Fibrinogen/aprotinin and thrombin/calcium chloride (Topical application route, route not applicable)
a-proe-TYE-nin, fye-BRIN-oh-jen, KAL-see-um KLOR-ide, THROM-bin
Uses of This Medicine:
Aprotinin, calcium chloride, fibrinogen, and thrombin combination is used to help control bleeding during surgery when other procedures to close a wound or incision, such as stitches, bands, and heat cannot be used. It is also used to help skin tissues stick together during skin graft or cosmetic surgery (eg, burn treatment or facelift procedures). This medicine is a fibrin sealant.
Artiss™ and Tisseel™ contain man-made proteins (aprotinin, fibrinogen, and thrombin) that are used to stop bleeding by helping the blood to clot.
This medicine is to be given only by or under the supervision of your doctor.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Artiss™ and Tisseel™ in children.
Appropriate studies on the relationship of age to the effects of Artiss™ have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Tisseel™ in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use of This Medicine:
A doctor or other trained health professional will give you this medicine. This medicine is applied only to your skin or incision during surgery. It may be used with a spray applicator.
This medicine should not be given as an injection.
Precautions While Using This Medicine:
It is very important that your doctor check you or your child closely while you are receiving this medicine to make sure it is working properly.
This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.
This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.
Side Effects of This Medicine:
- Less common
- Collection of blood or fluids under the skin
- deep, dark purple bruise
- itching, pain, redness, or swelling of the skin, wound, or treated area
- Incidence not known
- Blurred vision
- chest pain, discomfort, or tightness
- difficulty breathing
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, slow, pounding, or irregular heartbeat or pulse
- flushing, redness of the skin
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- numbness or tingling in the face, arms, or legs
- pain in the chest, groin, or legs, especially the calves
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe, sudden headache
- shortness of breath
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- trouble healing
- trouble speaking or walking
- unusual tiredness or weakness
- unusually warm skin
- Incidence not known
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 5/1/2020