Brand Name
Gavreto
Generic Name
Pralsetinib
View Brand Information FDA approval date: July 01, 2021
Classification: Kinase Inhibitor
Form: Capsule
What is Gavreto (Pralsetinib)?
GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA approved test .
Approved To Treat
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A Multi-center, Open-label, Drug-drug Interaction Study to Evaluate the Effect of Pralsetinib (Gavreto) on the Pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 Substrates, and Hormones Estradiol/Norethisterone Acetate in Patients With Advanced or Metastatic Solid Tumors
Summary: An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with rearranged during transfection (RET) fusion- or mutation-positive solid tumors
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Brand Information
Gavreto (Pralsetinib)
WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS
GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity
1DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg, light blue, opaque, hard hydroxypropyl methylcellulose (HPMC) capsule printed with "BLU-667" on the capsule shell body and "100 mg" on the capsule shell cap.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Serious Infections, Including Opportunistic Infections
- Interstitial Lung Disease/Pneumonitis
- Hypertension
- Hepatotoxicity
- Hemorrhagic Events
- Tumor Lysis Syndrome
- Risk of Impaired Wound Healing
- Embryo-Fetal Toxicity
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 pooled safety population in the WARNINGS AND PRECAUTIONS reflect exposure to GAVRETO as a single agent at 400 mg orally once daily in 540 patients in ARROW
4DESCRIPTION
Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (
The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH.
GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients:
citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide.
5HOW SUPPLIED/STORAGE AND HANDLING
GAVRETO (pralsetinib) 100 mg, light blue, opaque, immediate release, hydroxypropyl methylcellulose (HPMC) hard capsule printed with "BLU-667" on the capsule shell body and "100 mg" on the capsule shell cap are supplied as follows:
- Bottles of 60 capsules (NDC 71332-006-60).
- Bottles of 90 capsules (NDC 71332-006-90).
- Bottles of 120 capsules (NDC 71332-006-12).
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
7PRINCIPAL DISPLAY PANEL - 60 Capsule - Carton
NDC 71332-006-60
GAVRETO®
(pralsetinib)
capsules
(pralsetinib)
capsules
100 mg
For Oral Use
Rx only
60 Capsules
rigel
8PRINCIPAL DISPLAY PANEL - 90 Capsule - Carton
NDC 71332-006-90
GAVRETO®
(pralsetinib)
capsules
(pralsetinib)
capsules
100 mg
For Oral Use
Rx only
90 Capsules
rigel
