Adalimumab-aacf

2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis ( 2.1 ): Adults: 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week. Juvenile Idiopathic Arthritis ( 2.2 ): Pediatric Weight 2 Years of Age and Older Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week Crohn's Disease ( 2.3 ): Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29. Pediatric Patients 6 Years of Age and Older : Pediatric Weight Recommended Dosage Days 1 and 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week Ulcerative Colitis ( 2.4 ): Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57). Plaque Psoriasis or Adult Uveitis ( 2.5 ): Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose. Hidradenitis Suppurativa ( 2.6 ): Adults: Day 1: 160 mg (given in one day or split over two consecutive days) Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week 2.1 Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis The recommended subcutaneous dosage of Adalimumab-aacf for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti- inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with Adalimumab-aacf. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of Adalimumab-aacf to 40 mg every week or 80 mg every other week. 2.2 Juvenile Idiopathic Arthritis The recommended subcutaneous dosage of Adalimumab-aacf for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with Adalimumab-aacf. Pediatric Weight (2 Years of Age and older) Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week The only dosage form for Adalimumab-aacf that allows weight-based dosing for pediatric patients below 30 kg is the single-dose glass vial kit for institutional use only. 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. 2.3 Crohn's Disease Adults The recommended subcutaneous dosage of Adalimumab-aacf for adult patients with Crohn's disease (CD) is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a dosage of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with Adalimumab-aacf. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions ( 5.2 )] or MTX may be continued during treatment with Adalimumab-aacf if necessary. Pediatrics The recommended subcutaneous dosage of Adalimumab-aacf for pediatric patients 6 years of age and older with Crohn's disease (CD) is based on body weight as shown below: Pediatric Weight Recommended Dosage Days 1 through 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week The only dosage form for Adalimumab-aacf that allows weight-based dosing for pediatric patients below 40 kg is the single-dose glass vial kit for institutional use only 2.4 Ulcerative Colitis Adults The recommended subcutaneous dosage of Adalimumab-aacf for adult patients with ulcerative colitis is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) continue with a dosage of 40 mg every other week. Discontinue Adalimumab-aacf in adult patients without evidence of clinical remission by eight weeks (Day 57) of therapy. Aminosalicylates and/or corticosteroids may be continued during treatment with Adalimumab-aacf. Azathioprine and 6-mercaptopurine (6-MP) [ see Warnings and Precautions ( 5.2 )] may be continued during treatment with Adalimumab-aacf if necessary. 2.5 Plaque Psoriasis or Adult Uveitis The recommended subcutaneous dosage of Adalimumab-aacf for adult patients with plaque psoriasis (Ps) or Uveitis (UV) is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of adalimumab products in moderate to severe chronic Ps beyond one year has not been evaluated in controlled clinical studies. 2.6 Hidradenitis Suppurativa Adults The recommended subcutaneous dosage of Adalimumab-aacf for adult patients with hidradenitis suppurativa (HS) is an initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Begin 40 mg weekly or 80 mg every other week dosing two weeks later (Day 29). 2.7 Monitoring to Assess Safety Prior to initiating Adalimumab-aacf and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions ( 5.1 )] . 2.8 General Considerations for Administration Adalimumab-aacf Pen or prefilled syringe is intended for use under the guidance and supervision of a physician. A patient may self-inject Adalimumab-aacf or a caregiver may inject Adalimumab-aacf using either the Adalimumab-aacf Pen or prefilled syringe if a physician determines that it is appropriate, and with medical follow-up, as necessary, after proper training in subcutaneous injection technique. Adalimumab-aacf may be taken out of the refrigerator for 15 to 30 minutes before injecting to allow the liquid to come to room temperature. Do not remove the cap or cover while allowing it to reach room temperature. Carefully inspect the solution in the Adalimumab-aacf Pen, or prefilled syringe or single dose institutional use vial for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, do not use the product. Adalimumab-aacf does not contain preservatives. Therefore, discard unused portions of drug remaining in the syringe. Instruct patients using the Adalimumab-aacf Pen or prefilled syringe to inject the full amount in the syringe, according to the directions provided in the Instructions for Use [see Instructions for Use ]. Injections should occur at separate sites in the thigh or abdomen. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. The Adalimumab-aacf syringe plunger stopper and needle cover are not made with natural rubber latex. The Adalimumab-aacf single-dose institutional use vial kit is for administration within an institutional setting only, such as a hospital, physician's office, or clinic. Withdraw the dose using the vial adapter, the sterile syringe and needle provided. Only administer one dose per vial. The vial does not contain preservatives; discard unused portion. The Adalimumab-aacf vial and syringe stopper are not made with natural rubber latex. Read these Administration Instructions before using the Adalimumab-aacf Vial kit. Adalimumab-aacf is supplied in a carton containing 1 sterile single-use syringe, 1 sterile needle, 1 vial adapter, 2 alcohol preps and 1 glass vial providing 40 mg/0.8 mL of Adalimumab-aacf ( Figure A ) The contents of the Idacio Vial Kit are for single-dose (one-time) use only. Discard unused portion. Figure A Prior to Administration Remove the Adalimumab-aacf Vial Kit from the refrigerator and let it sit at room temperature for at least 30 minutes. Check the expiration date. Remove Vial Kit contents from the carton and inspect for damage. Do not use if any kit component or packaging has been damaged. Check the vial contents to make sure that the liquid is clear, colorless, and free of particles and flakes. Note : Prepare syringe just prior to administration and inject immediately. Do not store Adalimumab-aacf in the syringe. Step 1. Prepare Vial and Vial Adapter 1.1 Remove plastic flip off cap from vial and disinfect the rubber stopper. Do not touch the top of the vial after cleaning. 1.2 Without removing the vial adapter from its packaging, peel off the top cover ( Figure B ). Do not touch the vial adapter. Figure B 1.3 With the vial adapter still in its packaging, push the vial adapter onto the vial top until it snaps in place ( Figure C ). Figure C 1.4 Remove the vial adapter packaging ( Figure D ) Figure D Step 2. Connect Syringe to Vial Adapter 2.1 Remove syringe from outer packaging. Do not touch the syringe tip. 2.2 Hold the base of the vial adapter and connect the syringe to the vial adapter by turning it clockwise ( Figure E ). Figure E Step 3. Withdraw the Dose 3.1 Invert the vial completely with the vial adapter and syringe still connected ( Figure F ). Figure F 3.2 Slowly withdraw the prescribed dose of Adalimumab-aacf into the syringe for administration ( Figure G ). Remove air bubbles from the syringe. Do not pull the plunger rod out. Figure G Step 4. Disconnect the syringe 4.1 Turn over the vial and syringe. Hold the base of the vial adapter and disconnect the syringe from the vial adapter by turning it counterclockwise ( Figure H ). Do not touch the syringe tip. Figure H Step 5. Attach Needle Figure I 5.1 Peel open the outer needle packaging to uncover the yellow syringe connector ( Figure J ). Figure J 5.2 Insert the syringe tip into the syringe connector. Turn the syringe connector in a clockwise direction to tighten ( Figure K ). Figure K 5.3 Pull the outer needle packaging off ( Figure L ). Do not remove the clear needle cap. Figure L 5.4 Pull back the needle safety cover toward the syringe ( Figure M ). Do not remove the needle cover from the connector. Figure M Step 6. Administer medication 6.1 When you are ready to inject Adalimumab-aacf remove the clear needle cap by pulling it straight off and throw it away ( Figure N ). Do not recap the needle. Figure N 6.2 Administer the dose subcutaneously. 6.3 Place your thumb or index finger on the center of the textured finger pad and push the pink needle safety cover forward over the needle until you hear it click or feel it lock ( Figure O ). Figure O Step 7. Discard Used Syringe and Needle 7.1 Discard used syringe and needle into an appropriate sharps container. Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H Figure I Figure J Figure K Figure L Figure M Figure N Figure O

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1 INDICATIONS AND USAGE Adalimumab-aacf is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ): 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 RA.