further instructions. Q. Is it normal to feel a little bit of burning or pain during injection? A. You may feel a prick from the needle. Sometimes, the medicine can cause slight irritation near the injection site. Discomfort should be mild to moderate. If you have any side effects, including pain, swelling, or discoloration near the injection site, contact your healthcare provider. Go to next page Frequently Asked Questions Q. How should I dispose of a used prefilled syringe? A. Place the used prefilled syringe into an FDA-cleared sharps disposal container. If you do not have one you may use a household container that is: Q. How should I keep my prefilled syringes cool while traveling? A. Store them in a cool carrier between 36ºF to 46ºF (2ºC to 8ºC). Do not freeze them. Keep them in the original carton and protected from light. Your healthcare provider may know about special carrying cases. Q. Can I take my prefilled syringes on an airplane? A. Generally, you are allowed to carry your prefilled syringes with you on an airplane. Do not put them in your checked luggage. You should carry your prefilled syringes with you in your travel cooler at a temperature of 36ºF to 46ºF (2ºC to 8ºC). Keep your prefilled syringes in the original carton, and with its original preprinted labels and protected from light. Q. What if my prefilled syringe does not stay cool for an extended period of time? Is it dangerous to use? A. Contact 1-800-673-6242 for more information. Go to back cover If you have questions or concerns about your prefilled syringe, please contact your healthcare provider or call our toll-free help line at 1-800-673-6242. Bristol-Myers Squibb Company Princeton, NJ 08543 USA, U.S. License Number 1713 This Instructions for Use has been approved by the U.S. Food and Drug Administration. ORENCIA is a registered trademark of Bristol-Myers Squibb Company. BD UltraSafe Passive™ is a trademark of Becton, Dickinson, and Company. Revised 10/2023       ORENCIA ® ClickJect ™ (oh-REN-see-ah) (abatacept) Prefilled autoinjector ORENCIA ® ClickJect ™ (abatacept) injection Prefilled autoinjector 125 mg/mL, single-dose autoinjector, for subcutaneous use only Read these instructions before you use the ClickJect autoinjector and each time you get a refill. There may be new information. Before you use the autoinjector for the first time, make sure your healthcare provider shows you the right way to use it. Important: Before you begin: Get to know the ClickJect autoinjector Before use After use Gather supplies for your injection on a clean, flat surface (only the ClickJect autoinjector is included in the package): Go to Step 1 Step 1:  Prepare your autoinjector Let your ClickJect autoinjector warm up. Remove 1 autoinjector from the refrigerator and let it rest at room temperature for 30 minutes . Do not remove the autoinjector needle cover while allowing it to reach room temperature. Wash your hands well with soap and water. Examine the ClickJect autoinjector: Go to Step 2     Step 2:  Prepare for injection                Choose your injection site in either the stomach (abdomen) , front of the thighs , or outer area of upper arm (only if caregiver administered). Rotate injection site. Gently clean injection site: Pull orange needle cover straight off. Go to Step 3     Step 3:  Inject your dose Position the autoinjector so you can see the viewing window and it is at a 90° angle to the injection site. With your other hand, gently pinch the cleaned skin . Complete all steps to deliver your full dose of medicine: Push down on the skin to unlock the autoinjector. Press button, hold for 15 seconds and watch the window. Remove the ClickJect autoinjector from the injection site by lifting it straight up. After you remove it from your skin, the transparent tip will lock over the needle. Release the pinched skin. Go to Step 4     Step 4:  After the injection Care of injection site: Throwing away (disposing of) used ClickJect autoinjectors:         See Frequently Asked Questions for additional throwing away (disposal) information. If your injection is administered by a caregiver, this person must also handle the autoinjector