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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
No enhanced Introduction information available for this drug.
No enhanced Uses information available for this drug.
Generic name: SOMATROPIN (so-mah-TROW-pin)
Drug class: Growth Hormone Modulators
Therapeutic class: Endocrine
No enhanced Introduction information available for this drug.
No enhanced Uses information available for this drug.
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.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for SAIZEN-SAIZENPREP (somatropin):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Selected Retinoids (Systemic)/Growth Hormone SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. 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 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Growth Hormone/Oral Estrogens SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Growth hormone (somatropin or lonapegsomatropin-tcgd) binds to growth hormone receptors and stimulates Janus activating tyrosine kinases (JAK 1 and 2) and signal transducer activators of transcription (STAT1, STAT3, STAT5) to increase gene transcription and metabolism to produce and secrete insulin like growth factor-1 (IGF-1). IGF-1 promotes cell growth, proliferation, and survival. Estrogens block STAT phosphorylation and inhibit IGF-1 secretion and production.(1,2) Higher quantities of growth hormone are required to raise serum IGF-1 concentrations to the normal range. CLINICAL EFFECTS: Oral estrogens may reduce the IGF-1 response to growth hormone (somatropin and lonapegsomatropin-tcgd).(1-9) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of somatropin states a larger dose of somatropin may be required to achieve the treatment goal.(3-9) The manufacturer of lonapegsomatropin-tcgd states adults of any age concurrently taking oral estrogen should increase the dose of lonapegsomatropin-tcgd to 2.1 mg once weekly.(3) The American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for growth hormone deficiency states that higher recombinant human growth hormone (rhGH) doses are advised in women on oral estrogen therapy and that switching women to transdermal estrogen patches may allow lower rhGH doses to be used for equivalent IGF-1 responses.(10) DISCUSSION: A prospective study compared growth hormone replacement requirements in women with elevated estrogen (on oral estrogen), women without elevated estrogen (no estrogen therapy or on transdermal estrogen), and growth hormone treated adult hypopituitary males. Women on oral estrogen required 10.6 +/-0.7 mcg/kg/day or 867 +/- 45 mcg/day growth hormone, women not taking oral estrogen required 5.0 +/- 0.7 mcg/kg/day or 424 +/-57 mcg/day, and men required 4.1 +/- 0.6 mcg/kg/day or 376 +/-49 mcg/day.(1) A randomized cross-over study compared one month of treatment with ethinyl estradiol (20 mcg), conjugated equine estrogen (1.25 mg Premarin), and estradiol valerate (2 mg). All three formulations resulted in a significant reduction in IGF-1 levels compared to baseline.(11) A study compared IGF-1 concentrations in premenopausal women and postmenopausal women before and after 2 months of cyclical replacement therapy with either oral ethinyl estradiol (20 mcg daily) or transdermal 17 beta-estradiol (100 mcg patch applied twice weekly). Oral ethinyl estradiol significantly reduced circulating IGF-1 (0.70 +/- 0.09 to 0.47 +/- 0.04 units/mL, P < 0.02) levels. Transdermal 17-beta estradiol increased IGF-1 levels (0.86 +/- 0.15 to 1.10 +/- 0.14 units/mL, P < 0.005).(12) In a clinical trial, somapacitan administered once weekly was compared to somatropin once daily injections in patients with and without oral estrogen replacement therapy. Patients with oral estrogen therapy were administered 2 mg/wk compared to 1 mg/wk for patients without estrogen replacement therapy. Observed doses after titration for somapacitan and somatropin were highest for females on oral estrogen.