Inqovi (decitabine and cedazuridine)
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Inqovi (decitabine and cedazuridine) is a medication used for the treatment of adults with myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML).
Disease Indications
Leukemia
Manufacturer
Astex Pharmaceuticals
Usage
Intravenous
Medicine approved by
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Food and Drug Administration (FDA)
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Health Canada
Patients helped
- Over 2 million patients reached
- More than 11,000 patients helped
- 100% successful deliveries to 87 countries
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Package
Tablets
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Dr. Akshi Sudan
Patient Support Team Lead
Daniela Figueira, PharmaD
Patient Support Agent
What is Inqovi (decitabine and cedazuridine) for?
Inqovi (decitabine and cedazuridine) is a medication used for the treatment of adults with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
It is available in vial form each containing 35 mg decitabine and 100 mg cedazuridine.1
How does Inqovi (decitabine and cedazuridine) work?
In healthy cells, tumor suppressor genes slow down cell division and make sure growth and proliferation occurs normally. When the tumor suppressor gene function is disrupted, leading to uncontrolled growth and division, and ultimately to cancer.2
Decitabine has two functions. It ‘hypomethylates’, switches off, tumor suppressor genes, causing restoration of their function, and thereby help them regain control over cell division.1
Additionally, decitabine also functions as an antimetabolite. This means that it looks very similar to substances that are used by the cell for regular growth and division. When taken up by cells, these antimetabolites will have a cytotoxic effect, leading to death of rapidly dividing cells. Because normal cells do not proliferate often, they are relatively insensitive to decitabine’s effect.2
Cedazuridine is a cytidine deaminase (CDA) inhibitor. CDA is a type of protein that breaks down substances, including decitabine, making them less available for the body to use. By administering decitabine together with cedazuridine, the efficiency of decitabine will be increased.1,3
Where has Inqovi (decitabine and cedazuridine) been approved?
Inqovi (decitabine and cedazuridine) was approved for the treatment of adult patients with myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML) by:
- The Food and Drug Administration (FDA), USA on July 7, 2020.4
Inqovi (decitabine and cedazuridine) was granted Priority Review and Orphan Drug designation by the FDA, which is intended for the safe and effective treatment of rare diseases.4
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.
How is Inqovi (decitabine and cedazuridine) taken?
The standard dosage is:1
- 35 mg decitabine and 100 mg cedazuridine.
One Inqovi (decitabine and cedazuridine) tablet is taken orally once daily for 5 consecutive days of each 28-day cycle. for a minimum of 4 cycles until disease progression or unacceptable toxicity. A complete or partial response may take longer than 4 cycles.
When hematologic adverse events (i.e. too low complete blood cell count) occur, the next cycle should be delayed. If hematologic recovery occurs within 2 weeks, continue Inqovi administration at the same dose. If not, delay the next cycle for an additional 2 weeks, and resume the next cycle at reduced dose (see official prescribing information).1
Complete information about Inqovi (decitabine and cedazuridine) dosage and administration can be found in the official prescribing information listed in our references section.1
Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.
Are there any known adverse reactions or side effects of Inqovi (decitabine and cedazuridine)?
