What is Koate?
Koate (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting Koate. Recombinant this medicine replaces clotting Koate in the blood.
Recombinant Koate is used to treat or prevent bleeding episodes in adults and children with hemophilia A. Koate is sometimes given before a surgery.
Recombinant Koate can help prevent joint damage in children who have hemophilia A and no prior joint damage.
Recombinant Koate is not for use in treating von Willebrand disease.
Koate is not approved for use by anyone younger than 12 years old.
Recombinant Koate may also be used for purposes not listed in this medication guide.
Koate indications
Koate® Koate (Recombinant) is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital Koate deficiency or classic hemophilia).
Koate (Koate) is indicated for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.
Koate (Koate) can be of a significant therapeutic value for treatment of hemophilia A in certain patients with inhibitors to Koate. In clinical studies of Koate (Koate), study subjects who developed inhibitors on study continued to manifest a clinical response when inhibitor titers were < 10 BU. When an inhibitor is present, the dosage requirement of Koate is variable. The dosage can be determined only by a clinical response and by monitoring of circulating Koate levels after treatment .
Koate (Koate) does not contain von Willebrand factor and therefore is not indicated in von Willebrand's disease.
How should I use Koate?
Use Koate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Koate. Talk to your pharmacist if you have questions about this information.
- Koate is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Koate at home, a health care provider will teach you how to use it. Be sure you understand how to use Koate. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Wash your hands before and after use.
- If Koate was stored in the refrigerator, let it reach room temperature before mixing. Do not heat it.
- Mix by gently swirling. Do not shake.
- Koate should be clear to slightly cloudy and colorless. Do not use Koate if it contains particles, is very cloudy or discolored, or if the vial is cracked or damaged.
- Use Koate within 3 hours after it has been mixed, or after the gray rubber tip cap has been removed from the prefilled dual-chamber syringe. The medicine may be kept at room temperature during this time. Throw Koate away if it has not been used within 3 hours.
- When drawing a dose into a syringe, be sure to follow the procedure demonstrated to you by your doctor to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers.
- Carefully check that you have drawn the correct dose before administration.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Koate, call your doctor to find out what to do.
Ask your health care provider any questions you may have about how to use Koate.
Uses of Koate in details
This medication is used to control and prevent bleeding episodes in people with low levels of Koate (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low Koate levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of Koate, also called Koate. This product is used to temporarily replace the missing Koate, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop.
This medication should not be used to treat von Willebrand disease.
How to use Koate intravenous
This medication is given by injection into a vein as directed by your doctor. The medication may need to be given more slowly over a longer time depending on your dose and how you respond to it.
After first receiving this medication in a hemophilia treatment center or hospital, some patients may be able to give this medication to themselves at home. If your doctor directs you to give this medication at home, read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If you have any questions, ask your health care professional.
If the medication and the solution used to mix it were refrigerated, bring both to room temperature before combining. After adding the solution to the powder, gently swirl the mixture to completely dissolve the powder. Do not shake. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Use right away according to the product instructions.
The dosage is based on your medical condition, weight, blood test results, and response to treatment. Follow your doctor's instructions closely.
Tell your doctor if your condition does not improve or if it worsens.
Koate description
Koate is a high purity, sterile, powder for injection containing a human coagulation Koate (FVIII) and human von Willebrand factor (VWF) complex. Koate is manufactured from plasma donated by voluntary and non-remunerated donors from Hong Kong. It is intended for IV administration. The FVIII/VWF complex in Koate is purified from cryoprecipitate using selective precipitation and size exclusion chromatography steps. The Koate manufacturing process includes solvent detergent (tributyl phosphate and polysorbate 80) and dry heat treatment (80°C for 72 hrs) steps to reduce the potential for viral transmission. The solvent detergent, dry heat treatment and partitioning steps used in the manufacture of Koate have been demonstrated to be effective virus inactivation/removal steps in vitro for the relevant viruses human immunodeficiency virus (HIV) and hepatitis A virus (HAV), and also with model viruses for hepatitis B (HBV) and hepatitis C viruses (HCV). The manufacturing process also contributes to inactivation/removal of human parvovirus B19 (B19).
