Enhertu (fam-trastuzumab deruxtecan-nxki)
We can help with your prescription. Read the “Prescription Guide”.
You can access this medicine even if it's not approved in your country. Learn how.
Disease Indications
Breast Cancer, Gastric Cancer
Manufacturer
AstraZeneca Pharmaceuticals LP
Daiichi Sankyo Company Limited
Usage
Intravenous
Medicine approved by
-
European Medical Agency (EMA)
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Food and Drug Administration (FDA)
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Pharmaceuticals and Medical Devices Agency (PMDA)
Patients helped
- Over 1.2 million patients reached
- More than 11,000 patients helped
- 100% successful deliveries to 88 countries
We can help with your import documents
We are experts in import regulations. Scroll below to download the import guide for your country.
FREQUENTLY ASKED QUESTIONS
We help you access approved medicines that are not approved or available in your country of residence.
Legal
Finances
Payment
- Your permanent residence is outside the European Union
- You take the medicines with you, unused within 90 days after purchase
- You have a full original receipt (which we provide you)
Unfortunately, we are unable to help with VAT refunds following delivery or collection from our partner pharmacies outside of the Netherlands.
- If you are residing within the European Union and you are not a company
- If you are coming to Amsterdam, Luxembourg or Dusseldorf to pick up your order
In case of pick up, you may be eligible for a VAT tax refund if you live outside the European Union.
Price
Reimbursement
- That you want to import an approved medicine from abroad
- The lack of reasonable treatment options available in your country (if you can, include a letter from a doctor confirming this) - no alternative to the treatment.
- That the medicine has already been approved in another country (state the name of the country)
- That your treating doctor states that this medicine is the best option for you (include a copy of the prescription in the letter to the healthcare insurance company)
Ordering and shipping
Ordering
- Name of the patient
- Contact details of patient(email and phone number)
- Copy of patient’s ID
- Contact details of the Doctor (name, address, email and phone number)
- Shipping address
- Copy of the doctor's prescription
Shipping: We can deliver to the patient's residence, a pharmacy, or doctor's office / hospital, but this depends on the country. If you’re not sure what the right choice is for you, please get in touch with our Patient Support Team and we can help you work out your exact requirements.
Once we have received this information, one of our Patient Support Team members will then check your prescription and contact you to follow up on your order. Please note that other documents may be needed for import, we will guide you through the ordering process.
Generally not, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details.
As part of our protocols we might reach out to your treating doctor for verification or information updates. By sending us your prescription you allow us to do so.
- Patient's name and date of birth
- Name of the medicine and dosage
- Required quantity
- Doctor's name and signature
- Doctor's registration number and/or stamp
Ideally, the prescription should be issued in English. Alternatively, a translation (unofficial is sufficient) must be provided.
Please be aware that your doctor may be contacted by one of our team members or by the processing pharmacy in order to verify the prescription.
Shipping
Please be aware that due to the COVID-19 situation worldwide and the country lockdowns, we will sometimes experience delays in shipping.
For EMA approved medicines with prescriptions from within the Schengen zone, you can pick the medicines up from our partner pharmacy in Amsterdam, Luxembourg or Dusseldorf. For non-EMA approved medicines, with prescriptions from within the Schengen zone, you can pick the medicines up in our partner pharmacy in Dusseldorf. If you have requested to collect your medicines, you will receive a notification when the medicines are in the pharmacy and ready for you.
There are also options to deliver the medicines to other countries. Please get in touch with our Patient Support Team to discuss which other pick-up and delivery options may be suitable for you.
- Copy of the ID/passport of the patient
- Copy of the ID/passport of the person who is coming to pick up the medicines
- Letter signed by the patient stating that he/she authorises this person to pick up the medicines on his/her behalf
- Step 1 - Customs may need to check the package to verify its contents. In order to streamline this step, we include a letter for customs with information about the contents. Any additional questions will be answered by TheSocialMedwork as and when we are contacted by customs.
- Step 2 - In some countries, there are additional questions from the medical regulatory agencies (i.e. the FDA, EMA, etc). We provide them with all the necessary information based on the information provided by the patient, such as: the prescription, copy of ID and a letter from the treating doctor to show that the medicines are for personal use.
- Step 3 - Customs fees. In some cases, the recipient will be requested to pay taxes and duties. These should be arranged by the patient or receiver and are not covered by TheSocialMedwork unless stated otherwise.
Please be aware that the import of the medicines always requires customs clearance and active cooperation from the importing party. We will help and guide you but are dependent on your cooperation and responsiveness.
