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Adynovate belongs to a group of drugs called clotting factor VIII, which is used for the treatment and prevention of hemophilia in patients with hemophilia A caused by congenital factor VIII deficiency.
1. Uses and indications of Adynovate
ADYNOVATE also known as recombinant produced antifreeze factor, is a hemophilia anticoagulant. It is indicated in children and adults with hemophilia A (congenital due to factor VIII deficiency) to:
Treatment and control of acute bleeding episodes Postoperative management Routine prophylaxis to However, because Adynovate does not contain Von Willebrand factor and is therefore not suitable for use in this condition. At the same time, Adynovate is also not indicated in patients with hemophilia who have had a previous anaphylactic reaction to the drug.
2. Notes when taking Adynovate
2.1 Hypersensitivity reactions Hypersensitivity reactions may occur with Adynovate . Allergic hypersensitivity reactions, including anaphylaxis, have been reported with recombinant anti-aerophilic factor VIII products, including the parent molecule.
Initial signs of a hypersensitivity reaction that may progress to a possible anaphylactic reaction, include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus.
Therefore, it is necessary to discontinue immediately and initiate appropriate treatment if a hypersensitivity reaction occurs.
2.3 Neutralizing antibodies Formation of neutralizing antibodies (inhibitors) to factor VIII may occur after patients are treated with Adynovate.
Therefore, during treatment with Adynovate, patients should be monitored regularly for early detection of factor VIII inhibitory components by appropriate laboratory and clinical observations. Perform a factor VIII inhibitor test if the plasma factor VIII level is not reaching the expected rise, or if bleeding is not well controlled with the correct dose of Adynovate used. expected.
Tests to monitor:
Monitor plasma factor VIII activity by performing coagulation function testing Tests to confirm appropriate factor VIII levels have been achieved and sustained Monitor the development of factor VIII inhibitors. Perform a Bethesda inhibitor test to determine if a factor VIII inhibitor is present. If active plasma factor VIII levels are not achieved, or if bleeding is not controlled with the expected dose of Adynovate, use the Bethesda Units (BU) test to determine the likelihood that it is present. presence of neutralizing antibodies.
3. Side effects of the drug Adynovate
The most common Adynovate adverse events with an incidence greater than 1% reported in clinical studies were headache and nausea.
In addition, other side effects have been reported as:
Gastrointestinal disorders: Diarrhea (0.4%), nausea (0.8%) Immune system disorders: Hypersensitivity (0, 4%) Nervous system disorders: Headache (2.1%) Skin and subcutaneous tissue disorders: Rash (0.4%) Vascular disorders: Flushing (0.4%)
4. Instructions for patients when taking Adynovate
Call your doctor or go to the emergency room right away if a hypersensitivity reaction occurs. Initial signs of a hypersensitivity reaction, which the patient should be informed about, may include rash, urticaria, pruritus, facial swelling, chest tightness, and wheezing. Contact physician or treatment facility, monitor for further treatment and/or evaluation if clinical response to factor VIII therapy is not observed as this may be a sign of inhibitor development. . Advise patients to consult their doctor before traveling. When traveling, advise patients to carry a full supply of Adynovate according to current regimens to deal with possible bleeding events at any time. In summary, the drug Adynovate is an antifreeze factor produced by recombinant. Each vial of Adynovate for intravenous administration is the actual active factor VIII for the treatment of hemophilia. However, because the drug stops bleeding but can be less effective if neutralizing antibodies are present, patients should be monitored with testing for clotting factors as well as early detection of abnormalities.
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References: medsafe.govt.nz, webmd.com, fda.gov, adynovate.com, rxlist.com