Triamcinolone: (Major) Desmopressin is contraindicated with concomitant inhaled or systemic corticosteroid use due to an increased risk of hyponatremia. To minimize risk of hyponatremia and seizures, administer no more than once every 24 hours or for more than 3 consecutive days. Grading Central Diabetes Insipidus Induced by Immune Checkpoint Inhibitors: A Challenging Task. The woman had previously received desmopressin without the development of clinical symptoms of hyponatremia Ibuprofen; Famotidine: (Major) Additive hyponatremic effects may be seen in patients treated with desmopressin and drugs associated with hyponatremia including NSAIDs. anaphylactoid reactions / Rapid / 0-1.0anaphylactic shock / Rapid / 0-1.0seizures / Delayed / Incidence not knownwater intoxication / Delayed / Incidence not knowncoma / Early / Incidence not knownthrombosis / Delayed / Incidence not knownthromboembolism / Delayed / Incidence not knownstroke / Early / Incidence not knownmyocardial infarction / Delayed / Incidence not known, hyponatremia / Delayed / 0.9-12.0hypertension / Early / 1.7-2.6photophobia / Early / 0-2.0conjunctivitis / Delayed / 0-2.0confusion / Early / Incidence not knownelevated hepatic enzymes / Delayed / Incidence not knownhypotension / Rapid / Incidence not knownsinus tachycardia / Rapid / Incidence not knownpalpitations / Early / Incidence not knowninfertility / Delayed / Incidence not knownbalanitis / Delayed / Incidence not knowntolerance / Delayed / Incidence not known, xerostomia / Early / 0-14.0rhinitis / Early / 3.0-8.0headache / Early / 2.0-5.0pharyngitis / Delayed / 2.3-3.8dizziness / Early / 0-3.0epistaxis / Delayed / 2.0-3.0nasal congestion / Early / 1.4-2.9sneezing / Early / 2.3-2.6back pain / Delayed / 1.1-2.3chills / Rapid / 0-2.0asthenia / Delayed / 0-2.0rhinalgia / Early / 2.0-2.0ocular pruritus / Rapid / 0-2.0lacrimation / Early / 0-2.0diarrhea / Early / Incidence not knownabdominal pain / Early / Incidence not knowndyspepsia / Early / Incidence not knownnausea / Early / Incidence not knownlethargy / Early / Incidence not knownflushing / Rapid / Incidence not knowncough / Delayed / Incidence not knowninjection site reaction / Rapid / Incidence not knownoligospermia / Delayed / Incidence not known. 6 years or older: Her serum sodium concentration was 124 mmol/L within a day and was 135 mmol/L by the second day. Patients receiving intranasal treatment could begin oral therapy the night following (24 hours) the last intranasal dose. A woman who took both desmopressin and ibuprofen was found in a comatose state. Use combination with caution, and monitor patients for signs and symptoms of hyponatremia. Further hospitalization cost saving may be achieved through reduced Intranasal desmopressin 300 mcg results in maximal Factor VIII and von Willebrand Factor activity levels 150% to 250% of normal. government site. 14 A commonly cited double-blind trial suggests a conversion of 1 mg IV lorazepam to 2 mg of IV midazolam, which is further supported using a midazolam oral bioavailability of 40% due to a . Some studies have used 0.1 to 1 mcg IV/SC in 1 or 2 divided doses. Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) Although the pressor activity of desmopressin is very low compared to its antidiuretic activity, large doses of desmopressin should be used with other pressor agents like phenylephrine only with careful patient monitoring. Other evaluations have indicated that the terminal half-life for desmopressin is approximately 3 hours. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Following oral administration, the half-life of desmopressin is about 1.5 to 2.5 hours and is independent of dosage. Trauma Surg Acute Care Open. For children weighing less than 10 kg, dilute dose in 10 mL 0.9% Sodium Chloride for injection.Infuse IV slowly over 15 to 30 minutes.Pulse and blood pressure should be monitored during infusion. Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: (Moderate) Although the pressor activity of desmopressin is very low compared to its antidiuretic activity, large doses of desmopressin should be used with other pressor agents like phenylephrine only with careful patient monitoring. Her serum sodium concentration was 124 mmol/L within a day and was 135 mmol/L by the second day. Her serum sodium concentration was 124 mmol/L within a day and was 135 mmol/L by the second day. There is no increase in activity with doses greater than 0.4 mcg/kg, despite increases in desmopressin concentrations. Brand Names. May repeat dose if needed. Caution should be exercised when desmopressin is administered to a woman who is breast-feeding. WBC count of 15,00/mm 2. 