Zoryve Drug Information

    Generic name: ROFLUMILAST

    Phosphodiesterase 4 Inhibitor [EPC]

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    Uses of Zoryve

    Plaque Psoriasis

    ZORYVE ® cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

    Atopic Dermatitis

    ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

    Dosage & Administration of Zoryve

    Plaque Psoriasis Use ZORYVE cream, 0.3%, for the treatment of plaque psoriasis in adult and pediatric patients 6 years of age and older. Atopic Dermatitis Use ZORYVE cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. Use ZORYVE cream, 0.05%, for the treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

    Administration Instructions Apply ZORYVE cream to affected areas once daily and rub in completely. Wash hands after application. ZORYVE cream is for topical use only and not for ophthalmic, oral, or intravaginal use.

    For topical use only. Not for ophthalmic, oral, or intravaginal use. Plaque Psoriasis Apply ZORYVE cream, 0.3%, once daily to affected areas.

    Atopic Dermatitis Adult and Pediatric Patients 6 Years of Age and Older Apply ZORYVE cream, 0.15%, once daily to affected areas. Pediatric Patients 2 to 5 Years of Age Apply ZORYVE cream, 0.05%, once daily to affected areas.

    Side Effects of Zoryve

    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. Plaque Psoriasis Adult and Pediatric Subjects 6 Years of Age and Older In two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 and DERMIS-2), 881 adult and pediatric subjects 6 years of age or older with plaque psoriasis were treated with ZORYVE cream, 0.3%, or vehicle cream once daily for 8 weeks . The proportion of subjects who discontinued treatment due to an adverse reaction was 1.0% for subjects treated with ZORYVE cream, 0.3%, and 1.3% for subjects treated with vehicle cream. The most common adverse reaction that led to discontinuation of ZORYVE cream, 0.3%, was application site urticaria (0.3%). Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with ZORYVE cream, 0.3%, and for which the rate exceeded the rate for vehicle cream.

    Table 1: Adverse Reactions Reported in ≥1% of Adult and Pediatric Subjects 6 Years of Age and Older with Plaque Psoriasis Treated with ZORYVE Cream, 0.3%, (and More Frequently than Vehicle Cream) for 8 Weeks in Trials DERMIS-1 and DERMIS-2 Adverse Reaction ZORYVE Cream, 0.3% (N=576) n (%) Vehicle Cream (N=305) n (%) Diarrhea 18 0 Headache 14 3 Insomnia 8 2 Nausea 7 1 Application site pain 6 1 Upper respiratory tract infection 6 1 Urinary tract infection 6 2 In 594 subjects with plaque psoriasis who continued treatment with ZORYVE cream, 0.3%, for up to 64 weeks in open-label extension trials, the adverse reaction profile was consistent with that observed in vehicle-controlled trials. Atopic Dermatitis Adult and Pediatric Subjects 6 Years of Age and Older In two multicenter, randomized, double-blind, vehicle-controlled trials (INTEGUMENT-1 and INTEGUMENT-2), 1336 adult and pediatric subjects 6 years of age or older with mild to moderate atopic dermatitis were treated with ZORYVE cream, 0.15%, or vehicle cream once daily for 4 weeks . The proportion of subjects who discontinued treatment due to an adverse reaction was 1.6% for subjects treated with ZORYVE cream, 0.15%, and 1.1% for subjects treated with vehicle cream. Table 2 presents adverse reactions that occurred in at least 1% of subjects treated with ZORYVE cream, 0.15%, and for which the rate exceeded the rate for vehicle cream.

