Zorbtive Side Effects

Generic Name: somatropin

Please note - some side effects for Zorbtive may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Zorbtive - for the Consumer

Zorbtive

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zorbtive:

Gas; mild swelling (eg, of the hands or feet); muscle or joint pain; pain, swelling, redness, itching, or bruising at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using Zorbtive:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast enlargement in males; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; confusion; ear pain, discharge, or discomfort; fever; hearing problems; hip or knee pain; limp; new growth on the skin; one-sided weakness; persistent or severe cough or sore throat; severe or persistent muscle or joint pain; severe or persistent swelling of the hands, ankles, or feet; shortness of breath; slurred speech; snoring or irregular breathing during sleep; sudden, severe, or persistent headache, dizziness, nausea, or vomiting; symptoms of dehydration (eg, very dry mouth or skin); symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); symptoms of pancreas inflammation (eg, severe or persistent stomach or back pain, yellowing of the skin or eyes, fast heartbeat, unusual sweating); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Zorbtive Side Effects - for the Professional

Zorbtive

Table 2 summarizes the number of subjects by system-organ class who experienced an adverse event during the 4-week treatment period of the Phase III SBS study. To be listed in Table 2, an adverse event must have occurred in more than 10% of subjects in any treatment group.

Table 2:  Controlled Trial Adverse Events – 4 Week Treatment Period

Adverse Experiences	SOD[GLN]1 n=9 n (%)	r-hGH+SOD1 n=16 n (%)	r-hGH+SOD[GLN]1 n=16 n (%)
1 SOD[GLN] = Specialized Oral Diet supplemented with Glutamine; r-hGH + SOD = Human Growth Hormone plus Specialized Oral Diet; r-hGH + SOD[GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Glutamine
Total Number of Subjects with At Least One AE	8 (89)	16 (100)	16 (100)
Body as a Whole, General Disorders	4 (44)	15 (94)	15 (94)
Edema, Peripheral	1 (11)	11 (69)	13 (81)
Edema, Facial	0 (0)	8 (50)	7 (44)
Pain	1 (11)	3 (19)	1 (6)
Chest Pain	0 (0)	3 (19)	0 (0)
Fever	2 (22)	0 (0)	1 (6)
Back Pain	1 (11)	1 (6)	0 (0)
Flu-like Disorder	1 (11)	0 (0)	1 (6)
Malaise	0 (0)	2 (13)	0 (0)
Edema, Generalized	0 (0)	2 (13)	0 (0)
Abdomen Enlarged	1 (11)	0 (0)	0 (0)
Allergic Reaction	1 (11)	0 (0)	0 (0)
Rigors (Chills)	1 (11)	0 (0)	0 (0)
Gastrointestinal System Disorders	6 (67)	12 (75)	12 (75)
Flatulence	2 (22)	4 (25)	4 (25)
Abdominal Pain	1 (11)	4 (25)	2 (13)
Nausea	0 (0)	2 (13)	5 (31)
Tenesmus	3 (33)	1 (6)	3 (19)
Vomiting	1 (11)	3 (19)	3 (19)
Hemorrhoids	1 (11)	1 (6)	0 (0)
Mouth Dry	1(11)	1 (6)	0 (0)
Musculoskeletal System Disorders	1 (11)	7 (44)	7 (44)
Arthralgia	0 (0)	7 (44)	5 (31)
Myalgia	1 (11)	2 (13)	0 (0)
Resistance Mechanism Disorders	4 (44)	6 (38)	3 (19)
Infection	3 (33)	0 (0)	1 (6)
Infection Bacterial	1 (11)	3 (19)	0 (0)
Infection Viral	0 (0)	1 (6)	2 (13)
Moniliasis	0 (0)	2 (13)	0 (0)
Application Site Disorders	1 (11)	5 (31)	4 (25)
Injection Site Reaction	1 (11)	3 (19)	4 (25)
Injection Site Pain	0 (0)	5 (31)	0 (0)
Central and Peripheral Nervous System Disorders	2 (22)	4 (25)	4 (25)
Dizziness	0 (0)	1 (6)	2 (13)
Headache	1 (11)	1 (6)	1 (6)
Hypoasthesia	1 (11)	1 (6)	1 (6)
Skin and Appendages Disorders	2 (22)	4 (25)	4 (25)
Rash	0 (0)	1 (6)	2 (13)
Pruritis	1 (11)	0 (0)	1 (6)
Sweating Increased	0 (0)	2 (13)	0 (0)
Nail Disorder	1 (11)	0 (0)	0 (0)
Respiratory System Disorders	1 (11)	1 (6)	5 (31)
Rhinitis	1 (11)	0 (0)	3 (19)
Metabolic and Nutritional Disorders	1 (11)	3 (19)	1 (6)
Dehydration	1 (11)	3 (19)	0 (0)
Thirst	1 (11)	0 (0)	0 (0)
Urinary System Disorders	1 (11)	2 (13)	1 (6)
Pyelonephritis	1 (11)	0 (0)	0 (0)
Psychiatric Disorders	2 (22)	1 (6)	0 (0)
Depression	2 (22)	0 (0)	0 (0)
Reproductive Disorders, Female	1 (11)	2 (13)	0 (0)
Breast Pain Female	1 (11)	1 (6)	0 (0)
Hearing and Vestibular Disorders	0 (0)	0 (0)	2 (13)
Ear or Hearing Symptoms	0 (0)	0 (0)	2 (13)

