Enhertu
Generic name: fam-trastuzumab deruxtecan
Dosage form: intravenous infusion
Drug class: HER2 inhibitors
What is Enhertu?
Enhertu is a medicine used in adults to treat very specific types of breast cancer, stomach cancer and non-small cell lung cancer (NSCLC). Enhertu is made up of two cancer-fighting medicines, a targeted cancer therapy and a chemotherapy drug.
This medicine is usually given as an infusion into a vein every 3 weeks. The first infusion will take over 90 minutes but your next infusions are usually given over 30 minutes.
Enhertu (generic name: fam-trastuzumab deruxtecan-nxki) is not the same medicine as trastuzumab or ado-trastuzumab emtansine.
Enhertu was first approved by the FDA on December 20, 2019.
What is Enhertu used for?
Breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive
- Breast cancer in adults that cannot be removed by surgery or that has spread to other parts of your body (metastatic) and
- you have already received a prior 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 their early-stage breast cancer.
Breast cancer that is HER2-low (IHC 1+ or IHC 2+/ISH-)
- Breast cancer in adults that cannot be removed by surgery or that has spread to other parts of your body (metastatic) and
- who have received prior chemotherapy in the metastatic setting or
- developed disease recurrence during or within six months of completing adjuvant chemotherapy.
Stomach cancer that is HER2-positive
- gastric or gastroesophageal junction (GEJ) adenocarcinoma cancer in adults and
- you have already received a prior trastuzumab-based regimen and has
- spread to areas near your stomach (locally advanced) or
- that has spread to other parts of your body (metastatic).
Non-small cell lung cancer (NSCLC) that has activating HER2 (ERBB2) mutations
- in adults that have NSCLC that cannot be removed by surgery or that has spread to other parts of your body (metastatic)
- patient has already received prior systemic therapy
- activating HER2 (ERBB2) mutations have been detected by a FDA-approved test.
How does Enhertu work?
Enhertu is a chemotherapy and a targeted cancer therapy as it is made up of two cancer-fighting medicines, a targeted cancer therapy joined to a chemotherapy drug. It works by preventing cancer cells from multiplying which slows the cancer growth and progression, and then its second action is to damage or kill the cancer cells.
The two active parts of Enhertu include:
- monoclonal antibody (fam-trastuzumab) which attaches to the HER2 receptor on cancer cells, this helps prevent cancer cells from multiplying which slows the cancer growth and cancer progression
- a type of chemotherapy (topoisomerase I inhibitor) which damages or causes death to cancer cells.
Important information
Enhertu can cause serious side effects, including:
- Lung problems that may be severe, life-threatening or that may lead to death. If you develop lung problems your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you get any of the following signs and symptoms:
- cough
- trouble breathing or shortness of breath
- fever
- other new or worsening breathing symptoms (e.g., chest tightness, wheezing)
- Low white blood cell count (neutropenia). Low white blood cell counts are common with this medicine and can sometimes be severe. Your healthcare provider will check your white blood cell counts before starting this medicine and before starting each dose. Tell your healthcare provider right away if you develop any signs or symptoms of an infection or have fever or chills during treatment with this medicine.
- Heart problems that may affect your heart's ability to pump blood. Your healthcare provider will check your heart function before starting treatment. Tell your healthcare provider right away if you get any of the following signs and symptoms:
- new or worsening shortness of breath
- coughing
- feeling tired
- swelling of your ankles or legs
- irregular heartbeat
- sudden weight gain
- dizziness or feeling light-headed
- loss of consciousness
Your healthcare provider will check you for these side effects during your treatment with this medicine. Your healthcare provider may reduce your dose, delay treatment or completely stop treatment with this medicine if you have severe side effects.
- Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with this medicine.
- If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with this medicine. See more information below about this medicine and pregnancy.
- Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with this medicine and for at least 4 months after the last dose.
What should I tell my healthcare provider before using Enhertu?
Before you receive this medicine, tell your healthcare provider about all of your medical conditions, including if you:
- have lung or breathing problems.
- have signs or symptoms of an infection.
- have or have had any heart problems.
- if you are pregnant or planning a pregnancy, as this medicine can harm your unborn baby. See more information below about this medicine and pregnancy.
- are breastfeeding or plan to breastfeed. It is not known if Enhertu passes into your breast milk. Do not breastfeed during treatment with this medicine and for 7 months after the last dose.
Dosing information
Do not substitute ENHERTU for or with trastuzumab (Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera) or adotrastuzumab emtansine (Kadcyla).
Enhertu is given into your vein as an intravenous infusion.
The dose you are given will depend on how much you weigh and whether you have gastric cancer, breast cancer and NSCLC. It is usually given once every 3 weeks (21 day cycle) until your disease progresses or you start to have toxic effects. Sometimes this may mean a pause in treatment, your dose being reduced or even treatment being stopped.
If you have an infusion-related reaction your healthcare provider may slow down or temporarily stop your infusion of this medicine, or if you have a severe infusion reaction they may permanently stop this treatment.
If you miss a planned dose of this medicine, call your healthcare provider right away to schedule an appointment. Do not wait until the next planned treatment cycle
What are the possible side effects of Enhertu?
Enhertu can cause serious side effects. See "Important information” above.
The most common side effects of Enhertu include:
- nausea
- low white blood cell counts
- low red blood cell counts
- feeling tired
- vomiting
- increased liver function tests levels
- low platelet counts
- constipation
- decreased appetite
- diarrhea
- low levels of blood potassium
- cough
Enhertu may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.
These are not all of the possible side effects of this medicine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Interactions
Some medications interact with Enhertu, so it is important to tell your doctor about any medicines that you are currently taking, or if you start or stop any medicine while you are having cancer treatment. Also tell your doctor about any over-the-counter medicines, vitamins, minerals or herbal products that you take.
Pregnancy and Breastfeeding
Pregnancy
You should not take Enhertu if you are pregnant or planning a pregnancy, as it can harm your unborn baby.
- If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with this medicine.
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with this medicine and for at least 7 months after the last dose.
- Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with Enhertu and for at least 4 months after the last dose.
- This medicine may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.
Breastfeeding
Enhertu and breastfeeding:
- It is not known if Enhertu passes into your breast milk.
- Do not breastfeed during treatment with Enhertu and for 7 months after the last dose.
Storage
Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
Store in the original carton to protect from light until time of reconstitution.
Do not shake the reconstituted or diluted solution.
What are the ingredients in Enhertu?
Active Ingredient: fam-trastuzumab deruxtecan-nxki.
Inactive Ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and sucrose
Who makes Enhertu?
Enhertu is manufactured by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 U.S. License No. 2128
Enhertu is marketed by: Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 and AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
Popular FAQ
Enhertu (Fam-trastuzumab deruxtecan-nxki) is a chemo drug (chemotherapy) and it is also a targeted therapy anti-cancer drug. Continue reading
References
- Food and Drug Administration (FDA) Enhertu Product Label
- Shanu Modi, M.D., Cristina Saura, M.D., Ph.D., Toshinari Yamashita, M.D., et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med 2020; 382:610-621.DOI: 10.1056/NEJMoa1914510 https://www.nejm.org/doi/10.1056/NEJMoa1914510
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