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.
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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 (
Chemical Structure
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
PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
8PRINCIPAL DISPLAY PANEL - 200 mg Bottle Label
NDC 72064-120-30
AYVAKIT™
200 mg
Rx only
PRINCIPAL DISPLAY PANEL - 200 mg Bottle Label
9PRINCIPAL DISPLAY PANEL - 300 mg Bottle Label
NDC 72064-130-30
AYVAKIT™
300 mg
Rx only
PRINCIPAL DISPLAY PANEL - 300 mg Bottle Label
10PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
NDC 72064-125-30
AYVAKIT™
25 mg
Rx only
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
11PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
NDC 72064-150-30
AYVAKIT™
50 mg
Rx only
PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label