DOPTELET® (avatrombopag) Safety Profile for CLD Patients | DOPTELET® HCP

Pooled Doptelet safety data from ADAPT‐1 and ADAPT-2 (N=430)^1,2*

Thrombotic/Thromboembolic Complications¹

In clinical trials, 0.4% (1/274) of patients with chronic liver disease treated with Doptelet developed a treatment-emergent event of portal vein thrombosis

Serious Adverse Reactions¹

The most common serious adverse reaction reported in patients with CLD treated with Doptelet compared to placebo was hyponatremia (0.7% vs 0%)

Adverse reactions with a frequency of ≥3% in adults with CLD treated with Doptelet¹

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Low discontinuation rates (<1%) due to adverse reactions (anemia, pyrexia, and myalgia).¹

No increase in hepatotoxicity was reported in ADAPT‑1 and ADAPT‑2.²

Incidence of thrombosis (1/430): In ADAPT-1 and ADAPT-2, there was one treatment-emergent event of portal vein thrombosis.¹

Please see additional Important Safety Information for Doptelet below.

*ADAPT-1 and ADAPT-2 were 2 identically designed, multicenter, randomized, double-blind, placebo-controlled studies.¹
^†Treatment-emergent adverse reactions sorted in descending order by total patients treated with Doptelet (N=274).¹

CLD=chronic liver disease.

Review Doptelet dosing and scheduling

Doptelet is taken once daily for 5 days with food.

DOPTELET (avatrombopag) [prescribing information]. Morrisville, NC: AkaRx, Inc; 2025.
Terrault N, Chen Y, Izumi N, et al. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018;155(3):705-718.

Indication & Important Safety Information

INDICATION

DOPTELET is indicated for the treatment of:

Thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure

IMPORTANT SAFETY INFORMATION

WARNINGS and PRECAUTIONS

Thrombotic/Thromboembolic Complications
DOPTELET has been associated with thrombotic and thromboembolic complications in patients with CLD. In patients with CLD, thromboembolic events (portal vein thrombosis) occurred in 0.4% (1/274) of patients receiving DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions and acquired risk factors.

DOPTELET should not be administered to patients with CLD in an attempt to normalize platelet counts. Monitor platelet counts and follow the dosing guidelines to achieve target platelet counts. Monitor patients receiving DOPTELET for signs and symptoms of thromboembolic events and institute treatment promptly.

DRUG INTERACTIONS

Moderate or Strong Dual CYP2C9 and CYP3A4 Inducers or Inhibitors
Concomitant use of DOPTELET with a moderate or strong dual inhibitor or inducer of CYP2C9 and CYP3A4 may increase the risk of DOPTELET toxicities or reduce DOPTELET or efficacy.

ADVERSE REACTIONS

The most common serious adverse reaction was hyponatremia.
The most common adverse reactions (≥3%) were pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

USE IN SPECIFIC POPULATIONS

DOPTELET may cause fetal harm when administered to a pregnant woman.
Breastfeeding is not recommended during treatment with DOPTELET and for at least 2 weeks after the last dose.

These are not all the possible risks associated with DOPTELET. Please see Full Prescribing Information for DOPTELET.
To report suspected adverse reactions, contact Sobi North America at 1-866-773-5274 or FDA at 1-800-FDA-1088.

Discover the Doptelet Copay Program

Eligible commercially insured patients may qualify for the Doptelet Connect program

What's the program?

Eligible patients may pay as little as $0 for each Doptelet prescription
Annual maximum benefit up to $15,000

Eligible patients must:

Have commercial insurance that covers Doptelet
Not be enrolled in any state or federal healthcare program such as Medicare, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DOD), or TRICARE
Be ≥1 year old
Be a resident in the United States or a US Territory

How to enroll:

Approved pharmacies, healthcare professionals, and Doptelet Connect can enroll patients
Patients can enroll themselves as well as their caregivers
Please call 1-833-368-2663 Monday–Friday 8:30 AM–7 PM ET for more information

Terms and Conditions

Patients pay as little as $0 per prescription. Copay Program has an annual calendar cap of $15,000
The Copay Saving Program is void where prohibited by law, taxes, or restricted
This offer is non-transferable, no substitutions are permissible, and this offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
Sobi, Inc. reserves the right to rescind, revoke, or amend this offer at any time without notice
The Patient Copay Program for Doptelet is not insurance and is not intended to substitute for insurance
Patients, pharmacists, and healthcare providers must not seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this Copay Program. Patients must not seek reimbursement from any health savings, flexible spending, or other healthcare reimbursement accounts for the amount of assistance received from the Copay Program
Certain information pertaining to your use of the Copay Program will be shared with Sobi, Inc., the sponsor of the Copay Program. The information disclosed will include the date the prescription is filled, the number of pills or product dispensed by the pharmacists, and the amount of your copay that will be paid for by using this Copay Program. For more information, please see the Sobi Privacy Policy at https://sobi-northamerica.com/privacy-policy
Acceptance in this Program is not conditioned on any past, present, or future purchase, including additional doses
Enrollment for the Copay Program is valid through the calendar year
Sobi reserves the right to change program terms at any time