Do you have patients who are tired of waking up early in the morning to take their medication for chronic immune thrombocytopenia, or chronic ITP?
Are they ready for a treatment that doesn’t involve added visits to and from your office for frequent injections for administration?
Do you know if they’re tired of watching their calcium intake day after day?
Well, we may have a solution for you! (Cheesy upbeat instrumental theme music starts playing in background)
Let’s talk about Doptelet, a treatment for thrombocytopenia in adult patients with chronic ITP, when other treatments just haven’t worked well enough.
Ah, thanks for tuning in! My name is Barry, and today I’m here to tell you about Doptelet. It’s the only oral thrombopoietin receptor agonist — also known as TPO-RA— that your patients can take...
anytime, anywhere, with any food.
Now, maybe you already know a little bit about Doptelet, including that you should monitor patients and adjust the dose based on their platelet counts and other treatments they’re taking.
But there’s so much more to share! In fact, I’ve got a special guest with me...
Should we bring her out? Yes! Come on over, let’s go meet her!
When I say “Dop,” you say “telet”
DOP
TELET
DOP
TELET
DOP
TELET
DOP
TELET
DOP
TELET
DOP
TELET
Oh, great job. Speaking of great jobs, I am accompanied by Dr. Layla Van Doren, who is going to Dop-TELL-us about the results from the Doptelet clinical trials.
Before we get into it, tell us about yourself Dr. Van Doren.
Well, I’m a hematologist and I treat adult patients with chronic ITP.
Well, I’m a host and I treat adults with entertainment.
If you have any questions about Doptelet, we’re taking calls at 1–*ring*
Oh! That was fast [laughs].
Oh, hello to our first caller! Hi [CALLER], what question do you have for us today?
Hi, thanks for having me! I’m eager to learn more about this TPO-RA called Doptelet for my adult patients! First off, how was Doptelet studied?
Amazing question. Everybody, wasn’t that an amazing question?
[cheers]
Yeah! Doctor, was it an amazing question?
That was a great question, Caller. Let’s start with the patient population. 49 adults who had received 1 or more previous chronic ITP therapies were enrolled. The average baseline platelet count at the time of enrollment was less than 30K platelets per microliter.
Now, let’s go over some key endpoints. The primary efficacy endpoint was the cumulative number of weeks of platelet response, which was defined as a platelet count of 50K per microliter or higher, and this is in the absence of any rescue therapy over a 6-month treatment period.
A secondary endpoint was the proportion of patients with a platelet response at Day 8 of the clinical trial.
It’s crazy, cuz I was gonna say the same exact thing!
[cheers]
And, if anyone wants more information about the clinical trial design, visit the Doptelet website!
[pinging]
Oh! Now what could that be? It seems someone on the Doptel-net wants to know: I heard that Doptelet acts fast and lasts. What does that mean?
That’s another great question! As you know, results vary for each patient. But let’s look at some study results. If you see the graph on the screen, you’ll see that Doptelet helped raise AND maintain platelet counts. Going back to the primary endpoint, patients on Doptelet maintained target platelet counts of 50K platelets per microliter for a median of 12.4 cumulative weeks, and this was in the absence of any rescue therapy.
Dr. Van Doren, am I seeing things or is there a bit of an uptick over on this chart over here? I mean, what is that?
Yes! What this shows is a rapid response in median platelet counts. In fact, in as few as 8 days, 66% of patients taking Doptelet reached their goal platelet count of 50K per microliter.
Wow!
Did that help answer your question?
It sure did! I’m glad you’re here to save the
day-ta.
Now doc, what else do you think we need to know about Doptelet? Is there anything our audience needs to watch out for? Dop-TELL-it to the viewers.
Well, for any medication, it’s always important to be aware of the safety information. Something our viewers should know is Doptelet is a TPO-RA, and TPO-RAs have been associated with thrombotic and thromboembolic complications in patients with chronic ITP, so you should always consider the potential increased thrombotic risk when administering Doptelet to patients with known risk factors for thromboembolism.
You should know that the most common adverse reactions in the clinical trial were: headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Oh, wow. Folks, I am sorry to dop-TELL you this, but it seems like this is...
all the time we have for our Q&A. Remember to...
dop-TELL your patients about Doptelet, and keep watching for important information you need to know! (Host reads ISI, see next page)
[cheers]
INDICATION
DOPTELET® (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Thrombotic/Thromboembolic Complications. DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic complications in patients with chronic liver disease (0.4%; (1/274) in DOPTELET-treated patients) and thromboembolic complications in patients with chronic immune thrombocytopenia (7%; (9/128) in DOPTELET-treated patients). Portal vein thrombosis has been reported in patients with chronic liver disease, and thromboembolic events (arterial and venous) have been reported in patients with chronic immune thrombocytopenia treated with TPO receptor agonists.
Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions.
DOPTELET should not be administered to patients with chronic liver disease or chronic immune thrombocytopenia in an attempt to normalize platelet counts. Monitor platelet counts, and for signs and symptoms of thromboembolic events and institute treatment promptly.
Serious Adverse Reactions
Serious adverse reaction that occurred more frequently in patients treated with DOPTELET (9%; 12/128) compared to placebo (5%; 1/22) was headache, occurring in 1.6% (2/128).
Adverse Reactions
The most common adverse reactions (≥10%) in patients with chronic immune thrombocytopenia were headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.
Postmarketing Experience
Following the approval of DOPTELET, hypersensitivity reactions involving the immune system, including, but not limited to, pruritus, rash, choking sensation, swollen face, and swollen tongue have been reported.
These are not all the possible risks associated with DOPTELET. Please see Full Prescribing Information for DOPTELET at www.doptelethcp.com
To report suspected adverse reactions, contact Sobi North America at 1-866-773- 5274 or FDA at 1-800-FDA-1088.
