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Anagrelide 1 mg Capsule, 60-count — NDC 62135-0313-60 package photo
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Anagrelide 1 mg Capsule, 60-count — NDC 62135-313-60 (Billing 62135-0313-60)

by Chartwell RX, LLC · 60 CAPSULE in 1 BOTTLE

This is a package of 60 capsules of Anagrelide 1 mg Capsule from Chartwell RX, LLC, marketed since Apr 2005 and currently FDA-listed; retail pharmacies pay about $1.41 per capsule (NADAC). It is this product's only package size.

NDC 62135-0313-60
🏷️ FDA NDC (as labeled) 62135-313-60 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-313-60
Product NDC 62135-313
11-digit billing NDC 62135031360
NCPDP billing unit EA — each (per item)
RxCUI 597850, 597852
UNII VNS4435G39
UPC 0362135312121, 0362135313609
Application # ANDA076683
SPL Set ID e031dfb3-56e1-4fea-95f2-c2936e2057a0
Established class (EPC) Platelet-reducing Agent
Mechanism of action Phosphodiesterase 3 Inhibitors
Physiologic effect Decreased Platelet Production
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-04-18
Route ORAL
Dosage form CAPSULE
Substance ANAGRELIDE HYDROCHLORIDE ANHYDROUS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 85156010100130
GCN Seq No 036863
GCN 22392
HICL code 012902
Ingredient (HICL) Anagrelide Hcl
HIC1 code N
Therapeutic class — broad (HIC1) Bone Marrow
HIC2 code N1
Therapeutic class — intermediate (HIC2) Affecting Blood, Non-Iron Hematinics And Others
HIC3 code N1D
Therapeutic class — specific (HIC3) Platelet Reducing Agents
AHFS code 20:12.14.00
AHFS class Platelet-Reducing Agents
FDB label name ANAGRELIDE HCL 1 MG CAPSULE
FDB brand name Anagrelide Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 036863
  • GCN: 22392
  • GPI-14 (Medi-Span): 85156010100130
  • HICL (First Databank): 012902
  • AHFS class code: 20:12.14.00
  • RxCUI (RxNorm): 597850
Why two NDCs? The FDA registers this code as 62135-313-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62135-0313-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Platelet-reducing Agent class.

Pharmacologic class Platelet-reducing Agent
Drug family (ATC) Other antineoplastic agents
How it works Phosphodiesterase 3 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ANAGRELIDE HCL 1 MG CAPSULE Ingredient Anagrelide Hcl
📗 Our plain-language guide HelloPharmacist
  • Anagrelide is bringing down a platelet count that's dangerously high because of a bone marrow disorder. When you have too many platelets, your blood can form clots too easily — whi...
  • What exactly is this medication doing for me?
  • You can take anagrelide capsules with or without food — there's no strict requirement. Food does slow down how quickly the medication is absorbed, but it doesn't meaningfully chang...
  • Can I take this with food, or does it need to be on an empty stomach?
📖 Read our full Anagrelide guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $1.413 $84.79 / 60 capsules
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.09 $65.18 / 60 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $1.564 $1.413
▼ Down 4% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62135-0313-60 You're viewing this Main listing 60 CAPSULE in 1 BOTTLE 2024-02-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
anagrelide 1 mg 13668-0462-01 Torrent 100 capsules $1.413 AB Availability likely —
Anagrelide 1 mgthis 62135-0313-60 Chartwell 60 capsules $1.413 — Availability likely —
Anagrelide 1 mg 70954-0881-10 ANI 100 capsules $1.413 AB Availability likely —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2005
On the market since
Apr 2005
📍
2026
Currently FDA-listed
21 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA076683 (ANDA)
Labeler code62135
First marketedApr 2005
Product typeHuman Prescription Drug
Portfolio521 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 words ▾

1 INDICATIONS AND USAGE Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. Anagrelide is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • The starting dose for adults is 0.5 mg four times a day or 1 mg twice a day. ( 2.1 ) • The starting dose for pediatric patients is 0.5 mg per day. ( 2.1 ) • Maintain the starting dose for at least one week and then titrate to maintain target platelet counts.