1. <>/Metadata 485 0 R/ViewerPreferences 486 0 R>> Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. The antidiuretic effects of the drug last for about 5 to 21 hours, followed by an abrupt cessation of activity that occurs over a 60- to 90-minute period. Desmopressin: Corticosteroids (Systemic) may enhance the hyponatremic . [61810], Initially, 5 mcg (0.05 mL) intranasally, given in 1 to 2 divided doses, then titrated to response. Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer. Furosemide: (Contraindicated) Desmopressin is contraindicated with concomitant loop diuretic use due to an increased risk of hyponatremia. Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) Monitor serum sodium more frequently during concomitant desmopressin and thiazide diuretic use due to increased risk of water intoxication with hyponatremia. About 1/4 to 1/3 of patients can be controlled by a single daily dose. Her serum sodium concentration was 124 mmol/L within a day and was 135 mmol/L by the second day. Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer. Hemophilia A and von Willebrand's Disease (Type I): The recommended dosage is 0.3 mcg/kg actual body weight (to a maximum of 20 mcg) administered by intravenous infusion over 15 minutes to 30 minutes. The administration of carbamazepine prior to administration of desmopressin may act to reduce the duration of action of desmopressin. Also remove sticky note when IV to po is addressed. The woman had previously received desmopressin without the development of clinical symptoms of hyponatremia Methyclothiazide: (Moderate) Monitor serum sodium more frequently during concomitant desmopressin and thiazide diuretic use due to increased risk of water intoxication with hyponatremia. A woman who took both desmopressin and ibuprofen was found in a comatose state. FOIA Paediatr Drugs. Monoamine oxidase inhibitors: (Moderate) Additive hyponatremic effects may be seen in patients treated with desmopressin and drugs associated with hyponatremia and SIADH including monoamine oxidase inhibitors (MAOIs). Of course, hypertonic bicarbonate could also be used, as discussed last week. hydrochlorothiazide, nortriptyline, tranexamic acid, imipramine, desmopressin, Pamelor, Microzide, vasopressin, Tofranil. A woman who took both desmopressin and ibuprofen was found in a comatose state. Med Surg ATI Proctored Exam Test Bank A 1 Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer. Dependent on route of administration and indication for therapy. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Monitor renal function and clinical status closely during use. 0.3 to 0.4 mcg/kg/dose IV or subcutaneously once. Olopatadine; Mometasone: (Major) Desmopressin is contraindicated with concomitant inhaled or systemic corticosteroid use due to an increased risk of hyponatremia. Conversion of IV Midazolam. If administered more than once a day, adjust for an adequate diurnal rhythm of urine output. Caution should be used when coadministering these agents. Many persons with type 2 vWD do not respond to desmopressin and require alternate treatment; however, a desmopressin trial can help confirm diagnosis and may be useful in some instances of mild bleeding in persons with type 2 vWD. As her serum sodium concentration was 121 mmol/L, and her plasma osmolality was low in the presence of a high-normal urine osmolality and normal sodium excretion, she was treated with fluid restriction. Hydrocortisone (systemic): Drug information - UpToDate The recommended maintenance dose is 10 mcg/day to 40 mcg/day intranasally (0.1 mL/day to 0.4 mL/day) in 1 to 3 divided doses. -. Intranasal: 5 mcg/day as a single dose or in 2 divided doses. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. more than 50 kg: 150 mcg in each nostril. Use combination with caution, and monitor patients for signs and symptoms of hyponatremia. In addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Desmopressin was administered orally (0.2 mg) and intravenously (2 microg), daytime and night-time, yielding four in-hospital sessions, separated by at least 2 days. As her serum sodium concentration was 121 mmol/L, and her plasma osmolality was low in the presence of a high-normal urine osmolality and normal sodium excretion, she was treated with fluid restriction. Caution should be used when coadministering these agents. 150 mcg into each nostril once for a total dose of 300 mcg. The 0.83 mcg dose did not meet all prespecified efficacy endpoints in clinical trials, but may have a lower risk of hyponatremia. The initial and terminal half-lives for desmopressin are 7.8 and 75.5 minutes, respectively, resulting in a prompt onset of action with a long duration of action. Desmopressin | Drugs | BNF | NICE Do not transfer any remaining solution to another bottle. Fluid restriction was to be observed, with fluid intake was limited to a minimum from 1 hour before intranasal administration, until the next morning, or at least 8 hours after administration. 2005 Apr;95(6):804-9. doi: 10.1111/j.1464-410X.2005.05405.x. Baseline renal function should be assessed. Pharmacologic: antidiuretic hormones + + + Indications + + PO, SC, IV, Intranasal: Treatment of diabetes insipidus caused by a deficiency of vasopressin. As her serum sodium concentration was 121 mmol/L, and her plasma osmolality was low in the presence of a high-normal urine osmolality and normal sodium excretion, she was treated with fluid restriction. 0.2 to 0.6 mg orally once daily before bedtime. A woman who took both desmopressin and ibuprofen was found in a comatose state. A woman who took both desmopressin and ibuprofen was found in a comatose state. Barnabei A, Strigari L, Corsello A, Paragliola RM, Iannantuono GM, Salvatori R, Corsello SM, Torino F. Front Endocrinol (Lausanne). After Desmopressin is first used, a review of your child's progress and response should be made within 4 weeks. The woman had previously received desmopressin without the development of clinical symptoms of hyponatremia Lidocaine; Epinephrine: (Minor) The antidiuretic response to desmopressin may be reduced in patients receiving high doses of epinephrine concomitantly. Use combination with caution, and monitor patients for signs and symptoms of hyponatremia. 55.3 mcg sublingually once daily, 1 hour before bedtime without water. Her serum sodium concentration was 124 mmol/L within a day and was 135 mmol/L by the second day. The https:// ensures that you are connecting to the A desmopressin response requires an increase of at least 2 times the baseline von Willebrand factor (vWF) activity and an increase of both vWF and factor VIII concentrations of more than 0.5 International Units/mL for at least 4 hours. Use combination with caution, and monitor patients for signs and symptoms of hyponatremia. Initiate at low dose and increase as necessary. Caution should be used when coadministering these agents. What is the standard conversion technique to calculate those dosages from a typical. As her serum sodium concentration was 121 mmol/L, and her plasma osmolality was low in the presence of a high-normal urine osmolality and normal sodium excretion, she was treated with fluid restriction. The 0.83 mcg dose did not meet all prespecified efficacy endpoints in clinical trials, but may have a lower risk of hyponatremia. Meclofenamate Sodium: (Major) Additive hyponatremic effects may be seen in patients treated with desmopressin and drugs associated with hyponatremia including NSAIDs. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Her serum sodium concentration was 124 mmol/L within a day and was 135 mmol/L by the second day. %f2fDWBRex1*s GZhlNx;hI>l!dKc:cmEg2&M*?*q$|sa[`ov#1q=[`0GP/==g5>dof?N~;1Y Would you like email updates of new search results? Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer. Once the dose is in the tube, hold the tube with your fingers, about 3/4 inch from the end.Put the tube into a nostril, until your fingers touch the nostril. HHS Vulnerability Disclosure, Help The mean (+/- S.D.) Desmopressin nasal sprays may not be substituted for each other due to significant differences in concentration. 