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Drug overview for SAIZEN SAIZENPREP (somatropin):
Generic name: somatropin (so-mah-TROW-pin)
Drug class: Growth Hormone Modulators
Therapeutic class: Endocrine
Somatropin is a recombinant human growth hormone (hGH) with an amino acid sequence identical to that of hGH of pituitary origin.
Somatropin is used in the treatment of short stature or growth failure due to growth hormone deficiency or other conditions. Other indications for the drug include the treatment of HIV patients with wasting or cachexia or for the treatment of short bowel syndrome in adults. There are multiple recombinant growth hormone preparations commercially available in the US.
Although clinically similar, differences exist among the products in FDA-approved indications, administration, and dosing schedules. Disease-specific treatment risks also vary among the various growth failure indications; consult guidelines and preparation-specific labeling for additional guidance.
Generic name: somatropin (so-mah-TROW-pin)
Drug class: Growth Hormone Modulators
Therapeutic class: Endocrine
Somatropin is a recombinant human growth hormone (hGH) with an amino acid sequence identical to that of hGH of pituitary origin.
Somatropin is used in the treatment of short stature or growth failure due to growth hormone deficiency or other conditions. Other indications for the drug include the treatment of HIV patients with wasting or cachexia or for the treatment of short bowel syndrome in adults. There are multiple recombinant growth hormone preparations commercially available in the US.
Although clinically similar, differences exist among the products in FDA-approved indications, administration, and dosing schedules. Disease-specific treatment risks also vary among the various growth failure indications; consult guidelines and preparation-specific labeling for additional guidance.
DRUG IMAGES
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The following indications for SAIZEN SAIZENPREP (somatropin) have been approved by the FDA:
Indications:
Adult growth hormone deficiency
Pituitary dwarfism
Professional Synonyms:
Adult GH deficiency
GH deficiency dwarfism
Growth failure due to isolated growth hormone deficiency
Growth failure due to isolated somatotropin deficiency
Hypophysial dwarfism
Lorain-Levi dwarfism
Lorain-Levi infantilism
Lorain-Levi syndrome
Pituitary infantilism
Indications:
Adult growth hormone deficiency
Pituitary dwarfism
Professional Synonyms:
Adult GH deficiency
GH deficiency dwarfism
Growth failure due to isolated growth hormone deficiency
Growth failure due to isolated somatotropin deficiency
Hypophysial dwarfism
Lorain-Levi dwarfism
Lorain-Levi infantilism
Lorain-Levi syndrome
Pituitary infantilism
The following dosing information is available for SAIZEN SAIZENPREP (somatropin):
No enhanced Dosing information available for this drug.
Somatropin is administered by subcutaneous injection. Subcutaneous injections should be made into the back of the upper arm, abdomen, buttock, or thigh with regular rotation of injection sites to avoid lipoatrophy. The manufacturer of Zorbtive(R) states to administer the drug by subcutaneous injection at a 90degrees angle into the top side of the thigh, the areas around the belly button, the back of the upper arms, or the buttocks or hips.
Rotate injection sites; do not administer injections into areas where the skin is tender, bruised, red, or hard. Somatropin is commercially available in various dosage forms for subcutaneous administration including single-dose or multi-dose vial kits containing lyophilized powder and diluent vials, two-chamber cartridges containing lyophilized powder and diluent, and cartridge kits containing lyophilized powder and diluent in prefilled syringes; all powder formulations require reconstitution prior to administration, and some require product specific delivery devices. Somatropin is also available as a solution for subcutaneous administration in ready-to-use prefilled pens, injection devices, or cartridges.
Prior to the first injection of somatropin, store preparations and diluent (if supplied) at 2-8degreesC in the original carton for protection from light and physical damage; exceptions include storing Serostim(R), Saizen(R), and Zorbtive(R) at 15-30degreesC until the expiration date on the manufacturer's label and Genotropin Miniquick(R), which may be stored at or below 25degreesC for up to 3 months after dispensing. Avoid storage under conditions of extreme heat or cold, and do not shake or freeze the drug; protect from light. Patients and/or their caregivers should be cautioned against sharing or reusing syringes, needles, and/or devices.