(13) An open-label, randomized crossover study in growth hormone deficient women compared oral estrogen with transdermal estrogen treatment while on growth hormone. Women received incremental doses of growth hormone (0.5, 1.0, 2.0 units/day for 1 week; increased to next dose each week) for 8 weeks and estradiol valerate (2 mg/day) or transdermal estrogen patches (Estraderm-TTS 100 mcg). IGF-1 levels were significantly reduced during oral estrogen treatment and rose dose-dependently during growth hormone administration by a lower magnitude compared with transdermal treatment (change in IGF-1: 109 +/-43% vs. 135 +/-41%).(14) |
2-METHOXYESTRADIOL, ABIGALE, ABIGALE LO, ACTIVELLA, AFIRMELLE, ALTAVERA, ALYACEN, AMETHIA, AMETHYST, ANGELIQ, APRI, ARANELLE, ASHLYNA, AUBRA, AUBRA EQ, AUROVELA, AUROVELA 24 FE, AUROVELA FE, AVERI, AVIANE, AYUNA, AZURETTE, BALCOLTRA, BALZIVA, BEYAZ, BIJUVA, BLISOVI 24 FE, BLISOVI FE, BRIELLYN, CAMRESE, CAMRESE LO, CAZIANT, CHARLOTTE 24 FE, CHATEAL EQ, CONJUGATED ESTROGENS, COVARYX, COVARYX H.S., CRYSELLE, CYRED, CYRED EQ, DASETTA, DAYSEE, DESOGESTR-ETH ESTRAD ETH ESTRA, DIETHYLSTILBESTROL, DOLISHALE, DROSPIRENONE-ETH ESTRA-LEVOMEF, DROSPIRENONE-ETHINYL ESTRADIOL, DUAVEE, EEMT, EEMT H.S., ELINEST, ENPRESSE, ENSKYCE, ESTARYLLA, ESTRADIOL, ESTRADIOL BENZOATE, ESTRADIOL CYPIONATE, ESTRADIOL HEMIHYDRATE, ESTRADIOL HEMIHYDRATE MICRO, ESTRADIOL MICRONIZED, ESTRADIOL VALERATE, ESTRADIOL-NORETHINDRONE ACETAT, ESTRIOL, ESTRIOL MICRONIZED, ESTROGEN-METHYLTESTOSTERONE, ESTRONE, ETHINYL ESTRADIOL, FALMINA, FEIRZA, FEMLYV, FINZALA, FYAVOLV, GALBRIELA, GEMMILY, HAILEY, HAILEY 24 FE, HAILEY FE, ICLEVIA, INTROVALE, ISIBLOOM, JAIMIESS, JASMIEL, JINTELI, JOLESSA, JOYEAUX, JULEBER, JUNEL, JUNEL FE, JUNEL FE 24, KAITLIB FE, KALLIGA, KARIVA, KELNOR 1-35, KURVELO, LARIN, LARIN 24 FE, LARIN FE, LESSINA, LEVONEST, LEVONORG-ETH ESTRAD-FE BISGLYC, LEVONORGESTREL-ETH ESTRADIOL, LO LOESTRIN FE, LO-ZUMANDIMINE, LOESTRIN, LOESTRIN FE, LOJAIMIESS, LORYNA, LOW-OGESTREL, LUIZZA, LUTERA, MARLISSA, MIBELAS 24 FE, MICROGESTIN, MICROGESTIN FE, MILI, MIMVEY, MINZOYA, MONO-LINYAH, MYFEMBREE, NATAZIA, NECON, NEXTSTELLIS, NIKKI, NORETHINDRON-ETHINYL ESTRADIOL, NORETHINDRONE-E.ESTRADIOL-IRON, NORGESTIMATE-ETHINYL ESTRADIOL, NORTREL, NYLIA, OCELLA, ORIAHNN, ORTHO TRI-CYCLEN, ORTHO-NOVUM, PHILITH, PIMTREA, PORTIA, PREMARIN, PREMPHASE, PREMPRO, RECLIPSEN, RIVELSA, ROSYRAH, SAFYRAL, SETLAKIN, SIMLIYA, SIMPESSE, SPRINTEC, SYEDA, TARINA 24 FE, TARINA FE, TARINA FE 1-20 EQ, TAYTULLA, TILIA FE, TRI-ESTARYLLA, TRI-LEGEST FE, TRI-LINYAH, TRI-LO-ESTARYLLA, TRI-LO-MARZIA, TRI-LO-MILI, TRI-LO-SPRINTEC, TRI-MILI, TRI-SPRINTEC, TRI-VYLIBRA, TRI-VYLIBRA LO, TURQOZ, TYBLUME, TYDEMY, VALTYA, VELIVET, VESTURA, VIENVA, VIORELE, VOLNEA, VYFEMLA, VYLIBRA, WERA, WYMZYA FE, XARAH FE, XELRIA FE, YASMIN 28, YAZ, ZARAH, ZOVIA 1-35, ZUMANDIMINE |
The following contraindication information is available for SAIZEN-SAIZENPREP (somatropin):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
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.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 22 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 Diabetic retinopathy Fracture Gastroenteritis Hyperglycemia Hyperparathyroidism Intracranial hypertension Leukemia Neoplasm Papilledema Pituitary insufficiency Retinal disorder Sleep apnea Slipped capital epiphyses |
There are 35 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 Type 2 diabetes mellitus Urinary tract infection |
The following precautions are available for SAIZEN-SAIZENPREP (somatropin):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
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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