Growth Hormone (Norditropin; Nutropin; Genotropin; Humatrope; Omnitrope; Saizen; Sogroya; Skytrofa; Zomacton; Serostim; Zorbtive; Ngenla)

Human Growth Hormones (hGH; somatropin)
Norditropin Flexpro; Nutropin AQ NuSpin; Genotropin; Humatrope; Omnitrope; Saizen; Sogroya (somapacitan-beco); Skytrofa (lonapegsomatropin-tcgd); Zomacton; Serostim; Zorbtive; Ngenla (somatrogon-ghla)

Self-Administration – subcutaneous

Diagnosis Considered for Coverage:

In pediatrics:

• Growth failure associated with chronic renal insufficiency before renal transplant
• Growth failure associated with Noonan syndrome
• Growth failure associated with Prader-Willi syndrome
• Growth failure associated with short-stature homeobox (SHOX)-containing gene deficiency
• Growth failure associated with Turner syndrome
• Growth failure in children born small for gestational age (SGA)
• Growth failure due to growth hormone deficiency (GHD)

In adults:

• Adults with GHD
• Human immunodeficiency virus-associated wasting or cachexia
• Treatment of short bowel syndrome in patients receiving specialized nutritional support

Coverage Criteria:

For treatment of ADULTS for growth hormone deficiency (GHD) using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, Sogroya, or Zomacton:

• Dose does not exceed FDA-labeled or off-label recommendation (see below)
  • Norditropin Flexpro (somatropin) – titrate to effective dose (or up to 0.016 mg/kg/day)
  • Nutropin AQ NuSpin (somatropin) – titrate to effective dose (or up to 0.025 mg/kg/day in patients 35 years old or less, or 0.0125 mg/kg/day in patients older than 35 years of age)
  • Genotropin (somatropin) – titrate to effective dose (or up to 0.08 mg/kg/week)
  • Humatrope (somatropin) – titrate to effective dose (or up to 0.0125 mg/kg/day)
  • Omnitrope (somatropin) – titrate to effective dose (or up to 0.08 mg/kg/week)
  • Saizen (somatropin) – titrate to effective dose
  • Sogroya (somapacitan-beco) – titrate to effective dose up to 8 mg once weekly
  • Zomacton (somatropin) – titrate to effective dose (or up to 0.0125 mg/kg/day); AND
• Patient is 18 years of age or older; AND
• Being prescribed by or in consultation with an endocrinologist; AND
• One of the following:
  • Clinical records document that GHD is a result of pituitary or hypothalamic disease from a known cause (e.g., damage from surgery, cranial irradiation, head trauma, subarachnoid hemorrhage, craniopharyngioma, pituitary hypoplasia, ectopic posterior pituitary, etc.)
  • Clinical records document ONE of the following:
    • Patient has 1 or 2 pituitary hormone deficiencies (PHD) (adrenocorticotropic hormone [ACTH], luteinizing hormone [LH], follicle stimulating hormone [FSH], thyroid stimulating hormone [TSH], antidiuretic hormone [ADH]), and BOTH of the following are documented in the medical record:
      • Insulin-like growth factor-1 (IGF-1) is below the mean of the reference range for gender and age (less than 50^th percentile of the reference range).
      • Adult GHD is confirmed by a provocative growth hormone stimulation test performed after all PHD have been optimally treated, with one of the following GH peak value results:
        • Insulin tolerance test (ITT) less than or equal to 5 mcg/L
        • Glucagon test less than or equal to 3 mcg/L (or 1 mcg/L if BMI is greater than 30 kg/m2)
        • Macimorelin test less than or equal to 2.8 mcg/L
    • Patient has 3 or more pituitary hormone deficiencies (ACTH, LH, FSH, TSH, ADH) documented in medical record, and the following is documented in the medical record:
      • IGF-1 is below the 3rd percentile (more than 2 standard deviations [SDs] below the mean) of the reference range for gender and age;
    • Patient has undergone TWO provocative growth hormone stimulation tests with two of the following GH peak value results:
      • Insulin tolerance test (ITT) less than or equal to 5 mcg/L
      • Glucagon test less than or equal to 3 mcg/L (or 1 mcg/L if BMI is greater than 30 kg/m2)
      • Macimorelin test less than or equal to 2.8 mcg/L; AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of GHD in Transition Phase Adolescent Patients using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, Sogroya, Zomacton, or Skytrofa:

• Dose does not exceed FDA-labeled or off-label recommendation (see below)
  • Norditropin Flexpro (somatropin) – titrate to effective dose (or up to 0.016 mg/kg/day)
  • Nutropin AQ NuSpin (somatropin) – titrate to effective dose (or up to 0.025 mg/kg/day in patients 35 years old or less, or 0.0125 mg/kg/day in patients older than 35 years of age)
  • Genotropin (somatropin) – titrate to effective dose (or up to 0.08 mg/kg/week)
  • Humatrope (somatropin) – titrate to effective dose (or up to 0.0125 mg/kg/day)
  • Omnitrope (somatropin) – titrate to effective dose (or up to 0.08 mg/kg/week)
  • Saizen (somatropin) – titrate to effective dose up to 8 mg once weekly
  • Sogroya (somapacitan-beco) – maximum recommended dosage is 8 mg once weekly
  • Skytrofa (lonapegsomatropin-tcgd) – 0.24 mg/kg given once-weekly in patients age 1 year and older who weigh at least 11.5kg
  • Zomacton (somatropin) – titrate to effective dose (or up to 0.0125 mg/kg/day); AND
• Being prescribed by or in consultation with an endocrinologist; AND
• Medical record documents a diagnosis of childhood GHD continuing into adulthood from ONE of the following:
  • Structural or functional abnormalities developed before birth (embryopathic/congenital) 
  • Genetic mutations
  • Irreversible structural hypothalamic-pituitary disease (i.e., permanent lesions, damage)
  • Panhypopituitarism (i.e., production and secretion of all hormones by the pituitary gland is reduced)
  • IGF-1 is below the 3rd percentile (more than 2 standard deviations [SDs] below the mean) of the reference range for gender and age
  • hGH therapy has been discontinued for at least one month followed by a provocative growth hormone stimulation test with ONE of the following GH peak value results:
    • Insulin tolerance test (ITT) less than or equal to 5 mcg/L
    • Glucagon test less than or equal to 3 mcg/L (or 1 mcg/L if BMI is greater than 30 kg/m2)
    • Macimorelin test less than or equal to 2.8 mcg/L; AND
• One of the following:
  • Epiphyses (growth plates) are closed on bone radiograph (X-ray)
  • Patient has reached expected adult height; AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of PEDIATRICS for growth hormone deficiency (GHD) using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, Zomacton, Skytrofa, or Ngenla:

• Dose does not exceed FDA-labeled or off-label recommendation (see below)
  • Norditropin Flexpro (somatropin) – 0.17 mg/kg/week to 0.24 mg/kg/week
  • Nutropin AQ NuSpin (somatropin) – up to 0.3 mg/kg/week
  • Genotropin (somatropin) – 0.16 mg/kg/week to 0.24 mg/kg/week
  • Humatrope (somatropin) – 0.18 mg/kg/week to 0.3 mg/kg/week
  • Omnitrope (somatropin) – 0.16 mg/kg/week to 0.24 mg/kg/week
  • Saizen (somatropin) – 0.18 mg/kg/week
  • Skytrofa (lonapegsomatropin-tcgd) – 0.24 mg/kg given once-weekly in patients age 1 year and older who weigh at least 11.5kg
  • Zomacton (somatropin) – 0.18 mg/kg/week to 0.3 mg/kg/week; AND
• Patient is less than 18 years of age; AND
• Ngenla only: Patient is 3 years of age or older AND
• Being prescribed by or in consultation with an endocrinologist; AND
• Diagnosis of pediatric GHD is confirmed by ONE of the following:
  • Infant is less than 4 months of age and has suspected GHD based on clinical presentation (e.g., persistent neonatal hypoglycemia, persistent or prolonged neonatal jaundice/elevated bilirubin, male infant with microgenitalia, midline anatomical defects, failure to thrive, etc.)
  • History of neonatal hypoglycemia (low blood sugar) associated with pituitary disease
  • Diagnosis of pediatric panhypopituitarism
  • Medical records confirm all of the following:
    • One of the following:
      • Patient’s height is more than 2 SDs below the mid-parental height estimate
      • Patient’s height is less than 1.2 percentile (2.25 or more SDs below the mean) for age and gender prior to starting growth hormone therapy
      • Growth velocity (measured over one year prior to starting growth hormone therapy) is less than 2 SDs below the mean for age and gender
      • Delayed skeletal maturation of more than 2 SD below mean for age and gender (e.g., delayed more than 2 years compared with chronological age)
    • All of the following:
      • Patient is female and bone age is less than 14 years, OR patient is male and bone age is less than 16 years;
      • One of the following:
        • Patient has failed TWO provocative growth hormone stimulation tests (defined as peak value of growth hormone level less than 10 mcg/L) within the past year. (e.g. Arginine, Clonidine, Glucagon, insulin, Levodopa)
        • Patient is less than 1 year of age and insulin like growth factor 1 (IGF-1) or insulin growth factor binding protein-3 (IGFBP-3) is below the reference range (more than 2 SDs below the mean) adjusted for gender and age; AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of PEDIATRICS for small for gestational age (SGA) using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, or Zomacton:

• Dose does not exceed FDA-labeled or off-label recommendation (see below)
  • Norditropin Flexpro (somatropin) – up to 0.47 mg/kg/week
  • Nutropin AQ NuSpin (somatropin) – no labeled dose recommendation
  • Genotropin (somatropin) – up to 0.48 mg/kg/week
  • Humatrope (somatropin) – up to 0.47 mg/kg/week
  • Omnitrope (somatropin) – up to 0.48 mg/kg/week
  • Saizen (somatropin) – no labeled dose recommendation
  • Zomacton (somatropin) – up to 0.47 mg/kg/week; AND
• Patient is less than 18 years of age; AND
• Being prescribed by or in consultation with an endocrinologist; AND
• Patient’s birth weight OR length at birth is below the 3rd percentile (more than 2 SDs below the mean) corrected gestational age (corrected gestational age = actual age in weeks – # weeks preterm); AND
• Height measured at 2 years of age is equal to or below the 3rd percentile (more than 2 SDs below the mean) for age and gender; AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of PEDIATRICS for chronic renal failure (CRF) before renal transplant, Noonan syndrome, Prader-Willi syndrome, homeobox (SHOX) gene deficiency, Turner syndrome using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, or Zomacton:

• Dose does not exceed FDA-labeled or off-label recommendation (see below)
  • Norditropin Flexpro (somatropin) – up to 0.46 mg/kg/week (Noonan), 0.47 mg/kg/week (Turner), 0.24 mg/kg/week (Prader-Willi)
  • Nutropin AQ NuSpin (somatropin) – up to 0.35 mg/kg/week (CKD), 0.375 mg/kg/week (Turner)
  • Genotropin (somatropin) – up to 0.33 mg/kg/week (Turner), 0.24 mg/kg/week (Prader-Willi)
  • Humatrope (somatropin) – up to 0.375 mg/kg/week (Turner), 0.35 mg/kg/week (SHOX)
  • Omnitrope (somatropin) – up to 0.33 mg/kg/week (Turner), 0.24 mg/kg/week (Prader-Willi)
  • Saizen (somatropin) – no labeled dose recommendation
  • Zomacton (somatropin) – up to 0.375 mg/kg/week (Turner), 0.35 mg/kg/week (SHOX); AND
• Being prescribed by or in consultation with an endocrinologist, OR for CRF only: prescribed by or in consultation with a nephrologist or endocrinologist; AND
• For CRF only: glomerular filtration rate (GFR) is less than 60 mL/min; AND
• For Turner Syndrome only: Patient is female and bone age is less than 14 years; AND
• For CRF, Noonan Syndrome, or SHOX gene deficiency only: Patient is female and bone age is less than 14 years, OR patient is male and bone age is less than 16 years; AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of Human Immunodeficiency Virus (HIV)-associated wasting syndrome or cachexia using Serostim:

• Dose does not exceed 0.1 mg/kg subcutaneously once daily to a maximum daily dose of 6 mg
  • 55 kg or greater (121 lbs or greater) – 6 mg daily
  • 45 to 55 kg (99-120 lbs) – 5 mg daily
  • 35 to 44 kg (75-98 lbs) – 4 mg daily
  • Less than 35 kg (less than 75 lbs) – 0.1 mg/kg daily; AND
• One of the following:
  • Unintentional weight loss of greater than 10% over the last 12 months
  • Unintentional weight loss of greater than 7.5% over the last 6 months
  • Loss of 5% body cell mass (BCM) within 6 months
  • Body mass index (BMI) less than 20 kg/m2
  • All of the following:
    • Patient is male
    • BMC is less than 35% of total body weight
    • BMI is less than 27 kg/m2
  • All of the following:
    • Patient is female
    • BMC is less than 23% of total body weight
    • BMI is less than 27 kg/m2; AND
• Provider attestation that patient had a nutritional evaluation since onset of wasting first occurred; AND
• Patient has not had weight loss as a result of other underlying treatable conditions (e.g., depression, mycobacterium avium complex, chronic infectious diarrhea, or malignancy with the exception of Kaposi's sarcoma limited to skin or mucous membranes); AND
• Anti-retroviral therapy has been optimized to decrease the viral load.