( 2.2 ) • Do not exceed a dose increment of 0.5 mg/day in any one week. Do not exceed 10 mg/day or 2.5 mg in a single dose. ( 2.2 ) • Moderate hepatic impairment: Start with 0.5 mg per day.

( 2.3 )

2.1Recommended Starting Dosage Adults: The recommended starting dosage of anagrelide capsules is 0.5 mg four times daily or 1 mg twice daily. Pediatric Patients: The recommended starting dosage of anagrelide capsule is 0.5 mg daily.

2.2Dose Titration Based Upon Platelet Response Continue the starting dose for at least one week and then titrate to reduce and maintain the platelet count below 600,000/μL, and ideally between 150,000/μL and 400,000/μL. The dose increment should not exceed 0.5 mg/day in any one week. Dosage should not exceed 10 mg/day or 2.5 mg in a single dose.

Most patients will experience an adequate response at a dose of 1.5 to 3.0 mg/day. Monitor platelet counts weekly during titration then monthly or as necessary.

2.3Dose Modifications for Hepatic Impairment In patients with moderate hepatic impairment (Child Pugh score 7 to 9) start anagrelide capsules therapy at a dose of 0.5 mg/day and monitor frequently for cardiovascular events [see Warnings and Precautions (5.1) , Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . Patients with moderate hepatic impairment who have tolerated anagrelide capsules therapy for one week may have their dose increased. The dose increase increment should not exceed 0.5 mg/day in any one week.

Avoid use of anagrelide capsules in patients with severe hepatic impairment.

2.4Clinical Monitoring Anagrelide capsules therapy requires clinical monitoring, including complete blood counts, assessment of hepatic and renal function, and electrolytes. To prevent the occurrence of thrombocytopenia, monitor platelet counts every two days during the first week of treatment and at least weekly thereafter until the maintenance dosage is reached. Typically, platelet counts begin to respond within 7 to 14 days at the proper dosage.

In the clinical trials, the time to complete response, defined as platelet count ≤600,000/μL, ranged from 4 to 12 weeks. In the event of dosage interruption or treatment withdrawal, the rebound in platelet count is variable, but platelet counts typically will start to rise within 4 days and return to baseline levels in one to two weeks, possibly rebounding above baseline values. Monitor platelet counts frequently.

💊 Dosage Forms and Strengths 88 words ▾

3 DOSAGE FORMS AND STRENGTHS 0.5 mg : Size #3, hard gelatin capsules, white opaque cap with white opaque body, imprinted "CE" in black ink on cap and imprinted "55" in black ink on body, filled with white to off white powder. 1 mg : Size #3, hard gelatin capsules, grey opaque cap with grey opaque body, imprinted "CE" in black ink on cap and imprinted "56" in black ink on body, filled with white to off white powder. Capsules: 0.5 mg and 1 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiovascular Toxicity: QT prolongation and ventricular tachycardia have been reported with anagrelide. Obtain a pre-treatment cardiovascular examination including an ECG in all patients. Monitor patients for cardiovascular effects.

( 5.1 ) Pulmonary Hypertension: Assess underlying cardiopulmonary disease prior to initiating therapy. ( 5.2 ) Bleeding Risk: Monitor patients for bleeding, including those receiving concomitant therapy with other drugs known to cause bleeding. ( 5.3 )

5.1Cardiovascular Toxicity Torsades de pointes and ventricular tachycardia have been reported with anagrelide. Obtain a pre‑treatment cardiovascular examination including an ECG in all patients. During treatment with anagrelide monitor patients for cardiovascular effects and evaluate as necessary.