Carefully instruct patients on the proper, safe disposal of needles, syringes, and unused drug. Patients should be supplied with a puncture-resistant container for the proper, safe disposal of such equipment after use.
Rotate injection sites; do not administer injections into areas where the skin is tender, bruised, red, or hard. Somatropin is commercially available in various dosage forms for subcutaneous administration including single-dose or multi-dose vial kits containing lyophilized powder and diluent vials, two-chamber cartridges containing lyophilized powder and diluent, and cartridge kits containing lyophilized powder and diluent in prefilled syringes; all powder formulations require reconstitution prior to administration, and some require product specific delivery devices. Somatropin is also available as a solution for subcutaneous administration in ready-to-use prefilled pens, injection devices, or cartridges.
Prior to the first injection of somatropin, store preparations and diluent (if supplied) at 2-8degreesC in the original carton for protection from light and physical damage; exceptions include storing Serostim(R), Saizen(R), and Zorbtive(R) at 15-30degreesC until the expiration date on the manufacturer's label and Genotropin Miniquick(R), which may be stored at or below 25degreesC for up to 3 months after dispensing. Avoid storage under conditions of extreme heat or cold, and do not shake or freeze the drug; protect from light. Patients and/or their caregivers should be cautioned against sharing or reusing syringes, needles, and/or devices.
Carefully instruct patients on the proper, safe disposal of needles, syringes, and unused drug. Patients should be supplied with a puncture-resistant container for the proper, safe disposal of such equipment after use.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| SAIZEN 8.8 MG SAIZENPREP CART | Maintenance | Adults inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily |
No generic dosing information available.
The following drug interaction information is available for SAIZEN SAIZENPREP (somatropin):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Selected Retinoids (Systemic)/Growth Hormone SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Both systemic retinoids(1-8,11) and growth hormones(9-11) have been independently associated with medication-induced intracranial hypertension. CLINICAL EFFECTS: The concurrent use of oral retinoids(1-8) with growth hormones(9-10) may increase the risk of intracranial hypertension (pseudotumor cerebri). Early signs of intracranial hypertension include papilledema (inflammation of the optic nerve), headache, nausea, vomiting, and visual disturbances such as blurred vision, double vision, and loss of vision.(12) PREDISPOSING FACTORS: Women of childbearing age with high body mass may have a higher risk of developing intracranial hypertension.(8) PATIENT MANAGEMENT: The US manufacturer of tretinoin advises avoiding concomitant use of other products that can cause intracranial hypertension.(1) Patients who present with symptoms of intracranial hypertension should be screened for papilledema. If papilledema is present, they should discontinue the drug and be referred to a neurologist for further treatment.(1-8) DISCUSSION: Vitamin A derivatives and growth hormone have both been strongly associated with intracranial hypertension. A review of ocular side effects from the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, the Food and Drug Administration, and medical journals from 1979 to 2003 found 21 patients who developed intracranial hypertension while taking tretinoin, acitretin, or etretinate at prescribed doses. Symptom onset occurred at an average of 2-3 months after starting retinoid therapy and all except 3 cases resolved within a few months after discontinuing therapy.(8) In a systematic review of 580 reported cases of medication-induced intracranial hypertension between January 1900 and June 2019 found in MEDLINE, EMBASE, and Cochrane Review Databases, there were 259 verifiable cases of intracranial hypertension. Vitamin A derivatives were implicated in 84 cases, though 25 cases occurred with excessive vitamin A supplementation. Growth hormone was implicated in 24 cases, all of which occurred in pediatric patients and involved frequent or higher doses of growth hormone.(12) |
ABSORICA, ABSORICA LD, ACCUTANE, ACITRETIN, AMNESTEEM, CLARAVIS, ISOTRETINOIN, RETINOIC ACID, TRETINOIN, TRETINOIN ACID, ZENATANE |
There are 0 moderate interactions.
