Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Birth control: Effective birth control should be practiced while using this medication as this medication may harm the baby if used during pregnancy. For women capable of becoming pregnant, effective birth control must be in place at least one month before starting this medication. Treatment should not begin until the second or third day of the next normal menstrual period. A negative pregnancy test result must be obtained within the 2 weeks before starting treatment.
Birth control should be continued for at least one month after stopping this medication.
Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.
If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.
Dizziness/reduced alertness: All-trans retinoic acid may affect the mental or physical abilities needed to drive or operate machinery, particularly if it is causing severe headache or dizziness. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.
Retinoic Acid Syndrome: This medication can cause a number of symptoms related to the over-production of white blood cells. Although this condition can be corrected if it is identified early, it can cause the failure of multiple organs in the body and become fatal if not treated appropriately. If you experience fever; shortness of breath; dizziness or fainting; swelling of the hands, feet and ankles; or sudden weight gain, contact your doctor immediately.
Pregnancy: All-trans retinoic acid is associated with a very high risk of birth defects if taken during pregnancy. Therefore, this medication should not be used during pregnancy, and effective birth control must be used. If you become pregnant while using this medication, contact your doctor immediately.
Breast-feeding: It is not known if all-trans retinoic acid passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. It is recommended that women not breast-feed while receiving all-trans retinoic acid treatment due to risk of harm to the infant.