ZORBTIVE SIDE EFFECTS
- Generic Name: somatropin rdna origin for injection
- Brand Name: Zorbtive
- Drug Class: Growth Hormone Analogs
SIDE EFFECTS
The following serious adverse reactions are described below and elsewhere in the labeling:
- Neoplasms
- Acute Critical Illness
- Impaired Glucose Intolerance/Diabetes Mellitus
- Hypersensitivity Reactions
- Lipoatrophy
- Fluid Retention and Arthralgia
- Carpel Tunnel Syndrome
- Pancreatitis
- Hypoadrenalism
- Hypothyroidism
- Intracranial Hypertension
- Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative
Clinical Trials Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot always be directly compared to the rates in the clinical trials of another drug, and may not reflect the adverse reaction rates observed in practice.
In a double-blind, randomized, placebo-controlled clinical trial, 32 patients were exposed to Zorbtive® for 4 weeks. Of the 41 patients enrolled in the trial, 16 patients received Zorbtive® (0.1 mg/kg per day) plus supportive oral diet, 16 patients received subcutaneous Zorbtive® (0.1 mg/kg per day) plus supportive oral diet plus oral glutamine (30 grams per day), and 9 patients received placebo with specialized oral diet and oral glutamine (30 grams per day).
The most common adverse reactions occurring in greater than 20% of patients treated with Zorbtive® alone and at a higher frequency than in the control group include peripheral edema, facial edema, arthralgia, injection site pain, flatulence, and abdominal pain.
Table 1 summarizes adverse reactions that occurred in at least 10% of patients receiving Zorbtive® , alone or in combination with glutamine and at a higher incidence than in the control group.
Table 1: Adverse Reactions* in a Randomized, Placebo Controlled Trial of Zorbtive® in Adult Patients with Short Bowel Syndrome: 4 Week Treatment Period
| Adverse Reaction | Treatment Group* | ||
| Zorbtive® alone n=16 n (%) |
Zorbtive® + Glutamine n=16 n (%) |
Control (Placebo + Glutamine) n=9 n (%) |
|
| Peripheral edema | 11 (69) | 13 (81) | 1 (11) |
| Facial edema | 8 (50) | 7 (44) | 0 (0) |
| Arthralgia | 7 (44) | 5 (31) | 0 (0) |
| Injection site pain | 5 (31) | 0 (0) | 0 (0) |
| Flatulence | 4 (25) | 4 (25) | 2 (22) |
| Abdominal pain | 4 (25) | 2 (13) | 1 (11) |
| Injection site reaction | 3 (19) | 4 (25) | 1 (11) |
| Vomiting | 3 (19) | 3 (19) | 1 (11) |
| Pain | 3 (19) | 1 (6) | 1 (11) |
| Nausea | 2 (13) | 5 (31) | 0 (0) |
| *occurring at in ≥10% of Zorbtive® -treated patients and at a higher incidence than control | |||
After 4 weeks of treatment with Zorbtive® patients were discharged for follow-up on a supportive oral diet supplemented either with glutamine or glutamine placebo, and subjects were re-evaluated as outpatients 12 weeks later. No new adverse drug reactions were observed in the follow up period.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Zorbtive® or other somatropin products. 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.
Zorbtive® :
- headache
- gynecomastia
Other somatropin products:
- new onset impaired glucose tolerance, new onset type 2 diabetes mellitus, exacerbation of preexisting diabetes mellitus, diabetic ketoacidosis, diabetic coma
- serious systemic hypersensitivity reactions, including anaphylaxis and angioedema
- pancreatitis
- leukemia
SRC: NLM .