    Table 2: Adverse Reactions Reported in ≥1% of Adult and Pediatric Subjects 6 Years of Age and Older with Atopic Dermatitis Treated with ZORYVE Cream, 0.15%, (and More Frequently than Vehicle Cream) for 4 Weeks in Trials INTEGUMENT-1 and INTEGUMENT-2 Adverse Reaction ZORYVE Cream, 0.15% (N=885) n (%) Vehicle Cream (N=451) n (%) Headache 26 4 Nausea 17 2 Application site pain 13 3 Diarrhea 13 2 Vomiting 13 2 The adverse reaction of insomnia was reported in fewer than 1% of subjects treated with ZORYVE cream, 0.15%. Pediatric Subjects 2 to 5 Years of Age In a multicenter, randomized, double-blind, vehicle-controlled trial (INTEGUMENT-PED), 652 pediatric subjects 2 to 5 years of age with mild to moderate atopic dermatitis were treated with ZORYVE cream, 0.05%, or vehicle cream once daily for 4 weeks . Table 3 presents adverse reactions that occurred in at least 1% of subjects treated with ZORYVE cream, 0.05%, and for which the rate exceeded the rate for vehicle cream. Table 3: Adverse Reactions Reported in ≥1% of Pediatric Subjects 2 to 5 Years of Age with Atopic Dermatitis Treated with ZORYVE Cream, 0.05%, (and More Frequently than Vehicle) for 4 Weeks in Trial INTEGUMENT-PED Adverse Reaction ZORYVE Cream, 0.05% N=437 n (%) Vehicle Cream N=215 n (%) Upper respiratory tract infection 18 3 Diarrhea 11 1 Vomiting 9 0 Rhinitis 7 0 Conjunctivitis 6 0 Headache 5 0 Adult and Pediatric Subjects 2 Years of Age and Older The long-term safety of ZORYVE cream, 0.15%, and ZORYVE cream, 0.05%, was assessed in an open-label extension trial of 1219 subjects 2 years of age and older with mild to moderate atopic dermatitis who had completed one of the 4-week vehicle-controlled trials. The safety profile observed in the open-label extension trial was generally consistent with the safety profile observed at Week 4.

    Drug Interactions with Zoryve

    Effects of Other Drugs on

    ZORYVE Cream Drugs that Inhibit Cytochrome P450 (CYP) Enzymes No formal drug-drug interaction studies were conducted with ZORYVE cream; however, the co-administration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with ZORYVE cream, weigh the potential for increased adverse reactions against benefit . Oral Contraceptives Containing Gestodene and Ethinyl Estradiol The co-administration of roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with ZORYVE cream, weigh the potential for increased adverse reactions against benefit .

    Pregnancy Safety for Zoryve

    Pregnancy Risk Summary There are insufficient data available on the use of ZORYVE cream in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, roflumilast administered orally to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 36 and 31 times the maximum recommended human dose (MRHD), respectively. Roflumilast induced post-implantation loss in rats at oral doses greater than or equal to 12 times the MRHD. Roflumilast induced stillbirth and decreased pup viability in mice at oral doses 19 and 59 times the MRHD, respectively.

    Roflumilast has been shown to adversely affect pup post-natal development when dams were treated with an oral dose 59 times the MRHD during pregnancy and lactation periods in mice ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. 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 Labor or Delivery Avoid using ZORYVE cream during labor and delivery.

    There are no human studies that have investigated effects of ZORYVE cream on preterm labor or labor at term; however, animal studies showed that oral roflumilast disrupted the labor and delivery process in mice. Data Animal Data In an embryo-fetal development study, pregnant rats were dosed orally during the period of organogenesis with up to 1.8 mg/kg/day roflumilast (36 times the MRHD on a mg/m 2 basis). No evidence of structural abnormalities or effects on survival rates were observed. Roflumilast did not affect embryo-fetal development at a maternal oral dose of 0.2 mg/kg/day (4 times the MRHD on a mg/m 2 basis). In a fertility and embryo-fetal development study, male rats were dosed orally with up to 1.8 mg/kg/day roflumilast for 10 weeks and females for 2 weeks prior to pairing and throughout the organogenesis period.