The following contraindication information is available for SAIZEN SAIZENPREP (somatropin):
Drug contraindication overview.
*Acute critical illness after open heart surgery, abdominal surgery, or multiple accidental trauma, or acute respiratory failure. *Hypersensitivity to somatropin or any of the excipients. *Active malignancy.
*Active proliferative or severe non-proliferative diabetic retinopathy. *Pediatric patients with closed epiphyses. *Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment, due to the risk of sudden death.
*Acute critical illness after open heart surgery, abdominal surgery, or multiple accidental trauma, or acute respiratory failure. *Hypersensitivity to somatropin or any of the excipients. *Active malignancy.
*Active proliferative or severe non-proliferative diabetic retinopathy. *Pediatric patients with closed epiphyses. *Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment, due to the risk of sudden death.
There are 5 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Acute respiratory failure |
| Diabetic retinopathy |
| Major traumatic injury |
| Morbid obesity |
| Sleep apnea |
There are 7 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Adrenocortical insufficiency |
| Idiopathic intracranial hypertension |
| Malignancy |
| Pancreatitis |
| Slipped capital epiphyses |
| Snoring |
| Untreated hypothyroidism |
There are 6 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Carpal tunnel syndrome |
| Diabetes mellitus |
| Edema |
| Hypertension |
| Progression of nevus |
| Scoliosis |
The following adverse reaction information is available for SAIZEN SAIZENPREP (somatropin):
Adverse reaction overview.
Common adverse reactions reported in adult and pediatric patients receiving somatropin include upper respiratory infection, fever, pharyngitis, headache, injection site reactions (such as pain, numbness, redness, and swelling), rashes, lipoatrophy, otitis media, edema, flatulence, abdominal pain, arthralgia, carpal tunnel syndrome, paresthesia, myalgia, peripheral edema, flu syndrome, and impaired glucose tolerance.
Common adverse reactions reported in adult and pediatric patients receiving somatropin include upper respiratory infection, fever, pharyngitis, headache, injection site reactions (such as pain, numbness, redness, and swelling), rashes, lipoatrophy, otitis media, edema, flatulence, abdominal pain, arthralgia, carpal tunnel syndrome, paresthesia, myalgia, peripheral edema, flu syndrome, and impaired glucose tolerance.
There are 23 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dyspnea Hypertension Hypothyroidism Increased alanine transaminase Increased aspartate transaminase |
| Rare/Very Rare |
|---|
|
Acute pancreatitis Adrenocortical insufficiency Anaphylaxis Angioedema Diabetes mellitus Diabetic retinopathy Fracture Gastroenteritis Hyperglycemia Hyperparathyroidism Intracranial hypertension Leukemia Neoplasm Papilledema Pituitary insufficiency Retinal disorder Sleep apnea Slipped capital epiphyses |
There are 34 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Arthralgia Carpal tunnel syndrome Edema Headache disorder Hematoma Injection site sequelae Lipodystrophy Muscle rigidity Myalgia Peripheral edema |
Acne vulgaris Back pain Hypoesthesia Nausea Paresthesia Skin atrophy Upper respiratory infection Vomiting |
| Rare/Very Rare |
|---|
|
Abnormal glucose tolerance Acute bacterial otitis media Alopecia Body fluid retention Fatigue Fever Gynecomastia Hematuria Increased appetite Mood changes Pharyngitis Progression of nevus Skin rash Tonsillitis Urinary tract infection |
The following precautions are available for SAIZEN SAIZENPREP (somatropin):
Safety and efficacy of somatropin for the management of children with growth failure due to inadequate secretion of endogenous growth hormone are supported by 3 open-label, multicenter trials conducted over a duration of 2 years (2 trials) and 8 years (1 trial). Safety and efficacy of somatropin for the management of children with short stature associated with Turner syndrome are supported by one long-term, randomized, dose-response study and 3 long-term, open-label, multicenter studies with concurrent or historical controls. Safety and efficacy of somatropin for the management of children with idiopathic short stature are supported by one dose-response study, one placebo-controlled study, and 3 randomized studies.
