Venclexta / Venclyxto (venetoclax) Starter pack

pill
100 % legal and regulated
Secured logistics globally
24/7 track & trace delivery
Safe payment by bank transfer or credit card

We are registered as an independent intermediary for medicines with the Dutch Ministry of Health

Venclexta / Venclyxto (venetoclax) Starter pack

How to buy Venclexta / Venclyxto: You can order Venclexta / Venclyxto (venetoclax) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer AbbVie
Disease Blood Cancer
Indication Chronic Lymphocytic Leukemia (CLL) in presence of 17p deletion
Mode of Action BCL-2 inhibitor (chemotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 1257044-40-8
HS Code 30021098
Strength 10 mg, 50 mg, 100 mg

Who is venetoclax for?

Venetoclax is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy [1]. Venetoclax is marketed in the USA and in Australia under the name Venclexta, and in the Europen Union under the name Venclyxto.

Recommended dose

Complete information about venetoclax dosage and administration can be found here [1][8][9].
The recommended therapy consists of a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg.
  • Week 1: 20 mg daily.
  • Week 2: 50 mg daily.
  • Week 3: 100 mg daily.
  • Week 4: 200 mg daily
  • Week 5+: 400 mg daily.
  • The starter pack covers the treatment up to week 4. For week 5 and beyond venetoclax is dispensed as a one month supply in a bottle containing 120 100 mg-tablets.
  • Concomitant use with strong inhibitors of CYP3A at initiation and during ramp-up phase is contraindicated [1][8][9].
Consult your treating doctor for personalised dosing.

What is venetoclax and how does it work?

Venetoclax is a BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion [1][8][9] or patients with relapsed or refractory CLL when other medicines are unsuitable or have failed [8][9].
CLL is a slow-growing disease in which too many immature lymphocytes (white blood cells) accumulate in the blood and bone marrow [2]. About 10 percent of patients with untreated CLL and approximately 20 percent of patients with relapsed CLL have a particular chromosomal abnormality (17p deletion) [3] that is related to a specific type of CLL named B-Cell lymphoma 2 (BCL-2).
Patients with CLL who have a 17p deletion lack a portion of the 17th chromosome where resides a gene involved with the identification and elimination of faulty cells [4]. This gene thus acts to suppress cancer growth. In the presence of a 17p deletion, healthy cells are unable to use this identification/elimination pathway to prevent and control malignant cells [5].
Venetoclax is a selective inhibitor of a protein, named B-Cell lymphoma 2 (BCL-2 protein), that inhibits cell death (anti-apoptotic protein). Overexpression of BCL-2 protein has been demonstrated in BCL-2 cells where it mediates tumour cell survival and has been associated with resistance to chemotherapeutics. Patients with 17p deletion usually have poor outcomes with conventional chemo-immunotherapy [6]. Venetoclax is the first FDA-approved treatment that helps restore the process of apoptosis (cell death) by binding directly to the BCL-2 protein and preventing the inhibition of cell death [1].
The presence of 17p deletion can be assessed through the use of the FDA-approved companion diagnostic Vysis CLL FISH probe kit [3]. More information about the test can be found on the webpage of Abbott Molecular [7]

What is venetoclax's approval status?

Venetoclax was approved by
  • FDA (USA) on April 11, 2016
for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy [1].
  • EMA (EU) on December 5, 2016
  • TGA (AUS) on January 05, 2017
for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion or patients with relapsed or refractory CLL when other medicines are unsuitable or have failed [8][9].
The FDA approval was based on a single-arm clinical trial of 106 patients with CLL who have a 17p deletion and who had received at least one prior therapy. Trial participants took venetoclax orally every day, beginning with 20 mg and increasing over a five-week period to 400 mg. Results showed that 80.2 percent (95% CI, (71.3, 87.3)) of trial participants experienced a complete or partial remission of their cancer (5.7% complete remission + 1.9% complete remission with incomplete marrow recovery). The median time to first response was 0.8 months (range: 0.1 to 8.1 months). The duration of response (DOR) ranged from 2.9 to 19.0+ months [3][1]. Most common adverse reactions (≥20%) were neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue. Venetoclax can cause rapid reduction in tumours and thus poses a risk for tumour lysis syndrome (TLS) in the initial 5­ week ramp-up phase [1].
The EMA approval was based on the fact that studies have shown that a high proportion of patients have their cancer cells partially or completely cleared following treatment with venetoclax. In a main study of 107 previously treated patients with CLL and 17p deletion, 75 % responded partially or completely to venetoclax. In another study of 64 patients with or without 17p deletion or TP53 mutation, the response rate was 67 %. Patients in this second study had all previously taken B‑cell receptor pathway inhibitors [10]. The Australian approval was based on the first study, among others [9].
 
