Somatropin rDNA Origin for Injection

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

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 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.

Read the entire FDA prescribing information for Zorbtive (Somatropin rDNA Origin for Injection)