Common adverse reactions
The most common adverse reactions (≥20% of patients) listed in the prescribing information include:1
- Low white blood cell count (leukopenia)
- Low blood platelets (thrombocytopenia)
- Low white blood cell count (neutropenia)
- Low red blood cell count (anemia)
- Tiredness
- Constipation
- Bleeding
- Muscle pain
- Pain or sores in your mouth or throat
- Joint pain
- Nausea
- Shortness of breath
- Diarrhea
- Rash
- Dizziness
- Fever with low white blood cell count (febrile neutropenia)
- Swelling of arms or legs
- Headache
- Cough
- Decreased appetite
- Upper respiratory tract infection
- Pneumonia
- Changes in liver function tests
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:1
- Febrile neutropenia
- Pneumonia
- Sepsis
Use in a specific population
Inqovi (decitabine and cedazuridine) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.1
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
1. Full prescribing information [FDA]: Inqovi (decitabine and cedazuridine) [PDF]
Astex Pharmaceuticals, July 2020
2. Types of Chemotherapy Agents and Regimens - Antimetabolites
Chemoth, last checked July 22, 2020
3. Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical announce FDA and Health Canada approval of INQOVI® (decitabine and cedazuridine) tablets
Astex Pharmaceuticals press release, July 2020
4. FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home
FDA press release, July 7 2020
The Food and Drug Administration (FDA), USA, approval of Inqovi (decitabine and cedazuridine) for the treatment of adults with myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML) was based on the data from Study ASTX727-02/ASCERTAIN (NCT03306264) and supporting phase 1/2 clinical study ASTX727-01-B (NCT02103478).1
ASCERTAIN was a multicenter, open label, randomized, crossover phase 3 study that involved 133 adult patients with MDS or CMML, including all French-American-British (FAB) classification criteria and IPSS Intermediate-1, Intermediate-2, or high-risk prognostic scores. Patients were randomly assigned to groups, to receive Inqovi 35 (mg decitabine and 100 mg cedazuridine) orally in Cycle 1 and decitabine 20 mg/m2 intravenously in Cycle 2 or the reverse sequence. Both INQOVI and intravenous decitabine were administered once daily on Days 1 through 5 of the 28-day cycle. Starting with Cycle 3, all patients received Inqovi orally once daily on 5 subsequent days of each 28-day cycle until disease progression or unacceptable toxicity.2
Study ASTX727-01-B was a 2-stage, open-label phase 1/2 dose escalation and dose confirmation study (first stage) to evaluate safety and pharmacokinetics (second stage). The study involved 80 adult patients with MDS or CMML.3
Results
The major efficacy outcome measure was the comparison of total 5-day decitabine Area-Under-The-Curve (AUC) between Inqovi and intravenous decitabine. The geometric mean ratio of the 5-day cumulative decitabine AUC following 5 consecutive once daily doses of INQOVI compared to that of intravenous decitabine was 99% (90% CI: 93, 106).1
Safety findings from the study were consistent with those anticipated with IV decitabine, with no significant differences in the incidence of most common adverse events between oral Inqovi and intravenous decitabine. The most common adverse events, regardless of causality in patients in the first 2 randomized cycles who received oral C-DEC, were thrombocytopenia (43.8%), neutropenia (35.4%), anemia (36.9%), and fatigue (23.8%).4
ASCERTAIN is now being extended to include patients with acute myeloid leukemia (AML) unsuitable to receive intensive induction chemotherapy.5
References
1. Full prescribing information [FDA]: Inqovi (decitabine and cedazuridine) [PDF]
Astex Pharmaceuticals, July 2020
2. Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML
Clinical Trials, last updated July 15, 2020
3. Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral CDAi in Patients With MDS
Clinical Trials, last updated Jan 9, 2020
4. Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical announce FDA and Health Canada approval of INQOVI® (decitabine and cedazuridine) tablets
Astex Pharmaceuticals press release, July 2020
5. An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
Clinical Trials, last updated July 10, 2020
Inqovi (decitabine and cedazuridine) treatment costs
The cost for a monthly or yearly treatment of Inqovi (decitabine and cedazuridine) depends on your prescription requirements which includes the dosage in g/mg/ml/etc and medicine type (Tablets).
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 Inqovi (decitabine and cedazuridine) 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.
Inqovi (decitabine and cedazuridine) price and additional costs
The price of Inqovi (decitabine and cedazuridine)
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 Inqovi (decitabine and cedazuridine) 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 Inqovi (decitabine and cedazuridine)
When you buy Inqovi (decitabine and cedazuridine), 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.
Inqovi (decitabine and cedazuridine) reimbursement
It might be possible for you to claim the cost of Inqovi (decitabine and cedazuridine) 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.
Room temperature shipping
For this medication, standard shipping applies. This means that a consistent room temperature of 15 to 25°C is maintained during transit.
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 buy Inqovi: You can order Inqovi 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.
