AUDIENCE: Psychiatry, Internal Medicine, Pharmacy
ISSUE: FDA has approved a brand name change for the antidepressant vortioxetine (Brintellix) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine ticagrelor (Brilinta). The new brand name of the drug vortioxetine will be Trintellix, and it is expected to be available starting in June 2016. No other changes will be made to the label or packaging, and the medicine is exactly the same.
Because of the lag time associated with manufacturing bottles with the new brand name, health care professionals and patients may continue to see bottles of vortioxetine labeled with the brand name vortioxetine (Brintellix) during the transition period.
In a July 2015 MedWatch Alert (available at: http://1.usa.gov/1rtqoEq), FDA warned that name confusion between vortioxetine (Brintellix) and ticagrelor (Brilinta) had resulted in prescribing and dispensing errors since vortioxetine (Brintellix) was approved in September 2013. Due to continued reports of name confusion between the two medicines used for very different purposes, FDA worked with vortioxetine (Brintellix) manufacturer Takeda Pharmaceuticals to change the drug's brand name.
BACKGROUND: Vortioxetine (Brintellix/Trintellix) is used to treat a certain type of depression called major depressive disorder in adults. It is in a class of antidepressants called serotonin reuptake inhibitors (SSRIs) that work by affecting chemicals in the brain that may become unbalanced.
RECOMMENDATION: Health care professionals should check carefully to make sure they have prescribed or dispensed the correct medicine. During the transition to the new brand name change of vortioxetine from Brintellix to Trintellix, prescribers can reduce the risk of name confusion by including the generic name of the medication they are ordering, in addition to the brand name and indication for use. Patients should make sure they have received the correct medicine. Vortioxetine (Trintellix) tablets will look the same as the vortioxetine (Brintellix) tablets. Those having any questions or concerns should talk to their prescriber or pharmacist.
Individuals responsible for ordering and stocking the medicine should be aware that vortioxetine (Trintellix) will have a new National Drug Code (NDC) number. It is important for drug information content publishers and medication-related electronic system administrators to use the new brand name vortioxetine (Trintellix) and NDC number once Takeda makes vortioxetine available under the new name Trintellix.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Ticagrelor may cause serious or life-threatening bleeding. Tell your doctor if you currently have or have had a condition that causes you to bleed more easily than normal; if you have recently had surgery or been injured in any way; or if you have or have ever had a stomach ulcer; bleeding in your stomach, intestines, or brain; a stroke or mini-stroke; a condition that may cause bleeding in your intestines such as polyps (abnormal growths in the lining of the large intestine); or liver disease. Tell your doctor and pharmacist if you are taking medications that may cause bleeding including anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven); heparin; other medications to treat or prevent blood clots; or regular use of non-steroidal anti-inflammatory medications such as ibuprofen (Advil, Motrin) and naproxen (Aleve). Your doctor also will probably not prescribe ticagrelor if you are likely to need heart bypass surgery (a certain type of open heart surgery) right away. While you are taking ticagrelor, you will probably bruise and bleed more easily than usual or bleed for longer than usual and may be more likely to have nosebleeds. However, if you experience any of the following symptoms, call your doctor immediately: bleeding that is unexplained, severe, long-lasting, or uncontrollable; pink or brown urine; red or black, tarry stools; vomit that is bloody or that looks like coffee grounds; or coughing up blood or blood clots.
If you are having surgery, including dental surgery, or any type of medical procedure, tell your doctor or dentist that you are taking ticagrelor. Your doctor will probably tell you to stop taking ticagrelor at least 5 days before your surgery is scheduled.
Your doctor will probably tell you to take a low dose of aspirin (less than 100 mg) during your treatment, but taking higher doses of aspirin may prevent ticagrelor from working as it should. Many over-the-counter (OTC) medications contain aspirin, so be sure to read all labels carefully. Do not take additional aspirin or aspirin-containing products during your treatment with ticagrelor without talking to your doctor.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ticagrelor and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking ticagrelor.
Why is this medication prescribed?
Ticagrelor is used along with aspirin to prevent serious or life-threatening problems with the heart and blood vessels in people who have had a heart attack or severe chest pain. It is also used to prevent blood clots from forming in people with coronary stents (metal tubes surgically placed in clogged blood vessels to improve blood flow) who have had a heart attack or severe chest pain. Ticagrelor is in a class of medications called antiplatelet medications. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke.
How should this medicine be used?
Ticagrelor comes as a tablet to take by mouth. It is usually taken with or without food two times a day. Take ticagrelor at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ticagrelor exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
There is another medication with a name similar to the brand name for ticagrelor. You should be sure that you receive ticagrelor and not the similar medication each time you fill your prescription. Be sure that the prescription your doctor gives you is clear and easy to read. Talk to your pharmacist to be sure that you are given ticagrelor. If you think you were given the wrong medication, talk to your pharmacist. Do not take any medication unless you are certain it is the medication that your doctor prescribed.
If you are unable to swallow ticagrelor tablets, you may crush the tablet and mix it with water. Drink the mixture immediately, then refill the glass with water and stir and again drink the mixture immediately. If you have a nasogastric (NG) tube, your doctor or pharmacist will explain how to prepare ticagrelor to give through an NG tube.
Ticagrelor will help prevent serious problems with your heart and blood vessels only as long as you take the medication. Continue to take ticagrelor even if you feel well. Do not stop taking ticagrelor without talking to your doctor. If you stop taking ticagrelor, there is a higher risk that you may have a heart attack or stroke. If you have a stent, there is also a higher risk that you could develop a blood clot in the stent if you stop taking ticagrelor too soon.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking ticagrelor,
- tell your doctor and pharmacist if you are allergic to ticagrelor, any other medications, or any of the ingredients in ticagrelor tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antibiotics such as clarithromycin (Biaxin, in PrevPak) and telithromycin (Ketek); antifungal medications such as itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); cholesterol-lowering medications such as lovastatin (Altoprev, in Advicor) and simvastatin (Zocor, in Simcor, in Vytorin); digoxin (Lanoxin); medications for high blood pressure; medications for human immunodeficiency virus (HIV) such as atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak), and saquinavir (Invirase);medications for seizures such as carbamazepine (Carbatrol, Equetro, Tegretol, others), phenobarbital, and phenytoin (Dilantin); nefazodone; and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had any type of lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) or asthma.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking ticagrelor, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Ticagrelor may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- shortness of breath that occurs while you are at rest, after a small amount of exercise, or after any physical activity
- chest pain
- fast, slow, pounding, or irregular heartbeat
Ticagrelor may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include the following:
- irregular heartbeat
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ticagrelor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.