Safety and efficacy of somatropin for the management of children with short stature or growth failure in SHOX deficiency are supported by a single randomized, controlled, 2-year, 3-arm, open-label study in 52 patients. Safety and efficacy of somatropin for the management of short stature in children born small for gestational age with no catch-up growth by 2 to 4 years of age are supported by 4 clinical studies. One study was a randomized, double-blind, 2-arm study and another was a randomized study of prepubertal, non-GHD, Japanese pediatric patients.
Safety and efficacy of somatropin for the management of short stature associated with Noonan syndrome are supported by a prospective, open-label, randomized, parallel group, 2-year study in 21 pediatric patients. Safety and efficacy of somatropin for the management of growth failure due to Prader-Willi syndrome are supported by 2 randomized, open label, controlled clinical trials. Sudden death after somatropin initiation has been reported in pediatric patients with Prader-Willi syndrome who had at least one of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection.
Safety and efficacy of somatropin in pediatric patients with HIV have not been established. Treatment appeared to be well tolerated and consistent with safety observations of adults treated with somatropin for HIV-associated wasting in 2 small studies of 11 children with HIV-associated failure to thrive who received somatropin 0.04 mg/kg per day for 26 weeks or somatropin 0.07
mg/kg per day for 4 weeks. Safety and efficacy of somatropin in pediatric patients with short bowel syndrome have not been established. Risks of growth hormone therapy specific to pediatric patients include risk of sudden death in pediatric patients with Prader-Willi syndrome, increased risk of second neoplasm in pediatric cancer survivors treated with radiation to the brain and/or head, intracranial hypertension, slipped capital femoral epiphysis, progression of preexisting scoliosis, and pancreatitis.
Benzyl alcohol may be a component of somatropin products or the diluent used for reconstitution. Benzyl alcohol has been associated with serious adverse events and death; ''gasping syndrome,'' (characterized by CNS depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with dosages >99 mg/kg per day in neonates and low-birth weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.
The combined daily metabolic load of benzyl alcohol from all sources should be considered. To decrease benzyl alcohol exposure in high-risk patients, consult the preparation-specific labeling to find a benzyl alcohol-free product or alternative diluents.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Safety and efficacy of somatropin for the management of children with short stature or growth failure in SHOX deficiency are supported by a single randomized, controlled, 2-year, 3-arm, open-label study in 52 patients. Safety and efficacy of somatropin for the management of short stature in children born small for gestational age with no catch-up growth by 2 to 4 years of age are supported by 4 clinical studies. One study was a randomized, double-blind, 2-arm study and another was a randomized study of prepubertal, non-GHD, Japanese pediatric patients.
Safety and efficacy of somatropin for the management of short stature associated with Noonan syndrome are supported by a prospective, open-label, randomized, parallel group, 2-year study in 21 pediatric patients. Safety and efficacy of somatropin for the management of growth failure due to Prader-Willi syndrome are supported by 2 randomized, open label, controlled clinical trials. Sudden death after somatropin initiation has been reported in pediatric patients with Prader-Willi syndrome who had at least one of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection.
Safety and efficacy of somatropin in pediatric patients with HIV have not been established. Treatment appeared to be well tolerated and consistent with safety observations of adults treated with somatropin for HIV-associated wasting in 2 small studies of 11 children with HIV-associated failure to thrive who received somatropin 0.04 mg/kg per day for 26 weeks or somatropin 0.07
mg/kg per day for 4 weeks. Safety and efficacy of somatropin in pediatric patients with short bowel syndrome have not been established. Risks of growth hormone therapy specific to pediatric patients include risk of sudden death in pediatric patients with Prader-Willi syndrome, increased risk of second neoplasm in pediatric cancer survivors treated with radiation to the brain and/or head, intracranial hypertension, slipped capital femoral epiphysis, progression of preexisting scoliosis, and pancreatitis.
