Anagrelide

Name: Anagrelide

Anagrelide Drug Class

Anagrelide is part of the drug class:

  • OTHER ANTINEOPLASTIC AGENTS

Side Effects of Anagrelide

Common side effects of anagrelide include the following:

  • headache
  • irregular heart beats
  • diarrhea
  • weakness
  • nausea
  • dizziness
  • body swelling
  • stomach pain
  • difficulty breathing
  • flatulence
  • vomiting

This is not a complete list of anagrelide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Serious side effects have been reported with anagrelide.

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

What should I discuss with my healthcare provider before taking anagrelide?

You should not use anagrelide if you are allergic to it.

To make sure anagrelide is safe for you, tell your doctor if you have:

  • liver disease;

  • personal or family history of long QT syndrome;

  • heart disease or congestive heart failure;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • bleeding or blood clotting disorder such as hemophilia;

  • kidney disease; or

  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether anagrelide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using anagrelide.

Anagrelide side effects

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:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats, fluttering in your chest;

  • sudden breathing problems, wheezing, dry cough or hack;

  • shortness of breath with mild exertion, swelling, rapid weight gain;

  • easy bruising or bleeding (nosebleeds, bleeding gums);

  • chest pain spreading to your jaw or shoulder, with sweating or general ill feeling;

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or

  • severe pain in your upper stomach spreading to your back, with nausea or vomiting.

Common side effects may include:

  • headache, weakness, dizziness;

  • flushing (warmth, redness, or tingly feeling);

  • stomach pain, gas, indigestion, loss of appetite;

  • nausea, vomiting, diarrhea;

  • swelling in your hands or feet;

  • fever, cough;

  • 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.

Uses For anagrelide

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 production of platelets in the body.

anagrelide is available only with your doctor's prescription.

What do I need to tell my doctor BEFORE I take Anagrelide?

  • If you have an allergy to anagrelide or any other part of anagrelide.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Liver disease or low potassium levels.
  • If you have ever had a long QT on ECG or other heartbeat that is not normal.
  • If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take anagrelide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Very bad dizziness or passing out.
  • Very bad headache.
  • Feeling very tired or weak.
  • Change in eyesight.
  • Not able to pass urine or change in how much urine is passed.
  • Low mood (depression).
  • Feeling confused.
  • Memory problems or loss.
  • A burning, numbness, or tingling feeling that is not normal.
  • Seizures.

How do I store and/or throw out Anagrelide?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a two year rat carcinogenicity study a higher incidence of uterine adenocarcinoma, relative to controls, was observed in females receiving 30 mg/kg/day (at least 174 times human AUC exposure after a 1 mg twice daily dose). Adrenal phaeochromocytomas were increased relative to controls in males receiving 3 mg/kg/day and above, and in females receiving 10 mg/kg/day and above (at least 10 and 18 times respectively human AUC exposure after a 1 mg twice daily dose).

Anagrelide hydrochloride was not mutagenic in the bacterial mutagenesis (Ames) assay or the mouse lymphoma cell (L5178Y, TK+/-) forward mutation assay, and was not clastogenic in the in vitro chromosome aberration assay using human lymphocytes or the in vivo mouse micronucleus test.

Anagrelide hydrochloride at oral doses up to 240 mg/kg/day (233 times the recommended human dose of 10 mg/day based on body surface area) had no effect on fertility and reproductive function of male rats. However, in fertility studies in female rats, oral doses of 30 mg/kg/day (29 times the recommended maximum human dose based on body surface area) or higher resulted in increased pre- and post-implantation loss and a decrease in the number of live embryos.

Animal Toxicology and/or Pharmacology

In the 2-year rat study, a significant increase in non-neoplastic lesions was observed in Anagrelide treated males and females in the adrenal (medullary hyperplasia), heart (myocardial hypertrophy and chamber distension), kidney (hydronephrosis, tubular dilation and urothelial hyperplasia) and bone (femur enostosis). Vascular effects were observed in tissues of the pancreas (arteritis/periarteritis, intimal proliferation and medial hypertrophy), kidney (arteritis/periarteritis, intimal proliferation and medial hypertrophy), sciatic nerve (vascular mineralization), and testes (tubular atrophy and vascular infarct) in Anagrelide treated males.

How Supplied/Storage and Handling

Anagrelide capsules, USP 0.5 mg are Size '4', hard gelatin capsule having grey opaque cap and white opaque body, imprinted '1453' on cap and '0.5 mg' on body with black ink containing white to off-white powder.

Bottles of 30                                                      NDC 13668-453-30

Bottles of 100                                                    NDC 13668-453-01

Carton of 100 capsules (10 x 10 unit-dose)      NDC 13668-453-74

Anagrelide capsules, USP 1 mg are Size '3', hard gelatin capsule having White opaque cap and White opaque body, imprinted '1462' on cap and '1 mg' on body with black ink containing white to off-white powder.

Bottles of 30                                                      NDC 13668-462-30

Bottles of 100                                                    NDC 13668-462-01

Carton of 100 capsules (10 x 10 unit-dose)      NDC 13668-462-74

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Index Terms

  • Anagrelide Hydrochloride
  • BL4162A

Special Populations Hepatic Function Impairment

AUC increased 8-fold with moderate hepatic function impairment.

Monitoring Parameters

Platelet count (every 2 days during the first week of treatment and at least weekly until the maintenance dose is reached; continue to monitor after cessation of treatment); CBC with differential (monitor closely during first 2 weeks of treatment), liver function (ALT and AST; baseline and during treatment), BUN, and serum creatinine (monitor closely during first weeks of treatment); serum electrolytes; blood pressure; heart rate; cardiovascular exam, including ECG (pretreatment; monitor during therapy); signs/symptoms of interstitial lung disease; monitor for thrombosis or bleeding

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, flatulence, diarrhea, or abdominal pain. Have patient report immediately to prescriber signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), angina, tachycardia, abnormal heartbeat, shortness of breath, excessive weight gain, swelling of arms or legs, severe dizziness, passing out, severe headache, severe loss of strength and energy, vision changes, urinary retention, change in amount of urine passed, depression, confusion, memory impairment, seizures, or burning or numbness feeling (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Liver Dose Adjustments

Use of anagrelide in patients with severe hepatic impairment is contraindicated. Patients with moderate hepatic impairment should receive a starting dose of 0.5 mg/day and be maintained at that dose for a minimum of 1 week (careful monitoring of cardiovascular effects should be instituted during this time). Incremental increases should not exceed more than 0.5 mg/day in any 1 week.

Precautions

-Anagrelide has not been studied in pediatric patients less than 7 years of age.
-Consult WARNINGS section for additional precautions.

Dialysis

Data not available

(web3)