For US adults only
HbC=hemoglobin C; HbE=hemoglobin E; HbH=hemoglobin H; HbS=hemoglobin S; NTDT=non–transfusion-dependent thalassemia; TDT=transfusion-dependent thalassemia.
*Included adverse reactions that occurred in at least 5% of patients in the AQVESME arm and at least 5% higher than the placebo arm.
†Insomnia (grouped preferred terms) includes: initial insomnia, middle insomnia, insomnia, and terminal insomnia.
There is a potential risk of liver injury with AQVESME.
In clinical studies:
Tell your healthcare provider right away if you develop any signs or symptoms of liver injury, including: yellowing of the skin or whites of the eyes, dark urine, pain in the upper right side of the stomach area, nausea, vomiting, or not feeling hungry.
Your healthcare provider may temporarily or permanently stop your treatments with AQVESME if you have abnormal liver blood test results.
AQVESME is only available through AQVESME REMS, a program designed to inform you of the potential risk of liver injury and to monitor your liver function. REMS programs are required by the Food and Drug Administration (FDA) for certain medicines to help manage the risk of serious side effects.
Your doctor will enroll you in AQVESME REMS to regularly monitor your liver function. They will provide you information about the potential risk of liver injury and about regular liver monitoring requirements. Blood tests will be done:
Your first 24 weeks taking AQVESME: Liver monitoring
*AQVESME is one pill taken twice daily.
Your doctor can help answer questions along the way. For more information about AQVESME REMS, visit AQVESMEREMS.com or call 1-800-625-9951.
AQVESME may cause serious side effects, including:
Liver injury. AQVESME can cause serious liver injury. Liver injury has happened in people with thalassemia within the first 6 months of treatment with AQVESME. Your healthcare provider will do blood tests to check your liver before you start treatment with AQVESME, every 4 weeks for the first 24 weeks of treatment, and as needed. Your healthcare provider may temporarily or permanently stop your treatment with AQVESME if you have abnormal liver blood tests.
Tell your healthcare provider right away if you develop any new or worsening signs or symptoms of liver problems, including:
In clinical studies of AQVESME, 2 of 301 people (0.66%) treated with AQVESME experienced adverse reactions suggestive of liver injury. Three additional people experienced adverse reactions suggestive of liver injury during the open-label extension periods, after switching from placebo to AQVESME. Of the 5 people, two had serious liver injury requiring hospitalization, including 1 who developed jaundice. Another developed jaundice without requiring hospitalization. All 5 people discontinued treatment with AQVESME, and these reactions improved upon treatment discontinuation.
Because of the risk for liver injury, AQVESME is only available through a restricted access program called the AQVESME Risk Evaluation and Mitigation Strategy (REMS).
Before taking AQVESME, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure to tell your healthcare provider if you take or use hormonal birth control (contraceptives). If you take or use hormonal birth control (except for intrauterine systems containing levonorgestrel), it may not work as well during treatment with AQVESME. Use a different type of birth control or use an additional nonhormonal birth control method (such as condoms) during treatment with AQVESME and for 28 days after stopping treatment with AQVESME. AQVESME and certain other medicines may affect each other and cause side effects. AQVESME may affect the way other medicines work, and other medicines may affect the way AQVESME works.
The most common side effects of AQVESME in patients:
These are not all of the possible side effects of AQVESME. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
AQVESME is a prescription medicine used to treat anemia (low red blood cells) in adults with alpha- or beta-thalassemia. It is not known if AQVESME is safe and effective in children.
Please see full Prescribing Information, including Medication Guide.
AQVESME may cause serious side effects, including:
Liver injury. AQVESME can cause serious liver injury. Liver injury has happened in people with thalassemia within the first 6 months of treatment with AQVESME. Your healthcare provider will do blood tests to check your liver before you start treatment with AQVESME, every 4 weeks for the first 24 weeks of treatment, and as needed. Your healthcare provider may temporarily or permanently stop your treatment with AQVESME if you have abnormal liver blood tests.
Tell your healthcare provider right away if you develop any new or worsening signs or symptoms of liver problems, including:
In clinical studies of AQVESME, 2 of 301 people (0.66%) treated with AQVESME experienced adverse reactions suggestive of liver injury. Three additional people experienced adverse reactions suggestive of liver injury during the open-label extension periods, after switching from placebo to AQVESME. Of the 5 people, two had serious liver injury requiring hospitalization, including 1 who developed jaundice. Another developed jaundice without requiring hospitalization. All 5 people discontinued treatment with AQVESME, and these reactions improved upon treatment discontinuation.
Because of the risk for liver injury, AQVESME is only available through a restricted access program called the AQVESME Risk Evaluation and Mitigation Strategy (REMS).
Before taking AQVESME, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure to tell your healthcare provider if you take or use hormonal birth control (contraceptives). If you take or use hormonal birth control (except for intrauterine systems containing levonorgestrel), it may not work as well during treatment with AQVESME. Use a different type of birth control or use an additional nonhormonal birth control method (such as condoms) during treatment with AQVESME and for 28 days after stopping treatment with AQVESME. AQVESME and certain other medicines may affect each other and cause side effects. AQVESME may affect the way other medicines work, and other medicines may affect the way AQVESME works.
The most common side effects of AQVESME in patients:
These are not all of the possible side effects of AQVESME. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
AQVESME is a prescription medicine used to treat anemia (low red blood cells) in adults with alpha- or beta-thalassemia. It is not known if AQVESME is safe and effective in children.
Please see full Prescribing Information, including Medication Guide.