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DATROWAY can cause serious side effects
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 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 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.
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
These are not an all-inclusive list of symptoms for DATROWAY-associated side effects or all possible side effects of DATROWAY. Call your medical care team for medical advice about symptoms or side effects. You may report side effects to Daiichi Sankyo at 1-877-437-7763 or to FDA at 1-800-FDA-1088.
Common side effects seen with DATROWAY
The most common side effects of DATROWAY include mouth ulcers and sores, nausea, tiredness, decreased white blood cell counts, decreased calcium, hair loss, decreased red blood cell counts, constipation, dry eye, vomiting, increased blood levels of liver enzymes, and an eye problem called keratitis.
In the trial, the majority of common side effects seen with DATROWAY were considered Grade 1 or 2, meaning they were mild or moderate in severity.*
Your doctor may reduce your dose of DATROWAY, delay treatment, or completely stop treatment if you have severe side effects
*Mild side effects are side effects you may have but they show no outward signs or medical intervention may not be needed. Moderate side effects may require some medical intervention or may affect you as you do your day-to-day activities. Severe side effects are side effects that require medical intervention and may have serious or life-threatening consequences.
Planning ahead
Side effects are possible with DATROWAY, so it's important to plan ahead and decide with your care team the best course of action to potentially prevent or treat certain side effects. After learning about the side effects seen in the clinical trials, review the Addressing Side Effects page for DATROWAY so that you and your care team can proactively prepare for potential side effects and hopefully have a more comfortable experience with DATROWAY.
Frequently asked questions
Want to know more?
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Q: How many people had to stop treatment because of side effects?
3% of people receiving DATROWAY discontinued treatment due to side effects. Refer to the Addressing Side Effects page for more information.
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Q: Is there anything I can do that may help me with certain side effects?
Consult your care team and refer to the Addressing Side Effects page for more information on how you can help treat or potentially prevent certain side effects.
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Q: How many people had serious side effects while on DATROWAY?
Serious side effects occurred in 15% of the people treated with DATROWAY.
