MYTESI new drug for diarrhea

[SoCalGal]

Don't have first hand info, but wouldn't hesitate to try this for diarrhea, would be willing to bet it's easier to deal with than Imodium! It is already FDA approved but I thought I'd share this trial info for anyone interested...

Preventing Diarrhea in Patients with HER2+ Breast Cancer
Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients Receiving Trastuzumab, Pertuzumab, and Docetaxel or Paclitaxel With or Without Carboplatin: HALT-D (NCT02910219)

Summary
To take part in this study, you must have HER2-positive breast cancer. You also must be scheduled to receive at least 3 cycles of chemotherapy with regimens known as THP or TCHP. This study is investigating whether an anti-diarrhea medicine can help prevent chemotherapy-induced diarrhea in HER2+ breast cancer patients. The anti-diarrhea medicine being used in this study is Crofelemer (Mytesi®). It is used to prevent diarrhea in HIV/AIDS patients. The THP chemotherapy regimen contains docetaxel (Taxotere®), trastuzumab (Herceptin®), and pertuzumab (Perjeta®). The TCHP regimen contains docetaxel (Taxotere®), carboplatin (Paraplatin®), trastuzumab (Herceptin®), and pertuzumab (Perjeta®).
This is a Phase II trial

What's involved:
You will be randomly assigned to 1 of 2 groups during the first 2 cycles of chemotherapy with THP or TCHP:

Group 1

Crofelemer (Mytesi®), by mouth, daily
Group 2

No intervention

[donocco]

SCG

I know a little bit about Mytesi. Even though Im basically a semi retired pharmacist I try to keep up with the new drugs. Mytesi stops diarrhea by blocking the secretion of Chloride ions with the accompanying water. I think the dosage is 125mg twice a day.\

As far as I can see it is FDA approved for diarrhea due to Aids drugs. Im not sure the insurance will be willing to pay for Her 2 Neu patients. I hope you can find a way around this. The main side effects of Crofelemer are bronchitis, acne like lesions and muscle pain. Hope this helps.

[Nguyen]

Thanks Paul, this will be very useful if we pick neratinib for the next step.

Nguyen