Description
Datopotamab deruxtecan-dlnk injection is used to treat non-small cell lung cancer (NSCLC) that has spread to areas outside of the lungs (locally advanced) or has spread to other parts of the body (metastatic) in patients who have an abnormal epidermal growth factor receptor (EGFR) and who have received previous treatment (eg, EGFR-directed medicine and platinum based chemotherapy). Your doctor will perform a test before you take this medicine.
Datopotamab deruxtecan-dlnk injection is also used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer that has spread (metastatic) or cannot be removed by surgery (unresectable) in patients who have received previous treatment (eg, endocrine-based treatment and chemotherapy for unresectable and metastatic disease).
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of datopotamab deruxtecan-dlnk injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of datopotamab deruxtecan-dlnk injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Eye or vision problems or
- Kidney disease or
- Liver disease or
- Lung or breathing problems—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 30 to 90 minutes. This medicine is usually given once every 3 weeks (21-day cycle).
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your doctor will give you other medicines (eg, allergy medicine, fever medicine, medicine to prevent nausea and vomiting) before you receive this medicine to help prevent unwanted effects.
Use preservative-free lubricant eye drops at least 4 times a day during treatment with this medicine. Do not use contact lenses unless directed by your eye doctor.
Your doctor will ask you to use a steroid-containing mouthwash 4 times a day and as need during treatment with this medicine. You should hold ice chips or ice water in your mouth while receiving this medicine.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 7 months after the last dose. Males with female partners who can become pregnant must use an effective birth control during treatment and for 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, trouble breathing, or thickening of bronchial secretions. These may be symptoms of a lung problem (eg, interstitial lung disease, pneumonitis).
This medicine may cause eye or vision problems. Check with your doctor right away if you have blurred vision, burning, dry or itching eyes, discharge, excessive tearing, eye redness, irritation, or pain, redness, pain, swelling of eye, eyelid, or inner lining of eyelid, or watering of the eyes. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor) when you start treatment, every year during treatment, at the end of treatment, and as needed.
Check with your doctor right away if you have swelling or inflammation of the mouth. These may be symptoms of stomatitis.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Blurred vision
- burning, dry or itching eyes
- cough
- diarrhea
- discharge, excessive tearing
- dizziness
- dry eye
- eye redness, irritation, or pain
- facial swelling
- fever or chills
- headache
- loss of taste or smell
- muscle or body aches
- nausea or vomiting
- redness, pain, swelling of the eye, eyelid, or inner lining of eyelid
- skin rash
- stuffy or runny nose
- swelling or inflammation of the mouth
- trouble breathing
- unusual tiredness or weakness
- watering of the eyes
Less common
- Agitation
- anxiety
- bladder pain
- bloody or cloudy urine
- chest pain
- coma
- confusion
- cough
- decreased urine output
- depression
- difficult, burning, or painful urination
- fainting
- fast heartbeat
- frequent urge to urinate
- general feeling of discomfort or illness
- hostility
- irritability
- lethargy
- lower back or side pain
- muscle twitching
- rapid weight gain
- seizures
- stupor
- swelling of the face, ankles, or hands
- thickening of bronchial secretions
Rare
- Pale skin
- unusual bleeding or bruising
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Darkening of the skin
- lack or loss of strength
- loss or thinning of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008469
