Safety
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Datroway Injection: Uses, Dosage, Side Effects, Precautions and Alternates
| Generic name | datopotamab deruxtecan-dlnk |
|---|---|
| Drug class | antineoplastic, antibody-drug conjugate (ADC) |
| Forms | injection (liquid given into a vein) |
Quick overview
Datroway Injection (datopotamab deruxtecan-dlnk) is a prescription antibody-drug conjugate given as an intravenous infusion to treat certain advanced or metastatic cancers, including specific types of non-small cell lung cancer and breast cancer. It works by targeting a protein on cancer cells and delivering chemotherapy directly into them. Datroway is administered by a healthcare provider, typically once every three weeks, and carries risks of lung, eye, and mouth-related side effects along with other precautions.
What is Datroway Injection
Datroway is a prescription cancer medicine given as an infusion into a vein. It is an antibody-drug conjugate that targets cancer cells with a specific protein on their surface and delivers a chemotherapy drug directly into those cells.
Datroway Injection uses
- Treating adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific EGFR gene mutation, in people who have already tried EGFR-targeted therapy and platinum-based chemotherapy
- Treating adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy
- Treating adults with unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative breast cancer who have already had endocrine-based therapy and chemotherapy
Benefits of Datroway Injection
- Treats certain advanced or metastatic cancers
- Targets TROP-2 on cancer cells
- Delivers a chemotherapy component directly to targeted tumor cells
- Approved for certain HR-positive/HER2-negative breast cancers
- Approved for certain EGFR-mutated non-small-cell lung cancers
- May help shrink tumors or slow disease progression in eligible patients
How Datroway Injection works
Datroway is an antibody-drug conjugate. It works by finding cancer cells that have a specific protein on their surface, attaching to this protein, and delivering a chemotherapy medicine directly into the cancer cell to kill it. This can help stop tumors from growing and can shrink the cancer.
Datroway Injection dosage
Datroway is given into a vein (IV) by a healthcare provider, usually once every three weeks. Your first infusion is given over 90 minutes; later infusions may be given over 30 minutes if you had no problems with the first one. You will be watched for side effects for at least 1 hour after your first two infusions, then at least 30 minutes after later infusions if no problems occurred.
Your healthcare provider may give you medicines before the infusion to help prevent nausea, vomiting, and infusion reactions, such as acetaminophen, diphenhydramine, or ondansetron. If you miss a planned dose, call your healthcare provider right away to schedule an appointment rather than waiting for the next treatment cycle.
Hold ice chips or ice water in your mouth during the infusion to help prevent mouth sores. Use a steroid-containing mouthwash as prescribed to help prevent and treat mouth sores. Use preservative-free lubricating eye drops regularly to help prevent eye problems. Avoid wearing contact lenses during treatment unless your eye doctor says it is okay.
| Age group | Dose |
|---|---|
| 18–64 years | 6 mg/kg IV once every 3 weeks, maximum 540 mg per dose for patients weighing ≥90 kg |
Available forms and strengths
- Injection (liquid given into a vein)
Side effects of Datroway Injection
Common
- Nausea
- Vomiting
- Constipation
- Tiredness
- Hair loss
- Low red blood cell counts
- Low white blood cell counts
- Increased blood calcium levels
- Increased liver enzyme levels
- Increased lactate dehydrogenase levels
- Muscle and joint pain
- Decreased appetite
- Rash
- Mouth sores
Serious
- Severe lung inflammation (interstitial lung disease/pneumonitis) that can be life-threatening or fatal
- Serious eye problems including dry eye, keratitis, blepharitis, conjunctivitis, and blurred vision
- Severe mouth ulcers and oral mucositis
- Severe allergic/infusion-related reactions, including anaphylaxis
- Harm to an unborn baby
- Fertility problems in males and females
Warnings and precautions
- Datroway can cause severe, life-threatening, or fatal lung inflammation (interstitial lung disease or pneumonitis). Your doctor will watch for new or worsening breathing symptoms and may treat you with corticosteroids, pause treatment, or stop it permanently depending on severity.