Human albumin is added to Koate as a stabiliser. Measured prior to the addition of albumin, the specific activity of Koate is nominally 50 FVIII:C IU/mg of total protein. Koate contains other proteins eg, fibrinogen, fibronectin, immunoglobulins (IgA, IgM, IgG) and transforming growth factor β (TGF-β), all of which are present at significantly lower levels than in normal plasma. When expressed as per mg clottable protein (fibrinogen), the specific activity of the final product is nominally 300 IU von Willebrand factor:Ristocetin cofactor (VWF:RCo)/mg and 150 IU FVIII:C/mg, based on the Koate VWF to FVIII ratio of 2:1.
Koate is available in the presentation detailed in Table 1.
Koate dosage
Treatment with Koate® Koate (Recombinant) should be initiated under the supervision of a physician experienced in the treatment of hemophilia A.
The labeled potency of Koate (Koate) is based on the European Pharmacopoeial chromogenic substrate assay, whereas other Koate products are labeled based on the one-stage clotting assay. With recombinant Koate products, the chromogenic assay typically yields results which are higher than the results obtained with the one-stage clotting assay. When switching between products it is important to individually titrate each patient's dose in order to ensure an adequate therapeutic response. Results of a comparative study that evaluated the effect of phospholipids on the one-stage clotting and chromogenic assays showed that the one-stage clotting assay gave results that were approximately 50% of the values obtained with the chromogenic assay. In addition, in clinical trials of Koate (Koate) use in the surgical setting in which multiple laboratories were used for plasma sample analysis, the ratio of Koate activity results as measured by a local laboratory one-stage clotting assay and the central laboratory chromogenic substrate assay was 0.8 (0.2-3.0).
When monitoring patients' Koate activity levels during treatment, the available clinical data suggest that either assay may be used. Most patients in clinical trials were monitored with the one-stage clotting assay. It is necessary to adhere to the incubation/activation times and other test conditions as specified by the assay manufacturers.
Dosage and duration of treatment depend on the severity of the Koate deficiency, the location and extent of bleeding, and the patient's clinical condition. Doses administered should be titrated to the patient's clinical response. In the presence of an inhibitor, higher doses may be required.
Precise monitoring of the replacement therapy by means of coagulation analysis (plasma Koate activity) is recommended, particularly for surgical intervention.
One international unit (IU) of Koate activity corresponds approximately to the quantity of Koate in one mL of normal human plasma. The calculation of the required dosage of Koate is based upon the empirical finding that, on average, 1 IU of Koate per kg body weight raises the plasma Koate activity by approximately 2 IU/dL per IU/kg administered. The required dosage is determined using the following formula:
Required units = body weight (kg)
x desired Koate rise (IU/dL or % of normal)
x 0.5 (IU/kg per IU/dL)
The following chart can be used to guide dosing in bleeding episodes and surgery:
3. Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution, and allow to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.
4. Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package.
5. While holding the adapter package, place the vial adapter over the vial and press down firmly on the package until the adapter spike penetrates the vial stopper.
6. Grasp the plunger rod per the diagram. Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe plunger by pushing and turning firmly.
7. Break off the tamper-resistant plastic tip cap from the diluent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. Place the cap on its top on a clean surface in a spot where it would be least likely to become environmentally contaminated. The cap may need to be replaced (if not administering reconstituted Koate (Koate) immediately).
8. Lift the package away from the adapter and discard the package.
9. Place the vial on a flat surface. Connect the diluent syringe to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured.
10. Slowly depress the plunger rod to inject all the diluent into the Koate (Koate) vial.
11. Without removing the syringe, gently swirl the contents of the vial until the powder is dissolved.
12. Inspect the final solution for specks before administration. The solution should appear clear and colorless.
Note: If you use more than one vial of Koate (Koate) per infusion, reconstitute each vial as per the previous instructions.
13. Invert the vial and slowly draw the solution into the syringe.
Note: If you prepared more than one vial of Koate (Koate), remove the diluent syringe from the vial adapter, leaving the vial adapter attached to the vial. Quickly attach a separate large luer lock syringe and draw back the reconstituted contents as instructed above. Repeat this procedure with each vial in turn. Do not detach the diluent syringes or the large luer lock syringe until you are ready to attach the large luer lock syringe to the next vial adapter.
14. Detach the syringe from the vial adapter by gently pulling and turning the syringe counter-clockwise. Discard the vial with the adapter attached. Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced. Do not touch the syringe tip or the inside of the cap.
Koate (Koate) should be administered within 3 hours after reconstitution. The reconstituted solution may be stored at room temperature prior to administration.
