THROMBIN-JMI

WARNING: SEVERE BLEEDING AND THROMBOSIS COMPLICATIONS

• THROMBIN-JMI can cause fatal severe bleeding or thrombosis. Thrombosis may result from the development of antibodies against bovine thrombin. Bleeding may result from the development of antibodies against factor V. These may cross-react with human factor V and lead to its deficiency.
• Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V.
• Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.
• Do not inject directly into the circulatory system. Because of its action in the clotting mechanism, THROMBIN-JMI can cause extensive intravascular clotting or death.
• Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V.
• Do not administer to patients with a history of hypersensitivity to THROMBIN-JMI, its components and/or to material of bovine origin.
• Do not use for treatment of severe or brisk arterial bleeding.
• Allergic reactions, including anaphylactic/anaphylactoid reactions, have been reported following administration of THROMBIN-JMI.
• Institute intensive supportive measures and treat individual symptoms. Secure the airway and establish adequate respiratory exchange.
• THROMBIN-JMI causes thrombosis if it enters the circulatory system due to its action in the clotting system. Apply topically. DO NOT INJECT.
• Inhibitory antibodies may develop in patients and interfere with hemostasis. Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V, due to the potential for these antibodies to interfere with hemostasis. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.
• Bleeding may result from the development of antibodies against factor V. These antibodies may cross-react with human factor V and lead to human factor V deficiency.
• Thrombosis may result from the development of antibodies against bovine thrombin.
• Because THROMBIN-JMI may cause the formation of clots in blood vessels if it enters the bloodstream, advise patients to consult their physician if they experience leg tenderness or swelling, chest pain, shortness of breath, or difficulty speaking or swallowing.

Most common adverse reactions (incidence greater than or equal to 2%) are hypersensitivity, bleeding, anemia, post-operative wound infection, thromboembolic events, hypotension, pyrexia, tachycardia and thrombocytopenia. In another study, the most common treatment-emergent adverse reactions (experienced by >5% patients within a treatment group) were procedural pain, nausea, constipation, pruritus, muscle spasms, insomnia, pyrexia, and vomiting.

Animal reproduction studies have not been conducted with THROMBIN-JMI. It is also not known whether THROMBIN-JMI can cause fetal harm when administered to a pregnant woman. THROMBIN-JMI should be given to a pregnant woman only if clearly needed.

It is not known whether this drug is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for THROMBIN-JMI and any potential adverse effects on the breastfed infant from THROMBIN-JMI or from the underlying maternal condition. 

Safety and effectiveness in children have not been established.

GEL-FLOW NT

GEL-FLOW NT should not be used in closure of skin incisions because it may interfere with healing of the skin edges. This is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.

GEL-FLOW NT must not be placed in intravascular compartments because of the risk of embolization.

Do not use GEL-FLOW NT in patients with known allergies to porcine collagen.

Life-threatening anaphylactic reactions, including death, have been reported after exposure to absorbable gelatin. Patients with history of allergies to porcine products may be at risk of serious acute hypersensitivity reactions, including anaphylaxis. If an anaphylactic reaction is observed, absorbable gelatin administration should be immediately discontinued and any applied product removed.

GEL-FLOW NT is not intended as a substitute for meticulous surgical technique and the proper application of ligatures, or other conventional procedures for hemostasis.

Unused, opened GEL-FLOW NT syringes or packs must be discarded. GEL-FLOW NT must not be resterilized.

Only the minimum amount of GEL-FLOW NT mixture necessary to achieve hemostasis should be used and applied to the bleeding site with pressure until bleeding stops. Once hemostasis is attained, excess GEL-FLOW NT mixture should be carefully removed.

The use of GEL-FLOW NT is not recommended in the presence of infection. GEL-FLOW NT should be used with caution in contaminated areas of the body.

The packing of GEL-FLOW NT, particularly within bony cavities, should be avoided, since swelling may interfere with normal function and/or possibly result in compression necrosis of surrounding tissues.

Whenever possible, GEL-FLOW NT should be removed after use in laminectomy procedures and from foramina in bone, once hemostasis is achieved. This is because GEL-FLOW NT may swell on absorbing fluids and produce nerve damage by pressure within confined bony spaces.

GELFOAM should not be placed in the vicinity of the cerebral ventricular space or where there is a possibility of a cerebrospinal fluid fistula to the target bleeding site. GELFOAM should also not be used as a tissue substitute to repair tissue defects of the dura or the cranium. GELFOAM may migrate from central nervous system cerebrospinal fluid surgical sites into the cerebral ventricular space and compromise the cerebrospinal fluid circulation. Hydrocephalus and cerebrospinal fluid retention, requiring a re-intervention to remove GELFOAM residue, have been reported in adult and pediatric patients. In some cases, these complications occurred several months after use of GELFOAM.

GEL-FLOW NT should not be used for controlling postpartum bleeding or menorrhagia.

GEL-FLOW NT should not be used in conjunction with autologous blood salvage circuits or methyl-methacrylate adhesives.

After placement, absorbable hemostatic agents may be visible on imaging studies until they are fully absorbed, which could be interpreted as pseudotumor/pseudomass appearance. Pseudoinfection/pseudoabscess has also been reported in the literature. Pseudotumor/pseudomass and pseudoinfection/pseudoabscess may result in additional invasive procedures, reoperations, and prolonged hospital stays.

There have been reports of the following events associated with the use of GELFOAM absorbable gelatin powder: fever (without demonstrated infection), infection, abscess formation, giant cell granuloma, CNS compression, foreign body reaction, encapsulation of fluid, hematoma, excessive fibrosis, prolonged fixation of a tendon, toxic shock syndrome, and hearing loss (in tympanoplasty surgeries).

In laminectomy operations, multiple neurologic events were reported, including but not limited to cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence.

Please see full Prescribing Information, including BOXED WARNING, for THROMBIN-JMI.

Please see Instructions for Use for GEL-FLOW NT.