 
References
[1] Summary of Product Characteristics [FDA]: Venclexta (venetoclax), AbbVie Inc., Apr. 2016.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208573s000lbl.pdf
[2] Anticancer Fund. Chronic lymphocytic leukemia. (last update: Aug. 2015), cited on 30/08/2016.
http://www.anticancerfund.org/cancers/chronic-lymphocytic-leukemia
[3] FDA News Release FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality, 11/04/2016.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm495253.htm
[4] Dr. Sharman's CLL & Lymphoma Blog. 17p Deletion in CLL, 15/10/2012.
http://www.cll-nhl.com/2012/10/17p-deletion-in-cll.html#.V4eRXJN96u4
[5] Patient Power. What exactly does a 17p deletion mean? (last updated: 6/04/2015), cited on 30/08/2016.
https://www.patientpower.info/what-exactly-does-a-17p-deletion-mean
[6] Jain N. and O'Brien S. Chronic Lymphocytic Leukemia With Deletion 17p: Emerging Treatment Options. Oncology. 15/11/2012.
http://www.cancernetwork.com/oncology-journal/chronic-lymphocytic-leukemia-deletion-17p-emerging-treatment-options
[7] Abbott. Vysis CLL FISH Probe Kit, cited on 30/08/2016.
https://www.abbottmolecular.com/products/vysis-cll-fish-probe-kit-ce.html#OrderingInformation
[8] Summary of Product Characteristics [EMA]: Venclyxto (venetoclax), AbbVie Ltd., Dec. 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004106/WC500218800.pdf
[9] Summary of Product Characteristics [TGA]: Venclexta (venetoclax), AbbVie Ltd., Jan. 2017.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-PI-01048-1
[10] EMA. Human Medicines: Venclyxto (venetoclax), 21/12/2016, cited on Jan. 2016.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004106/human_med_002045.jsp&mid=WC0b01ac058001d124

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.

How can we help?

★ ★ ★ ★ ★
 
 

We've received requests for support from patients and doctors in over 120 countries, and delivered medicines to 6 continents. They've given us a 5 star rating for our service. Read what our friends from around the world are saying...

"My experience has been excellent. TheSocialMedwork were totally knowledgeable about the medicine I was looking for, and how to get it delivered to me quickly and easily. I UNCONDITIONALLY recommend TSM to anyone, it is truly a world-class organisation."

— Charles, USA

"During the transaction process I was very well informed by TheSocialMedwork team. They have put so much effort to ensure the best service was offered to me. Moreover the medicine I ordered was imported two weeks earlier. I highly recommend TheSocialMedwork."

— Tomasz, Poland

"I hope you know how needed you are and what it means to get a prompt, succinct and helpful reply. You are our hero. You have given us realistic hope in obtaining needed drugs in a timely way."

— Regina, US

"TheSocialMedwork were so helpful in getting the right medication to me, expediting its delivery, and keeping in touch. They simply can't do enough to help you. I would not hesitate to recommend TheSocialMedwork to anybody. Lovely people."

— Stephen, UK

"Totally awesome! Keep up the great work you're doing!"

— Dee, Australia

"When the doctor tells you that there are no treatments left to try, search further - there may be new treatments in other countries."

— Charlotte, The Netherlands

"TheSocialMedwork's professional capabilities, kindness and patience deserve our gratitude and respect."

— Haoyu, China

"My daughter died at the age of 21 because she couldn't get the treatment that might have saved her life. Now TheSocialMedwork might be able to help people like Abigail to get the best treatment."

— Frank, Virginia, USA

"The team is highly professional, friendly and will take care of everything. More options for doctor and patients. This service is transparent, unique and necessary. Keep it up!"

— Pa Tric, Germany

"Excellent communication and clarifications given every time when requested. They also provide fantastic support and updates from the start till the end of the process of the medicine provisioning."

— Milos, Serbia & Montenegro

Registered with the Dutch Ministry of Health as an independent intermediary, Registration number 6730 BEM
Registered as a USA Delaware LLC.



Our service uses cookies.