    Roflumilast induced pre- and post-implantation loss at maternal oral doses greater than or equal to 0.6 mg/kg/day (12 times the MRHD on a mg/m 2 basis). Roflumilast did not cause fetal structural abnormalities at maternal oral doses up to 1.8 mg/kg/day (35 times the MRHD on a mg/m 2 basis). In an embryo-fetal development study in rabbits, pregnant does were dosed orally with 0.8 mg/kg/day roflumilast during the period of organogenesis. Roflumilast did not cause fetal structural abnormalities at the maternal oral doses of 0.8 mg/kg/day (31 times the MRHD on a mg/m 2 basis). In pre- and post-natal developmental studies in mice, dams were dosed orally with up to 12 mg/kg/day roflumilast during the period of organogenesis and lactation. Roflumilast induced stillbirth and decreased pup viability at maternal oral doses greater than 2 mg/kg/day and 6 mg/kg/day, respectively (19 and 59 times the MRHD on a mg/m 2 basis, respectively). Roflumilast induced delivery retardation in pregnant mice at maternal oral doses greater than 2 mg/kg/day (19 times the MRHD on a mg/m 2 basis). Roflumilast decreased pup rearing frequencies at a maternal oral dose of 6 mg/kg/day during pregnancy and lactation (59 times the MRHD on a mg/m 2 basis). Roflumilast also decreased survival and forelimb grip reflex and delayed pinna detachment in mouse pups at a maternal oral dose of 12 mg/kg/day (116 times the MRHD on a mg/m 2 basis).

    Pediatric Use of Zoryve

    Pediatric Use Plaque Psoriasis The safety and effectiveness of ZORYVE cream, 0.3%, for the topical treatment of plaque psoriasis, including intertriginous areas, have been established in pediatric patients 6 years of age and older. Use of ZORYVE cream, 0.3%, in pediatric patients 6 years of age and older is supported by data from two 8-week, vehicle-controlled, safety and efficacy trials which included 18 subjects 6 to 17 years of age, of whom 11 received ZORYVE cream, 0.3%. Use of ZORYVE cream, 0.3%, in pediatric patients 12 years of age and older is also supported by data from open-label trials of 2- and 24-weeks duration which included 18 subjects 12 to 17 years of age treated with ZORYVE cream, 0.3%. Use of ZORYVE cream, 0.3%, in pediatric patients 6 to less than 12 years of age is also supported by data from one 4-week, open-label, safety and pharmacokinetic (PK) study which included 20 pediatric subjects 6 to less than 12 years of age . The safety and effectiveness of ZORYVE cream, 0.3%, have not been established in pediatric patients younger than 6 years of age. Atopic Dermatitis ZORYVE Cream, 0.15% The safety and effectiveness of ZORYVE cream, 0.15%, for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 6 years of age and older.

    Use of ZORYVE cream, 0.15%, in this age group is supported by data from two 4-week, vehicle-controlled, safety and efficacy trials which included 615 subjects 6 to 17 years of age, of whom 406 received ZORYVE cream, 0.15%, . Use of ZORYVE cream, 0.15%, in pediatric patients 6 years of age and older is also supported by data from 481 pediatric subjects treated with ZORYVE cream, 0.15%, in open-label trials, of which 104 were treated for 52 weeks. In an open-label PK trial in 36 pediatric subjects 2 to 16 years of age, following topical administration of roflumilast cream, 0.15%, once daily for 2 weeks, mean systemic exposure of roflumilast and roflumilast N-oxide in subjects 2 to 5 years of age was approximately 3.2-fold and 5.2-fold higher, respectively, compared to subjects 12 to 16 years of age, and approximately 2-fold and 2.3-fold higher, respectively, compared to subjects 6 to 11 years of age. The safety and effectiveness of ZORYVE cream, 0.15%, have not been established in pediatric patients younger than 6 years of age.