Anagrelide increases the QTc interval of the electrocardiogram and increases the heart rate in healthy volunteers [see Clinical Pharmacology (12.2) ] . Do not use anagrelide in patients with known risk factors for QT interval prolongation, such as congenital long QT syndrome, a known history of acquired QTc prolongation, medicinal products that can prolong QTc interval and hypokalemia [see Drug Interactions (7.1) ] . Hepatic impairment increases anagrelide exposure and could increase the risk of QTc prolongation.

Monitor patients with hepatic impairment for QTc prolongation and other cardiovascular adverse reactions. The potential risks and benefits of anagrelide therapy in a patient with mild and moderate hepatic impairment should be assessed before treatment is commenced. Reduce anagrelide dose in patients with moderate hepatic impairment.

Avoid use of anagrelide in patients with severe hepatic impairment. In patients with heart failure, bradyarrhythmias, or electrolyte abnormalities, consider periodic monitoring with electrocardiograms [see Clinical Pharmacology (12.2) ] . Anagrelide is a phosphodiesterase 3 (PDE3) inhibitor and may cause vasodilation, tachycardia, palpitations, and congestive heart failure.

Other drugs that inhibit PDE3 have caused decreased survival when compared with placebo in patients with Class III–IV congestive heart failure [see Drug Interactions (7.2) ] . In patients with cardiac disease, use anagrelide only when the benefits outweigh the risks.

5.2Pulmonary Hypertension Cases of pulmonary hypertension have been reported in patients treated with anagrelide. Evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to initiating and during anagrelide therapy [see Adverse Reactions (6.1) ].

5.3Bleeding Risk Use of concomitant anagrelide and aspirin increased major hemorrhagic events in a post-marketing study. Assess the potential risks and benefits for concomitant use of anagrelide with aspirin, since bleeding risks may be increased. Monitor patients for bleeding, including those receiving concomitant therapy with other drugs known to cause bleeding (e.g., anticoagulants, PDE3 inhibitors, NSAIDs, antiplatelet agents, selective serotonin reuptake inhibitors) [see Drug Interactions (7.3) , Clinical Pharmacology (12.3) ] .

5.4Pulmonary Toxicity Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis) have been reported to be associated with the use of anagrelide in post-marketing reports. Most cases presented with progressive dyspnea with lung infiltrations. The time of onset ranged from 1 week to several years after initiating anagrelide.

If suspected, discontinue anagrelide and evaluate. Symptoms may improve after discontinuation [see Adverse Reactions (6) ] .

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Toxicity [see Warnings and Precautions (5.1) ] Pulmonary Hypertension [see Warnings and Precautions (5.2) ] Bleeding Risk [see Warnings and Precautions (5.3) ] Pulmonary Toxicity [see Warnings and Precautions (5.4) ] The most common adverse reactions (incidence ≥ 5%) are headache, palpitations, diarrhea, asthenia, edema, nausea, abdominal pain, dizziness, pain, dyspnea, cough, flatulence, vomiting, fever, peripheral edema, rash, chest pain, anorexia, tachycardia, malaise, paresthesia, back pain, pruritus, and dyspepsia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical 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 (14) ] diagnosed with myeloproliferative neoplasms of varying etiology (ET: 551; PV: 117; OMPN: 274) were exposed to anagrelide 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 (5.1) ] , pleural effusion, pulmonary infiltrates, pulmonary fibrosis, pulmonary hypertension, and pancreatitis. Of the 942 patients treated with anagrelide, 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 anagrelide (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 Anagrelide in at least 5% of Patients Adverse Reactions Anagrelide (N=942) (%) Cardiac disorders Palpitations 26% Tachycardia 8% Chest pain 8% General disorders and administration site conditions 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 : Ve… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Other PDE3 inhibitors: Exacerbation of inotropic effects. ( 7.2 ) Aspirin and Drugs that Increase Bleeding Risk : Increased risk of bleeding with concomitant use. ( 7.3 )

7.1Drugs that Prolong QT Avoid use of anagrelide 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 (5.1) and Clinical Pharmacology (12.2) ] .

