"June 10, 2015 -- A new class of medications can lower "bad" LDL cholesterol to unheard-of levels, and it may be on the horizon.
The new class is called PCSK9 inhibitors. An FDA advisory panel on Tuesday recommended that the agency approve t"...
(omega-3-acid ethyl esters) Capsules, USP
Read this Patient Information before you start taking OMTRYG, and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is OMTRYG?
OMTRYG is a prescription medicine used along with a low fat and low cholesterol diet to lower very high triglyceride (fat) levels in adults.
It is not known if OMTRYG changes your risk of having inflammation of your pancreas (pancreatitis).
It is not known if OMTRYG is safe and effective in children.
Who should not take OMTRYG?
Do not take OMTRYG if you are allergic to omega-3-acid ethyl esters or any of the ingredients in OMTRYG. See the end of this leaflet for a complete list of ingredients in OMTRYG.
What should I tell my doctor before taking OMTRYG?
Before you take OMTRYG, tell your doctor if you:
- have diabetes
- have a low thyroid problem (hypothyroidism)
- have a liver problem
- have a pancreas problem
- have a certain heart rhythm problem called atrial fibrillation or flutter
- are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to OMTRYG.
- are pregnant or plan to become pregnant. It is not known if OMTRYG will harm your unborn baby.
- are breastfeeding or plan to breastfeed. OMTRYG can pass into your breastmilk. You and your doctor should decide if you will take OMTRYG or breastfeed.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicine, vitamins, and herbal supplements.
OMTRYG can interact with certain other medicines that you are taking. Using OMTRYG with medicines that affect blood clotting (anticoagulants or blood thinners) may cause serious side effects.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take OMTRYG?
- Take OMTRYG exactly as your doctor tells you to take it.
- You should not take more than 4 capsules of OMTRYG each day. Either take all 4 capsules at one time, or 2 capsules two times a day.
- Do not change your dose or stop OMTRYG without talking to your doctor.
- Take OMTRYG with meals.
- Take OMTRYG capsules whole. Do not break, crush, dissolve, or chew OMTRYG capsules before swallowing. If you cannot swallow OMTRYG capsules whole, tell your doctor. You may need a different medicine.
- Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars before giving you OMTRYG. Stay on this diet while you take OMTRYG.
- Your doctor should do blood tests to check your triglyceride, bad cholesterol and liver function levels while you take OMTRYG.
What are the possible side effects of OMTRYG?
OMTRYG may cause serious side effects, including:
- increases in the results of blood tests used to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C).
- increases in the frequency of a heart rhythm problem (atrial fibrillation or flutter) may especially happen in the first few months of taking OMTRYG if you already have that problem.
The most common side effects of OMTRYG include:
- upset stomach
- a change in your sense of taste
Talk to your doctor if you have a side effect that bothers you or does not go away.
These are not all the possible side effects of OMTRYG. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800-FDA-1088.
How should I store OMTRYG?
- Store OMTRYG at room temperature between 68°F to 77°F (20°C to 25°C).
- Do not freeze OMTRYG.
- Safely throw away medicine that is out of date or no longer needed.
Keep OMTRYG and all medicines out of the reach of children.
General information about the safe and effective use of OMTRYG
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use OMTRYG for a condition for which it was not prescribed. Do not give OMTRYG to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information Leaflet summarizes the most important information about OMTRYG. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about OMTRYG that is written for health professionals.
For more information go to http://www.OMTRYG.com or call 1-855-3-OMTRYG (1-855-366-8794).
What are the ingredients in OMTRYG?
Inactive Ingredients: alpha-tocopherol (in sunflower oil), gelatin, glycerol, purified water
This patient labeling has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 4/4/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Omtryg Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Tips to keep it under control.