    ZORYVE Cream, 0.05% The safety and effectiveness of ZORYVE cream, 0.05%, for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 2 to 5 years of age. Use of ZORYVE cream, 0.05%, in this age group is supported by data from one 4-week, vehicle-controlled, safety and efficacy trial which included 652 subjects 2 to 5 years of age, of whom 437 received ZORYVE cream, 0.05%, . Use of ZORYVE cream, 0.05%, in pediatric patients 2 to 5 years of age is also supported by data from 572 pediatric subjects treated with ZORYVE cream, 0.05%, in open-label trials, of whom 353 were treated for 52 weeks. The safety and effectiveness of ZORYVE cream, 0.05%, have not been established in pediatric patients younger than 2 years of age and older than 6 years of age.

    Contraindications for Zoryve

    cream is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C) . Moderate to severe liver impairment (Child-Pugh B or C).

    Clinical Studies of Zoryve

    Plaque Psoriasis Adult and Pediatric Subjects 6 Years of Age and Older

    Two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 and DERMIS-2 ) enrolled a total of 881 adult and pediatric subjects 6 years of age or older with mild to severe plaque psoriasis. Subjects were randomized 2:1 to receive ZORYVE cream, 0.3%, or vehicle cream applied topically once daily for 8 weeks. The median age of the trial population was 47 years (range 6 to 88 years of age). The trial population was 64% male and 36% female; 82.3% were White, 7.1% Asian, 3.6% Black or African American, 0.9% Native Hawaiian or Other Pacific Islander, 0.7% American Indian or Alaska Native, 0.5% more than one race, 3.3% other races, and 1.6% with missing racial information.

    For ethnicity, 75.7% of subjects identified as Not Hispanic or Latino, 24.1% identified as Hispanic or Latino, and 0.2% were unknown. The median body surface area (BSA) affected of the trial population was 5.5% (range 2% to 20%). At baseline, 16% of subjects had an Investigator Global Assessment (IGA) score of 2 (mild), 76% had an IGA score of 3 (moderate), and 8% had an IGA score of 4 (severe). One hundred seventy-nine (20%) subjects had a baseline intertriginous IGA (I-IGA) score of 2 or higher (mild), and 678 (77%) subjects had a baseline Worst Itch Numeric Rating Scale (WI-NRS) score of 4 or higher on a scale of 0 to 10. The primary endpoint was the proportion of subjects who achieved IGA treatment success at Week 8 (Table 4). Success was defined as a score of "Clear" or "Almost Clear", plus a 2-grade improvement from baseline. Table 4: IGA Treatment Success IGA treatment success was defined as an IGA score of "Clear" or "Almost Clear", plus a 2-grade IGA score improvement from baseline at Week 8 (Multiple Imputation). at Week 8 in Adult and Pediatric Subjects 6 Years of Age and Older with Mild to Severe Plaque Psoriasis in Trials DERMIS-1 and DERMIS-2 DERMIS-1 DERMIS-2 ZORYVE Cream, 0.3% Vehicle Cream ZORYVE Cream, 0.3% Vehicle Cream Subjects randomized N=286 N=153 N=290 N=152 Abbreviations: CI = Confidence Interval IGA success 41.5% 5.8% 36.7% 7.1% Difference from vehicle (95% CI) Treatment difference and 95% CI are based on the CMH method stratified by site, baseline IGA, and baseline intertriginous involvement. 39.7% (32.4%, 47.0%) 29.5% (21.5%, 37.6%) Secondary endpoints included the proportion of subjects that achieved I-IGA success at Week 8 and WI-NRS success sequentially at Weeks 8, 4, and 2 (see Figure 1 ). WI-NRS success was defined as a reduction of at least 4 points from baseline in subjects with a baseline WI-NRS score of at least 4. Figure 1: WI-NRS Success WI-NRS success is a reduction of at least 4 points in subjects with a WI-NRS score of 4 or higher at baseline.

