Gavreto (Pralsetinib)

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 .

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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

100 mg

For Oral Use

Rx only

60 Capsules

rigel

8PRINCIPAL DISPLAY PANEL - 90 Capsule - Carton

NDC 71332-006-90

GAVRETO^®
(pralsetinib)
capsules

100 mg

For Oral Use

Rx only

90 Capsules

rigel