7.2PDE3 Inhibitors Anagrelide 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 (5.1) and Clinical Pharmacology (12.2) ] .

7.3Aspirin and Drugs that Increase Bleeding Risk Co-administration of single-dose or repeat-dose anagrelide and aspirin showed greater ex vivo anti-platelet aggregation effects than administration of aspirin alone [see Clinical Pharmacology (12.3) ] . Results from an observational study in patients with essential thrombocythemia suggest the rate of major hemorrhagic events (MHEs) in patients treated with anagrelide 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 anagrelide with aspirin should be assessed, particularly in patients with a high-risk profile for hemorrhage, before treatment is initiated [see Warnings and Precautions (5.3) ] . 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).

7.4CYP450 Interactions CYP1A2 inhibitors: Anagrelide and its active metabolite are primarily metabolized by CYP1A2. Drugs that inhibit CYP1A2 (e.g., fluvoxamine, ciprofloxacin) could increase the exposure of anagrelide. Monitor patients for cardiovascular events and titrate doses accordingly when CYP1A2 inhibitors are coadministered.

CYP1A2 inducers: CYP1A2 inducers could decrease the exposure of anagrelide. Patients taking concomitant CYP1A2 inducers (e.g., omeprazole) may need to have their dose titrated to compensate for the decrease in anagrelide exposure. CYP1A2 substrates: Anagrelide demonstrates limited inhibitory activity towards CYP1A2 in vitro and may alter the exposure of concomitant CYP1A2 substrates (e.g., theophylline, fluvoxamine, ondansetron).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Available data from case reports with anagrelide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal embryo-fetal studies, delayed fetal development (delayed skeletal ossification and reduced body weight) was observed in rats administered anagrelide hydrochloride during organogenesis at doses approximately 97 times the maximum clinical dose (10 mg/day) based on body surface area [see Data] . There are adverse effects on maternal and fetal outcomes associated with thrombocythemia in pregnancy [see Clinical Considerations ].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Thrombotic events, such as stroke, deep vein thrombosis, or myocardial infarction, can be complications of thrombocythemia. Thrombocythemia in pregnancy is associated with an increased risk for miscarriage, stillbirth, and other maternal outcomes, such as preeclampsia. Data Animal Data Anagrelide hydrochloride was administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 900 mg/kg/day in rats and up to 20 mg/kg/day in rabbits (875 and 39 times, respectively, the maximum clinical dose of 10 mg/day based on body surface area).

In rats, developmental delays were observed including reductions in fetal weight at 300 and 900 mg/kg/day and delays in skeletal ossification at doses of 100 mg/kg/day and higher. The dose of 100 mg/kg/day (600 mg/m 2 /day) in rats is approximately 97 times the maximum clinical dose based on body surface area. No adverse embryo-fetal effects were detected in rabbits at the highest dose of 20 mg/kg/day (39 times the maximal clinical dose based on body surface area).

In a pre- and post-natal study conducted in female rats, anagrelide hydrochloride administered at oral doses of 60 mg/kg/day (58 times the maximum clinical dose based on body surface area) or higher during organogenesis through lactation produced delay or blockage of parturition, deaths of non-delivering pregnant dams and their fully developed fetuses, and increased mortality in the pups born. In a placental transfer study, a single oral dose of [ 14 C]-anagrelide hydrochloride (3 mg/kg) was administered to pregnant rats on gestation Day 17.

Drug-related radioactivity was detected in maternal and fetal tissue.

8.2Lactation Risk Summary There is no information regarding the presence of anagrelide in human milk, the effect on the breastfed child, or the effects on milk production. Anagrelide or its metabolites have been detected in the milk of lactating rats [see Data] . Because of the potential for serious adverse reactions, including thrombocytopenia, in a breastfed child, advise patients that breastfeeding is not recommended during treatment with anagrelide and for one week following the last dose.

