What is Gavreto used for?

1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is appro

How does Gavreto work?

11 DESCRIPTION Pralsetinib is an oral receptor tyrosine kinase inhibitor.

What pharmaceutical form is Gavreto available in?

Gavreto: Kapsułki twarde 100 mg (doustna)

Is Gavreto OTC or prescription only?

Gavreto requires a doctor's prescription.

What are the side effects of Gavreto?

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections, Including Opportunistic Infections [see Warnings and Precautions (5.1) ] Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.2) ] Hypertension [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Hemorrhagic Events [see Warnings and Precautions (5.5) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.

Who should NOT take Gavreto?

4 CONTRAINDICATIONS None. None. ( 4 )

Does Gavreto interact with other medications?

7 DRUG INTERACTIONS Strong or moderate CYP3A inhibitors and/or P-gp inhibitors : Avoid coadministration. If coadministration cannot be avoided, reduce the dose of GAVRETO. ( 2.4 , 7.1 , 12.3 ) Strong or moderate CYP3A inducers : Avoid coadministration. If coadministration cannot be avoided, increase the dose of GAVRETO. ( 2.5 , 7.1 , 12.3 ) 7.1 Effects of Other Drugs on GAVRETO Strong or Moderate CYP3A and/or P-gp Inhibitors Concomitant use with a strong or moderate CYP3A inhibitor and/or a P-gp

Can Gavreto be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 ) Pediatric Use : Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur. ( 8.4 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. There are no available data on GAVRETO use in pregnant women to inform drug-asso

What precautions should be taken with Gavreto?

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Who manufactures Gavreto?

Roche Registration GmbH (Niemcy)

What ATC class does Gavreto belong to?

Gavreto: ATC L01EX23. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Gavreto

100 mg, Kapsułki twarde

INN: Pralsetinibum

Data updated: 2026-04-13

Available in:

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Form

Kapsułki twarde

Dosage

100 mg

Route

doustna

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from moisture.

About This Product

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