Drug Detail:Saizen (Somatropin [ soe-ma-troe-pin ])
Drug Class: Growth hormones
Highlights of Prescribing Information
SAIZEN (somatropin) for injection, for subcutaneous use
Initial U.S. Approval: 1987
Indications and Usage for Saizen
SAIZEN is a recombinant human growth hormone indicated for:
Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD) (1.1)
Adult: Treatment of adults with either adult onset or childhood onset GHD. (1.2)
Saizen Dosage and Administration
- Pediatric GHD: 0.18 mg/kg/week, divided into equal doses given either on 3 alternate days, 6 times per week or daily (2.1)
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Adult GHD: Either a non-weight based or a weight based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-1 concentrations (2.2)
Non-weight-based dosing: A starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight, and increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day (2.2)
Weight-based dosing: The recommended initial dose is not more than 0.005 mg/kg/day; the dose may be increased as tolerated to not more than 0.01 mg/kg/day after 4 weeks (2.2) - Injection sites should always be rotated to avoid lipoatrophy (2.3)
Dosage Forms and Strengths
- SAIZEN lyophilized powder in vial (3): 5 mg and 8.8 mg
- saizenprep® reconstitution device: One vial SAIZEN containing 8.8 mg somatropin and one cartridge diluent containing 1.51 mL 0.3% (w/v) metacresol in Sterile Water for Injection
Contraindications
- Acute Critical Illness (4)
- Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death (4)
- Active Malignancy (4)
- Hypersensitivity to somatropin or excipients (4)
- Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy (4)
- Children with closed epiphyses (4)
Warnings and Precautions
- Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk (5.1)
- Prader-Willi syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment. Discontinue treatment if these signs occur (5.2)
- Neoplasms: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin—in particular meningiomas as in patients treated with radiation to the head for their first neoplasm (5.3)
- Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked. Periodically monitor glucose levels in all patients Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment (5.4)
- Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction (5.5)
- Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention (5.6)
- Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome – especially in adults): May occur frequently. Reduce dose as necessary (5.7)
- Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism (5.8)
- Hypothyroidism: May first become evident or worsen (5.9)
- Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain (5.10)
- Progression of Preexisting Scoliosis: May develop (5.11)
- Reevaluation of Childhood Onset Adult GHD (5.12)
- Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain (5.15)
- Benzyl Alcohol (5.16)
Adverse Reactions/Side Effects
Most common adverse reactions are injection site reactions (such as pain, numbness, redness, and swelling), fluid retention, peripheral edema, arthralgia, myalgia, paresthesia, and headache. (6)
To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
- Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses (7.1)
- Glucocorticoid Replacement: Should be carefully adjusted (7.2)
- Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin (7.3)
- Oral Estrogen: Larger doses of somatropin may be required in women (7.4)
- Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment (7.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2020
Related/similar drugs
Genotropin, somatropin, Omnitrope, Humatrope, Norditropin, Sogroya, Norditropin FlexProFull Prescribing Information
1. Indications and Usage for Saizen
1.1 Pediatric Patients
SAIZEN (somatropin) is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.
2. Saizen Dosage and Administration
For subcutaneous injection.
SAIZEN therapy should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency or adult patients with either childhoodonset or adult-onset growth hormone deficiency.
2.1 Pediatric Growth Hormone Deficiency (GHD)
SAIZEN dosage and administration schedule should be individualized for each patient. The recommended weekly dosage is 0.18 mg/kg of body weight by subcutaneous injection. It should be divided into equal doses given either on 3 alternate days, 6 times per week or daily.
Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human growth hormone.
Treatment with SAIZEN of growth failure due to growth hormone deficiency should be discontinued when the epiphyses are fused.
2.2 Adult Growth Hormone Deficiency (GHD)
Either of two approaches to SAIZEN dosing may be followed: a weight-based regimen or a non-weight-based regimen.
3. Dosage Forms and Strengths
SAIZEN lyophilized powder (to be reconstituted with Bacteriostatic Water for Injection):
- 5 mg per vial
- 8.8 mg per vial
saizenprep® reconstitution device:
- One vial SAIZEN containing 8.8 mg somatropin and one cartridge diluent containing 1.51 mL 0.3% (w/v) metacresol in Sterile Water for Injection
5. Warnings and Precautions
5.1 Acute Critical Illness
Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin [see Contraindications (4)]. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients having acute critical illnesses should be weighed against the potential risk.