Table 3 summarizes the number of subjects by system-organ class who experienced an adverse event during the 12-week follow-up period of the Phase III SBS study. To be listed in Table 3, an adverse event must have occurred in more than 10% of subjects in any treatment group.

Table 3:  Controlled Trial Adverse Events – 12 Week Follow-Up Period

Adverse Experiences	SOD[GLN]1 n=9 n (%)	r-hGH+SOD1 n=15 n (%)	r-hGH+SOD[GLN]1 n=16 n (%)
1 SOD[GLN] = Specialized Oral Diet supplemented with Glutamine ;r-hGH + SOD = Human Growth Hormone plus Specialized Oral Diet; r-hGH + SOD[GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Glutamine
Total Number of Subjects with At Least One AE	7 (78)	12 (80)	13 (81)
Gastrointestinal System Disorders	3 (33)	7 (47)	7 (44)
Nausea	2 (22)	3 (20)	0 (0)
Vomiting	0 (0)	2 (13)	3 (19)
Abdominal Pain	0 (0)	3 (20)	1 (6)
Tenesmus	1 (11)	0 (0)	3 (19)
Pancreatitis	1 (11)	0 (0)	1 (6)
Constipation	1 (11)	0 (0)	0 (0)
Crohn's Disease Aggravated	1 (11)	0 (0)	0 (0)
Gastric Ulcer	1 (11)	0 (0)	0 (0)
Gastrointestinal Fistula	1 (11)	0 (0)	0 (0)
Resistance Mechanism Disorders	5 (56)	6 (40)	5 (31)
Infection Bacterial	3 (33)	0 (0)	2 (13)
Infection Viral	1 (11)	3 (20)	1 (6)
Infection	1 (11)	1 (7)	2 (13)
Sepsis	0 (0)	3 (20)	1 (6)
Body as a Whole, General Disorders	1 (11)	4 (27)	2 (13)
Fever	1 (11)	2 (13)	1 (6)
Fatigue	0 (0)	2 (13)	0 (0)
Respiratory System Disorders	1 (11)	2 (13)	4 (25)
Rhinitis	0 (0)	1 (7)	3 (19)
Laryngitis	1 (11)	0 (0)	0 (0)
Pharyngitis	1 (11)	0 (0)	0 (0)
Reproductive Disorders, Female	1 (11)	0 (0)	4 (25)
Vaginal Fungal Infection	1 (11)	0 (0)	0 (0)
Skin and Appendages Disorders	1 (11)	2 (13)	2 (13)
Rash	1 (11)	1 (7)	0 (0)
Musculoskeletal System Disorders	0 (0)	2 (13)	2 (13)
Arthralgia	0 (0)	2 (13)	2 (13)
Psychiatric Disorders	1 (11)	0 (0)	1 (6)
Depression	1 (11)	0 (0)	0 (0)
Insomnia	1 (11)	0 (0)	0 (0)
Urinary System Disorders	2 (22)	0 (0)	0 (0)
Pyelonephritis	1 (11)	0 (0)	0 (0)
Renal Calculus	1 (11)	0 (0)	0 (0)
Application Site Disorders	1 (11)	0 (0)	0 (0)
Injection Site Reaction	1 (11)	0 (0)	0 (0)
Liver and Biliary System Disorders	1 (11)	0 (0)	0 (0)
Hepatic Function Abnormal	1 (11)	0 (0)	0 (0)
Vascular Extracardiac Disorders	1 (11)	0 (0)	0 (0)
Vascular Disorder	1 (11)	0 (0)	0 (0)

