Simlandi adalimumab-ryvk Kit — NDC 50090-7718-0 (Billing 50090-7718-00)

1 INDICATIONS AND USAGE SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): 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. ( 1.1 ) Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. ( 1.2 ) Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

( 1.3 ) Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS. ( 1.4 ) Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients.

( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque Psoriasis (Ps): 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. ( 1.7 ) Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients ( 1.8 ) Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients ( 1.9 )

1.1Rheumatoid Arthritis SIMLANDI 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. SIMLANDI can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

1.2Juvenile Idiopathic Arthritis SIMLANDI is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. SIMLANDI can be used alone or in combination with methotrexate.

1.3Psoriatic Arthritis SIMLANDI is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. SIMLANDI can be used alone or in combination with non-biologic DMARDs.

1.4Ankylosing Spondylitis SIMLANDI is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

1.5Crohn’s Disease SIMLANDI is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

1.6Ulcerative Colitis SIMLANDI 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 )] .

1.7Plaque Psoriasis SIMLANDI 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. SIMLANDI 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 )] .

1.8Hidradenitis Suppurativa SIMLANDI is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.

1.9Uveitis SIMLANDI is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

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 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

2.1Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis The recommended subcutaneous dosage of SIMLANDI 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 SIMLANDI. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of SIMLANDI to 40 mg every week or 80 mg every other week.

2.2Juvenile Idiopathic Arthritis The recommended subcutaneous dosage of SIMLANDI 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 SIMLANDI. Pediatric Weight (2 Years of Age and older) Recommended Dosage 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 There is no dosage form for SIMLANDI that allows weight-based dosing for pediatric patients below 15 kg.

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.

2.3Crohn’s Disease Adults The recommended subcutaneous dosage of SIMLANDI 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 SIMLANDI.

Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions ( 5.2 )] or MTX may be continued during treatment with SIMLANDI if necessary. Pediatrics The recommended subcutaneous dosage of SIMLANDI 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 ever… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS SIMLANDI is a clear and colorless solution available as: Autoinjector Injection: 80 mg/0.8 mL in a single-dose autoinjector. Injection: 40 mg/0.4 mL in a single-dose autoinjector. Prefilled Syringe Injection: 80 mg/0.8 mL in a single-dose prefilled glass syringe.

Injection: 40 mg/0.4 mL in a single-dose prefilled glass syringe. Injection: 20 mg/0.2 mL in a single-dose prefilled glass syringe. Injection: Single-dose autoinjector: 80 mg/0.8 mL, and 40 mg/0.4 mL ( 3 ) Single-dose prefilled glass syringe: 80 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.2 mL ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Infections Inform patients that SIMLANDI may lower the ability of their immune system to fight infections. Instruct patients of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Warnings and Precautions ( 5.1 , 5.2 , 5.4) ] .

Malignancies Counsel patients about the risk of malignancies while receiving SIMLANDI [see Warnings and Precautions ( 5.2 )] . Hypersensitivity Reactions Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions [see Warnings and Precautions ( 5.3 ), How Supplied/Storage and Handling ( 16 )] . Other Medical Conditions Advise patients to report any signs of new or worsening medical conditions such as congestive heart failure, neurological disease, autoimmune disorders, or cytopenias.

Advise patients to report any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever [see Warnings and Precautions ( 5.5 , 5.6 , 5.8 , 5.9 )] . Instructions on Injection Technique Inform patients that the first injection is to be performed under the supervision of a qualified health care professional. If a patient or caregiver is to administer SIMLANDI, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of SIMLANDI [see Instructions for Use ] .

For patients who will use the SIMLANDI Autoinjector, tell them that they: Will hear a ‘1 st click’ when the orange needle sleeve is pressed against the injection site. The ‘1 st click’ means the start of the injection. Must keep holding the SIMLANDI Autoinjector against their squeezed, raised skin until all of the medicine is injected.

This can take up to 15 seconds. Will know that the injection has finished when the orange indicator fully appears in the window view, stops moving, and they hear a second ‘click’. Instruct patients to dispose of their used needles and syringes or used autoinjector in a FDA-cleared sharps disposal container immediately after use.

Instruct patients not to dispose of loose needles and syringes or autoinjector in their household trash. Instruct patients that if they do not have a FDA-cleared sharps disposal container, they may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting and puncture-resistant lid without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. Instruct patients that when their sharps disposal container is almost full, they will need to follow their community guidelines for the correct way to dispose of their sharps disposal container.

Instruct patients that there may be state or local laws regarding disposal of used needles and syringes. Refer patients to the FDA’s website at http://www.fda.gov/safesharpsdisposal for more information about safe sharps disposal, and for specific information about sharps disposal in the state that they live in. Instruct patients not to dispose of their used sharps disposal container in their household trash unless their community guidelines permit this.

Instruct patients not to recycle their used sharps disposal container. Brands listed are the trademarks of their respective owners. Manufactured By: Alvotech USA Inc.

Leesburg, VA 20175 U.S. License No. 2225 Product of Iceland Marketed By: Teva Pharmaceuticals Parsippany, NJ 07054

MEDICATION GUIDE SIMLANDI ® (sim-LAN-dee) (adalimumab-ryvk) injection, for subcutaneous use Read the Medication Guide that comes with SIMLANDI 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 doctor about your medical condition or treatment.

