Piqray Linked to Colitis

Piqray Linked to Colitis

Colitis has been identified as a new side effect of the targeted therapy Piqray.
Aug 23, 2022.

Based on post-marketing surveillance reports from doctors, the targeted therapy Piqray (chemical name: alpelisib) has been linked to colitis in people taking the medicine for advanced-stage, hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

The research was published online on Aug. 18, 2022, by the journal JAMA Oncology. Read the abstract of “Postmarketing Colitis Cases Associated With Alpelisib Use Reported to the US Food and Drug Administration.”


About Piqray

Piqray is used in combination with the hormonal therapy Faslodex (chemical name: fulvestrant) to treat advanced-stage or metastatic, hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation that has grown after treatment with hormonal therapy in women who are post-menopausal and men.

Piqray is a PI3K inhibitor that blocks the PI3K pathway. The PI3K pathway helps all cells — both healthy and cancer cells — get the energy they need. When this pathway is over-activated because of a mutation in the PIK3CA gene, it can allow cancer cells to survive and grow. PI3K inhibitors block this pathway, with the goal of killing cancer cells.

Like nearly all cancer medicines, Piqray can cause side effects, some of them serious. Although we know severe diarrhea is a possible side effect of Piqray, researchers have only just now identified colitis as a side effect as well.


About colitis

Colitis is swelling of the large intestine, also called the colon. Symptoms include:

  • abdominal pain

  • bloating

  • bloody stools

  • diarrhea

  • a constant urge to have a bowel movement (called tenesmus by doctors)

  • dehydration

  • fever

Colitis can be serious and may cause life-threatening complications, such as a tear in the intestines. So it’s important to talk to your doctor if you have symptoms.


About the study

It’s not possible to predict all the side effects a medicine might have when the U.S. Food and Drug Administration (FDA) approves it. The FDA’s post-marketing surveillance and risk assessment programs help the organization keep track of side effects as they come up. These programs rely on doctors who prescribe medicine to report any new side effects they see. The FDA uses the information to update the medicines’ prescribing information.

The FDA approved Piqray in 2019.

In this report, the researchers reviewed post-marketing surveillance reports of Piqray and colitis submitted to the FDA through Feb. 28, 2021.

Overall, 20 people — all of them women — were diagnosed with colitis linked to Piqray. All the women had at least one serious outcome because of colitis:

  • 19 were hospitalized

  • four had an intestinal tear

  • two died

The researchers investigated the link between the cases of colitis and Piqray and found that Piqray was probably responsible in four cases and possibly responsible in 16 cases.

There were 18 cases that reported how long the women were taking Piqray before they were diagnosed with colitis. Within six months of starting Piqray, 72% of those women developed colitis.

Of all 20 cases, nine women paused taking Piqray and 11 stopped taking it altogether.

As a result, the FDA updated Piqray’s prescribing information in May 2022 to include colitis as a side effect and added information on what to do if someone taking Piqray develops colitis.


What this means for you

If you’ve been prescribed Piqray, this is important information. It’s important to talk to your doctor right away if you have any colitis symptoms while taking Piqray — especially blood in your stool or ongoing diarrhea that doesn’t respond to medicine.

Learn more about Piqray.

Written by: Jamie DePolo, senior editor

— Last updated on September 20, 2022, 9:31 PM

Reviewed by 1 medical adviser
Brian Wojciechowski, MD
Crozer Health System, Philadelphia area, PA
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