carefully to prevent accidental needle stick injury and possibly spreading infection. Keep autoinjector and the sharps disposal container out of the reach of children. How to store ORENCIA ClickJect autoinjector Continued on next page     Frequently Asked Questions Q. Why do I need to allow the autoinjector to warm up at room temperature for 30 minutes prior to injecting? A. This step is primarily for your comfort. If the medicine is cold, the injection may take longer than 15 seconds. Never try to speed the warming process in any way, like using the microwave or placing the autoinjector in warm water. Q. What if I accidentally remove the needle cover (orange cap) before I’m ready to use the autoinjector? A. If you remove the cover before you are ready to use the autoinjector, be careful. Do not try to replace it. Use the autoinjector as soon as possible. While you prepare for the injection, carefully place the autoinjector on its side on a clean, flat surface. Be sure to keep the autoinjector away from children. Q. What if the autoinjector appears to be broken or damaged? A. Do not use the autoinjector. Contact your healthcare provider or pharmacist for further instructions. Q. What if the injection was not triggered? A. Before the injection can be triggered, the device must be unlocked. To unlock, firmly push the autoinjector down on the skin without touching the button. When the stop-point is felt, the device is unlocked and can be triggered by pushing the button. Q. I feel a little bit of burning or pain during injection. Is this normal? A. When giving an injection, you may feel a prick from the needle. Sometimes, the medicine can cause slight irritation near the injection site. If this occurs, the discomfort should be mild to moderate. If you experience any side effects, including pain, swelling, or discoloration near the injection site, contact your healthcare provider or pharmacist immediately. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Q. How do I know I received my full dose? A. Before lifting the autoinjector from the injection site, check to make sure that the blue indicator has stopped moving. Then, before throwing away (disposing of) the autoinjector, check the bottom of the transparent viewing window to make sure there is no liquid left inside. If the medicine has not been completely injected, consult your healthcare provider or pharmacist. Continued on next page Frequently Asked Questions Q. How should I throw away (dispose of) a used autoinjector? A. Place used autoinjector into an FDA-cleared sharps disposal container right away after use. Q. How should I keep my autoinjector cool while traveling? A. Your healthcare provider or pharmacist may be familiar with special carrying cases for injectable medicines. Store in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Protect from light. Q. Can I take my autoinjector on board an aircraft? A. Generally, this is allowed. Be sure to pack your autoinjector in your carry-on, and do not put it in your checked luggage. You should carry it with you in your travel cooler at a temperature of 36°F to 46°F (2°C to 8°C) until you are ready to use it. Airport security procedures and airline policies change from time to time, so it’s best to check with airport authorities and the airline for any special rules. Prior to flying, get a letter from your healthcare provider to explain that you are traveling with prescription medicine that uses a device with a needle; if you are carrying a sharps container in your carry-on baggage, notify the screener at the airport. Q. What if my autoinjector does not stay cool for an extended period of time? Is it dangerous to use? A. Contact 1-800-673-6242 for details.     If you have questions or concerns about your autoinjector, please contact a healthcare provider or call our toll-free help line at 1-800-673-6242. Bristol-Myers Squibb Company Princeton, NJ 08543 USA, U.S. License Number 1713 This Instructions for Use has been approved by the U.S. Food and Drug Administration. ORENCIA is a registered trademark and ClickJect is a trademark of Bristol-Myers Squibb Company. Revised 1/2024       