About us
- Complete the enquiry form on our Contact Us page
- Send an email: [email protected]
- Call us on:
- +31 20 808 4414 (EU)
- +1 646 381 0675 (US)
- +61 28 417 2910 (AUS)
Others
Available medicines
Medicine approval
The respective national and regional agencies, such as the Food and Drugs Administration (FDA) in the USA or the European Medical Authority (EMA) for the European Union assess these applications and make a decision on whether to approve new medicines. The review process is based on evaluation of the evidence provided by the company. Every agency uses a slightly different process.
- Phase I - performed in a small number of healthy volunteers or very sick patients with lack of treatment options, designed to study the effects of the medicine in the human body.
- Phase II - larger number of patients, designed to evaluate the safety and efficacy of the medicine and to determine if different dosages of the treatment have different effects.
- Phase III - large number of patient groups, designed to confirm the safety and efficacy of the medicine.
- Phase IV - after the medicine has received regulatory approval, designed to evaluate the long-term effects.
Updates
Enhertu-fam-trastuzumab deruxtecan-nxki
Package
One single-dose vial
Where can we deliver?
We have delivered medicines to more than 88 countries. Check if we have sent medicines to yours.
We currently can’t ship medicines to - contact us for alternative options.
Make an enquiry to receive information about the different options of obtaining for a patient in .
We haven’t shipped medicines to yet. You can count on us to make it happen.
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Yes, we have successfully delivered medicines to .
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PICK-UP IN PERSON FROM A PARTNER PHARMACY
We can arrange for you to pick up this medicine from our partner pharmacy in Luxembourg. Read more.
Pick-up from Luxembourg.
Depending on your particular circumstance, this option can be cheaper and require less paperwork than direct delivery. You can ask someone else to pick up the medicine on your behalf.
In some cases, medicines can be picked up from partner pharmacies in Amsterdam (the Netherlands) or Dusseldorf (Germany).
Tell our Patient Support Team if you’re interested in pick-up options for your order.
Our Patient Support Team will personally assist you along the way
Dr. Akshi Sudan
Patient Support Team Lead
Daniela Figueira, PharmaD
Patient Support Agent
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What is Enhertu (fam-trastuzumab deruxtecan-nxki) for?
Enhertu (fam-trastuzumab deruxtecan-nxki) is a prescription medicine used to treat patients with HER2-positive:
- Breast cancer that cannot be removed by surgery (unresectable) or that has spread to other parts of your body (metastatic), who have received one or more prior anti-HER2 breast cancer treatments, either in the metastatic phase or in the early-stage setting.
- Stomach (gastric) or gastroesophageal junction adenocarcinoma that has spread to areas near the stomach (locally advanced) or is metastatic, and who have received a prior trastuzumab-based regimen.
How effective is Enhertu (fam-trastuzumab deruxtecan-nxki) for breast cancer?
The approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for breast cancer was based on a clinical study of 184 women with previously treated HER2+ unresectable or metastatic breast cancer. The study showed that:
How effective is Enhertu (fam-trastuzumab deruxtecan-nxki) for stomach cancer?
The approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for stomach cancer was based on a study in 188 people with previously treated HER2+ advanced stomach cancer. Enhertu was compared with 2 commonly used chemotherapies (irinotecan or paclitaxel). The study showed that:
- 40.5% saw their tumors shrink with Enhertu
- 11.3% saw this while receiving chemotherapy
- 84% had their tumors shrink, stop growing, or the growth of their tumors slowed with Enhertu
- 61% saw this while receiving chemotherapy
Enhertu helped people with stomach cancer live 4 months longer than with chemotherapy:
- Half of the people taking Enhertu were alive at 12.5 months
- Half of the people taking chemotherapy were alive at 8.4 months
Which side effects can I expect with Enhertu (fam-trastuzumab deruxtecan-nxki)?
According to the study results published, the most common side effects of Enhertu (fam-trastuzumab deruxtecan-nxki) in people with HER2-positive breast or gastric cancer include: nausea, fatigue, vomiting, hair loss, constipation, decreased appetite, low (white and/or red) blood cell counts, low platelet counts, diarrhea, cough, and thrombocytopenia.
Enhertu may cause fertility problems in males, which may affect the ability to father children. Talk to your treating doctor if you have concerns about fertility.
Please note this is not intended to be a comprehensive guide. Consult your treating doctor and the prescribing information at the bottom of the page for full details of side effects.
How is Enhertu (fam-trastuzumab deruxtecan-nxki) taken?
Administration: intravenous infusion (IV) once every 3 weeks.
Dosage: 5.4 mg/kg body weight.
Please note this is not intended to be a treatment plan. For a personalised treatment plan, consult your doctor. For more details, you can also reference the full prescribing information at the bottom of the page.
