Brand Name

    US Brand Name

    Agrylin


    Description

    Anagrelide is used to decrease the risk of blood clots in patients who have thrombocythemia (too many platelets in the blood). It works to decrease the production of platelets in the body.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Capsule

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of anagrelide in children 7 years of age and older. Safety and efficacy have been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anagrelide in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

    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.

    • Abrocitinib
    • Bepridil
    • Cisapride
    • Defibrotide
    • Dronedarone
    • Levoketoconazole
    • Mesoridazine
    • Pimozide
    • Piperaquine
    • Saquinavir
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • Ziprasidone

    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.

    • Abciximab
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Adagrasib
    • Alfuzosin
    • Alipogene Tiparvovec
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Amtolmetin Guacil
    • Apixaban
    • Apomorphine
    • Ardeparin
    • Argatroban
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Arsenic Trioxide
    • Asenapine
    • Aspirin
    • Astemizole
    • Atazanavir
    • Azithromycin
    • Balofloxacin
    • Bedaquiline
    • Bemiparin
    • Besifloxacin
    • Betrixaban
    • Bivalirudin
    • Bromfenac
    • Bufexamac
    • Buprenorphine
    • Buserelin
    • Caplacizumab-yhdp
    • Celecoxib
    • Ceritinib
    • Certoparin
    • Chloroquine
    • Chlorpromazine
    • Choline Salicylate

    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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • 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 problems or
    • Congestive heart failure, history of or
    • Heart disease, history of or
    • Heart rhythm problems (eg, congenital long QT syndrome, QT prolongation) or
    • Hypokalemia (low potassium in the blood) or
    • Hypotension (low blood pressure) or
    • Kidney disease or
    • Lung disease (eg, interstitial lung disease), history of—Use with caution. May make these conditions worse.
    • Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
    • Liver disease, severe—Should not be used in patients with this condition.

    Proper Use

    Take this medicine exactly as directed 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 for side effects.

    You may take this medicine with or without food.

    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 (capsules):
      • For thrombocythemia:
        • Adults—At first, 0.5 milligram (mg) 4 times a day or 1 mg 2 times a day for at least 1 week. Your doctor may adjust your dose as needed.
        • Children 7 years of age and older—At first, 0.5 mg per day. Your doctor may adjust your dose as needed.
        • Children younger than 7 years of age—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.


    Precautions

    It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects. You will also need to have an ECG test (electrocardiogram) to check your heart rhythm.

    This medicine may cause unwanted effects on the heart. Check with your doctor right away if you or your child have chest pain, tightness, or discomfort, decreased urine output, dilated neck veins, extreme fatigue, a fast, pounding, or uneven heartbeat or pulse, pain or discomfort in the arms, jaw, back or neck, nausea or vomiting, sweating, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These could be symptoms of a serious heart problem.

    This medicine may also increase your risk of bleeding. Check with your doctor immediately if you or your child notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

    Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

    This medicine may cause lung problems, including interstitial lung disease or pulmonary hypertension (high blood pressure in the lungs). These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms of lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

    Do not stop using this medicine suddenly without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely. To do so will cause the platelet level in your blood to increase quickly.

    If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

    Do not take aspirin or aspirin-containing products since they may also affect your platelets. Do not take any other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. 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:

    More common

    • Bloating or swelling of the face, arms, hands, lower legs, or feet
    • body aches or pain
    • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • chest pain
    • congestion
    • cough
    • difficult or labored breathing
    • dryness or soreness of the throat
    • fast, irregular, pounding, or racing heartbeat or pulse
    • fever
    • hoarseness
    • rapid weight gain
    • runny nose
    • tender, swollen glands in the neck
    • tightness in the chest
    • trouble with swallowing
    • voice changes

    Less common

    • Anxiety
    • blurred vision
    • burning feeling while urinating
    • chills
    • cold sweats
    • confusion
    • decreased urine output
    • dehydration
    • difficult or painful urination
    • dilated neck veins
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • extreme tiredness or weakness
    • general feeling of discomfort or illness
    • headache
    • irregular breathing
    • joint pain
    • large, flat, blue, or purplish patches on the skin
    • loss of appetite
    • muscle aches and pains
    • nausea
    • noisy breathing
    • pale skin
    • redness of the face, neck, arms, and occasionally, upper chest
    • severe pain or pressure in the chest or the jaw, neck, back, or arms
    • sudden severe headache or weakness
    • swollen, painful, or tender lymph glands in the neck, armpit, or groin
    • trouble sleeping
    • troubled breathing with exertion
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting
    • vomiting of blood or material that looks like coffee grounds
    • weight gain

    Incidence not known

    • Clay-colored stools
    • dark urine
    • decreased appetite
    • dry cough
    • general feeling of tiredness or weakness
    • rapid breathing
    • skin rash or itching
    • stomach pain or tenderness
    • yellow eyes or skin

    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:

    More common

    • Back pain
    • belching
    • diarrhea
    • excess air or gas in the stomach or bowels
    • full feeling
    • heartburn
    • hives or welts
    • indigestion
    • lack or loss of strength
    • pain
    • passing gas
    • stomach discomfort, upset, or pain

    Less common

    • Burning feeling in the chest or stomach
    • change in vision
    • constipation
    • continuing ringing or buzzing or other unexplained noise in the ears
    • depression
    • difficulty with moving
    • double vision
    • hair loss or thinning of the hair
    • hearing loss
    • impaired vision
    • increased sensitivity of the skin to sunlight
    • leg cramps
    • loss of memory
    • muscle pain or stiffness
    • problems with memory
    • redness or other discoloration of the skin
    • seeing double
    • severe sunburn
    • sleepiness or unusual drowsiness
    • stuffy nose
    • swelling or inflammation of the mouth
    • swollen joints

    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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