Tuoteyhteenveto:

ORENCIA® (abatacept) for injection is a white lyophilized powder for intravenous infusion after reconstitution and dilution. It is supplied as an individually packaged, single-dose vial (one may use less than the full contents of the vial or use more than one vial) with a silicone-free disposable syringe, providing 250 mg of abatacept:                     NDC 0003-2187-10: in a clamshell presentation                     NDC 0003-2187-13: in a carton presentation ORENCIA® (abatacept) injection and ORENCIA® ClickJect (abatacept) injection are clear to slightly opalescent, colorless to pale yellow solutions for subcutaneous administration. ORENCIA (abatacept) injection, 50 mg/0.4 mL, 87.5 mg/0.7 mL, and 125 mg/mL, is supplied as single-dose disposable prefilled glass syringes with BD UltraSafe Passive™ needle guard and flange extenders. The Type I glass syringe has a coated stopper and fixed stainless steel needle (5 bevel, 29-gauge thin wall, ½-inch needle) covered with a rigid needle shield. The prefilled syringe provides ORENCIA in the following packages:                     NDC 0003-2814-11 (50 mg/0.4 mL): pack of 4 syringes with a passive needle safety guard                     NDC 0003-2818-11 (87.5 mg/0.7 mL): pack of 4 syringes with a passive needle safety guard                     NDC 0003-2188-11 (125 mg/mL): pack of 4 syringes with a passive needle safety guard ORENCIA (abatacept) ClickJect, 125 mg/mL, is supplied as a single-dose disposable prefilled autoinjector. The Type I glass syringe contained in the autoinjector has a coated stopper and fixed stainless steel needle (5 bevel, 27-gauge special thin wall, ½-inch needle) covered with a rigid needle shield. The autoinjector provides 125 mg of abatacept in 1 mL and is provided in the following package:                     NDC 0003-2188-51: pack of 4 autoinjectors Storage Refrigerate ORENCIA lyophilized powder supplied in a vial at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date on the vial. Protect the vials from light by storing in the original package until time of use. Refrigerate ORENCIA solution supplied in a prefilled syringe or ClickJect autoinjector at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date on the prefilled syringe or autoinjector. Protect from light by storing in the original package until time of use. Do not allow the prefilled syringe or autoinjector to freeze.

Valtuutuksen tilan:

Biologic Licensing Application

Valmisteyhteenveto

ORENCIA- ABATACEPT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ORENCIA- ABATACEPT INJECTION, SOLUTION
E.R. SQUIBB & SONS, L.L.C.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ORENCIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ORENCIA.
ORENCIA (ABATACEPT) FOR INJECTION, FOR INTRAVENOUS USE
ORENCIA (ABATACEPT) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Indication and Usage, Psoriatic Arthritis (1.3)
10/2023
Dosage and Administration, Dosage in Psoriatic Arthritis (2.3)
10/2023
INDICATIONS AND USAGE
ORENCIA is a selective T cell costimulation modulator indicated for:
•
•
•
•
Limitations of Use:
Concomitant use of ORENCIA with other immunosuppressives [e.g.,
biologic disease-modifying
antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not
recommended (1.5, 5.1).
DOSAGE AND ADMINISTRATION
INTRAVENOUS USE FOR ADULT RA (2.1) AND ADULT PSA (2.3)
•
BODY WEIGHT OF PATIENT
DOSE
NUMBER OF VIALS
Less than 60 kg
500 mg
2
60 to 100 kg
750 mg
3
More than 100 kg
1,000 mg
4
SUBCUTANEOUS USE FOR ADULT RA (2.1)
•
•
•
INTRAVENOUS USE FOR PJIA IN PEDIATRIC PATIENTS ≥6 YEARS OLD (2.2)
•
•
SUBCUTANEOUS USE FOR PJIA AND PSA IN PEDIATRIC PATIENTS ≥2 YEARS OLD
(2.2)
•
the treatment of adult patients with moderately to severely active
rheumatoid arthritis (RA). (1.1)
the treatment of patients 2 years of age and older with moderately to
severely active polyarticular
juvenile idiopathic arthritis (pJIA). (1.2)
the treatment of patients 2 years of age and older with active
psoriatic arthritis (PsA). (1.3)
the prophylaxis of acute graft versus host disease (aGVHD), in
combination with a calcineurin inhibitor
and methotrexate, in adults and pediatric patients 2 years of age and
older undergoing
hematopoietic stem cell transplantation (HSCT) from a matched or 1
allele-mismatched unrelated
donor. (1.4)
Administer at 0, 2, and 4 weeks, and every 4 weeks thereafter, as a
30-minute infus