Administration (Intravenous Injection)
Koate® Koate (Recombinant) should be administered using the tubing provided in this kit, and the pre-filled diluent syringe provided or a single sterile disposable plastic syringe. In addition, the solution should be withdrawn from the vial using the vial adapter.
1. Attach the syringe to the luer end of the infusion set tubing provided and perform venipuncture as instructed by your physician. In the absence of incompatibility studies, reconstituted Koate (Koate) should not be administered in the same tubing or container with other medicinal products. In vitro studies suggest that Koate may adsorb to the internal surfaces of some infusion equipment.
After reconstitution, Koate (Koate) should be injected intravenously over several minutes. The rate of administration should be determined by the patient's comfort level.
Following completion of Koate (Koate) treatment, remove the infusion set and discard. The amount of drug product remaining in the infusion set is not clinically significant.
Dispose of all unused solution, the empty vial(s), and the used needles and syringes in an appropriate container for throwing away waste that might hurt others if not handled properly.
Storage
Product as packaged for sale: Koate® Koate (Recombinant) should be stored under refrigeration at a temperature of 2° to 8°C (36° to 46°F). Koate (Koate) may also be stored at room temperature not to exceed 25°C (77°F) for up to 3 months, until the expiration date. The patient should write in the space provided on the outer carton the date the product was placed at room temperature. At the end of the 3-month period, the product should not be put back into the refrigerator, but should be used immediately or discarded. Freezing should be avoided to prevent damage to the pre-filled diluent syringe. During storage, avoid prolonged exposure of Koate® (Koate) vial to light. Do not use Koate (Koate) after the expiry date on the label.
Product after reconstitution: The product does not contain a preservative and should be used within 3 hours.
How supplied
Koate® Koate (Recombinant) is supplied in kits that include single-use (4 mL size, dried) vials which contain nominally 250, 500, 1000 or 2000 IU per vial:
250 IU Kit: NDC 58394–007–04
500 IU Kit: NDC 58394–006–04
1000 IU Kit: NDC 58394–005–04
2000 IU Kit: NDC 58394–011–04
Actual Koate activity in IU is stated on the label of each Koate® Koate (Recombinant) vial.
In addition, each Koate® Koate (Recombinant) kit contains: one pre-filled diluent syringe containing 4 mL 0.9% Sodium Chloride with plunger rod for assembly, one vial adapter, one sterile infusion set, two alcohol swabs, one bandage, one gauze, and one package insert.
REFERENCES
11. Kessler CM. An Introduction to Koate Inhibitors: The Detection and Quantitation. American Journal of Medicine. 1991;91(Supplement 5A):1S-5S.
This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. Manufactured and Distributed by: Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. Rev 12/07.
Koate interactions
See also:
What other drugs will affect Koate?
Interactions with Other Medicines: The interaction of Koate with other drugs has not been established in specific studies.
Effect on Laboratory Tests: FVIII and/or VWF are endogenous plasma proteins; no specific effects on laboratory tests are therefore anticipated.
Koate side effects
See also:
What are the possible side effects of Koate?
Allergic reactions or fever are rarely observed in patients receiving FVIII/VWF preparations. If any adverse event occurs while Koate is being administered, the rate of injection should be slowed or stopped to alleviate symptoms.
Adverse Events in Clinical Trials: Von Willebrand Disease (VWD): In the Koate pharmacokinetic clinical study, adverse events were reported by 11 out of the 12 VWD patients. Most events were mild to moderate in severity and considered not related to Koate. Nine (9) adverse events were considered by the investigator to be related to Koate and were reported by 2 of the 12 patients.
In the safety and efficacy trial, 22 of the 23 VWD patients experienced adverse events. Only 3 events were considered by the investigator to be probably or possibly related to Koate. Two (2) serious adverse events were reported: Iliacus myositis and upper respiratory tract infection, both considered unrelated to Koate. All other adverse events were considered unrelated or unlikely to be related to Koate.
Haemophilia A: In the initial pharmacokinetics clinical trial, only 1 of the 16 haemophilia A patients experienced 2 adverse events. Both events were single episodes, mild in severity and considered to be related to Koate.
