Doptelet
- Generic Name: avatrombopag tablets
- Brand Name: Doptelet
Doptelet (Avatrombopag Tablets) side effects drug center
Doptelet Side Effects Center
What Is Doptelet?
Doptelet (avatrombopag) is a thrombopoietin receptor agonist indicated for the treatment of low blood platelet count (thrombocytopenia) in adult patients with chronic liver disease who are scheduled to undergo a procedure.
What Are Side Effects of Doptelet?
Common side effects of Doptelet include:
- fever,
- abdominal pain,
- nausea,
- headache,
- fatigue, and
- swelling of extremities
Dosage for Doptelet
The recommended dose of Doptelet is based on a patient's platelet count prior to a scheduled procedure.
What Drugs, Substances, or Supplements Interact with Doptelet?
Doptelet may interact with itraconazole, fluconazole, rifampin, cyclosporine, and verapamil. Tell your doctor all medications and supplements you use.
Doptelet During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Doptelet; it may harm a fetus. Breastfeeding is not recommended while using Doptelet and for at least 2 weeks after the final dose.
Additional Information
Our Doptelet (avatrombopag) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Doptelet Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
You could develop a blood clot while using avatrombopag. Call your doctor or get emergency medical help if you have:
- chest pain, shortness of breath;
- fast heartbeats;
- pain, swelling, or redness in one or both legs;
- stomach pain or tenderness;
- sudden fever or chills, yellowing of your skin or eyes; or
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
- fever;
- easy bruising or bleeding (nosebleeds, bleeding gums), purple or red spots on your skin;
- feeling tired;
- headache, joint pain;
- cold symptoms such as runny or stuffy nose, sneezing, sore throat;
- nausea, stomach pain; or
- swelling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Doptelet (Avatrombopag Tablets)
Doptelet Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are discussed in detail in other sections of the labeling:
- Thrombotic/Thromboembolic Complications [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Patients With Chronic Liver Disease
The safety of DOPTELET was evaluated in two international, identically designed, randomized, double-blind, placebo-controlled trials, ADAPT-1 and ADAPT-2, in which 430 patients with chronic liver disease and thrombocytopenia received either DOPTELET (n=274) or placebo (n=156) daily for 5 days prior to a scheduled procedure, and had 1 post-dose safety assessment. Patients were divided into two groups based on their mean platelet count at baseline:
- Low Baseline Platelet Count Cohort (less than 40x109/L) who received DOPTELET 60 mg once daily for 5 days
- High Baseline Platelet Count Cohort (40 to less than 50x109/L) who received DOPTELET 40 mg once daily for 5 days
The majority of patients were males (65%) and median subject age was 58 years (ranging from 19-86 years of age). The racial and ethnic distribution was White (60%), Asian (33%), Black (3%) and Other (3%).
The most common adverse reactions (those occurring in ≥3% of patients) in the DOPTELET-treated groups (60 mg or 40 mg) across the pooled data from the two trials are summarized in Table 5.
Table 5: Adverse Reactions with a Frequency ≥3% in Patients with Chronic Liver Disease Treated with DOPTELET – Pooled Data ADAPT-1 and ADAPT-2
| Adverse Reactions | Low Baseline Platelet Count Cohort (<40x109/L) |
High Baseline Platelet Count Cohort (≥40 to <50x109/L) |
Combined Baseline Platelet Count Cohorts (<50x109/L) |
|||
| DOPTELET 60 mg (N=159) % |
Placebo (N=91) % |
DOPTELET 40 mg (N=115) % |
Placebo (N=65) % |
Total DOPTELET (N=274) % |
Total Placebo (N=156) % |
|
| Pyrexia | 11 | 9 | 8 | 9 | 10 | 9 |
| Abdominal Pain | 6 | 7 | 7 | 6 | 7 | 6 |
| Nausea | 6 | 8 | 7 | 6 | 7 | 7 |
| Headache | 4 | 8 | 7 | 5 | 6 | 6 |
| Fatigue | 4 | 4 | 3 | 2 | 4 | 3 |
| Edema Peripheral | 3 | 2 | 4 | 2 | 3 | 2 |
For the Low Baseline Platelet Count Cohort, the incidence of serious adverse reactions was 7% (11/159) in the 60 mg DOPTELET treatment group. For the High Baseline Platelet Count Cohort, the incidence of serious adverse reactions was 8% (9/115) in the 40 mg DOPTELET treatment group. The most common serious adverse reaction reported with DOPTELET was hyponatremia. Two DOPTELET-treated patients (0.7%) developed hyponatremia.