Data In a rat milk secretion study, a single oral dose of [ 14 C]‑anagrelide hydrochloride (3 mg/kg) was administered to lactating female rats on postnatal Day 10. Drug-related radioactivity was detected in the maternal milk and blood.

8.3Females and Males of Reproductive Potential Infertility Females Based on findings from animal studies, anagrelide may impair female fertility [see Nonclinical Toxicology (13.1) ].

8.4Pediatric Use The safety and effectiveness of anagrelide have been established in pediatric patients 7 years of age and older. There are no data for pediatric patients less than 7 years of age. Use of anagrelide in these pediatric… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 92 words ▾

10 OVERDOSAGE At higher than recommended doses, anagrelide hydrochloride has been shown to cause hypotension. There have been postmarketing case reports of intentional overdose with anagrelide hydrochloride. Reported symptoms include sinus tachycardia and vomiting.

Symptoms resolved with supportive management. Platelet reduction from anagrelide therapy is dose-related; therefore, thrombocytopenia, which can potentially cause bleeding, is expected from overdosage. In case of overdosage, stop anagrelide dosing and monitor platelet counts for thrombocytopenia and observe for possible complications such as bleeding.

Consider resumption of anagrelide dosing once the platelet count returns to the normal range.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism by which anagrelide reduces blood platelet count is unknown. In cell culture studies, anagrelide suppressed expression of transcription factors including GATA‑1 and FOG‑1 required for megakaryocytopoiesis, ultimately leading to reduced platelet production.

12.2Pharmacodynamics In blood withdrawn from normal volunteers treated with anagrelide, a disruption was found in the postmitotic phase of megakaryocyte development and a reduction in megakaryocyte size and ploidy. At therapeutic doses, anagrelide does not produce significant changes in white cell counts or coagulation parameters, and may have a small, but clinically insignificant effect on red cell parameters. The active metabolite, 3‑hydroxy anagrelide, has similar potency and efficacy to that of anagrelide in the platelet lowering effect; however, exposure (measured by plasma AUC) to 3‑hydroxy anagrelide is approximately 2‑fold higher compared to anagrelide.

Anagrelide and 3‑hydroxy anagrelide inhibit cyclic AMP phosphodiesterase 3 (PDE3) and 3‑hydroxy anagrelide is approximately forty times more potent than anagrelide (IC 50s = 0.9 and 36 nM, respectively). PDE3 inhibition does not alter platelet production. PDE3 inhibitors, as a class can inhibit platelet aggregation.

However, significant inhibition of platelet aggregation is observed only at doses of anagrelide higher than those typically required to reduce platelet count. PDE3 inhibitors have cardiovascular (CV) effects including vasodilation, positive inotropy and chronotropy. Cardiac Electrophysiology The effect of anagrelide dose (0.5 mg and 2.5 mg single doses) on the heart rate and QTc interval prolongation potential was evaluated in a double-blind, randomized, placebo- and active-controlled, cross‑over study in 60 healthy adult men and women.

A dose-related increase in heart rate was observed, with the maximum increase occurring around the time of maximal drug concentration (0.5 to 4 hours). The maximum change in mean heart rate occurred at 2 hours after administration and was +7.8 beats per minute (bpm) for 0.5 mg and +29.1 bpm for 2.5 mg. Dose-related increase in mean QTc was observed.

The maximum mean (95% upper confidence bound) change in QTcI (individual subject correction) from placebo after baseline-correction was 7.0 (9.8) ms and 13.0 (15.7) ms following anagrelide doses of 0.5 mg and 2.5 mg, respectively.

12.3Pharmacokinetics Dose proportionality has been found in the dose range 0.5 mg to 2.5 mg. Absorption Following oral administration of anagrelide, at least 70% is absorbed from the gastrointestinal tract. In fasted subjects, anagrelide peak plasma concentrations occur within about 1 hour after administration.

