WARNINGS
Before taking ATTRUBY, tell your healthcare provider about all your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if ATTRUBY will harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ATTRUBY. You may also report your pregnancy by calling the BridgeBio reporting line at 1-844-550-2246.
are breastfeeding or plan to breastfeed. It is not known if ATTRUBY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ATTRUBY.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
USES
What is ATTRUBY?
ATTRUBY is a prescription medicine used to treat adults with a disease that affects the heart muscle called cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM), to reduce death and hospitalization related to heart problems.
It is not known if ATTRUBY is safe and effective in children.
HOW TO USE
How should I take ATTRUBY?
Take ATTRUBY exactly as your healthcare provider tells you to.
Take ATTRUBY tablets by mouth 2 times a day, with or without food.
Swallow tablets whole. Do not cut, crush, or chew tablets.
What are the possible side effects of ATTRUBY?
The most common side effects of ATTRUBY were mild and include:
stomach-area (abdominal) pain
diarrhea
These are not all of the possible side effects of ATTRUBY.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ATTRUBY for a condition for which it was not prescribed. Do not give ATTRUBY to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ATTRUBY that is written for health professionals.
What are the ingredients in ATTRUBY?
Active ingredient: acoramidis Inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film coating and printing ink contain black iron oxide, glyceryl monocaprylocaprate, hypromellose, polyvinyl alcohol, propylene glycol, talc, titanium dioxide, and vinyl alcohol graft copolymer.
OVERDOSES
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
How should I store ATTRUBY?
• Store ATTRUBY tablets at room temperature between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C).
• Store in original blister card until use to protect from moisture.
Keep ATTRUBY and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 11/2024
Prescribing Information: revision date 11/2024
UDP-glucuronosyltransferases (UGT) Inducers and Strong CYP3A Inducers Acoramidis is metabolized by UGT enzyme-mediated glucuronidation. Concomitant use of UGT inducers can potentially decrease acoramidis exposure. While acoramidis is not metabolized by CYP3A, strong CYP3A inducers can also induce UGT enzymes. Avoid concomitant use of ATTRUBY with UGT inducers and strong CYP3A inducers.
Sensitive Cytochrome P450 2C9 (CYP2C9) substrates Acoramidis inhibits CYP2C9 and may result in an increase in CYP2C9 substrate concentrations when these drugs are co administered. Consider more frequent monitoring of patients for evidence of increased exposure (for example, signs of exposure related toxicity) when ATTRUBY is co administered with sensitive CYP2C9 substrates.
See WARNINGS above.
