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Enhertu

Pronunciation: en-HER-too

Generic Name: Fam-trastuzumab deruxtecan [FAM-tras-TOOZ-ue-mab-DER-ux-TEE-kan]
Formulation for Dose: Intravenous infusion (100mg vial)
Drug Class: HER2 inhibitors

What is Enhertu?

Enhertu (fam-trastuzumab-deruxtecan) is a HER2-directed antibody and topoisomerase inhibitor conjugate that is used to treat types of breast cancer, stomach cancer, and non-small cell lung cancer that have specific HER2 gene mutations.Enhertu operates by blocking HER2 receptors found on cancer cells in order to stop tumour cells from multiplying. This reduces cancer growth and spread, and its second function is to kill or damage the cancerous cells.

Enhertu consists of two anti-cancer drugs: an antibody monoclonal (fam-trastuzumab) and a chemotherapy agent (topoisomerase I inhibitor). Enhertu is a HER2-directed antibody as well as a topoisomerase inhibitor conjugate.

Enhertu is a HER2 inhibitor, which is a targeted treatment used to combat cancer. It was approved by the FDA for the treatment of cancer. The FDA initially approved Enhertu on December 20th, 2019.Enhertu is administered as an injection into a vein by your doctor.

Enhertu is generally only given every 3 weeks during a 21-day cycle of treatment. The first dose will last longer than 90 minutes. However, the subsequent infusions are typically scheduled over 30 minutes.The dosage you'll get will be contingent on the weight you are carrying and the type of cancer you have.

When you receive an infusion, it is possible that you suffer a reaction related to the infusion. If this occurs, your healthcare provider might delay or even stop the infusion. If you suffer from a serious infusion response, you and your health professional could stop the treatment for good.Your doctor will decide the length of time you will be treated with this medication. If you suffer from adverse reactions or your cancer grows, the dosage may be decreased, and treatment could be suspended or even halted.

Enhertu can cause you to feel sick and might make you vomit. Your physician may prescribe medication to help prevent vomiting and nausea.You'll require regular medical tests.

How to Take Enhertu?

Enhertu can be used by adult patients with:A breast tumour that's (HER2)-positive, is not easily removed by surgery, has spread, and already has an anti-HER2-based treatment.Cancer of the breast that's her2-low (IHC 1+, or IHC 2+/ISH) that is not surgically removed or spreads to different regions of your body patients who have received chemotherapy treatment for cancer that has spread or cancer that has recurred within 6 months after finishing adjuvant chemotherapy.

Stomach cancer that is Her2-positive is a gastric or gastroesophageal junction (GEJ) adenocarcinoma, and you've had trastuzumab-based therapy. Your cancer is spreading to regions close to your stomach (locally advanced) or expanding to other areas within the system (metastatic).

Non-small-cell lung cancer (NSCLC) that has activated the HER2 (ERBB2) modifications that are not able to be eliminated via surgery, or cancer that may have spread to additional areas within the body (metastatic), and you've had treatment with systemic drugs, and the activating HER2 (ERBB2) mutations were detected using an approved FDA test.

Enhertu (fam-trastuzumab derux tecan nxki) does not contain the exact same drug as trastuzumab (Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera). The medicines listed above contain trastuzumab but are not topoisomerase II inhibitors.Enhertu (fam-trastuzumab derux tecan nxki) can be a different medication than Kadcyla (ado-trastuzumab, emtansine), which has a different conjugate of antibody-drug.

What is the HER2 gene?

Certain cancerous cells possess more than one copy of the epidermal growth factor receptor (HER2) gene that produces a protein known as HER2, and these types of cancer are known as HER2-positive. The HER2 protein regulates cell growth. If your cancer is HER2-positive, it means that it will likely expand faster or return. Certain cancerous cells that are not HER2-positive contain HER2 proteins that are found on the cell's surface and are known as low-HER2-level. Cancer drugs such as Enhertu inhibit HER2 receptors to limit the ability of cancer to expand and spread.

Side effects of Enhertu

Common Enhertu side effects could include:

  • nausea, vomiting, and loss of appetite;
  • diarrhoea, constipation;
  • cough;
  • fatigue, fever;
  • low blood cell count;
  • low potassium
  • abnormal tests of liver function; or
  • hair loss.

