Simlandi

Indications and Usage, Hidradenitis Suppurativa (1.8) 10/2025 Indications and Usage, Uveitis (1.9) 10/2025 Dosage and Administration, Recommended Dosage in Juvenile Idiopathic Arthritis or Pediatric Uveitis (2.3) 10/2025 Dosage and Administration, Recommended Dosage in Hidradenitis Suppurativa (2.6) 10/2025 Warnings and Precautions, Autoimmunity (5.9) 10/2025 Indications and Usage, Hidradenitis Suppurativa ( 1.8 ) 10/2025 Indications and Usage, Uveitis ( 1.9 ) 10/2025 Dosage and Administration, Recommended Dosage in Juvenile Idiopathic Arthritis or Pediatric Uveitis ( 2.3 ) 10/2025 Dosage and Administration, Recommended Dosage in Hidradenitis Suppurativa ( 2.7 ) 10/2025 Warnings and Precautions, Autoimmunity ( 5.9 ) 10/2025

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 ) 1.1 Rheumatoid 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). 1.2 Juvenile 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. 1.3 Psoriatic 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. 1.4 Ankylosing Spondylitis SIMLANDI is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’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. 1.6 Ulcerative 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 )] . 1.7 Plaque 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 )] . 1.8 Hidradenitis Suppurativa SIMLANDI is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis 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 ( 2.2 ): 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 or Pediatric Uveitis ( 2.3 ): 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 ( 2.4 ): 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. 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 ( 2.5 ): 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 ( 2.6 ): Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose. Hidradenitis Suppurativa ( 2.7 ): 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 Adolescents 12 years of age and older: Adolescent Weight Recommended Dosage 30 kg (66 lbs) to less than 60 kg (132 lbs) Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week 60 kg (132 lbs) and greater 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 Recommended Tuberculosis Evaluation Prior to initiating SIMLANDI and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions ( 5.1 )] . 2.2 Recommended Dosage in Rheumatoid 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) [see Indication and Usage ( 1.1 , 1.3 , 1.4 )] 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. 2.3 Recommended Dosage in Juvenile Idiopathic Arthritis or Pediatric Patients with Uveitis The recommended subcutaneous dosage of SIMLANDI for pediatric patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) or pediatric uveitis [see Indications and Usage ( 1.2 , 1.9 )] , based on weight, is 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 or pediatric uveitis less than 2 years of age or in patients with a weight below 10 kg. 2.4 Recommended Dosage in Crohn’s Disease Subcutaneous Adult Dosage Regimen The recommended subcutaneous dosage of SIMLANDI for adult patients with moderately to severely active Cro …

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 )

4 CONTRAINDICATIONS None. None ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Malignancies [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Hepatitis B Virus Reactivation [see Warnings and Precautions ( 5.4 )] Neurologic Reactions [see Warnings and Precautions ( 5.5 )] Hematological Reactions [see Warnings and Precautions ( 5.6 )] Heart Failure [see Warnings and Precautions ( 5.8 )] Autoimmunity [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction with adalimumab was injection site reactions. In placebo-controlled trials, 20% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of patients receiving placebo. Most injection site reactions were described as mild and generally did not necessitate drug discontinuation. The proportion of patients who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies in patients with RA (i.e., Studies RA-I, RA-II, RA-III and RA-IV) was 7% for patients taking adalimumab and 4% for placebo-treated patients. The most common adverse reactions leading to discontinuation of adalimumab in these RA studies were clinical flare reaction (0.7%), rash (0.3%) and pneumonia (0.3%). Infections In the controlled portions of the 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, Ps, HS and UV, the rate of serious infections was 4.3 per 100 patient-years in 7973 adalimumab-treated patients versus a rate of 2.9 per 100 patient-years in 4848 control-treated patients. Serious infections observed included pneumonia, septic arthritis, prosthetic and post-surgical infections, erysipelas, cellulitis, diverticulitis, and pyelonephritis [see Warnings and Precautions ( 5.1 )] . Tuberculosis and Opportunistic Infections In 52 global controlled and uncontrolled clinical trials in RA, PsA, AS, CD, UC, Ps, HS and UV that included 24,605 adalimumab-treated patients, the rate of reported active tuberculosis was 0.20 per 100 patient-years and the rate of positive PPD conversion was 0.09 per 100 patient-years. In a subgroup of 10,113 U.S. and Canadian adalimumab-treated patients, the rate of reported active TB was 0.05 per 100 patient-years and the rate of positive PPD conversion was 0.07 per 100 patient-years. These trials included reports of miliary, lymphatic, peritoneal, and pulmonary TB. Most of the TB cases occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease. In these global clinical trials, cases of serious opportunistic infections have been reported at an overall rate of 0.05 per 100 patient-years. Some cases of serious opportunistic infections and TB have been fatal [see Warnings and Precautions ( 5.1 )] . Autoantibodies In the rheumatoid arthritis controlled trials, 12% of patients treated with adalimumab and 7% of placebo-treated patients that had negative baseline ANA titers developed positive titers at week 24. Two patients out of 3046 treated with adalimumab developed clinical signs suggestive of new-onset lupus-like syndrome. The patients improved following discontinuation of therapy. No patients developed lupus nephritis or central nervous system s …