For treatment of Short Bowel Syndrome (SBS) using Zorbtive:

• Dose does not exceed 0.1 mg/kg subcutaneously once daily to a maximum daily dose of 8 mg
  • 75 kg or greater (165 lbs or greater) – 8 mg daily
  • 65 to 74 kg (143-164 lbs) – 7 mg daily
  • 55 to 64 kg (121-142 lbs) – 6 mg daily
  • 45 to 54 kg (99-120 lbs) – 5 mg daily
  • 35 to 44 kg (75-98 lbs) – 4 mg daily
  • Less than 35 kg (less than 75 lbs) – 0.1 mg/kg daily; AND
• Being prescribed by or in consultation with a gastroenterologist; AND
• Patient is currently receiving specialized intravenous (IV) nutritional support (e.g., peripheral parenteral nutrition [PPN], total parenteral nutrition [TPN], fluid, and micronutrient supplements); AND
• Patient has not previously received 4 weeks of treatment with Zorbtive.

Reauthorization Criteria:

For treatment of ADULTS for growth hormone deficiency (GHD) using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, Sogroya, or Zomacton:

• Dose does not exceed FDA labeled recommendation; AND
• Being prescribed by or in consultation with an endocrinologist; AND
• Evidence of ongoing monitoring as demonstrated by documentation within the past 12 months of an IGF-1 level; AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of GHD in Transition Phase Adolescent Patients using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, Sogroya, Zomacton, or Skytrofa:

• Dose does not exceed FDA-labeled or off-label recommendation; AND
• Being prescribed by or in consultation with an endocrinologist; AND
• Evidence of ongoing monitoring as demonstrated by documentation within the past 12 months of an IGF-1 level; AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of PEDIACTICS for growth hormone deficiency (GHD) using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, Zomacton, Skytrofa, or Ngenla:

• Dose does not exceed FDA-labeled or off-label recommendation; AND
• Documentation shows height increase of at least 2 cm/year over the previous year of treatment; AND
• Expected adult height goal is documented but not attained; AND
• Prescribed by on in consultation with an endocrinologist; AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of PEDIACTICS for small for gestational age (SGA) using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, or Zomacton:

• Dose does not exceed FDA-labeled or off-label recommendation; AND
• Documentation shows height increase of at least 2 cm/year over the previous year of treatment; AND
• Expected adult height goal is documented but not attained; AND
• Prescribed by on in consultation with an endocrinologist; AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of PEDIACTICS for chronic renal failure (CRF) before renal transplant, Noonan syndrome, Prader-Willi syndrome, homeobox (SHOX) gene deficiency, Turner syndrome using Norditropin Flexpro, Nutropin AQ NuSpin, Genotropin, Humatrope, Omnitrope, Saizen, or Zomacton:

• Dose does not exceed FDA-labeled or off-label recommendation; AND
• Being prescribed by or in consultation with an endocrinologist, OR for CRF only: prescribed by or in consultation with a nephrologist or endocrinologist; AND
• One of the following:
  • For CRF, SHOX, GHD, Turner, Noonan:
    • Documentation shows height increase of at least 2 cm/year over the previous year of treatment; AND
    • Expected adult height goal is documented but not attained
  • For Prader-Willi: One of the following: 
    • Documentation shows height increase of at least 2 cm/year over the previous year of treatment, AND expected adult height goal is documented but not attained
    • Evidence of positive response to therapy (e.g., increase in total lean body mass, decrease in fat mass); AND
• For non-preferred hGH agents: Patient has a contraindication or intolerable side effects to ALL of the following preferred agents not expected with the requested non-preferred hGH agent:
  • Norditropin Flexpro
  • Nutropin AQ NuSpin
  • Omnitrope

For treatment of Human Immunodeficiency Virus (HIV)-associated wasting syndrome or cachexia using Serostim:

• Dose does not exceed 0.1 mg/kg subcutaneously (SC) daily (up to 6 mg); AND
• Evidence of positive response to therapy (i.e., greater than or equal to 2% increase in body weight and/or BCM); AND
• One of the following targets or goals has not been achieved:
  • Weight
  • BCM
  • BMI

Coverage Duration:

For HIV-associated wasting syndrome or cachexia using Serostim:

• Initial: 3 months
• Reauthorization: 6 months

For SBS using Zorbtive:

• 4 weeks (Treatment will not be authorized beyond 4 weeks. Administration of Zorbtive for more than 4 weeks has not been adequately studied).

