Zontivity

1 What is Zontivity?

Brand: Zontivity

Generic: Vorapaxar

Zontivity is used to lower risk of having blood clots in patients with a history of heart attack or with reduced blow flow in their legs.

This medicine is available only with your doctor's prescription. This product is available in the tablet dosage form.

2 What to Know Before Using

Before using Zontivity, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of vorapaxar in the pediatric population. Safety and efficacy have not been established.

Geriatric Population: Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vorapaxar in the elderly. However, elderly patients are more likely to have bleeding problems, which may require caution in patients receiving vorapaxar.

Pregnancy: All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Atazanavir
  • Boceprevir
  • Cobicistat
  • Delavirdine
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Nelfinavir
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Tipranavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Apixaban
  • Ardeparin
  • Argatroban
  • Bivalirudin
  • Carbamazepine
  • Certoparin
  • Clarithromycin
  • Conivaptan
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Edoxaban
  • Enoxaparin
  • Enzalutamide
  • Fondaparinux
  • Fosphenytoin
  • Heparin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Lepirudin
  • Mitotane
  • Nadroparin
  • Nefazodone
  • Parnaparin
  • Phenindione
  • Phenobarbital
  • Phenprocoumon
  • Phenytoin
  • Primidone
  • Protein C
  • Reviparin
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rivaroxaban
  • St John's Wort
  • Telithromycin
  • Tinzaparin
  • Vilazodone
  • Voriconazole
  • Warfarin

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding
  • Stroke
  • Transient ischemic attack, history of—Should not be used in patients with these conditions
  • Bleeding problems
  • Hypotension (low blood pressure) 
  • Kidney problems 
  • Liver problems 
  • Low body weight 
  • Medical procedures (eg, coronary angiography, percutaneous coronary intervention)
  • Surgery (eg, coronary artery bypass graft surgery [CABG]), recent—May increase risk for bleeding problems
  • Liver disease, severe—Use is not recommended in patients with this condition

3 Proper Usage

To use Zontivity properly, you must follow all instructions given by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food. You may take this medicine with aspirin or clopidogrel as prescribed by your doctor.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

To lower risk of blood clots:

  • Adults—2.08 milligrams (mg) once a day.
  • Children—Use and dose must be determined by your doctor.

Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

4 Precautions to Take

Before using Zontivity, there are some precautions you must take. It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly.

Blood tests may be needed to check for unwanted effects. This medicine may increase your risk of serious bleeding problems.

Call your doctor right away if you have bleeding that is severe or that you cannot control, coughing up blood, pink, red, or brown urine, red or black stools, or vomiting blood or material that looks like coffee grounds.

This medicine can cause you to bleed and bruise more easily. Take precautions to avoid injury. Brush and floss your teeth gently, do not play rough sports, and be careful with sharp objects.

Do not stop taking this medicine without checking first with your doctor. Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Zontivity. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common:

  • bloody or black, tarry stools
  • constipation
  • pale skin
  • severe stomach pain
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds

Rare:

  • confusion
  • a headache, sudden and severe
  • nausea and vomiting
  • weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common:

  • discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • rashes
  • trouble concentrating
  • trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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