Cytogenetics and the evolution of medical genetics
Factor VIII Treatment Video Perspectives
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'); $('.Footer-signup .Email-signup select.Is-invalid').After(''); $('.Footer-signup .Email-signup select:not(.Is-invalid)').After(''); var styledSelect = $('.Footer-signup .Email-signup select').Next('div.Select-styled'); styledSelect.Html('Choose your specialty*'); var list = $('', { 'class': 'select-options' }).InsertAfter(styledSelect); for (var i = 0; i ', { text: $('.Footer-signup .Email-signup select').Children('option').Eq(i).Text(), rel: $('.Footer-signup .Email-signup select').Children('option').Eq(i).Val() }).AppendTo(list); if ($('.Footer-signup .Email-signup select').Children('option').Eq(i).Is(':selected')) { $('li[rel="' + $('.Footer-signup .Email-signup select').Children('option').Eq(i).Val() + '"]').AddClass('is-selected') } } var listItems = list.Children('li'); styledSelect.Click(function (e) { e.StopPropagation(); $('div.Select-styled.Active').Not($(this)).Each(function () { $(this).RemoveClass('active').Next('ul.Select-options').Hide(); }); $(this).ToggleClass('active').Next('ul.Select-options').Toggle(); }); let selectElem = $('.Footer-signup .Email-signup select'); listItems.Click(function (e) { e.StopPropagation(); styledSelect.Html('' + $(this).Html() + '
').RemoveClass('active'); $(selectElem).Val($(this).Attr('rel')); list.Hide(); }); $(document).Click(function () { styledSelect.RemoveClass('active'); list.Hide(); }); $('.Known-user .Input-target input').Attr('tabindex', '-1') $('.Update-link i').On('keypress', function(e){ if(e.KeyCode == 13) { $(this).Click(); $('#knownInfoModal .Close').Focus(); } })Humate-p
Humate-p Generic Name & Formulations General DescriptionAntihemophilic Factor VIII/Von Willebrand Factor Complex (human) 250 IU FVIII + 600 IU VWF, 500 IU FVIII + 1200 IU VWF, 1000 IU FVIII + 2400 IU VWF; per vial; lyophilized pwd for IV infusion after reconstitution; contains albumin.
Pharmacological ClassCoagulation factor complex.
How SuppliedSingle-use vials—1 (w. Diluent, supplies)
Humate-p Indications IndicationsTreatment and prevention of bleeding in adults with Hemophilia A. Treatment of spontaneous and trauma-induced bleeding, and prevention of excessive bleeding during and after surgery in adults and children with von Willebrand disease (VWD).
Humate-p Dosage and Administration AdultMax injection rate: 4mL/min. Hemophilia A: Minor bleed: 15 IU FVIII/kg (obtain 30% FVIII increase) once; if needed, may give ½ dose once or twice daily for 1–2 days. Moderate bleed: initially 25 IU FVIII/kg (obtain 50% FVIII increase), then 15 IU FVIII/kg (maintain 30% FVIII increase) every 8–12hrs for 1–2 days, then repeat dose for 1–2 times daily for a total of 7 days or until healed. Severe bleed: initially 40–50 IU FVIII/kg, then 20–25 IU FVIII/kg every 8hrs (maintain 80–100% FVIII increase) for 7 days, then repeat dose for 1–2 times daily for additional 7 days (maintain 30–50% FVIII increase). VWD: Type 1 (Mild): major bleed: initially 40–60 IU/kg, then 40–50 IU/kg every 8–12hrs for 3 days, then once daily for a total of 7 days. Type 1 (Moderate or severe): minor bleed: 40–50 IU/kg for 1–2 doses; major bleed: initially 50–75 IU/kg, then 40–60 IU/kg every 8–12hrs for 3 days, then once daily for a total of 7 days. Types 2 and 3: minor bleed: 40–50 IU/kg for 1–2 doses; major bleed: initially 60–80 IU/kg, then 40–60 IU/kg every 8–12hrs for 3 days, then once daily for a total of 7 days. For dosing in surgery: see literature.