5.2 Prader-Willi Syndrome in Children
There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If, during treatment with somatropin, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [see Contraindications (4)]. SAIZEN is not indicated for the long term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
5.3 Neoplasms
In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence [see Contraindications (4)]. Monitor all patients with a history of GHD secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor.
Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, practitioners should thoroughly consider the risks and benefits of starting somatropin in these patients. If treatment with somatropin is initiated, these patients should be monitored carefully for development of neoplasms.
Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes of preexisting nevi.
5.4 Glucose Intolerance/Diabetes Mellitus
Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in susceptible patients. As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment and new onset type 2 diabetes mellitus has been reported in patients. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin therapy. The doses of antihyperglycemic drugs (i.e., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients.
5.5 Intracranial Hypertension
Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropin products. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Funduscopic examination should be performed routinely before initiating treatment with somatropin to exclude preexisting papilledema, and periodically during the course of somatropin therapy. If papilledema is observed by funduscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with somatropin can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with Turner syndrome, chronic renal insufficiency, and Prader-Willi syndrome may be at increased risk for the development of IH.
5.6 Severe Hypersensitivity
Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Contraindications (4)].
5.7 Fluid Retention
Fluid retention during somatropin replacement therapy in adults may occur. Clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) are usually transient and dose dependent.
5.8 Hypoadrenalism
Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment [see Section 7.1, 11-β Hydroxysteroid Dehydrogenase Type 1].
5.9 Hypothyroidism
Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, in particular, the growth response in children. Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism. In patients with growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Therefore, patients treated with somatropin should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.
5.10 Slipped Capital Femoral Epiphysis in Pediatric Patients
Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders (including pediatric growth hormone deficiency and Turner syndrome) or in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated.
5.11 Progression of Preexisting Scoliosis in Pediatric Patients
Progression of scoliosis can occur in patients who experience rapid growth. Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis. However, somatropin has not been shown to increase the occurrence of scoliosis. Skeletal abnormalities including scoliosis are commonly seen in untreated Turner syndrome patients. Scoliosis is also commonly seen in untreated patients with Prader-Willi syndrome. Physicians should be alert to these abnormalities, which may manifest during somatropin therapy.
5.12 Reevaluation of Childhood Onset Adult GHD
Patients with epiphyseal closure who were treated with somatropin replacement therapy in childhood should be reevaluated according to the criteria in INDICATIONS AND USAGE before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. Experience with prolonged treatment in adults is limited.
5.13 Lipoatrophy
When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site [see Dosage and Administration (2.3)].
5.14 Laboratory Tests
Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH), and IGF-1 may increase with somatropin therapy.
5.15 Pancreatitis
Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin–treated patient, especially a child, who develops persistent severe abdominal pain.
5.16 Benzyl Alcohol
Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The "gasping syndrome," (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/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. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.
6. Adverse Reactions/Side Effects
The following important adverse reactions are also described elsewhere in the labeling:
- Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1)]
- Fatalities in children with Prader-Willi syndrome [see Warnings and Precautions (5.2)]
- Neoplasms [see Warnings and Precautions (5.3)]
- Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4)]
- Intracranial hypertension [see Warnings and Precautions (5.5)]
- Severe hypersensitivity [see Warnings and Precautions (5.6)]
- Fluid retention [see Warnings and Precautions (5.7)]
- Hypoadrenalism [see Warnings and Precautions (5.8)
- Hypothyroidism [see Warnings and Precautions (5.9)]
- Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.10)]
- Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.11)]
- Lipoatrophy [see Warnings and Precautions (5.13)]
- Pancreatitis [see Warnings and Precautions (5.15)]
- Benzyl alcohol [see Warnings and Precautions (5.16)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation, and may not reflect the adverse reaction rates observed in practice.
6.2 Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to SAIZEN with the incidence of antibodies to other products may be misleading. In the case of growth hormone, antibodies with binding capacities lower than 2 mg/mL have not been associated with growth attenuation. In a very small number of patients treated with somatropin, when binding capacity was greater than 2 mg/mL, interference with the growth response was observed.
6.3 Post-Marketing Experience
The following adverse reactions have been identified during post approval use of SAIZEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products [See Warnings and Precautions (5.6)].