Frequently Asked Questions about Enhertu (fam-trastuzumab deruxtecan-nxki)
How does Enhertu (fam-trastuzumab deruxtecan-nxki) work?
Enhertu is an HER2-targeting antibody-drug conjugate.1 The molecule is made up of 3 parts:
- An HER2-recognising antibody, which is a type of protein designed to recognise and attach to the HER2 antigen present on cancer cells.
- The molecule DXd, a topoisomerase I inhibitor, which damages the tumor cell’s DNA and inhibits further DNA replication.
- A compound that conjugates (links) these two parts together.
When the HER2-recognising antibody binds to HER2 on the cancer cell, Enhertu is taken up by the cell and the linker is cleaved, releasing DXd. DXd then causes the destruction of HER2-positive cancer cells.1,2
For more details about the way Enhertu (fam-trastuzumab deruxtecan-nxki) works, consult your doctor or see the prescribing information at the bottom of the page. This is not intended to be a comprehensive scientific explanation.
What are some contraindications to taking Enhertu (fam-trastuzumab deruxtecan-nxki)?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What is the most important information you should know about Enhertu (fam-trastuzumab deruxtecan-nxki)?
Enhertu can cause serious side effects. Pay special attention to new or worsening symptoms as they may be related to:
- Lung problems, such as interstitial lung disease and pneumonitis
- Low white blood cell count (neutropenia)
- Weakening of the heart
Enhertu may cause harm to your unborn baby. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Enhertu and for at least 7 months after the last dose.
Males who have female partners that are able to become pregnant should use effective contraception during treatment with Enhertu and for at least 4 months after the last dose.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
Where has Enhertu (fam-trastuzumab deruxtecan-nxki) been approved?
Enhertu (fam-trastuzumab deruxtecan-nxki) was approved by:
- Food and Drug Administration (FDA), USA:
- on 20 December 2019 with an accelerated approval for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.1,3
- on 15 January 2020 for patients with previously treated HER2-positive metastatic gastric cancer.7
- on 5 May 2022 for patients with unresectable or metastatic HER2-positive breast cancer after one prior anti-HER2 therapy.10
- European Medicines Agency (EMA), Europe:
- on 18 January 2021 for the treatment of HER2-positive metastatic breast cancer.9
- PMDA, Japan:
- on 25 March 2020 for the treatment of HER2 positive unresectable or recurrent breast cancer after prior chemotherapy (limit the use to patients who are refractory or intolerant to standard treatments).4
- on 25 September 2020 for the treatment of HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy.8
The FDA granted Enhertu with Breakthrough Therapy and Orphan Drug Designation for the treatment of patients with advanced HER2-positive gastric cancer, and it is now under Priority Review for this indication.5
Enhertu also received Breaktrough Therapy Designation for the treatment of HER2-mutant metastatic non-small cell lung cancer (NSCLC).6
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
Downloads
References
1. Full prescribing information [FDA]: Enhertu (fam-trastuzumab deruxtecan-nxki)[PDF]
Manufacturer: Daiichi Sankyo, Inc., Dec. 2019
2. FDA Approves Enhertu for Unresectable or Pretreated Metastatic HER2-Positive Breast Cancer
Breast Cancer, last checked July 15 2020
3. ENHERTU® Approved in the U.S. for HER2 Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2-Based Regimens
Press release Daiichi Sankyo Inc., Dec. 2019
4. ENHERTU® Approved in Japan for Treatment of Patients with HER2 Positive Unresectable or Metastatic Breast Cancer
Press release Daiichi Sankyo Inc., Mar. 2020
5. Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer
Press release Astra Zeneca, Oct. 2020
6. Enhertu granted Breakthrough Therapy Designation in the US for HER2-mutant metastatic non-small cell lung cancer
Press release Astra Zeneca, May 2020
7. AstraZeneca, Daiichi's breast cancer drug gets broader U.S. approval
Press release Astra Zeneca, Jan 2021
8. ENHERTU® Approved in Japan for the Treatment of Patients with HER2 Positive Metastatic Gastric Cancer
Press release, Sept 2020
9. Enhertu approved in the EU for the treatment of HER2-positive metastatic breast cancer
Press release Astra Zeneca, Jan 2021
10. Move over, Roche: AstraZeneca and Daiichi's Enhertu snags FDA nod for earlier breast cancer use
Press release, May 2022
For more information please visit our blog page"What is Enhertu?"