- Datroway can cause eye problems, some of which are severe, including dry eye, keratitis, blepharitis, and blurred vision. Regular eye exams and preservative-free lubricating eye drops are recommended, and contact lenses should be avoided unless approved by an eye doctor.
- Datroway commonly causes stomatitis (mouth ulcers and oral mucositis), which can be severe. Using a steroid-containing mouthwash and holding ice chips or ice water in the mouth during infusions can help prevent and manage this.
- Datroway may cause serious harm to an unborn baby because its active component is genotoxic and affects dividing cells. Effective contraception is needed during and after treatment for both men and women.
- Datroway may cause fertility problems in both men and women, which could affect the ability to have children in the future.
- Datroway can harm an unborn baby. A pregnancy test is needed before starting treatment. Women who can become pregnant should use effective birth control during treatment and for 7 months after the last dose. Men with partners who can become pregnant should use effective birth control during treatment and for 4 months after the last dose.
- It is not known if Datroway passes into breast milk. Women should not breastfeed during treatment and for 1 month after the last dose because of the risk of harm to a breastfed child.
- People with kidney problems should be monitored for increased side effects, including breathing-related reactions, while taking Datroway.
- People with moderate liver impairment should be monitored closely for increased side effects, since there is limited data in this group. Datroway's recommended dose has not been established for people with severe liver impairment.
- It isn't known for certain how alcohol affects Datroway, but heavy drinking can weaken your immune system and may make it harder for your body to fight cancer. Drinking alcohol may also increase tiredness caused by the medicine.
Storage
- Datroway is usually given by a health care provider in a hospital or clinic. You will not store it at home.
When to see a doctor
- Get help right away if you have cough, trouble breathing or shortness of breath, fever, chest tightness, or wheezing, as these may be signs of serious lung problems.
- Contact your care team right away if you notice new or worsening eye symptoms such as dry eyes, eye pain, redness, swelling, irritation, increased tears, a feeling of something in your eye, discharge, crusting, light sensitivity, or blurred vision.
- Tell your care team right away if you develop mouth pain, swelling, redness, ulcers, or sores.
- Tell your care team right away if you become pregnant or think you might be pregnant during treatment.
- Get emergency help right away for signs of a serious allergic reaction, such as breathing problems or wheezing, racing heart, fever or feeling very ill, swelling of the face, lips, mouth, tongue, or throat, trouble swallowing, throat tightness, itching, rash, hives, dizziness, fainting, stomach cramps, or joint pain.
- If you think you or someone else has received too much Datroway, get medical help right away or contact a poison control center.
Alternatives
- Enhertu (trastuzumab deruxtecan)
- Trodelvy (sacituzumab govitecan)
Watch the video
FAQs
What is Datroway Injection used for?
Datroway treats adults with certain advanced or metastatic cancers, including EGFR-mutated non-small cell lung cancer, triple-negative breast cancer, and HR-positive, HER2-negative breast cancer, in patients who have already tried specific prior therapies.
How is Datroway Injection given?
Datroway is given as an IV infusion by a healthcare provider, usually once every three weeks. The first infusion takes about 90 minutes, and later infusions may take 30 minutes if no problems occurred before.
What are the serious side effects of Datroway Injection?
Serious side effects include severe, potentially life-threatening lung inflammation, serious eye problems like dry eye and keratitis, severe mouth ulcers, severe allergic or infusion-related reactions, harm to an unborn baby, and fertility problems.
Can Datroway Injection harm an unborn baby?
Yes, Datroway can cause serious harm to an unborn baby. A pregnancy test is needed before starting treatment, and effective contraception is required during and after treatment for both men and women.
What precautions help prevent mouth sores with Datroway Injection?
Holding ice chips or ice water in the mouth during infusions and using a steroid-containing mouthwash as prescribed can help prevent and manage mouth sores caused by Datroway.
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Sources
Video
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