Benzyl alcohol may be a component of somatropin products or the diluent used for reconstitution. Benzyl alcohol has been associated with serious adverse events and death; ''gasping syndrome,'' (characterized by CNS depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with dosages >99 mg/kg per day in neonates and low-birth weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.
The combined daily metabolic load of benzyl alcohol from all sources should be considered. To decrease benzyl alcohol exposure in high-risk patients, consult the preparation-specific labeling to find a benzyl alcohol-free product or alternative diluents.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes or any impact on reproductive capacity. The American Association of Clinical Endocrinologists (AACE)/American College of Endocrinology (ACE) and Endocrine Society guidelines state that due to insufficient evidence of safety or efficacy, routine use of somatropin for conception or continued use during pregnancy in women with GHD is not recommended. Benzyl alcohol is rapidly metabolized in pregnancy; therefore, exposure to the fetus is unlikely.
Intravenously administered drugs containing benzyl alcohol have caused adverse reactions in premature neonates and low birth weight infants. To avoid fetal exposure to benzyl alcohol in women continuing somatropin during pregnancy, consult the preparation-specific labeling to find a benzyl alcohol-free product or alternative diluents. Animal reproduction studies were conducted with various somatropin preparations at doses in excess of normal human doses (e.g., 1 mg/kg per day, 3.3 mg/kg per day), resulting in growth hormone blood levels in excess of human therapeutic levels (e.g., 19 and 24 times higher, respectively), and administered at different time frames corresponding to the periods of organogenesis or gametogenesis. No adverse effects were observed on gestation, morphogenesis, parturition, lactation, postnatal development, or reproductive capacity of the offspring.
Intravenously administered drugs containing benzyl alcohol have caused adverse reactions in premature neonates and low birth weight infants. To avoid fetal exposure to benzyl alcohol in women continuing somatropin during pregnancy, consult the preparation-specific labeling to find a benzyl alcohol-free product or alternative diluents. Animal reproduction studies were conducted with various somatropin preparations at doses in excess of normal human doses (e.g., 1 mg/kg per day, 3.3 mg/kg per day), resulting in growth hormone blood levels in excess of human therapeutic levels (e.g., 19 and 24 times higher, respectively), and administered at different time frames corresponding to the periods of organogenesis or gametogenesis. No adverse effects were observed on gestation, morphogenesis, parturition, lactation, postnatal development, or reproductive capacity of the offspring.
There is no information regarding the presence of somatropin in human milk; limited data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone, and no adverse effects on the breastfed infant have been reported with somatropin. Consider the benefits of breast-feeding and the importance of somatropin to the woman along with the potential adverse effects on the breast-fed infant from the drug or underlying maternal condition. Benzyl alcohol is rapidly metabolized in lactating women; therefore, exposure in the breast-fed infant is unlikely.
Intravenously administered drugs containing benzyl alcohol have caused adverse reactions in premature neonates and low birth weight infants. To avoid infant exposure to benzyl alcohol from women continuing somatropin while breast-feeding, consult the preparation-specific labeling to find a benzyl alcohol-free product or alternative diluents.
Intravenously administered drugs containing benzyl alcohol have caused adverse reactions in premature neonates and low birth weight infants. To avoid infant exposure to benzyl alcohol from women continuing somatropin while breast-feeding, consult the preparation-specific labeling to find a benzyl alcohol-free product or alternative diluents.
Experience in patients >=65 years of age is insufficient to determine whether they respond differently to somatropin than younger patients. Elderly patients may be more sensitive to somatropin, may be more prone to develop adverse reactions, and lower initial doses with smaller dosage adjustment increments are recommended.
The following prioritized warning is available for SAIZEN SAIZENPREP (somatropin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for SAIZEN SAIZENPREP (somatropin)'s list of indications:
| Adult growth hormone deficiency | |
| E23.0 | Hypopituitarism |
| E23.1 | Drug-induced hypopituitarism |
| E89.3 | Postprocedural hypopituitarism |
| Pituitary dwarfism | |
| E23.0 | Hypopituitarism |
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