Recothrom Spray Kit

Drug overview for RECOTHROM SPRAY KIT (thrombin (recombinant)):

Generic name: thrombin (recombinant)
Drug class: Topical Hemostatics
Therapeutic class: Hematological Agents

Thrombin alfa (thrombin (recombinant)), a biosynthetic (recombinant DNA origin) preparation of naturally occurring human thrombin, is a topical hemostatic agent.

No enhanced Uses information available for this drug.

DRUG IMAGES

RECOTHROM 20,000 UNIT VIAL

The following indications for RECOTHROM SPRAY KIT (thrombin (recombinant)) have been approved by the FDA:

Indications:
Surgical hemostasis adjunct

Professional Synonyms:
None.

Moderate List
No disease contraindications

The following adverse reaction information is available for RECOTHROM SPRAY KIT (thrombin (recombinant)):

Overview
Severe
Less Severe

Adverse reaction overview.

The most common adverse effects reported in patients receiving thrombin alfa in clinical studies were incision site complications, procedural pain, nausea, constipation, insomnia, and vomiting; such adverse effects are expected to be common in a postoperative population and a causal relationship to the drug has not been established.

There are 5 severe adverse reactions.

More Frequent	Less Frequent
None.	Anemia Hypersensitivity drug reaction Hypotension

Rare/Very Rare
Anaphylaxis Thrombotic disorder

There are 2 less severe adverse reactions.

More Frequent	Less Frequent
None.	Fever Tachycardia

Rare/Very Rare
None.

The following precautions are available for RECOTHROM SPRAY KIT (thrombin (recombinant)):

Pediatric
Pregnant
Lactation
Geriatric

Thrombin alfa has been evaluated in a limited number of pediatric patients (12-17 years of age) undergoing burn wound excision prior to grafting. Manufacturer states that safety and efficacy in pediatric patients younger than 12 years of age have not been established.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category C. (See Users Guide.)

No enhanced Lactation information available for this drug.

Among the total number of patients enrolled in the phase 2 and phase 3 pivotal trials of thrombin alfa applied with an absorbable gelatin sponge, 38% were 65 years of age or older, and 16% were 75 years of age or older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients and other clinical experience has not revealed any evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.