What is the most important information I should know about SIMLANDI? SIMLANDI is a medicine that affects your immune system. SIMLANDI 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 doctor should test you for TB before starting SIMLANDI. Your doctor should check you closely for signs and symptoms of TB during treatment with SIMLANDI. You should not start taking SIMLANDI if you have any kind of infection unless your doctor says it is okay.

Before starting SIMLANDI, tell your doctor if you: think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired 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 doctor if you are not sure. live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use SIMLANDI. Ask your doctor if you do not know if you have lived in an area where these infections are common. have or have had hepatitis B. use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6-mercaptopurine, 6-MP). are scheduled to have major surgery.

After starting SIMLANDI, call your doctor right away if you have an infection, or any sign of an infection. SIMLANDI can make you more likely to get infections or make any infection that you may have worse. Cancer For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including SIMLANDI, the chances of getting cancer may increase.

There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers. People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma. If you use TNF blockers including SIMLANDI, your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin).

These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that does not heal. Some people receiving TNF blockers including SIMLANDI developed a rare type of cancer called hepatosplenic T-cell lymphoma.

This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6-MP).

What is SIMLANDI? SIMLANDI is a medicine called a Tumor Necrosis Factor (TNF) blocker. SIMLANDI is used: To reduce the signs and symptoms of: moderate to severe RA in adults.

SIMLANDI can be used alone, with methotrexate, or with certain other medicines. moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. SIMLANDI ca… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE SIMLANDI ® (sim-LAN-dee) (adalimumab-ryvk) injection, for subcutaneous use 40 mg/0.4 mL Single-Dose Autoinjector Before Injecting: Your healthcare provider should show you how to use SIMLANDI before you use it for the first time. Call your healthcare provider or 1-888-483-8279 if you have any questions. SIMLANDI Autoinjector Parts Important Information You Need to Know Before Injecting SIMLANDI Do not use the Autoinjector and call your healthcare provider or pharmacist if: Liquid is cloudy, discolored, or has flakes or particles in it Expiration date has passed Liquid has been frozen (even if thawed) or left in direct sunlight The Autoinjector has been dropped or crushed Keep the Clear Cap on until right before your injection.

How should I store SIMLANDI? Store SIMLANDI in the refrigerator between 36°F to 46°F (2°C to 8°C). Store SIMLANDI in the original carton until use to protect it from light.

Do not freeze Refrigerated SIMLANDI may be used until the expiration date printed on the SIMLANDI carton, dose tray or Autoinjector. If needed, for example when you are traveling, you may also store SIMLANDI at room temperature up to 77°F (25°C) for up to 30 days. Throw away SIMLANDI if it has been kept at room temperature and not used within 30 days.

Record the date you first remove SIMLANDI from the refrigerator in the spaces provided on the carton and dose tray. Do not store SIMLANDI in extreme heat or cold. Do not drop or crush SIMLANDI.

The prefilled syringe is glass. Keep SIMLANDI, injection supplies, and all other medicines out of reach of children. Read Instructions on All Pages Before Using the SIMLANDI Autoinjector Step 1 Take SIMLANDI out of the refrigerator (see Figure A ).

Leave SIMLANDI at room temperature for 15 to 30 minutes before injecting (see Figure B ). Do not remove the Clear Cap while allowing SIMLANDI to reach room temperature. Do not warm SIMLANDI in any other way.

For example, do not warm it in a microwave or in hot water. Do not use the Autoinjector if liquid has been frozen (even if thawed). Step 2 Check expiration date on the Autoinjector label (see Figure C ).

Do not use the Autoinjector if expiration date has passed. Place the following on a clean, flat surface (see Figure D ): 1 single-dose Autoinjector and alcohol swab 1 cotton ball or gauze pad (not included) Puncture-resistant sharps disposal container (not included). See Step 9 at the end of this Instructions for Use for instructions on how to throw away (dispose of) your SIMLANDI Autoinjector Wash and dry your hands (see Figure E ).

Step 3 Choose an injection site (see Figure F ): On the front of your thighs or Your abdomen (belly) at least 2 inches from your navel (belly button) Different from your last injection site Wipe the injection site in a circular motion with the alcohol swab (see Figure G ). Do not inject through clothes Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques Step 4 Hold the Autoinjector with the Gray Body Grip Area facing up. Check the window (see Figure H ).

It is normal to see 1 or more bubbles in the window Make sure the liquid is clear and colorless Do not use the Autoinjector if the liquid is cloudy, discolored, or has flakes or particles in it Do not use the Autoinjector if it has been dropped or crushed Step 5 Pull the Clear Cap straight off of the Autoinjector (see Figure I ). Throw the Clear Cap away. It is normal to see a few drops of liquid come out of the needle Never put the clear cap back on.

It may damage the needle. Turn the Autoinjector so that the orange needle sleeve points toward the injection site. Step 6 Squeeze the skin at your injection site to make a raised area and hold it firmly until the injection is complete.

Place the orange needle sleeve straight (90° angle) against the injection site (see Figure J ). Hold the Autoinjector so that you can see the window. Step 7 It is important that you firmly push the Autoinj… [Excerpted — this section continues on DailyMed.]