Leukemia has been reported in a small number of growth hormone deficient patients treated with growth hormone. It is uncertain whether this increased risk is related to the pathology of growth hormone deficiency itself, growth hormone therapy, or other associated treatments such as radiation therapy for intracranial tumors. So far, epidemiological data fail to confirm the hypothesis of a relationship between growth hormone therapy and leukemia.
The following additional adverse reactions have been observed during the appropriate use of somatropin: headaches (children and adults), gynecomastia (children), and pancreatitis (children and adults) (see Warnings and Precautions [5.14]).
7. Drug Interactions
7.1 Inhibition of 11β-Hydroxysteroid Dehydrogenase Type 1 (11βHSD-1)
The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH and somatropin inhibit 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. As a consequence, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required in patients treated with somatropin. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1 [see Warnings and Precautions (5.8)].
7.2 Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment
Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of somatropin in children. Therefore, glucocorticoid replacement dosing should be carefully adjusted in children receiving concomitant somatropin and glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.
7.3 Cytochrome P450-Metabolized Drugs
Limited published data indicate that somatropin treatment increases cytochrome P450 (CYP450) mediated antipyrine clearance in man. These data suggest that somatropin administration may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine). Careful monitoring is advisable when somatropin is administered in combination with other drugs known to be metabolized by CYP450 liver enzymes. However, formal drug interaction studies have not been conducted.
8. Use In Specific Populations
8.3 Nursing Mothers
It is not known whether SAIZEN is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SAIZEN is administered to a nursing woman.
8.5 Geriatric Use
The safety and effectiveness of SAIZEN in patients aged 65 and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of SAIZEN, and therefore may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.2)].
8.6 Hepatic Impairment
A reduction in somatropin clearance has been noted in patients with hepatic dysfunction as compared with normal controls. However, no studies have been conducted for SAIZEN in patients with hepatic impairment [see Clinical Pharmacology (12.3)].
11. Saizen Description
SAIZEN is a human growth hormone produced by recombinant DNA technology. SAIZEN has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. SAIZEN is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene.
SAIZEN is a sterile, non pyrogenic, white, lyophilized powder intended for subcutaneous injection after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The reconstituted solution has a pH of 6.5 to 8.5.
12. Saizen - Clinical Pharmacology
12.1 Mechanism of Action
Somatropin (as well as endogenous growth hormone) binds to dimeric growth hormone receptors located within the cell membranes of target tissue cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by IGF-1 produced in the liver and also locally (e.g., skeletal growth, protein synthesis), while others are primarily a consequence of the direct effects of somatropin (e.g., lipolysis) [see Pharmacodynamics (12.2)].
16. How is Saizen supplied
16.1 How Supplied
SAIZEN can be administered using (1) a standard sterile disposable syringe and needle, (2) a compatible SAIZEN needle-free injection device or (3) a compatible SAIZEN needle injection device. For proper use, refer to the Instructions for Use provided with the administration device.
SAIZEN is a sterile, non pyrogenic, white, lyophilized powder supplied in packages containing:
1 vial of 5 mg SAIZEN and 1 vial of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1005-2
1 vial of 8.8 mg SAIZEN and 1 vial of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1088-1
1 saizenprep® cartridge of 8.8 mg SAIZEN and 1.51 mL Sterile Water for Injection 0.3% (w/v) metacresol as antimicrobial preservative NDC 44087-0016-1
17. Patient Counseling Information
Prior to self-administration of the product at home, ensure to train patients and caregivers how to prepare and administer the product correctly to help avoid wrong technique and dosing errors.
Patients being treated with SAIZEN (and/or their parents) should be informed about the potential benefits and risks associated with SAIZEN treatment. This information is intended to better educate patients (and caregivers); it is not a disclosure of all possible adverse or intended effects.
Patients and caregivers who will administer SAIZEN should receive appropriate training and instruction on the proper use of SAIZEN from the physician or other suitably qualified health care professional. A puncture-resistant container for the disposal of used syringes and needles should be strongly recommended. Patients and/or parents should be thoroughly instructed in the importance of proper disposal, and cautioned against any reuse of needles and syringes. This information is intended to aid in the safe and effective administration of the medication.
To reconstitute SAIZEN, inject the diluent into the vial of SAIZEN aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. DO NOT SHAKE. Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. SAIZEN MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.
SAIZEN
somatropin kit |
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SAIZEN
somatropin kit |
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SAIZENPREP
somatropin kit |
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Labeler - EMD Serono, Inc. (088514898) |