In the tolerability, safety and efficacy clinical trial, 21 of the 30 haemophilia A patients experienced adverse events. Twenty-three (23) of the adverse events were considered to be related or possibly related to Koate. One (1) of the patients who experienced back pain and skeletal pain during the safety and efficacy trial also experienced these symptoms during the initial pharmacokinetics trial. All of these related adverse events were considered to be mild in severity.
Koate contraindications
See also:
What is the most important information I should know about Koate?
Do not use this medicine if you have ever had a severe allergic reaction to Koate in the past, or if you are allergic to mouse proteins.
Before using human Koate, your specific blood clotting disorder must be diagnosed as Koate deficiency. Human Koate will not treat von Willebrand disease.
Your body may develop antibodies to this medication, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.
To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.
Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.
This medicine is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
Active ingredient matches for Koate:
Antihemophilic Factor in Bulgaria, Croatia (Hrvatska), Israel, Malaysia, United States.
A factor VIII preparation in Indonesia.
Antihemophilic Factor Human 250[iU] in 5mL;
Coagulation Factor VIII/Human in Israel, United States.
Factor VIII in Russia.
List of Koate substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Kiovig 100mg/ml (Oman) | |
| Koate DVI | |
| Koate HP (Pakistan) | |
| Koate-DVI (Bulgaria, Croatia (Hrvatska), Georgia, Hong Kong, Indonesia, Lithuania, Russian Federation, Serbia, Taiwan, Turkey) | |
| Injectable; Injection; Coagulation Factor VIII Human 250 IU (Grifols) | |
| Injectable; Injection; Coagulation Factor VIII Human 500 IU (Grifols) | |
| Injectable; Injection; Coagulation Factor VIII Human 1, 000 IU (Grifols) | |
| Koate-DVI / single-dose 250 IU x 5 mL (Grifols) | |
| Koate-DVI 500 IU x 5 mL (Grifols) | |
| Koate-DVI 1000 IU x 10 mL (Grifols) | |
| Koate-DVI 250 IU x 5 mL (Grifols) | |
| Koate-DVI / single-dose 250 AFU x 1's (Grifols) | $ 115.05 |
| Koate-DVI / Single-dose 250 IU x 5 mL x 1's (Grifols) | $ 157.26 |
| Koate-DVI 500 IU x 5 mL x 1's (Grifols) | $ 314.52 |
| Koate-DVI inj 1000 IU 10 mL x 1's (Grifols) | |
| Koate-DVI inj 250 IU / single-dose 5 mL x 1's (Grifols) | |
| Koate-DVI inj 500 IU 5 mL x 1's (Grifols) | |
| Koate-DVI 1000 (Israel) | |
| Koate-DVI 250 (Israel) | |
| Koate-DVI 500 (Israel) | |
| Koate-DVI human | |
| Koate-DVI injection | |
| Koate-HP | |
| Injectable; Injection; Antihemophilic Factor Human 1000 units (Bayer) | |
| Injectable; Injection; Antihemophilic Factor Human 1800 units (Bayer) | |
| Koate-HP 1500 IU x 1's (Bayer) | |
| Koate-HP injection | |
| Kogenate (Belgium, Canada, Georgia, Germany, Hungary, Ireland, Italy, Luxembourg, New Zealand, Portugal, Taiwan, United Kingdom, United States) | |
| Injectable; Injection; Coagulation Factor VIII 250 IU (Bayer) | |
| Injectable; Injection; Coagulation Factor VIII 500 IU (Bayer) | |
| Injectable; Injection; Coagulation Factor VIII 1, 000 IU (Bayer) | |
| Injectable; Injection; Coagulation Factor VIII 2, 000 IU (Bayer) | |
| KOGENATE Bayer (Austria, Bulgaria, Croatia (Hrvatska), Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Netherlands, Norway, Slovenia, Spain, Sweden) | |
| Kogenate FS Bio-Set | |
| Kogenate FS injection | |
| Kogenate FS recombinant | |
| Kogenate FS w/BIO-SET | |
| Kogenate FS with Bioset | |
| Kogenate FS with Bioset recombinant | |
| Kogenate injection | |
| Kogenate-FS (China, Colombia, Peru, Singapore, Thailand, Tunisia, Turkey) | |
| Kovaltry | |
| Kryobulin VH (Canada) | |
| Injectable; Injection; Antihemophilic Factor Human 500 units (Immuno) | |
| Injectable; Injection; Antihemophilic Factor Human 1000 units (Immuno) | |
| Liberate | |
See 348 substitutes for Koate | |
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