Adverse reactions resulting in discontinuation of DOPTELET were anemia, pyrexia, and myalgia; each was reported in a single (0.4%) patient in the DOPTELET (60 mg) treatment group.
Patients With Chronic Immune Thrombocytopenia
The safety of DOPTELET was evaluated in four clinical trials in patients with chronic immune thrombocytopenia: two Phase 3 trials (one randomized, double-blind, placebo-controlled trial, and one randomized, double-blind, active-controlled trial) and two Phase 2 trials (one randomized, double-blind, placebo-controlled, dose-ranging, trial, and one open-label extension trial) in 161 patients with chronic immune thrombocytopenia in both the double-blind and open-label extension phases.
The pooled safety data from these four clinical trials includes 128 patients who received 2.5 to 40 mg of DOPTELET once daily for a median duration of exposure of 29.1 weeks and had 1 post-dose safety assessment. The majority of patients were female (63%) and median subject age was 50.5 years (ranging from 18-88 years of age). The racial and ethnic distribution was White (84%), Black (6%), Asian (6%) and Other (6%).
The most common adverse reactions (those occurring in ≥10% of patients) in the DOPTELET-treated patients across the pooled safety data from the four trials are summarized in Table 6.
Table 6: Adverse Reactions with a Frequency ≥10% in Patients with Chronic Immune Thrombocytopenia Treated with DOPTELET - Pooled Data from Clinical Trials
| Adverse Reactions | DOPTELET (N=128) % | Placebo (N= 22) % |
| Headache | 31 | 14 |
| Fatigue | 28 | 9 |
| Contusion | 26 | 18 |
| Epistaxis | 19 | 18 |
| Upper Respiratory Tract Infection | 15 | 5 |
| Arthralgia | 13 | 0 |
| Gingival Bleeding | 13 | 0 |
| Petechiae | 11 | 9 |
| Nasopharyngitis | 10 | 0 |
The incidence of serious adverse reactions was 9% (12/128) in the DOPTELET treatment group. Serious adverse reactions reported in more than 1 individual DOPTELET-treated patient included headache, occurring in 1.6% (2/128).
Adverse reactions resulting in discontinuation of DOPTELET that were reported in more than 1 patient included headache, occurring in 1.6% (2/128).
Postmarketing Experience
The following adverse reactions have been identified during post approval use of DOPTELET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders
Hypersensitivity reactions including pruritus, rash, choking sensation, erythema, pharyngeal edema, pruritus generalized, rash macular, swelling face, and swollen tongue.
DRUG INTERACTIONS
Effect Of Other Drugs On DOPTELET In Patients With Chronic Immune Thrombocytopenia
Moderate Or Strong Dual Inhibitors Of CYP2C9 And CYP3A4
Concomitant use with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4 increases avatrombopag AUC [see CLINICAL PHARMACOLOGY], which may increase the risk of DOPTELET toxicities. Reduce the starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4 (see Table 4) [see DOSAGE AND ADMINISTRATION].
In patients starting moderate or strong dual inhibitors of CYP2C9 and CYP3A4 while receiving DOPTELET, monitor platelet counts and adjust DOPTELET dose as necessary (see Table 3) [see DOSAGE AND ADMINISTRATION].
Moderate Or Strong Dual Inducers Of CYP2C9 And CYP3A4
Concomitant use with a moderate or strong dual inducer of CYP2C9 and CYP3A4 decreases avatrombopag AUC [see CLINICAL PHARMACOLOGY] which may reduce DOPTELET efficacy. Increase the recommended starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inducer of CYP2C9 and CYP3A4 (see Table 4) [see DOSAGE AND ADMINISTRATION].
In patients starting moderate or strong dual inducers of CYP2C9 and CYP3A4 while receiving DOPTELET, monitor platelet counts and adjust DOPTELET dose as necessary (see Table 3) [see DOSAGE AND ADMINISTRATION].
Patients with Chronic Liver Disease
No dosage adjustments are required for patients with chronic liver disease.
Read the entire FDA prescribing information for Doptelet (Avatrombopag Tablets)
&Copy; Doptelet Patient Information is supplied by Cerner Multum, Inc. and Doptelet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.