Fam-trastuzumab deruxtecan-nxki (intravenous route)

Enhertu

Fam-trastuzumab deruxtecan-nxki injection is used to treat HER2-positive (IHC 3+ or ISH positive) metastatic (cancer that has spread to other parts of the body) or unresectable (cancer that cannot be removed with surgery) breast cancer in patients who have previously received an anti-HER2 breast cancer treatment for metastatic disease or have breast cancer that has come back during or within 6 months of completing treatment for early-stage breast cancer. Fam-trastuzumab deruxtecan-nxki injection is also used to treat HER2-low metastatic (cancer that has spread to other parts of the body) or unresectable (cancer that cannot be removed with surgery) breast cancer in patients who have previously received treatment for metastatic disease or have breast cancer that has come back during or within 6 months of completing treatment (after surgery). Fam-trastuzumab deruxtecan-nxki injection is also used to treat metastatic (cancer that has spread to other parts of the body) or unresectable (cancer that cannot be removed with surgery) non-small cell lung cancer (NSCLC) in patients whose cancer has an abnormal HER2 gene and who have previously received treatment. Fam-trastuzumab deruxtecan-nxki injection is also used to treat HER2-positive (IHC 3+ or IHC 2+/ ISH positive) metastatic (cancer that has spread to other parts of the body) or locally advanced (cancer that has spread to areas near the stomach) stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have previously received trastuzumab-based regimen. Fam-trastuzumab deruxtecan-nxki injection is also used to treat HER2-positive (IHC 3+) metastatic (cancer that has spread to other parts of the body) or unresectable (cancer that cannot be removed with surgery) solid tumors in patients who have previously received treatment that did not work well. Your doctor will test for the presence of the HER2 gene. HER2 protein is produced by some tumors. Fam-trastuzumab deruxtecan-nxki interferes with the growth of this protein which also prevents tumor growth. The tumor cells will then be destroyed by the body. This medicine is to be given only by or under the immediate supervision of your doctor. This product is available in the following dosage forms:

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: 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. Appropriate studies have not been performed on the relationship of age to the effects of Enhertu® in the pediatric population. Safety and efficacy have not been established. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Enhertu® in the elderly. However, elderly patients are more likely to have unwanted side effects which may require caution in patients receiving this medicine. 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. 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. 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. 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: