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
Crofab Side Effects, and Drug Interactions - Crotalidae Polyvalent Immune Fab (Ovine)
Crofab Side Effects, and Drug Interactions - Crotalidae Polyvalent Immune Fab (Ovine)
SIDE EFFECTS
• The majority of adverse reactions to CroFab reported in clinical studies
were mild or moderate in severity.
• The most common adverse events reported in the clinical studies were
urticaria and rash. Adverse events involving the skin and appendages (primarily
rash, urticaria, and pruritus) were reported in 14 of the 42 patients (Table
6).
• Of the 25 patients who experienced adverse reactions, 3 patients experienced
severe or serious adverse reactions. The 1 patient who experienced a serious
adverse event had a recurrent coagulopathy due to envenomation, which required
re-hospitalization and additional antivenin administration. This patient eventually
made a complete recovery.The other 2 had severe adverse reactions that consisted
of 1 patient who developed severe hives following treatment and 1 patient
who developed a severe rash and pruritus several days following treatment.
Both patients recovered following treatment with antihistamines and prednisone.
• One patient discontinued CroFab therapy due to an allergic reaction.
|
Table 6. Incidence of Clinical Adverse Events in Studies
of CroFab by Body System
|
|
Adverse Events
|
n=42* Number of Events
|
|
Body as a Whole
|
|
Back pain
|
2
|
|
Chest pain
|
1
|
|
Cellulitis
|
1
|
|
Wound infection
|
1
|
|
Chills
|
1
|
|
Allergic reaction †
|
1
|
|
Serum sickness
|
1
|
|
Skin and Appendages
|
|
Urticaria
|
7
|
|
Rash
|
5
|
|
Pruritus
|
3
|
|
Subcutaneous nodule
|
1
|
|
Cardiovascular System
|
|
Hypotension
|
1
|
|
Respiratory System
|
|
Asthma
|
1
|
|
Cough
|
1
|
|
Increased sputum
|
1
|
|
Digestive System
|
|
Nausea
|
3
|
|
Anorexia
|
1
|
|
Hematologic/Lymphatic
|
|
Coagulation disorder
|
3
|
|
Ecchymosis
|
1
|
|
Musculoskeletal
|
|
Myalgia
|
1
|
|
Nervous System
|
|
Circumoral paresthesia
|
1
|
|
General paresthesia
|
1
|
|
Nervousness
|
1
|
|
* Of the 42 patients receiving CroFab in the clinical
studies, 25 experienced an adverse event. A total of 40 adverse events
was experienced by these 25 patients.
|
|
† Allergic reaction consisted of urticaria, dyspnea and
wheezing in 1 patient.
|
In the 42 patients treated with CroFab for minimal or moderate
crotalid envenomations, there were 7 events classified as early serum reactions
and 5 events classified as late serum reactions, and none were serious (Table
7). In the clinical studies, serum reactions consisted mainly of urticaria and
rash,and all patients recovered without sequelae.
|
Table 7. Incidence of Early and Late Serum Reactions (Reactions
Associated with CroFab Infusion)
|
|
|
n=42* Number of Events
|
|
Early Serum Reactions
|
|
Urticaria
|
5
|
|
Cough
|
1
|
|
Allergic reaction**
|
1
|
|
Late Serum Reactions
|
|
Rash
|
2
|
|
Pruritus
|
1
|
|
Urticaria
|
1
|
|
Serum sickness†
|
1
|
|
* 6 of the 42 patients experienced an adverse event associated
with an early serum reaction and 4 experienced an adverse event associated
with a late serum reaction. Two additional patients were considered to
have a late serum reaction by the investigator, although no associated
adverse event was reported.
|
|
** Allergic reaction consisted of urticaria, dyspnea
and wheezing in 1 patient.
|
|
† Serum sickness consisted of severe rash and pruritus
in 1 patient.
|
DRUG INTERACTIONS
Studies of drug interactions have not been conducted with CroFab.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal carcinogenicity and reproduction studies have not been
conducted with CroFab.
Pregnancy
Pregnancy Category C.Animal reproduction studies have not been
conducted with CroFab. It is also not known whether CroFab can cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity. CroFab
should be given to a pregnant woman only if clearly needed.
CroFab contains mercury in the form of ethyl mercury from
thimerosal (see PRECAUTIONS, General). Although
there are limited toxicology data on ethyl mercury, high dose and acute exposures
to methyl mercury have been associated with neurological and renal toxicities.
Developing fetuses and very young children are most susceptible and therefore,
at greater risk.
Nursing Mothers
It is not known whether CroFab is excreted in human breast
milk. Because many drugs are excreted in human milk, caution should be exercised
when CroFab is administered to a nursing woman.
Geriatric Use
Specific studies in elderly patients have not been conducted.
Pediatric Use
Specific studies in pediatric patients have not been conducted.
The absolute venom dose following snakebite is expected to be the same in children
and adults, therefore,no dosage adjustment for age should be made.
CroFab contains mercury in the form of ethyl mercury from
thimerosal (see PRECAUTIONS, General). Although
there are limited toxicology data on ethyl mercury, high dose and acute exposures
to methyl mercury have been associated with neurological and renal toxicities.
Developing fetuses and very young children are most susceptible and therefore,
at greater risk.
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