3 months and older: Dependent on route of administration and indication for therapy.Less than 3 months: Safety and efficacy have not been established. Chlorpropamide: (Moderate) Additive hyponatremic effects may be seen in patients treated with desmopressin and drugs associated with SIADH including chlorpropamide. 1995 Apr;42(4):373-8. doi: 10.1111/j.1365-2265.1995.tb02645.x [ PubMed ] 10646654 Yamamoto T, Fukuyama J, Fujiyoshi A. Which lab value should prompt the nurse to question a medication dosage increase? The study had an open, randomised, four-way cross-over design. Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) Monitor serum sodium more frequently during concomitant desmopressin and thiazide diuretic use due to increased risk of water intoxication with hyponatremia. Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer. Blood pressure and heart rate monitoring during infusion is recommended. DDAVP/Desmopressin Injection - Summary of Product Characteristics (SmPC Do not transfer any remaining solution to another bottle. Methods: The study had an open, randomised, four-way cross-over design. A woman who took both desmopressin and ibuprofen was found in a comatose state. <> Formoterol; Mometasone: (Major) Desmopressin is contraindicated with concomitant inhaled or systemic corticosteroid use due to an increased risk of hyponatremia. (Synthetic analog of vasopressin-posterior pituitary hormone). Ketorolac (Toradol) <>/Metadata 2732 0 R/ViewerPreferences 2733 0 R>> Loop diuretics: (Contraindicated) Desmopressin is contraindicated with concomitant loop diuretic use due to an increased risk of hyponatremia. There is no information on the effects of desmopressin on the breast-fed infant or on milk production. The distribution of the drug is unknown, and it is not clear whether desmopressin crosses the placenta. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). MeSH Patients previously receiving intranasal treatment may begin oral therapy the night following (24 hours) the last intranasal dose. Clipboard, Search History, and several other advanced features are temporarily unavailable. Fill in the blank - Do not enter the label - Rounding - Verify answer - Conversions - Practice questions. Patients receiving intranasal treatment could begin oral therapy the night following (24 hours) the last intranasal dose. Use combination with caution, and monitor patients for signs and symptoms of hyponatremia. 2023 Feb 10;21:eRC0124. Decrease bleeding following cardiac bypass: 0.3 mcg/kg ivpb. Use combination with caution, and monitor patients for signs and symptoms of hyponatremia. Doses may be titrated up to 0.6 mg PO once daily at bedtime, depending on individual patient response. Fluid restriction should be observed, and fluid intake should be limited to a minimum from 1 hour before administration, until the next morning, or at least 8 hours after administration. Eprosartan; Hydrochlorothiazide, HCTZ: (Moderate) Monitor serum sodium more frequently during concomitant desmopressin and thiazide diuretic use due to increased risk of water intoxication with hyponatremia. 1 to 2 mcg IV twice a day or CAREFULLY BEFORE ACCESSING OR USING THIS SITE. celebrity wifi packages cost. Chlorthalidone: (Moderate) Monitor serum sodium more frequently during concomitant desmopressin and thiazide diuretic use due to increased risk of water intoxication with hyponatremia. The pump will stay primed for up to 1 week. Maintenance dose range: 10 mcg/day to 40 mcg/day intranasally (0.1 mL/day to 0.4 mL/day) in 1 to 3 divided doses. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. I would recommend making an appointment with your regular doctor to see what might be causing this. DrugBank Accession Number. Maintenance dose range: 10 mcg/day to 30 mcg/day intranasally (0.1 mL/day to 0.3 mL/day) in 1 to 2 divided doses. Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer. Last updated on Apr 7, 2022. Use combination with caution, and monitor patients for signs and symptoms of hyponatremia. Wash the rhinal tube in water and shake well, until no water is left in the tube.To avoid the spread of infection, do not use the container for more than 1 person.For 2.5 mL bottles, discard after 25 sprays (doses) because the amount delivered thereafter per spray may be substantially less than the recommended dose. September, 2004 Hospira 2004 EN-0511 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA. 50 kg or less: 150 mcg Dilute DDAVP Injection in sterile 0.9% Sodium Chloride Injection, USP and infuse slowly over 15 minutes to 30 minutes. Adults and children 12 years of age and older0.5 to 1 milliliter (mL), divided into 2 doses and injected under the skin in the morning and evening. Dose range is 5 to 30 mcg/day. Desmopressin is administered intravenously or subcutaneously.Desmopressin (DDAVP) injection has an antidiuretic hormone activity of 16 International Units/mL; 1 mcg desmopressin is equivalent to 4 International Units antidiuretic hormone activity.If given preoperatively, desmopressin injection should be given 30 minutes before the scheduled procedure.Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Desmopressin acetate for SC injection was administered in the left or right upper arm at a dose of 0.12 g, which was selected from pre-clinical bioavailability study results. Rapid IV bolus Unauthorized use of these marks is strictly prohibited. Single-dose administration has been used for uremic bleeding in patients with renal failure; however, repeat doses are not recommended. The following pharmacist will check on these open i-Vents and close then when appropriate. The necessity for repeat administration of DDAVP or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. Desmopressin Acetate Injection 4 mcg/mL dosage must be determined for each patient and adjusted according to the pattern of response. The woman had previously received desmopressin without the development of clinical symptoms of hyponatremia Chlorpheniramine; Phenylephrine: (Moderate) Although the pressor activity of desmopressin is very low compared to its antidiuretic activity, large doses of desmopressin should be used with other pressor agents like phenylephrine only with careful patient monitoring. IV: 0.3 mcg/kg once slowly over 15-30 minutes. As her serum sodium concentration was 121 mmol/L, and her plasma osmolality was low in the presence of a high-normal urine osmolality and normal sodium excretion, she was treated with fluid restriction. Most patients respond to 1 to 2 doses; administer a second dose 8 to 24 hours after the first dose if needed. Her serum sodium concentration was 124 mmol/L within a day and was 135 mmol/L by the second day. Adult dosing should not be used in this age group; adverse events such as hyponatremia-induced seizures may occur. The woman had previously received desmopressin without the development of clinical symptoms of hyponatremia Chlorothiazide: (Moderate) Monitor serum sodium more frequently during concomitant desmopressin and thiazide diuretic use due to increased risk of water intoxication with hyponatremia. A woman who took both desmopressin and ibuprofen was found in a comatose state. If the product has not been used for more than 3 days, re-prime by pumping 2 actuations into the air.Instruct the patient to blow their nose, tilt the head back slightly, and insert the nasal applicator into the left or right nostril, keeping the nasal applicator upright. Tilt bottle so that the tube inside the bottle draws from the deepest portion of the medication.If given preoperatively, intranasal desmopressin should be administered 2 hours before surgery.To avoid the spread of infection, do not use the container for more than 1 person.Discard spray pump after 25 sprays since the amount delivered thereafter per spray may be substantially less than the recommended dose. 2 0 obj Use careful attention to fluid management to avoid hyponatremia in the peripartum and postpartum period and weigh the possible therapeutic advantages against the possible risks in each individual case. To prime, press down 4 times. As her serum sodium concentration was 121 mmol/L, and her plasma osmolality was low in the presence of a high-normal urine osmolality and normal sodium excretion, she was treated with fluid restriction. *Ovv]pu}gz$3 Desmopressin nasal spray can be resumed when these conditions resolve. Despite low bioavailability, the pharmacodynamic effects of oral desmopressin were similar in magnitude to those after intravenous dose at night and during the first 6 h after daytime administration. Do Not Copy, Distribute or otherwise Disseminate without express permission. I don't know why you would suddenly notice a decrease in your symptoms after 34 years. The woman had previously received desmopressin without the development of clinical symptoms of hyponatremia Prednisolone: (Major) Desmopressin is contraindicated with concomitant inhaled or systemic corticosteroid use due to an increased risk of hyponatremia. CrCl 50 mL/minute or more: No dosage adjustment is needed.CrCl less than 50 mL/minute OR eGFR less than 50 mL/minute/1.73 m2: Use is contraindicated. A woman who took both desmopressin and ibuprofen was found in a comatose state. Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer. Hydrocodone; Ibuprofen: (Major) Additive hyponatremic effects may be seen in patients treated with desmopressin and drugs associated with hyponatremia including NSAIDs. It may be given in the nose, by injection into a vein, by mouth, or under the tongue. After at least 7 days of treatment, the dose may be increased to 1.66 mcg, if needed, provided the serum sodium is within the normal range during treatment with the 0.83 mcg dose. 100 unit / 100 ml (1 unit/ml). For a patient requiring volume resuscitation, a large volume of normal saline could be . PDF Dose Conversion & Administration Guide Chlorthalidone; Clonidine: (Moderate) Monitor serum sodium more frequently during concomitant desmopressin and thiazide diuretic use due to increased risk of water intoxication with hyponatremia. Desmopressin can be started or resumed 3 days or 5 half-lives after the corticosteroid is discontinued, whichever is longer. Initially, 0.05 mg PO twice daily, then titrate to response. Celecoxib: (Major) Additive hyponatremic effects may be seen in patients treated with desmopressin and drugs associated with hyponatremia including NSAIDs. Typical maintenance dose was 10 to 40 mcg/day (0.1 to 0.4 mL/day). Sulindac: (Major) Additive hyponatremic effects may be seen in patients treated with desmopressin and drugs associated with hyponatremia including NSAIDs. Background. Step-down therapy: changing to an oral drug that is a different compound and has different frequency, dose, or spectrum of activity. Diabetes Insipidus: This formulation is administered subcutaneously or by direct intravenous injection. Pediatric Pharmacology of Desmopressin in Children with Enuresis: A Comprehensive Review. In general, desmopressin is contraindicated in persons with heart failure or uncontrolled hypertension because fluid retention increases the risk for worsening of underlying conditions that are susceptible to volume status. The woman had previously received desmopressin without the development of clinical symptoms of hyponatremia Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) Monitor serum sodium more frequently during concomitant desmopressin and thiazide diuretic use due to increased risk of water intoxication with hyponatremia. A pharmacokinetic and pharmacodynamic comparison of desmopressin administered as whole, chewed and crushed tablets, and as an oral solution. Caution should be used when coadministering these agents. As her serum sodium concentration was 121 mmol/L, and her plasma osmolality was low in the presence of a high-normal urine osmolality and normal sodium excretion, she was treated with fluid restriction. desmopressin iv to po conversion As her serum sodium concentration was 121 mmol/L, and her plasma osmolality was low in the presence of a high-normal urine osmolality and normal sodium excretion, she was treated with fluid restriction. Ddavp, Nocdurna, Octostim. You can adjust the side column for all the news articles in the 'side column' tab above Generic name: DESMOPRESSIN ACETATE 4ug in 1mL The initial response is reproducible if DDAVP is administered every 2 to 3 days. The woman had previously received desmopressin without the development of clinical symptoms of hyponatremia Celecoxib; Tramadol: (Major) Additive hyponatremic effects may be seen in patients treated with desmopressin and drugs associated with hyponatremia including NSAIDs. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Prior to treatment with DDAVP Injection, verify that factor VIII coagulant activity levels are >5% and exclude the presence of factor VIII autoantibodies.