Possible side effects with DATROWAY

Certain side effects, including serious or even possibly fatal ones, were seen in people treated with DATROWAY. Make sure to tell your care team right away if you experience any side effects.

DATROWAY can cause serious side effects

  • Lungs icon

    Lung problems

    Lung problems that may be severe, life-threatening, or that may lead to death can occur with DATROWAY. If you develop lung problems, your doctor may treat you with corticosteroid medicines. Tell your care team right away if you have any of the following: cough, trouble breathing or shortness of breath, fever, or other new or worsening breathing symptoms such as chest tightness or wheezing.

  • Eye irritation icon

    Eye problems

    Eye problems are common with DATROWAY and can also be severe. Tell your care team right away if you develop any new or worsening eye problems during treatment with DATROWAY, including dry eyes, eye pain, eye redness, eye swelling, eye irritation, increased tears, feeling like something is in your eyes, discharge from your eyes, eye crusting, sensitivity to light, blurred vision, or vision changes.

  • Mouth sores icon

    Mouth ulcers and sores

    Mouth ulcers and sores are common with DATROWAY and can also be severe. Tell your care team right away if you develop mouth pain, swelling, redness, ulcers, or sores during treatment with DATROWAY.

  • Pregnancy icon

    Harm to your unborn baby

    DATROWAY may cause harm to your unborn baby. Tell your care team right away if you become pregnant or think you might be pregnant during treatment with DATROWAY.

    • If you are able to become pregnant, your care team should do a pregnancy test before you start treatment  
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 7 months after the last dose
    • Males who have partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after the last dose

This is not a complete possible side effects for DATROWAY. Please see the Important Safety Information below. Talk to your doctor if you experience any side effects. You may report side effects to Daiichi Sankyo at 1-877-437-7763 or to the FDA at 1-800-FDA-1088.

This is not a complete list of possible side effects for DATROWAY. Please see the Important Safety Information below. Talk to your doctor if you experience any side effects. You may report side effects to Daiichi Sankyo at 1-877-437-7763 or to the FDA at 1-800-FDA-1088.

Common side effects seen with DATROWAY

The most common side effects of DATROWAY when used in adults with HR+/HER2– breast cancer include nausea, tiredness, decreased white blood cell counts, decreased blood levels of calcium, hair loss, decreased red blood cell counts, constipation, dry eye, vomiting, increased blood levels of liver enzymes, an eye problem called keratitis, and increased blood levels of alkaline phosphate. 

In the trial, the majority of common side effects seen with DATROWAY were mild or moderate in severity. Mild side effects may not affect your daily activities, and medical intervention may not be needed. Moderate side effects may affect your daily activities and may require some medical intervention. Severe side effects usually require medical intervention and may have serious or life-threatening consequences.

*An eye problem called keratitis.

Your doctor may reduce your dose of DATROWAY, interrupt treatment, or completely stop treatment if you have certain side effects. In the clinical trial, about 3% of people needed to stop taking DATROWAY due to side effects.

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Planning ahead

With any treatment, side effects are possible, so it’s important to plan ahead and decide with your care team the best course of action that this may help manage certain side effects. After learning about the side effects seen in the clinical trials, review the Managing Side Effects page so that you and your care team can prepare ahead of time for possible side effects.

Battling cancer requires courage, resilience, and the right information to help keep you moving forward.

A woman stands in front of a blue and teal background with bokeh lights.
A woman stands in front of a blue and teal background with bokeh lights.
Not an actual patient.