March 27, 2017
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"The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of factor VIII-containing products to evaluate the risk of neutralizing antifactor VIII alloantibodies (inhibitors) developing in patients"...




  • Dose: Tell the patient that their dose will be adjusted on a weekly basis until they are on a dose that lowers their platelets to an appropriate level. This will also help the patient to adjust to common side effects. Tell the patient to contact their doctor if they experience tolerability issues, so the dose or dosing frequency can be adjusted [see DOSAGE AND ADMINISTRATION].
  • Cardiovascular effects: Tell the patient to contact a doctor immediately if they experience chest pain, palpitations, or feel their heartbeat is irregular [see WARNINGS AND PRECAUTIONS].
  • Risk of bleeding: Warn the patient that concomitant aspirin (or other medicines that affect blood clotting) may increase the risk of bleeding. Tell the patient to contact a doctor immediately if they experience signs or symptoms of bleeding (e.g. vomit blood, pass bloody or black stools) or experience unexplained bruising/bruise more easily than usual [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].

Last reviewed on RxList: 8/5/2015
This monograph has been modified to include the generic and brand name in many instances.

Agrylin - User Reviews

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