    Over Time in Adult and Pediatric Subjects 12 Years of Age and Older with Mild to Severe Plaque Psoriasis in Trials DERMIS-1 and DERMIS-2 † The treatment difference at Week 2 in DERMIS-1 was not statistically significant. Among subjects with an I-IGA score of at least 2 (mild) at baseline (approximately 22% of subjects in DERMIS-1 and 19% in DERMIS-2), there was a higher percentage of subjects who achieved I-IGA success at Week 8 in the group who received ZORYVE cream, 0.3%, compared to the group who received vehicle cream (DERMIS-1: 71.5% vs. 13.8%; DERMIS-2: 67.5% vs. 17.4%). Figure 1

    Atopic Dermatitis Adult and Pediatric Subjects 6 Years of Age and Older

    Two multicenter, randomized, double-blind, vehicle-controlled trials (INTEGUMENT-1 and INTEGUMENT-2 ) enrolled a total of 1337 adult and pediatric subjects 6 years of age and older (615 subjects were 6 to 17 years of age) with mild to moderate atopic dermatitis. Subjects were randomized 2:1 to receive ZORYVE cream, 0.15%, or vehicle cream applied once daily for 4 weeks. The median age of the trial population was 20 years (range 6 to 91 years of age). The trial population was 57% female; 59.5% were White, 20.3% Black or African American, 13.2% Asian, 3.4% other races, 2.8% more than one race, 0.6% American Indian or Alaska Native, and 0.1% Native Hawaiian or Other Pacific Islander.

    For ethnicity, 82.8% of subjects identified as Not Hispanic or Latino, 16.6% identified as Hispanic or Latino, and 0.6% were unknown. At baseline, subjects had a mean affected BSA of 14% (range of 3% to 88%), and 42% had facial involvement. At baseline, 24% of subjects had a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2 (mild), and 76% had a vIGA-AD score of 3 (moderate). Eight hundred thirteen (60.8%) subjects 12 years of age and older had a baseline WI-NRS score of 4 or higher on a scale of 0 to 10. The primary endpoint was the proportion of subjects who achieved vIGA-AD treatment success at Week 4 (Table 5). Success was defined as a score of "Clear" or "Almost Clear", plus a 2-grade improvement from baseline.

    Secondary endpoints included the proportion of subjects that achieved vIGA-AD success at Weeks 2 and 1 (Figure 2) and WI-NRS success at Weeks 4, 2, and 1 (Table 6, Figure 3). WI-NRS success was defined as a reduction of at least 4 points from baseline in subjects 12 years of age or older with a baseline WI-NRS score of at least 4. Table 5: vIGA-AD Success vIGA-AD success was defined as a vIGA-AD score of "Clear" or "Almost Clear", plus a 2-grade vIGA-AD score improvement from baseline at Week 4 (Multiple Imputation). at Week 4 in Adult and Pediatric Subjects 6 Years of Age and Older with Mild to Moderate Atopic Dermatitis in Trials INTEGUMENT-1 and INTEGUMENT-2 INTEGUMENT-1 INTEGUMENT-2 ZORYVE Cream, 0.15% Vehicle Cream ZORYVE Cream, 0.15% Vehicle Cream Abbreviations: CI = Confidence Interval Subjects randomized N=433 N=221 N=451 N=232 vIGA-AD success 32.0% 15.2% 28.9% 12.0% Difference from vehicle (95% CI) The difference in percent and related 95% CIs are Mantel-Haenszel estimates stratified by pooled study site and vIGA-AD randomization strata. 17.4% (11.09%, 23.75%) 16.5% (10.61%, 22.42%) Figure 2: vIGA-AD Success vIGA-AD success was defined as a vIGA-AD score of "Clear" or "Almost Clear", plus a 2-grade vIGA-AD score improvement from baseline at Week 4 (Multiple Imputation). Over Time in Adult and Pediatric Subjects 6 Years of Age and Older with Mild to Moderate Atopic Dermatitis in Trials INTEGUMENT-1 and INTEGUMENT-2 † The treatment difference at Week 1 in INTEGUMENT-2 was not statistically significant. Table 6: WI-NRS Success WI-NRS success was defined as a reduction of at least 4 points from baseline for subjects 12 years of age or older with a baseline score of at least 4. at Week 4 in Adult and Pediatric Subjects 12 Years of Age and Older with Mild to Moderate Atopic Dermatitis in Trials INTEGUMENT-1 and INTEGUMENT-2 INTEGUMENT-1 INTEGUMENT-2 ZORYVE Cream, 0.15% Vehicle Cream ZORYVE Cream, 0.15% Vehicle Cream Abbreviations: CI = Confidence Interval Subjects randomized N=433 N=221 N=451 N=232 Subjects ≥12 years randomized with baseline WI-NRS ≥4 N=278 N=135 N=264 N=136 WI-NRS success 33.6% 20.7% 30.2% 12.4% Difference from vehicle (95% CI) The difference in percent and related 95% CIs are Mantel-Haenszel estimates stratified by pooled study site and vIGA-AD randomization strata. 13.3% (4.01%, 22.60%) 15.0% (6.52%, 23.54%) Figure 3: WI-NRS Success WI-NRS success in subjects 12 years of age or older is a reduction of at least 4 points in subjects with a WI-NRS score of 4 or higher at baseline. Over Time in Adult and Pediatric Subjects 12 Years of Age and Older with Mild to Moderate Atopic Dermatitis in Trials INTEGUMENT-1 and INTEGUMENT-2 Pediatric Subjects 2 to 5 Years of Age A multicenter, randomized, double-blind, vehicle-controlled trial (INTEGUMENT-PED ) enrolled a total of 652 pediatric subjects 2 to 5 years of age with mild to moderate atopic dermatitis.

