A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Vyndaqel affects a protein called transthyretin (TTR, made primarily in the liver). Transthyretin-mediated amyloidosis (ATTR) is a condition in which abnormal deposits of TTR protein build-up in many parts of the body, interfering with normal function. A build-up of TTR in the heart can lead to heart failure. People with hereditary ATTR amyloidosis have a DNA mutation that can be passed from one generation to the next. People with wild-type ATTR amyloidosis do not have abnormal DNA and cannot pass on the condition. Vyndaqel is used in adults with hereditary or wild type ATTR to treat cardiomyopathy (damage of the heart muscle) caused by a build-up of TTR. Vyndaqel may also be used for purposes not listed in this medication guide.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Vyndaqel and Vyndamax are not equivalent medicines and may not have the same dosing schedule. Take either Vyndaqel or Vyndamax exactly as your doctor has recommended. Avoid medication errors by using only the form and strength your doctor prescribes. Swallow the capsule whole and do not crush, chew, break, or open it. You may take Vyndaqel with or without food. Store at room temperature away from moisture and heat. Keep each capsule in the blister pack until you are ready to take a dose.
The active ingredient in Vyndaqel is tafamidis meglumine.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Less serious side effects may be more likely, and you may have none at all. 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.