Avatrombopag
DOPTELET
Pronunciation: a-va-TROM-boe-pag (dop-TEL-et)
What it isOral thrombopoietin-receptor agonist stimulating platelet production; chronic ITP and periprocedural thrombocytopenia in liver disease.
Why this oneUnlike eltrombopag, it has no polyvalent-cation chelation restriction and no hepatotoxicity boxed warning.
What limits itPlatelets can overshoot and cause thrombosis, including portal-vein thrombosis; monitor counts rather than chasing normalization.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Thrombocytopenia in chronic liver disease, scheduled procedure | Adults | Platelets <40 x 10^9/L: 60 mg QD x5 days; 40 to <50: 40 mg QD x5 days (begin 10-13 days pre-procedure) | 5-day course only; procedure 5-8 days after last dose | 60 mg QD x 5 days |
| Chronic immune thrombocytopenia, insufficient response to prior therapy | Adults | 20 mg QD (tablets) | Lowest dose keeping platelets >=50 x 10^9/L (levels: 20 mg QW up to 40 mg QD) | 40 mg/day |
| Persistent/chronic immune thrombocytopenia | 6-17 yr (tablets) | 20 mg QD | Lowest dose keeping platelets >=50 x 10^9/L | 40 mg/day |
| Persistent/chronic immune thrombocytopenia | 1 to <6 yr (Sprinkle granules) | 10 mg QD | Lowest dose keeping platelets >=50 x 10^9/L | 20 mg/day |
Titration ITP: adjust one dose level at a time; wait 2 weeks after each change before further adjustment
Renal Undefined
Hepatic Undefined
Do not use to normalize platelet counts; stop if platelets >400 x 10^9/L (restart one level lower when <150)
Instructions
- Take with food
- Sprinkle: open capsules and mix granules with soft food or liquid; take immediately; do not swallow capsules whole or chew/crush granules
- Tablets and Sprinkle are NOT substitutable mg-for-mg (granules more bioavailable); if switching, monitor platelets weekly until stable
- Missed dose: take as soon as remembered; do not double; resume usual time next day
- ITP: platelets weekly until stable >=50 x 10^9/L, then monthly; weekly x4 wks after stopping
- ITP with moderate/strong dual CYP2C9+CYP3A4 inhibitors: start 20 mg (peds 1-<6: 10 mg) three times weekly; with dual inducers: start 40 mg (peds 1-<6: 20 mg) QD
- ITP: discontinue if platelets <50 after 4 wks at max dose, or >400 after 2 wks at lowest weekly dose
Available strengths
- tab 20 mg
- granules 10 mg
Cautions
- Thrombotic/thromboembolic complications (TPO-receptor agonist class): portal vein thrombosis 0.4% in CLD; arterial/venous events 7% in adult ITP
- Consider thrombotic risk with inherited (Factor V Leiden, prothrombin 20210A, antithrombin/protein C or S deficiency) or acquired (antiphospholipid syndrome) risk factors
- Hypersensitivity reactions reported postmarketing
Adverse reactions
- CLD (>=3%): pyrexia, abdominal pain, nausea, headache, fatigue, peripheral edema; hyponatremia (serious)
- Adult ITP (>=10%): headache, fatigue, contusion, epistaxis, URTI, arthralgia, gingival bleeding, petechiae, nasopharyngitis
- Pediatric ITP (>=10%): viral infection, nasopharyngitis, cough, pyrexia, oropharyngeal pain
Pregnancy May cause fetal harm (animal data at exposures well above human); insufficient human data
Lactation Breastfeeding not recommended during treatment and for >=2 weeks after last dose; for short courses, pump and discard
Cost
| Strength | #/mo | generic $ | CostPlus | |
|---|---|---|---|---|
| 20 mg | tab | 30 qd | not offered | |
| 10 mg | granules | per unit | not offered |
Generic entry2028 est.
NO BOXED WARNINGS
Principal riskNo FDA boxed warning.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityThrombosis and excessive platelet response are the principal serious risks.