ChildrenMax injection rate: 4mL/min. VWD: Type 1 (Mild): major bleed: initially 40–60 IU/kg, then 40–50 IU/kg every 8–12hrs for 3 days, then once daily for a total of 7 days. Type 1 (Moderate or severe): minor bleed: 40–50 IU/kg for 1–2 doses; major bleed: initially 50–75 IU/kg, then 40–60 IU/kg every 8–12hrs for 3 days, then once daily for a total of 7 days. Types 2 and 3: minor bleed: 40–50 IU/kg for 1–2 doses; major bleed: initially 60–80 IU/kg, then 40–60 IU/kg every 8–12hrs for 3 days, then once daily for a total of 7 days. For dosing in surgery: see literature.
Humate-p Contraindications ContraindicationsPrevious anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations.
Humate-p Boxed WarningsNot Applicable
Humate-p Warnings/Precautions Warnings/PrecautionsConfirm Factor VIII or von Willebrand factor deficiency prior to treatment. Increased risk of thromboembolic events in VWD. Contains human plasma; monitor for possible infection transmission. Large or frequent doses: monitor hematocrit for signs of hemolytic anemia. Monitor for development of inhibitors. Pregnancy (Cat.C).
Humate-p PharmacokineticsSee Literature
Humate-p InteractionsNot Applicable
Humate-p Adverse Reactions Adverse ReactionsAllergic reaction, GI upset, inj site reactions, mild vasodilation, pruritus, paresthesia, peripheral edema, antibody formation; anaphylaxis, thrombosis.
Humate-p Clinical TrialsSee Literature
Humate-p Note NotesReport all infections suspected to be transmitted by Humate-P to (800) 504–5434.
Humate-p Patient CounselingSee Literature
TargED Bio Raises €39m For New Clot-busting Drug
There's been hardly any change in the use of clot-dissolving (thrombolytic) therapies for conditions like heart attack and stroke for decades, but a small Dutch biotech – TargED Biopharmaceuticals – is hoping to disrupt the market with a new and improved therapy.
It has just raised €39 million ($44 million) in first-round financing to help realise that ambition and take its lead product – called Microlyse – into clinical development.
Microlyse is a thrombolytic fusion protein that targets von Willebrand factor (vWF), a glycoprotein in the blood that is a carrier protein for Factor VIII and is part of the process that causes platelets to stick together in clot formation.
That is the first step in the formation of a clot, with the initial clumped platelets later bound together by the addition of fibrin – which is the target of current thrombolytic drugs like alteplase, reteplase and tenecteplase.
According to TargED, Microlyse has the potential to offer increased potency and an improved side-effect profile compared to current thrombolytic drugs . It is the first compound to achieve targeted enzyme delivery, using a single domain antibody, directly to blood clots, it says.
Targeting vWF makes Microlyse a rival to Sanofi's Cablivi (caplacizumab), a vWF binding antibody that became the first approved treatment for patients with the rare blood-clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP) in 2018.
The condition, estimated to affect one patient in 250,000, is a life-threatening, autoimmune-based blood clotting disorder characterised by extensive clot formation in small blood vessels throughout the body.
Preclinical studies have suggested that Microlyse dissolves micro-clots seven times more quickly that Cablivi in animal models, without affecting other elements of the clotting cascade that can lead to bleeding side effects.
TargED intends to go after aTTP in its initial clinical development programme for the new drug, but has aspirations to go further.
It is also planning to develop it for acute ischaemic stroke, a much larger potential indication but one that has been challenging to target with thrombolytics because of a narrow therapeutic window that means treatment has to start very quickly after symptoms of a stroke are observed.
The Series A financing came from an international investor syndicate comprising of Andera Partners, Fund+, Hadean Ventures, Inkef Capital and Sunstone Life Science Ventures.
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