7 DRUG INTERACTIONS Abatacept: Increased risk of serious infection. ( 5.1 , 5.11 , 7.2 ) Anakinra: Increased risk of serious infection. ( 5.1 , 5.7 , 7.2 ) Live vaccines: Avoid use with SIMLANDI. ( 5.10 , 7.3 ) 7.1 Methotrexate Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX). Although MTX reduced the apparent clearance of adalimumab, the data do not suggest the need for dose adjustment of either SIMLANDI or MTX [see Clinical Pharmacology ( 12.3 )] . 7.2 Biological Products In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of SIMLANDI with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions ( 5.7 , 5.11 )] . A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of SIMLANDI and other biologic products for the treatment of RA, PsA, AS, CD, UC, Ps, HS, and UV. Concomitant administration of SIMLANDI with other biologic DMARDS (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. 7.3 Live Vaccines Avoid the use of live vaccines with SIMLANDI [see Warnings and Precautions ( 5.10 )] . 7.4 Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased concentrations of cytokines (e.g., TNFα, IL-6) during chronic inflammation. It is possible for products that antagonize cytokine activity, such as adalimumab products, to influence the formation of CYP450 enzymes. Upon initiation or discontinuation of SIMLANDI in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 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% to 4% and 15% to 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 to 19.7 mcg/mL in cord blood, 4.28 to 17.7 mcg/mL in infant serum, and 0 to 16.1 mcg/mL in maternal serum. In all but one case, the cord blood concentration of adali …

12.1 Mechanism of Action Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. Adalimumab products do not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated concentrations of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased concentrations of TNF are also found in psoriasis plaques. In Ps, treatment with SIMLANDI may reduce the epidermal thickness and infiltration of inflammatory cells. The relationship between these pharmacodynamic activities and the mechanism(s) by which adalimumab products exert their clinical effects is unknown. Adalimumab products also modulate biological responses that are induced or regulated by TNF, including changes in the concentrations of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC 50 of 1-2 X 10 -10 M).

11 DESCRIPTION Adalimumab-ryvk is a tumor necrosis factor blocker. Adalimumab-ryvk is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-ryvk is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. SIMLANDI ® (adalimumab-ryvk) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SIMLANDI autoinjector or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of SIMLANDI is clear and colorless, with a pH of 5.0-5.6. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of SIMLANDI contains adalimumab-ryvk (80 mg), polysorbate 80 (0.80 mg), sodium chloride (0.47 mg), sucrose (69.83 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of SIMLANDI contains adalimumab-ryvk (40 mg), polysorbate 80 (0.40 mg), sodium chloride (0.23 mg), sucrose (34.9 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of SIMLANDI contains adalimumab-ryvk (20 mg), polysorbate 80 (0.20 mg), sodium chloride (0.12 mg), sucrose (17.46 mg), and Water for Injection, USP. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH.

