Systemic Mastocytosis Treatments
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Brand Name
Ayvakit
Generic Name
Avapritinib
View Brand Information FDA approval date: January 09, 2020
Classification: Kinase Inhibitor
Form: Tablet
What is Ayvakit (Avapritinib)?
AYVAKIT is a kinase inhibitor indicated for: Gastrointestinal Stromal Tumor the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha exon 18 mutation, including PDGFRA D842V mutations.
Approved To Treat
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Related Clinical Trials
A Phase 1 Study of Avapritinib in Combination With Decitabine in Patients With Systemic Mastocytosis With an Associated Hematologic Neoplasm (SM-AHN)
Summary: Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) is a challenging disease to treat. Targeted KIT inhibitors have been approved for this indication based on their ability to control the mastocytosis portion of the disease, but patients frequently experience progression of the concomitant myeloid malignancy (i.e. the AHN). Using a combination approach to treat both aspects of t...
Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors
Summary: This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA and have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Avapritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Avapritinib may help to control the growth ...
A Prospective Non-Interventional Study to Describe the Effectiveness of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Patients With Indolent Systemic Mastocytosis and Symptoms That Are Not Adequately Controlled With Symptomatic Treatments in Real-World Settings
Summary: This is a non-interventional study assessing the effectiveness of avapritinib (BLU-285) in the management of ISM in real-world settings in Germany. The study also seeks to address the existing data gap in the natural history and management of participants with ISM. The study is designed to follow each participant up to a maximum of 24 months.
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Brand Information
Ayvakit (avapritinib)
1DOSAGE FORMS AND STRENGTHS
Tablets:
- 25 mg, round, white film-coated tablet with debossed text. One side reads "BLU" and the other side reads "25".
- 50 mg, round, white film-coated tablet with debossed text. One side reads "BLU" and the other side reads "50".
- 100 mg, round, white film-coated, printed with blue ink "BLU" on one side and "100" on the other side.
- 200 mg, capsule shaped, white film-coated, printed with blue ink "BLU" on one side and "200" on the other side.
- 300 mg, capsule shaped, white film-coated, printed with blue ink "BLU" on one side and "300" on the other side.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Intracranial hemorrhage
- Cognitive effects
- Photosensitivity
3.1Clinical 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.
The data in the WARNINGS AND PRECAUTIONS reflect exposure to AYVAKIT at 25 mg to 600 mg orally once daily in 995 patients enrolled in one of five clinicals trials conducted in patients with advanced malignancies and systemic mastocytosis, including NAVIGATOR, EXPLORER, PATHFINDER and PIONEER
4DESCRIPTION
Avapritinib is a kinase inhibitor with the chemical name (
The solubility of avapritinib in 0.1N HCl (pH 1.0) and buffer solutions at pH 2.5, 4.0, and 7.0 (at 25°C) is 3.6 mg/mL, 0.14 mg/mL, 0.07 mg/mL and <0.001 mg/mL respectively, indicating a decrease in solubility with increasing pH.
AYVAKIT (avapritinib) film-coated tablets for oral use are supplied with five strengths that contain 25 mg, 50 mg, 100 mg, 200 mg or 300 mg of avapritinib. The tablets also contain inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The blue printing ink, used only for avapritinib 100 mg, 200 mg and 300 mg strength tablets, contains ammonium hydroxide, black iron oxide, esterified shellac, FD&C blue 1, isopropyl alcohol, n-butyl alcohol, propylene glycol, and titanium dioxide.
5HOW SUPPLIED/STORAGE AND HANDLING
AYVAKIT (avapritinib) tablets are supplied as follows:
25 mg, round, white film-coated tablet with debossed text. One side reads "BLU" and the other side reads "25"; available in bottles of 30 tablets (NDC 72064-125-30).
50 mg, round, white film-coated tablet with debossed text. One side reads "BLU" and the other side reads "50"; available in bottles of 30 tablets (NDC 72064-150-30).
100 mg, round, white film-coated tablet, printed with blue ink "BLU" on one side and "100" on the other side; available in bottles of 30 tablets (NDC 72064-110-30).
200 mg, capsule shaped, white film-coated tablet, printed with blue ink "BLU" on one side and "200" on the other side; available in bottles of 30 tablets (NDC 72064-120-30).
300 mg, capsule shaped, white film-coated tablet, printed with blue ink "BLU" on one side and "300" on the other side; available in bottles of 30 tablets (NDC 72064-130-30).
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
7PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
NDC 72064-110-30
AYVAKIT™
100 mg
Rx only
8PRINCIPAL DISPLAY PANEL - 200 mg Bottle Label
NDC 72064-120-30
AYVAKIT™
200 mg
Rx only
9PRINCIPAL DISPLAY PANEL - 300 mg Bottle Label
NDC 72064-130-30
AYVAKIT™
300 mg
Rx only
10PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
NDC 72064-125-30
AYVAKIT™
25 mg
Rx only
11PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
NDC 72064-150-30
AYVAKIT™
50 mg
Rx only