Serious Enhertu side effects

Contact a medical professional immediately. If you are experiencing symptoms that indicate an allergy, such as hives, breathing difficulties, or swelling of your lips, face, and tongue,

Enhertu may cause serious side effects. Contact your doctor immediately if you experience:

  • The chest is tight; there's a wheezing cough; new or progressively worsening breath shortness;
  • Heartbeats that are pounding or racing through your chest
  • Fever, tiredness, and dizziness;
  • Leg swelling and weight gain suddenly;
  • A feeling of lightheadedness, as if you're passing out;
  • low blood cell counts, chills, fever, mouth sores, skin sores, easy bruising, unusual bleeding, white skin, and cold hands and feet;
  • Low potassium level Leg cramps, constipation, irregular heartbeats, fluttering of your chest, more frequent urination, or thirst Tingling or numbness, muscular weakness, or a limb sensation

Your treatment for cancer could be delayed or discontinued permanently if you experience certain negative side effects.

This isn't a complete list of all the side effects. Others could happen. Consult your physician for advice regarding medical adverse effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

Warnings

Enhertu could cause severe or life-threatening effects on your lungs or heart. Call your doctor immediately if you notice an earache, fatigue, chest tightness, dizziness, coughing up, heartbeat irregularity, or shorter or more frequent breath shortness.

Enhertu may reduce or suppress our immune system. This means you could contract an infection or get bleeding quickly. Consult your physician when you notice unusual bruises or bleeding or indications of illness (fever weakening, chills, cold or flu signs, or regular or repeated illnesses).

Men and women who are taking this medication should utilise effective birth control in order to avoid the onset of pregnancy. Birth control should be maintained for seven months after having taken the final dose of Enhertu for women and for four months for men.Your doctor will run blood tests to ensure there are no medical conditions that could hinder you from using this medicine.

Before you Take this Drug

Before you begin this medication, inform your doctor about your medical conditions, particularly those with

  • Have any breathing or lung concerns?
  • Are exhibiting symptoms or signs of the infection.
  • Have had or been through in the past heart-related issues

There is a chance that you'll need undergo a negative pregnancy test prior to beginning the treatment.

Pregnancy

Enhertu may harm an unborn baby when the mother or father is taking this medication. You should not use Enhertu when you are pregnant or planning to become pregnant because it could harm the unborn baby.

If you're a woman and are capable of becoming pregnant, your healthcare professional must conduct an ultrasound test prior to you beginning treatment with this drug. Females who can get pregnant should take advantage of the most effective methods of contraception (contraception) when they are treated with this medication and for a minimum of seven months following taking the previous dose.

If you're a male with a female partner who can get pregnant, you must utilise the most effective methods of contraception (contraception) while you are using Enhertu and for at least four months following the expiration of your last dose.This medication could cause fertility issues in males that could impact their ability to father children. Discuss this with your physician if you are concerned regarding fertility.

Breastfeeding

Inhertu, breastfeeding, and enhertu:

  • It isn't known whether Enhertu gets into your breast milk.
  • Do not breastfeed while you are treated with Enhertu or for 7 months following the final dose.

Details on Dosage

Usual Adult Dose of Unresectable Metastatic Breast Cancer:

  • 5.4 mg/kg IV every three months (a 21-day cycle) delivered by intravenous injection until the disease progresses or it is unacceptably toxic.

Usual Adult Dose for Unresectable or Metastatic HER2-Mutant NSCLC:

  • 5.4 mg/kg IV once every 3 months (21-day cycle) administered as intravenous infusions until the disease progresses or it is unacceptably toxic.

Usual Adult Dose for Locally Advanced or Metastatic Gastric Cancer

  • 6.4 mg/kg three times per week (a 21-day cycle) administered as an intravenous infusion up to the progression of the disease or unacceptably toxic

Comments:

  • Infuse the first time over 90 minutes. Then administer successive infusions for 30 minutes if previous infusions were well tolerated.
  • Infusions can be stopped or slowed down if a patient exhibits symptoms associated with infusions.
  • Always stop treatment for serious reactions to infusions.

For more details on Enhertu dosing information, click this link.

What Happens if I Miss the Dose?

If you do not make an appointment to receive your injection, contact your doctor to make an appointment. Do not wait until your next scheduled treatment cycle.

What Happens If I Overdose?

Since the medicine is prescribed by a medical expert in a medical environment, it is highly unlikely for an overdose to occur.

What Should be Avoided?

Follow the doctor's advice regarding any restrictions on your food, drink, or activity.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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