All other indications:

• Initial: 1 year
• Reauthorization: 1 year

Dosing: 

For diagnosis of Pediatric growth hormone deficiency:

• 0.66 mg/kg subQ once weekly on the same day each week; utilize actual body weight for dosage

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

• Idiopathic short stature (ISS, also called non-GHD short stature)
• Anti-aging treatment

Additional Information:

• Examples of hypothalamic disease that may cause hypopituitarism (low pituitary gland function) include:
  • Mass lesions – benign (craniopharyngiomas) and malignant tumors (metastatic from lung, breast, etc.)
  • Radiation – for CNS and nasopharyngeal malignancies
  • Infiltrative lesions – sarcoidosis, Langerhans cell histiocytosis
  • Infections – tuberculous meningitis
  • Other – traumatic brain injury, stroke
• Examples of pituitary disease that may cause hypopituitarism (low pituitary gland function) include:
  • Mass lesions – pituitary adenomas, other benign tumors, cysts
  • Pituitary surgery
  • Pituitary radiation
  • Infiltrative lesions – hypophysitis (inflammation of the pituitary gland or pituitary stalk), hemochromatosis
  • Infection/abscess
  • Infarction – Sheehan syndrome
  • Apoplexy
  • Genetic mutations
  • Empty sella
• Agents used for provocative growth hormone stimulation tests include macimorelin, glucagon, arginine, clonidine, and levodopa (L-Dopa). Peak value must be assessed using more than one time point (e.g. 0, 30, 60, 90, 120 minutes). There is no evidence against performing more than one stimulation test sequentially at the same office visit.
• When you do not have two or more of the pituitary hormones, it is known as hypopituitarism. The lack of all pituitary hormones is known as panhypopituitarism. The pituitary hormones are adrenocorticotropic hormone (ACTH), luteinizing hormone (LH), follicle stimulating hormone (FSH), thyroid stimulating hormone (TSH), antidiuretic hormone (ADH), prolactin, and oxytocin.
• Growth charts recommended by the Centers for Disease Control and Prevention (CDC) for pediatric patients: https://www.cdc.gov/growthcharts/who_charts.htm
• Serostim injection sites, which may be located on thigh, upper arm, abdomen or buttock, should be rotated to avoid local irritation.
• Serostim is available as single-use vials (5 mg or 6 mg per vial in package of 7 vials) and a multi-dose administration vial (4 mg per vial in package of 7 vials) which is reconstituted in 0.5 to 1 mL of Bacteriostatic Water.

Policy Updates:

• 11/16/2021 – New therapeutic class policy approved by P&T.
• 05/17/2022 - Added Skytrofa to GHD coverage criteria for pediatrics and transition phase.
• 09/21/2023 - Added Omnitrope as a preferred agent due to shortage of Norditrpin Flexpro and Nutropin AQ NuSpin. (P&T Ad-hoc decision)
• 03/01/2024 (policy effective date) – New policy approved by WHA P&T Committee. (P&T, 02/20/2024) (P&T meeting date) 

References:

1. Genotropin Prescribing Information. Pfizer Inc. New York, NY. April 2019.
2. Humatrope Prescribing Information. Eli Lilly and Company. Indianapolis, IN. October 2019.
3. Norditropin Flexpro Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. March 2020.
4. Nutropin AQ NuSpin Prescribing Information. Genentech, Inc. South San Francisco, CA. December 2016.
5. Omnitrope Prescribing Information. Sandoz Inc. Princeton, NJ. June 2019.
6. Saizen Prescribing Information. EMD Serono, Inc. Rockland, MA. February 2020.
7. Serostim Prescribing Information. EMD Serono, Inc. Rockland, MA. June 2019.
8. Sogroya Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. October 2021.
9. Zomacton Prescribing Information. Ferring Pharmaceuticals Inc. Parsippany, NJ. July 2018.
10. Zorbtive Prescribing Information. EMD Serono, Inc. Rockland, MA. September 2019.
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