Pharmacokinetic data obtained from healthy volunteers comparing the pharmacokinetics of anagrelide in the fed and fasted states showed that administration of a 1 mg dose of anagrelide with food decreased the C max by 14%, but increased the AUC by 20%. Food decreased the C max of the active metabolite 3‑hydroxy anagrelide by 29%, although it had no effect on the AUC. Elimination Anagrelide and 3 ‑ hydroxy anagrelide are eliminated with plasma half-lives of approximately 1.5 and 2.5 hours, respectively.

Anagrelide and 3‑hydroxy anagrelide do not accumulate in plasma when the clinical dose regimens are administered. Metabolism: Anagrelide is primarily metabolized by CYP1A2 to the active metabolite, 3‑hydroxy anagrelide, which is subsequently metabolized by CYP1A2 to the inactive metabolite, RL603. Less than 1% of the administered dose is recovered in the urine as anagrelide, and approximately 3% and 16% to 20% of the administered dose is recovered as 3 ‑ hydroxy anagrelide and RL603, respectively.

Drug Interactions Aspirin : In two pharmacodynamic interaction studies in healthy subjects, co-administration of single-dose anagrelide 1 mg and aspirin 900 mg or repeat-dose anagrelide 1 mg once daily and aspirin 75 mg once daily s… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 138 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Anagrelide Capsules, USP, are available as: 0.5 mg : Size #3, hard gelatin capsules, white opaque cap with white opaque body, imprinted "CE" in black ink on cap and imprinted "55" in black ink on body, filled with white to off white powder. They are supplied as follows: Bottles of 120 capsules NDC 62135-312-12 1 mg : Size #3, hard gelatin capsules, grey opaque cap with grey opaque body, imprinted "CE" in black ink on cap and imprinted "56" in black ink on body, filled with white to off white powder.

They are supplied as follows: Bottles of 60 capsules NDC 62135-313-60 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required.

📋 Description 140 words ▾

11 DESCRIPTION Anagrelide Hydrochloride, USP is a platelet-reducing agent. Its chemical name is 6,7-dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one monohydrochloride monohydrate. The molecular formula is C 10 H 7 Cl 2 N 3 O•HCl•H 2 O which corresponds to a molecular weight of 310.55.

The structural formula is: Anagrelide Hydrochloride, USP is an off-white powder. It is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and dimethylformamide. Anagrelide Capsules, USP is supplied as capsules for oral administration, containing 0.5 mg and 1 mg of anagrelide base (as anagrelide hydrochloride, USP).

The capsules also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and crospovidone. Capsule shell contains gelatin, titanium dioxide and black iron oxide (1mg). Additionally, capsule shells are imprinted with black imprint ink, it contains ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. image description

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Dose: Tell the patient that their dose will be adjusted on a weekly basis until they are on a dose that lowers their platelets to an appropriate level. This will also help the patient to adjust to common side effects. Tell the patient to contact their doctor if they experience tolerability issues, so the dose or dosing frequency can be adjusted [see Dosage and Administration (2) ] .

Cardiovascular effects: Tell the patient to contact a doctor immediately if they experience chest pain, palpitations, or feel their heartbeat is irregular [see Warnings and Precautions (5.1) ] . Risk of Pulmonary Hypertension: Tell the patient to contact a doctor immediately if they experience shortness of breath, swelling in legs or ankles, or lips and skin turn a bluish color [see Warnings and Precautions (5.2) ]. Risk of bleeding: Warn the patient that concomitant aspirin (or other medicines that affect blood clotting) may increase the risk of bleeding.