Adverse events that occurred in 1% to less than 10% of study participants receiving Zorbtive® in the placebo-controlled clinical efficacy trial are listed below by body system. The list of adverse events has been compiled regardless of casual relationship to Zorbtive®.

Body as a Whole, General:  edema, periorbital edema

Gastrointestinal System:  melena, rectal hemorrhage, mouth disorder, steatorrhea

Musculoskeletal System:  arthritis, arthropathy, bursitis, cramps

Resistance Mechanism Disorders:  fungal infection

Application Site Disorders:  reaction pain, inflammation at injection sites

Central and Peripheral Nervous System:  parasthesia, phantom pain, visual field defect

Respiratory System:  bronchospasm, dyspnea, pharyngitis, respiratory disorder, respiratory infection

Platelet, Bleeding and Clotting Disorders:  purpura, prothrombin decrease

Skin and Appendages:  skin disorder, increased sweating, alopecia, bullous eruption

Psychiatric:  insomnia

Metabolic and Nutritional:  hypomagnesemia,

Urinary System Disorders:  dysuria, urinary tract infection, abnormal urine

Reproduction Disorders, Female:  breast enlargement, vaginal fungal infection

Heart Rate and Rhythm Disorders:  tachycardia

Vascular Extracardiac Disorders:  vasodilatation

The safety profile of patients receiving Zorbtive® with glutamine was similar to the safety profile of patients receiving Zorbtive® without glutamine. During the baseline period, 88% of patients receiving Zorbtive® with glutamine, 88% of patients receiving Zorbtive® without glutamine, and 78% of patients receiving Zorbtive® placebo with glutamine reported baseline signs and symptoms (BSS). During the treatment period, 100% of patients receiving Zorbtive® with and without glutamine reported at least one adverse event (AE), whereas 89% of patients receiving Zorbtive® placebo with glutamine reported at least one AE. During the follow-up period, 81% of patients receiving Zorbtive® with glutamine, 80% of patients receiving Zorbtive® without glutamine and 78% of patients receiving Zorbtive® placebo with glutamine experienced at least one AE. Comparison of the number of serious adverse events (SAEs) before and during treatment demonstrates that this subject population experiences numerous BSSs and AEs due to their underlying conditions and parenteral nutrition complications. Four subjects (25%) receiving Zorbtive® without glutamine and one subject (11%) receiving Zorbtive® placebo with glutamine experienced at least one SAE during the treatment period (Zorbtive® without glutamine:  chest pain, purpura, fungal infection, pharyngitis; Zorbtive® placebo with glutamine: hemorrhoids). None of the subjects receiving Zorbtive® with glutamine experienced SAEs during the treatment period. During the follow-up period, 3 subjects (19%) receiving Zorbtive® with glutamine, 5 subjects (33%) receiving Zorbtive® without glutamine and 3 subjects (33%) receiving Zorbtive® placebo with glutamine experienced at least one SAE. There were no deaths in this study.