10 OVERDOSAGE Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. Consider contacting the Poison Help line (1-800-222-1222) or medical toxicologist for additional overdose management recommendations.

16 HOW SUPPLIED/STORAGE AND HANDLING SIMLANDI ® (adalimumab-ryvk) injection is supplied as a preservative-free, sterile, clear and colorless solution for subcutaneous administration. The following packaging configurations are available. SIMLANDI Autoinjector Carton - 80 mg/0.8 mL (One Count) SIMLANDI is supplied in a carton containing one alcohol prep and one dose tray. The dose tray consists of a single-dose autoinjector, containing a 1 mL prefilled glass syringe with a fixed 29-gauge (1/2 inch) needle, providing 80 mg/0.8 mL of SIMLANDI. The SIMLANDI autoinjector is not made with natural rubber latex. The NDC number is NDC 51759 -274- 17. SIMLANDI Autoinjectors Carton - 80 mg/0.8 mL (Three Count) SIMLANDI is supplied in a carton containing four alcohol preps and three dose trays. Each dose tray consists of a single-dose autoinjector, containing a 1 mL prefilled glass syringe with a fixed 29-gauge (1/2 inch) needle, providing 80 mg/0.8 mL of SIMLANDI. The SIMLANDI autoinjector is not made with natural rubber latex. The NDC number is NDC 51759 -274- 03. SIMLANDI Autoinjector Carton - 40 mg/0.4 mL (One Count) SIMLANDI is supplied in a carton containing one alcohol prep and one dose tray. The dose tray consists of a single-dose autoinjector, containing a 1 mL prefilled glass syringe with a fixed 29-gauge (1/2 inch) needle, providing 40 mg/0.4 mL of SIMLANDI. The SIMLANDI autoinjector is not made with natural rubber latex. The NDC number is NDC 51759 -402- 17. SIMLANDI Autoinjectors Carton - 40 mg/0.4 mL (Two Count) SIMLANDI is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose autoinjector, containing a 1 mL prefilled glass syringe with a fixed 29-gauge (1/2 inch) needle, providing 40 mg/0.4 mL of SIMLANDI. The SIMLANDI autoinjector is not made with natural rubber latex. The NDC number is NDC 51759 -402- 02. SIMLANDI Prefilled Syringe Carton - 80 mg/0.8 mL (One Count) SIMLANDI is supplied in a carton containing two alcohol preps and one dose tray. The dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, 1/2 inch needle and fitted with a plunger rod, finger grip and a rigid needle cover, providing 80 mg/0.8 mL of SIMLANDI. The gray needle cover is not made with natural rubber latex. The NDC number is NDC 51759- 523 -21. SIMLANDI Prefilled Syringe Carton - 40 mg/0.4 mL (Two Count) SIMLANDI is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, 1/2 inch needle and fitted with a plunger rod, finger grip and a rigid needle cover, providing 40 mg/0.4 mL of SIMLANDI. The gray needle cover is not made with natural rubber latex. The NDC number is NDC 51759- 412 -22. SIMLANDI Prefilled Syringe Carton - 20 mg/0.2 mL (Two Count) SIMLANDI is supplied in a carton containing two alcohol preps and two dose trays. Each dose tray consists of a single-dose, 1 mL prefilled glass syringe with a fixed thin wall, 1/2 inch needle and fitted with a plunger rod, finger grip and a rigid needle cover, providing 20 mg/0.2 mL of SIMLANDI. The gray needle cover is not made with natural rubber latex. The NDC number is NDC 51759- 386 -22. Storage and Stability Do not use beyond the expiration date on the container. SIMLANDI 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, SIMLANDI may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 30 days, with protection from light. SIMLANDI should be discarded if not used within the 30-day period. Record the date when SIMLANDI is first removed from the refrigerator in the spaces provided on the carton and dose tray. Do not store SIMLANDI in extreme heat or cold.