A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Serostim Side Effects, and Drug Interactions - Somatropin (rDNA origin)
Serostim Side Effects, and Drug Interactions - Somatropin (rDNA origin)
SIDE EFFECTS
In two placebo-controlled clinical trials in which 205 patients
were treated with Serostim® [somatropin (rDNA origin) for injection]
the most common adverse reactions judged to be associated with Serostim®
were musculoskeletal discomfort and increased tissue turgor (swelling, particularly
of the hands or feet) (see PRECAUTIONS:
GENERAL). These symptoms were generally rated by investigators as mild to moderate
in severity and usually subsided with continued treatment. Discontinuations
as a result of these events were rare.
Because of the diverse clinical manifestations of AIDS, and
the frequent occurrence of adverse events associated with underlying disease
process, it was often difficult to distinguish adverse events possibly associated
with the administration of Serostim® from underlying signs or
symptoms of AIDS or associated intercurrent illnesses.
Clinical adverse events which occurred during the first 12
weeks of study in at least 10% of those who received Serostim® during
the two placebo-controlled trials are listed below by treatment group, without
regard to causality assessment.
Table 2: Controlled Trials Adverse Events
|
Adverse Event
|
Serostim® (n=205) %
|
Placebo (n=150) %
|
|
Musculoskeletal discomfort
|
53.7
|
33.3
|
|
Fever
|
31.2
|
29.3
|
|
Increased tissue turgor
|
27.3
|
2.7
|
|
Diarrhea
|
25.9
|
20.0
|
|
Neuropathy
|
25.9
|
17.3
|
|
Nausea
|
25.9
|
16.0
|
|
Headache
|
19.0
|
20.7
|
|
Abdominal pain
|
17.1
|
18.7
|
|
Fatigue
|
17.1
|
16.0
|
|
Leukopenia
|
15.1
|
24.7
|
|
Albuminuria
|
15.1
|
9.3
|
|
Granulocytopenia
|
14.1
|
21.3
|
|
Lymphadenopathy
|
14.1
|
16.0
|
|
Increased sweating
|
14.1
|
8.7
|
|
Anorexia
|
12.2
|
9.3
|
|
Anemia
|
12.2
|
8.7
|
|
Vomiting
|
11.7
|
12.0
|
|
SGOT increased
|
11.7
|
6.0
|
|
Insomnia
|
11.2
|
9.3
|
|
Tachycardia
|
11.2
|
6.0
|
|
Hyperglycemia
|
10.2
|
6.0
|
|
SGPT increased
|
10.2
|
5.3
|
Adverse events that occurred in 1% to less than 10% of study
participants receiving Serostim® in the two placebo-controlled
clinical efficacy studies are listed below by body system. The list of adverse
events has been compiled regardless of causal relationship to Serostim®.
Body as a Whole: rigors, flu-like symptoms, back pain, malaise,
asthenia, carpal tunnel syndrome (see PRECAUTIONS:
GENERAL), chest pain, hot flashes, allergic reaction.
Gastrointestinal System: oral leukoplakia, flatulence, dyspepsia,
dry mouth, constipation, ulcerative stomatitis, increased amylase, dysphagia,
esophagitis, colitis, pancreatitis, rectal disorder, gastritis, tongue ulceration,
gingivitis
Musculoskeletal System: muscle weakness
Central and Peripheral Nervous System: dizziness, convulsions,
hypertonia, neuralgia, tremor, encephalopathy, nystagmus, meningism
Respiratory System: dyspnea, coughing, sinusitis, upper respiratory
tract infection, pharyngitis, rhinitis, pneumonia, bronchitis, increased sputum,
respiratory disorder, bronchospasm, pneumonitis, pleurisy
White Blood Cell and Reticuloendothelial System Disorders:
cervical lymphadenopathy, eosinophilia
Skin and Appendages: skin disorder, folliculitis, rash, alopecia,
photosensitivity reaction, erythematous rash, pruritus, abnormal pigmentation,
seborrhea, dermatitis, skin ulceration, acne, skin discoloration, verruca
Psychiatric: depression, anxiety, somnolence, nervousness,
appetite increased, amnesia, abnormal thinking
Metabolic and Nutritional: hypertriglyceridemia, increased
alkaline phosphatase, dehydration, increased creatine phosphokinase, increased
LDH, glycosuria, hypokalemia, cachexia, thirst, acidosis
Immune System Dysfunction: moniliasis, bacterial infection,
Pneumocystis carinii infection, viral infection, infection, Herpes simplex,
sepsis, abscess, fungal infection, Herpes zoster
Urinary System: hematuria, urinary tract infection, nocturia
Liver and Biliary System: abnormal hepatic function, hepatomegaly, hepatitis
Vision: retinitis, abnormal vision, photophobia
Platelet, Bleeding and Clotting: thrombocytopenia, purpura
Cardiovascular, General: abnormal ECG, heart murmur, hypertension,
hypotension
Application Site: injection site pain, injection site reaction
Neoplasms: Kaposi’s sarcoma
Male Reproductive: Epididymitis, penis disorder, inguinal hernia
Hearing and Vestibular: earache, ear disorder, decreasing hearing
Endocrine: gynecomastia, male breast pain
The types and incidences of adverse events reported in an open-label,
extension trial and in a single, foreign trial, for up to one year, were not
different from, or greater in frequency, than those observed in the primary,
placebo-controlled, clinical trials.
During post-marketing surveillance, cases of new onset glucose
intolerance, diabetes mellitus and exacerbation of preexisting diabetes mellitus
have been reported in patients receiving Serostim®. Some patients
developed diabetic ketoacidosis and diabetic coma. In some patients, these conditions
improved when Serostim® was discontinued while in others the
glucose intolerance persisted. Some patients necessitated initiation or adjustment
of antidiabetic treatment while on Serostim®.
DRUG INTERACTIONS
Formal in vitro drug interaction studies have not been conducted.
No data are available on drug interactions between Serostim®
and HIV protease inhibitors or the non-nucleoside reverse transcriptase inhibitors.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies
for carcinogenicity have not been performed with Serostim®. There
is no evidence from animal studies to date of Serostim®-induced
mutagenicity or impairment of fertility.
Pregnancy: Pregnancy Category B. Reproduction studies have
been performed in rats and rabbits. Doses up to 5 to 10 times the human dose,
based on body surface area, have revealed no evidence of impaired fertility
or harm to the fetus due to Serostim®. There are, however, no
adequate and well controlled studies in pregnant women. Because animal reproduction
studies are not always predictive of human response, this drug should be used
during pregnancy only if clearly needed.
Nursing Women: It is not known whether Serostim®
is excreted in human milk. Because many drugs are excreted in human milk, caution
should be exercised when Serostim® is administered to a nursing
woman.
Pediatric Use: In two small studies, 11 children with HIV associated
failure to thrive were treated subcutaneously with human growth hormone. In
one study, five children (age range, 6 to 17 years) were treated with 0.04 mg/kg/day
for 26 weeks. In a second study, six children (age range, 8 to 14 years) were
treated with 0.07 mg/kg/day for 4 weeks. Treatment appeared to be well tolerated
in both studies. These preliminary data collected on a limited number of patients
with HIV associated failure to thrive appear to be consistent with safety observations
in growth hormone treated adults with AIDS wasting.
Geriatric Use: Clinical studies with Serostim®
did not include sufficient numbers of subjects aged 65 and over to determine
whether they respond differently from younger subjects. Elderly patients may
be more sensitive to growth hormone action, and may be more prone to develop
adverse reactions. Thus, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range.
top
