GAVRETO Safety
GAVRETO offers a well-established safety profile
Safety of GAVRETO was evaluated in 138 patients with RET-altered thyroid cancer1*
*Includes 19 patients with RET fusion-positive thyroid cancer.
RET+=rearranged during transfection.
Adverse reactions (≥15%) in RET-altered thyroid cancer patients who received GAVRETO in ARROW1
| Adverse Reactions | GAVRETO (N=138)* | |
| Grades 1-4 (%) | Grades 3-4 (%) | |
| Musculoskeletal | ||
| Musculoskeletal pain† | 42 | 0.7‡ |
| Gastrointestinal | ||
| Constipation | 41 | 0.7‡ |
| Diarrhea† | 34 | 5‡ |
| Abdominal pain† | 17 | 0.7‡ |
| Dry mouth | 17 | 0 |
| Stomatitis† | 17 | 0.7‡ |
| Nausea | 17 | 0.7‡ |
| Vascular | ||
| Hypertension | 40 | 21‡ |
| General | ||
| Fatigue† | 38 | 6‡ |
| Edema† | 29 | 0 |
| Pyrexia | 22 | 2.2‡ |
| Respiratory | ||
| Cough† | 27 | 1.4‡ |
| Dyspnea† | 22 | 2.2‡ |
| Nervous system | ||
| Headache† | 24 | 0 |
| Peripheral neuropathy† | 20 | 0 |
| Dizziness† | 19 | 0.7‡ |
| Dysgeusia† | 17 | 0 |
| Skin and subcutaneous | ||
| Rash† | 24 | 0 |
| Metabolism and nutrition | ||
| Decreased appetite | 15 | 0 |
*Includes 19 patients with RET fusion-positive thyroid cancer.
†For grouped terms, please refer to the U.S. Prescribing Information (USPI).
‡Only includes a Grade 3 adverse reaction.
Clinically relevant adverse reactions in <15% of patients who received GAVRETO included tumor lysis syndrome and increased creatine phosphokinase.
Dose reductions, interruptions, and discontinuations due to adverse reactions while taking GAVRETO1,2
- 3.6% discontinued due to adverse reactions considered treatment-related by the trial investigator2
- 9% of patients permanently discontinued GAVRETO due to any adverse reaction1
- 44% of patients treated experienced dose reductions due to an adverse reaction1
- 67% of patients treated experienced dosage interruptions due to an adverse reaction1
Select laboratory abnormalities (≥20%) worsening from baseline in patients who received GAVRETO in ARROW1
| Laboratory Abnormality§ | GAVRETO (N=138)* | |
| Grades 1-4 (%) | Grades 3-4 (%) | |
| Chemistry | ||
| Decreased calcium (corrected) | 70 | 9 |
| Increased aspartate aminotransferase (AST) | 69 | 4.3 |
| Increased alanine aminotransferase (ALT) | 43 | 3.6 |
| Increased creatinine | 41 | 0 |
| Decreased albumin | 41 | 1.5 |
| Decreased sodium | 28 | 2.2 |
| Decreased phosphate | 28 | 8 |
| Decreased magnesium | 27 | 0.7 |
| Increased potassium | 26 | 1.4 |
| Increased bilirubin | 24 | 1.4 |
| Increased alkaline phosphatase | 22 | 1.4 |
| Hematology | ||
| Decreased lymphocytes | 67 | 27 |
| Decreased hemoglobin | 63 | 13 |
| Decreased neutrophils | 59 | 16 |
| Decreased platelets | 31 | 2.9 |
GAVRETO showed Grades 3-4 AST/ALT elevations of 4.3% and 3.6%.1
*Includes 19 patients with RET fusion-positive thyroid cancer.
§Denominator for each laboratory parameter is based on the number of patients with a baseline and post-treatment laboratory value available, which ranged from 135 to 138 patients.
Other clinically relevant laboratory abnormalities in patients who received GAVRETO included increased phosphate (40%).1
When should I modify dosage?
View the recommended dose reductions for GAVRETO for adverse reactions.
GAV_THR-25011 0525
References:
1. GAVRETO® [Package insert], South San Francisco, CA: Rigel Pharmaceuticals, Inc.
2. GAVRETO: Data on file, Rigel Pharmaceuticals, Inc. June 2024.