Tell the patient to contact a doctor immediately if they experience signs or symptoms of bleeding (e.g., vomit blood, pass bloody or black stools) or experience unexplained bruising/bruise more easily than usual [see Warnings and Precautions (5.3) , Drug Interactions (7.1) ] . Lactation: Advise patients not to breastfeed during treatment with anagrelide and for one week following the last dose [see Use in Specific Populations (8.2) ] . Infertility: Advise females of reproductive potential treatment with anagrelide may impair fertility [see Use in Specific Populations (8.3) , Nonclinical Toxicology (13.1) ] .

Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71827 Rev. 02/2024

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Clinical Studies in Adult Patients: A total of 942 patients with myeloproliferative neoplasms including 551 patients with Essential Thrombocythemia (ET), 117 patients with Polycythemia Vera (PV), 178 patients with Chronic Myelogenous Leukemia (CML), and 96 patients with other myeloproliferative neoplasms (OMPN), were treated with anagrelide in three clinical trials. Patients with OMPN included 87 patients who had Myeloid Metaplasia with Myelofibrosis (MMM) and 9 patients who had unclassified myeloproliferative neoplasms.

Patients were enrolled in clinical trials if their platelet count was ≥900,000/μL on two occasions or ≥650,000/μL on two occasions with documentation of symptoms associated with thrombocythemia. The mean duration of anagrelide therapy for ET, PV, CML, and OMPN patients was 65, 67, 40, and 44 weeks, respectively; 23% of patients received treatment for 2 years. Patients were treated with anagrelide starting at doses of 0.5 mg to 2.0 mg every 6 hours.

The dose was increased if the platelet count was still high, but to no more than 12 mg each day. Efficacy was defined as reduction of platelet count to or near physiologic levels (150,000/μL to 400,000/μL). The criteria for defining subjects as “responders” were reduction in platelets for at least 4 weeks to ≤600,000/μL, or by at least 50% from baseline value.

Subjects treated for less than 4 weeks were not considered evaluable. The results are depicted graphically below: Time on Treatment Weeks Years Baseline 4 12 24 48 2 3 4 Mean* 1131 683 575 526 484 460 437 457 N 923 † 868 814 662 530 407 207 55 *x10 3 /μL † Nine hundred and forty-two subjects with myeloproliferative neoplasms were enrolled in three research studies. Of these, 923 had platelet counts measured over the duration of the studies.

Anagrelide was effective in phlebotomized patients as well as in patients treated with other concomitant therapies including hydroxyurea, aspirin, interferon, radioactive phosphorus, and alkylating agents. Clinical Study in Pediatric Patients: An open-label safety and PK/PD study was conducted in 18 pediatric patients 7 through 16 years of age (8 children 7 through 11 years of age and 10 adolescents 12 through 16 years of age, mean age of 12 years; 8 males and 10 females) with thrombocythemia secondary to ET as compared to 17 adult patients (mean age of 66 years, 9 males and 8 females).

Prior to entry on to the study, 17 of 18 pediatric patients and 12 of 17 adult patients had received anagrelide treatment for an average of 2 years. The median starting total daily dose, determined by retrospective chart review, for pediatric and adult patients with ET who had received anagrelide prior to study entry was 1 mg for each of the three age groups (7 through 11 and 12 through 16 years of age and adults). The starting dose for 6 anagrelide-naive patients at study entry was 0.5 mg once daily.

At study completion, the median total daily maintenance doses were similar across age groups, median of 1.75 mg for children of 7 through 11 years of age, 2.25 mg in adolescents 12 through 16 years of age, and 1.5 mg for adults. image description

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, 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 pheochromocytomas 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.

13.2Animal 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.

📄 Package Label / Principal Display Panel 33 words ▾

PRINCIPAL DISPLAY PANNEL Anagrelide Capsules, USP 0.5 mg - NDC 62135-312-12 - 120s - Bottle Label Anagrelide Capsules, USP 1 mg - NDC 62135-313-60 - 60s - Bottle Label image description image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62135-0312-12 · Chartwell 62135-0315-30 · Chartwell →
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