POZ Community Forums
Meds, Mind, Body & Benefits => Questions About Treatment & Side Effects => Topic started by: gadawg1979 on April 01, 2013, 02:26:20 am
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Will start this off. Post as u see fit. First question, do the hot flashes ever stop?
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Dietary requirements changed in Europe for fixed dose combination rilpivirine/tenofovir/FTC (Eviplera) (Complera)
Summary:390kcal, 12g Fat are enough (not 540kcal, 21g Fat as before)
"On 20 March 2013, Gilead isseud a letter noting that the European Medicines Agency (EMA) had modified the Summary of Product Characteristics (SPC) for the fixed dose combination rilpivirine/tenofovir/FTC (Eviplera). [1]
The new recommendation is to take Eviplera “with food”. Previously the indication was “take with a meal” (See Section 4.2 in the SPC). [2]
This was based on a review of results from a pharmacokinetic study that was presented at the Glasgow conference, reporting a slightly different impact of food on rilpivirine absorption when part of the fixed dose combination Eviplera compared to when taken as a separate medication. [3]
This study reported that rilpivirine and tenofovir exposure are increased after intake of a standard (533 kcal, 21 g fat) or light meal (390 kcal, 12 g fat) relative to fasting conditions. Compared to fasting conditions, rilpivirine AUC was 9% and 16% higher with a light meal or standard meal, respectively. Compared to standard meal, RPV AUC was 14% and 6% lower with fasted or light meal administration, respectively. These details have not been added to Section 5.2 of the SPC on pharmacokinetic proterties.
These changes only relate to the prescribing information with regard to food intake for the FDC formulation. The SPC for single agent rilpivirine still retains the requirement to take with a standard (533 kcal) meal."
http://i-base.info/htb/21240 (http://i-base.info/htb/21240)
http://www.jiasociety.org/index.php/jias/article/view/18333/1776 (http://www.jiasociety.org/index.php/jias/article/view/18333/1776)
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First question, do the hot flashes ever stop?
I'm guessing that nobody responded to your question because no one else (here anyway) has been having hot flashes that they're attributing to Complera.
Have you talked to your doctor about this? One thing that comes to mind is hormone levels - have yours been checked? Thyroid possibly too. Have your thyroid levels been checked?
Please talk to your doctor about this.
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Thanks Anne will do know I have border line low t
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No. They do not. I still have them on occasion. The side effects do wear mostly off. Check my thread that I am about to update that chronicles my treatment with Complera.