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Side Effects by Body System - for Healthcare Professionals

General

Somatropin is generally well tolerated with minimal adverse effects.

Oncologic

Oncologic side effects have included rare reports of leukemia, however, the association with human growth hormone is uncertain.

Immunologic

Immunologic adverse reactions have included the rare development of persistent antibodies in patients treated with recombinant human growth hormone. The development of antibodies may be greater with the use of somatrem than with somatropin, although the overall incidence is very low.

An IgG antibody has been identified. No antibodies to the IgE class have been detected. Growth hormone antibody binding capacities less than 2 mg/L have not led to growth attenuation. Testing for antibodies should be carried out in any patient failing to respond to treatment.

Primate studies have failed to reveal evidence of histopathological changes due to immune complex formation.

Nervous system

Nervous system effects have included headaches, weakness, paresthesia and hypethesia.

Musculoskeletal

Musculoskeletal side effects have included localized muscle pain, carpal tunnel syndrome, aggravation of preexisting scoliosis, jaw prominence and slipped capital femoral epiphysis. Patients with Short Stature Homeobox Containing Gene (SHOX) Deficiency have reported scoliosis and arthralgia.

Endocrine

Endocrine side effects have included mild hyperglycemia, gynecomastia, and, rarely pancreatitis. New-onset type 2 diabetes mellitus in children and adults has been reported in postmarketing experience. Elevations in IGF-1 (insulin like growth factor 1) and insulin levels have occurred consistently in adults. Alterations in thyroid hormone metabolism may occur.

Serum levels of inorganic phosphorus, alkaline phosphatase and parathyroid hormone (PTH) may increase during treatment with somatropin. The mechanism is unknown. These potential changes should be considered when evaluating patient laboratory measurements.

During postmarketing surveillance, cases of new onset glucose intolerance, diabetes mellitus and exacerbations of preexisting diabetes mellitus have been reported in patients receiving the Serostim brand of somatropin. Some patients developed ketoacidosis and diabetic coma. In some patients, these conditions improved when Serostim was discontinued but not in all patients.

Cardiovascular

Edema occurs more often in adults, appears to be dose-related, and is due to the antinatriuretic effect of growth hormone.

Cardiovascular side effects have included mild, transient, peripheral edema in up to 2.5% of patients during early treatment with somatropin. Intracranial hypertension is a rare effect that may present with papilledema, visual changes, headache, nausea and vomiting. Postmarketing reports have included hypertension.

Other

Athletes using human growth hormone for doping purposes may experience cardiac, renal, and splenic hypertrophy, cardiac myopathy, fluid retention, glucose intolerance, abnormal bone growth, and an increased risk of cancers.

Chronic use of human growth hormone by athletes can lead to toxicity seen in acromegaly.

There is no risk of acquiring Creutzfeldt-Jakob disease from recombinant human growth hormone, as with the previously marketed pituitary derived human growth hormone.

Dermatologic

Dermatologic side effects have included rash, pruritus, increased sweating and increased growth of preexisting nevi (hereditary malformation of the skin). Patients with Short Stature Homeobox Containing Gene (SHOX) Deficiency have reported excessive number of cutaneous nevi.

Metabolic

Metabolic side effects have included mild transient hyperglycemia and lipolysis in adults which resulted in a statistically significant decrease in total body fat (14% to 20%) and a significant reductions in total cholesterol and/or LDL levels. No changes in HDL have been observed. Elderly patients have exhibited triglyceride elevations. The long-term effect of recombinant human growth hormone on lipid metabolism is unknown.

Local

Local side effects have included localized injection site reactions and pain.

Other

Other side effects have included an increased incidence of otitis media and other ear disorders in Turner syndrome patients. Other side effects reported in Turner syndrome patients have included influenza-like illness, upper respiratory tract infection, eczema, excessive growth of hands and feet, and exacerbation of preexisting scoliosis.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea and vomiting.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions.

Respiratory

Respiratory side effects have included rhinitis, bronchitis and upper respiratory tract infections. Postmarketing reports have included dyspnea and sleep apnea.

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