HER2+ Breast Cancer
The Food and Drug Administration (FDA), USA,approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of unresectable or metastatic HER2+ breast cancer was based on data from the study DESTINY-Breast01 (NCT03248492).1
DESTINY-Breast01 was a multicentered, international, single-arm phase 2 study and involved 184 female patients with HER2+, unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies. Patients received Enhertu at a dose of 5.4 mg/kg by intravenous infusion every 3 weeks.2
Results
The two major efficacy outcomes were overall response rate (ORR), which is defined as the proportion of patients who have a partial or complete response to therapy, and duration of response (DOR), which is the time between the initial response to therapy and subsequent disease progression or relapse.2
The majority of people in the study, 60.3%, saw their tumors shrink with Enhertu:3
- Some people achieved a 4.3% complete response
- 56.0% of people achieved a partial response
97% of people treated with Enhertu had their tumors shrink, stop growing, or the growth of their tumors slowed.3
In half of the people who responded to Enhertu, this response lasted on average 14.8 months.3
HER2+ Stomach Cancer
The approval by the U.S. Food and Drug Administration of Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of HER2+ advanced stomach (gastric) cancer was based on results from the DESTINY-Gastric01 trial (NCT03329690).1
DESTINY-Gastric01 was an open-label, randomized, phase 2 trial, that studied trastuzumab deruxtecan as compared with chemotherapy in patients with HER2+ advanced gastric cancer. The study involved 187 patients who received trastuzumab deruxtecan 6.4 mg/kg of body weight every 3 weeks4
Results
The main efficacy outcome was the overall response rate (ORR), which is defined as the proportion of patients who have a partial or complete response to therapy. A secondary outcome was overall survival.4
In this study, Enhertu helped people live longer than with chemotherapy. Tumors shrank in more people treated with Enhertu than with chemotherapy.5
The majority of people in the study, 40.5% of people saw a response with Enhertu and 11.3% did with chemotherapy:5
- 7.9% of people receiving Enhertu achieved a complete response vs. no one receiving chemotherapy.
- 32.5% of people receiving Enhertu achieved a partial response, vs. 11.3% of those receiving chemotherapy.
84% of people receiving Enhertu had their tumors shrink, stop growing, or the growth of their tumors slowed, and 61% of people saw this while receiving chemotherapy.5
Half of the study participants who responded were alive at 12.5 months. For people taking chemotherapy, half of the people were alive at 8.4 months. This was about 4 months longer with Enhertu.5
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Enhertu (fam-trastuzumab deruxtecan-nxki) for the approved indication.1
References
1. Full prescribing information [FDA]: Enhertu (fam-trastuzumab deruxtecan-nxki) [PDF]
Daiichi Sankyo, Inc., Dec. 2019
2. A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Clinical trial, cited Sept 2020
3. Trastuzumab Deruxtecan in Previously Treated HER2+ Breast Cancer
Modi S, et al., NEJM, Feb 2020
4. DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer
Clinical trial DESTINY-Gastric01, cited Jan 2020
5. Trastuzumab Deruxtecan in Previously Treated HER2+ Gastric Cancer
Shitara K, et al., NEJM, Jun 18, 2020
Enhertu (fam-trastuzumab deruxtecan-nxki) price in other currencies*
| Package | Euro | Polish złoty |
|---|---|---|
| 100 mg of fam-trastuzumab deruxtecan-nxki | 3965 EUR | 18282 PLN |
*The prices listed above are based on the cheapest package size and strength TheSocialMedwork has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.
Enhertu (fam-trastuzumab deruxtecan-nxki) treatment costs
The cost for a monthly or yearly treatment of Enhertu (fam-trastuzumab deruxtecan-nxki) depends on your prescription requirements which includes the dosage in mg and medicine type (One single-dose vial ).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Enhertu (fam-trastuzumab deruxtecan-nxki) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Enhertu (fam-trastuzumab deruxtecan-nxki) price and additional costs
The price of Enhertu (fam-trastuzumab deruxtecan-nxki)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
Our Named Patient support fee
TheSocialMedwork provides access to Enhertu (fam-trastuzumab deruxtecan-nxki) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
Shipping costs
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
You can read a detailed overview of prices and costs here.
Payment methods when you buy Enhertu (fam-trastuzumab deruxtecan-nxki)
When you buy Enhertu (fam-trastuzumab deruxtecan-nxki), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Enhertu (fam-trastuzumab deruxtecan-nxki) reimbursement
It might be possible for you to claim the cost of Enhertu (fam-trastuzumab deruxtecan-nxki) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Cold chain shipping
Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping. For more details, please see our article on cold chain delivery.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Four steps to access the medicines you need
How and where to access and buy Enhertu: You can access Enhertu from TheSocialMedwork if the drug has not been approved or is not available in your country.
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Step 1
You send a request for your medicine online
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
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Step 2
We verify your prescription and medical details
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
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Step 3
We source your medicine
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
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Step 4
We deliver your medicine
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
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Disclaimer
Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.
