Agrylin
- Generic Name: anagrelide
- Brand Name: Agrylin
Agrylin (Anagrelide) side effects drug center
Agrylin Side Effects Center
What Is Agrylin?
Agrylin (anagrelide hydrochloride) is a platelet-reducing agent used to treat thrombocythemia (also called thrombocytosis), a blood cell disorder in which too many platelet cells are produced, causing bleeding or blood-clotting problems. Agrylin is available in generic form.
What Are Side Effects of Agrylin?
Common side effects of Agrylin include:
- headache,
- diarrhea,
- constipation,
- weakness,
- stomach pain,
- upset stomach,
- gas,
- nausea,
- vomiting,
- loss of appetite,
- dizziness,
- rash or itching,
- runny or stuffy nose,
- sore throat,
- numbness or tingly feeling,
- back pain,
- vision problems, or
- ringing in your ears.
Tell your doctor if you have serious side effects of Agrylin including:
- unusual bleeding or bruising,
- black stools,
- swelling of the ankles or feet,
- rapid or difficult breathing,
- stomach or abdominal pain,
- unusual tiredness,
- a change in the amount of urine,
- pink or bloody urine, or
- vomit that looks like coffee grounds.
Dosage for Agrylin
The recommended adult starting dosage of Agrylin is 0.5 mg four times daily or 1 mg twice daily (2 capsules of 0.5 mg twice a day), for at least one week. Starting doses in pediatric patients range from 0.5 mg per day to 0.5 mg four times daily.
What Drugs, Substances, or Supplements Interact with Agrylin?
Agrylin may interact with:
- fluvoxamine,
- theophylline,
- birth control pills, or
- medications to treat congestive heart failure
Tell your doctor all medications you use.
Agrylin During Pregnancy and Breastfeeding
Agrylin is not recommended for use during pregnancy because of possible harm to a fetus. If you become pregnant or think you may be pregnant, inform your doctor. Consult your doctor about birth control. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Additional Information
Our Agrylin (anagrelide hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Agrylin Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- easy bruising or bleeding (nosebleeds, bleeding gums);
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- chest pain or pressure;
- fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);
- shortness of breath;
- swelling in your lower legs; or
- blue colored lips or skin.
Common side effects may include:
- fast heartbeats, chest pain, breathing problems;
- numbness, tingling, burning pain;
- headache, weakness, dizziness;
- stomach pain, gas, indigestion, loss of appetite;
- nausea, vomiting, diarrhea;
- swelling in your hands or feet;
- fever, cough, not feeling well;
- back pain; or
- rash, itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Agrylin (Anagrelide)
Agrylin Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Toxicity [see WARNINGS AND PRECAUTIONS]
- Pulmonary Hypertension [see WARNINGS AND PRECAUTIONS]
- Bleeding Risk [see WARNINGS AND PRECAUTIONS]
- Pulmonary Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Studies In Adult Patients
In three single-arm clinical studies, 942 patients [see Clinical Trials] diagnosed with myeloproliferative neoplasms of varying etiology (ET: 551; PV: 117; OMPN: 274) were exposed to AGRYLIN with a mean duration of approximately 65 weeks. Serious adverse reactions reported in these patients included the following: congestive heart failure, myocardial infarction, cardiomyopathy, cardiomegaly, complete heart block, atrial fibrillation, cerebrovascular accident, pericardial effusion [see WARNINGS AND PRECAUTIONS], pleural effusion, pulmonary infiltrates, pulmonary fibrosis, pulmonary hypertension, and pancreatitis. Of the 942 patients treated with AGRYLIN, 161 (17%) were discontinued from the study because of adverse reactions or abnormal laboratory test results. The most common adverse reactions resulting in treatment discontinuation were headache, diarrhea, edema, palpitations, and abdominal pain.
The most frequently reported adverse reactions to AGRYLIN (in 5% or greater of 942 patients with myeloproliferative neoplasms) in clinical trials were listed in Table 1.
Table 1 : Adverse Reactions Reported in Clinical Studies of AGRYLIN in at least 5% of Patients
| Adverse Reactions | AGRYLIN (N=942) (%) |
| Cardiac disorders | |
| Palpitations | 26% |
| Tachycardia | 8% |
| Chest pain | 8% |
| General disorders and administration siteconditions | |
| Asthenia | 23% |
| Edema | 21% |
| Pain | 15% |
| Fever | 9% |
| Peripheral edema | 9% |
| Malaise | 6% |
| Gastrointestinal disorders | |
| Diarrhea | 26% |
| Nausea | 17% |
| Abdominal pain | 16% |
| Vomiting | 10% |
| Flatulence | 10% |
| Anorexia | 8% |
| Dyspepsia | 5% |
| Respiratory, thoracic and mediastinal disorders | |
| Dyspnea | 12% |
| Cough | 6% |
| Skin and subcutaneous tissue disorders | |
| Rash | 8% |
| Pruritus | 6% |
| Musculoskeletal and connective tissue disorders | |
| Back pain | 6% |
| Nervous system disorders | |
| Headache | 44% |
| Dizziness | 15% |
| Paresthesia | 6% |
Adverse Reactions (frequency 1% to <5%) Included
General disorders and administration site conditions: Flu symptoms, chills.
Cardiac disorders: Arrhythmia, angina pectoris, heart failure, syncope.
Vascular disorders: Hemorrhage, hypertension, postural hypotension, vasodilatation.
Gastrointestinal disorders: Constipation, gastrointestinal hemorrhage, gastritis.
Blood and lymphatic system disorders: Anemia, thrombocytopenia, ecchymosis.
Hepatobiliary disorders: Elevated liver enzymes.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Psychiatric disorders: Depression, confusion, nervousness.
Nervous system disorders: Somnolence, insomnia, amnesia, migraine headache.
Respiratory, thoracic and mediastinal disorders: Epistaxis, pneumonia.
Skin and subcutaneous tissue disorders: Alopecia.
Eye disorders: Abnormal vision, diplopia.
Ear and labyrinth disorders: Tinnitus.
Renal and urinary disorders: Hematuria, renal failure.
Other Less Frequent Adverse Reactions (<1%) Were
Cardiac disorders: Ventricular tachycardia, supraventricular tachycardia.
Nervous system disorders: Hypoesthesia.
Clinical Study In Pediatric Patients
The frequency of adverse reactions observed in pediatric patients was similar to adult patients. The most common adverse reactions observed in pediatric patients were fever, epistaxis, headache, and fatigue during the 3-month AGRYLIN treatment in the study. Episodes of increased pulse and decreased systolic or diastolic blood pressure beyond the normal ranges in the absence of clinical symptoms were observed. Other adverse reactions reported in these pediatric patients receiving AGRYLIN treatment were palpitations, headache, nausea, vomiting, abdominal pain, back pain, anorexia, fatigue, and muscle cramps.
Postmarketing Experience
The following adverse reactions have been identified during post-marketing use of AGRYLIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac disorders: Prinzmetal angina, Torsades de pointes.
Respiratory, thoracic and mediastinal disorders: Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia, and interstitial pneumonitis) [see WARNINGS AND PRECAUTIONS].
Renal and urinary disorders: Tubulointerstitial nephritis.
Hepatobiliary disorders: Clinically significant hepatotoxicity (including symptomatic ALT and AST elevations and elevations greater than three times the ULN).
Other adverse reactions in pediatric patients reported in spontaneous reports and literature reviews include:
Blood and lymphatic system disorders: Anemia.
Skin and subcutaneous tissue disorders: Cutaneous photosensitivity.
Investigations: Elevated leukocyte count.
DRUG INTERACTIONS
Drugs That Prolong QT
Avoid use of AGRYLIN in patients taking medications that may prolong QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
PDE3 Inhibitors
AGRYLIN is a phosphodiesterase 3 (PDE3) inhibitor. Avoid use of drug products with similar properties such as inotropes and other PDE3 inhibitors (e.g., cilostazol, milrinone) [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Aspirin And Drugs That Increase Bleeding Risk
Co-administration of single-dose or repeat-dose AGRYLIN and aspirin showed greater ex vivo anti-platelet aggregation effects than administration of aspirin alone [see CLINICAL PHARMACOLOGY]. Results from an observational study in patients with essential thrombocythemia suggest the rate of major hemorrhagic events (MHEs) in patients treated with AGRYLIN is higher than in those subjects treated with another cytoreductive treatment. The majority of the major hemorrhagic events occurred in patients who were also receiving concomitant anti-aggregatory treatment (primarily, aspirin). Therefore, the potential risks of the concomitant use of AGRYLIN with aspirin should be assessed, particularly in patients with a high-risk profile for hemorrhage, before treatment is initiated [see WARNINGS AND PRECAUTIONS].
Monitor patients for bleeding, particularly those receiving concomitant therapy with other drugs known to cause bleeding (e.g., anticoagulants, PDE3 inhibitors, NSAIDs, antiplatelet agents, selective serotonin reuptake inhibitors).
CYP450 Interactions
CYP1A2 Inhibitors
AGRYLIN and its active metabolite are primarily metabolized by CYP1A2. Drugs that inhibit CYP1A2 (e.g., fluvoxamine, ciprofloxacin) could increase the exposure of AGRYLIN. Monitor patients for cardiovascular events and titrate doses accordingly when CYP1A2 inhibitors are co-administered.
CYP1A2 Inducers
CYP1A2 inducers could decrease the exposure of AGRYLIN. Patients taking concomitant CYP1A2 inducers (e.g., omeprazole) may need to have their dose titrated to compensate for the decrease in AGRYLIN exposure.
CYP1A2 Substrates
AGRYLIN demonstrates limited inhibitory activity towards CYP1A2 in vitro and may alter the exposure of concomitant CYP1A2 substrates (e.g., theophylline, fluvoxamine, ondansetron).
Read the entire FDA prescribing information for Agrylin (Anagrelide)
© Agrylin Patient Information is supplied by Cerner Multum, Inc. and Agrylin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.