    Subjects were randomized 2:1 to receive ZORYVE cream, 0.05%, or vehicle cream applied once daily for 4 weeks. The median age of the trial population was 3 years (range 2 to 5 years of age). The trial population was 52% male; 69.1% were White, 15.4% Black or African American, 8.3% Asian, 1.8% other races, 4.9% more than one race, and 0.5% American Indian or Alaska Native. For ethnicity, 82.2% of subjects identified as Not Hispanic or Latino, 17.4% identified as Hispanic or Latino, and 0.5% were unknown.

    At baseline, subjects had a mean affected BSA of 22% (range of 3% to 82%), and 53% had facial involvement. At baseline, 22% of subjects had a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 2 (mild), and 78% had a vIGA-AD score of 3 (moderate). The primary endpoint was the proportion of subjects who achieved vIGA-AD treatment success at Week 4 (Table 7). Success was defined as a score of "Clear" or "Almost Clear", plus a 2-grade improvement from baseline. Secondary endpoints included the proportion of subjects that achieved vIGA-AD success at Weeks 1 and 2 (Figure 4). Table 7: vIGA-AD Success vIGA-AD success was defined as a vIGA-AD score of "Clear" or "Almost Clear", plus a 2-grade vIGA-AD score improvement from baseline at Week 4 (Multiple Imputation). at Week 4 in Pediatric Subjects 2 to 5 Years of Age with Mild to Moderate Atopic Dermatitis in Trial INTEGUMENT-PED INTEGUMENT-PED ZORYVE Cream, 0.05% Vehicle Cream Subjects randomized N=436 N=215 Abbreviations: CI = Confidence Interval vIGA-AD success 25.4% 10.7% Difference from vehicle (95% CI) The difference in percent and related 95% CIs are Mantel-Haenszel estimates stratified by pooled study site and vIGA-AD randomization strata. 14.9% (9.04%, 20.79%) Figure 4: vIGA-AD Success vIGA-AD success was defined as a vIGA-AD score of "Clear" or "Almost Clear", plus a 2-grade vIGA-AD score improvement from baseline at Week 4 (Multiple Imputation). Over Time in Pediatric Subjects 2 to 5 Years of Age with Mild to Moderate Atopic Dermatitis in Trial INTEGUMENT-PED Figure 2 Figure 3 Figure 4

    Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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