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GAVRETO (pralsetinib)
- medullary thyroid cancer with RET gene mutation
- RET fusion-positive metastatic NSCLC
- thyroid cancer with RET fusion gene
100 mg capsule
- 4 capsules (400 mg) by oral route once daily
Default screening record
- 1 capsule (100 mg) by oral route once daily
- 2 capsules (200 mg) by oral route once daily
- 3 capsules (300 mg) by oral route once daily
- 4 capsules (400 mg) by oral route once daily
- 6 capsules (600 mg) by oral route once daily
- 8 capsules (800 mg) by oral route once daily
- None
Contraindicated
- None
Severe
Moderate
- None
- Invasive surgical procedure
- Lactation
Contraindicated
- Abnormal hepatic function tests
- Hemorrhage
- Hypertension
- Impaired wound healing
- Interstitial lung disease
- Pregnancy
Severe
Moderate
- None
GAVRETO (pralsetinib)
- medullary thyroid cancer with RET gene mutation
- RET fusion-positive metastatic NSCLC
- thyroid cancer with RET fusion gene
- Anemia
- Hypocalcemia
- Hyponatremia
- Increased alanine transaminase
- Increased alkaline phosphatase
- Increased aspartate transaminase
- Lymphopenia
- Neutropenic disorder
- Constipation
- Fatigue
- Hyperphosphatemia
- Hypertension
- Musculoskeletal pain
More Frequent
Severe
Less Severe
- Hemorrhage
- Hypophosphatemia
- Interstitial lung disease
- Interstitial pneumonitis
- Pneumonia
- Sepsis
- Thrombocytopenic disorder
- Tumor lysis syndrome
- Cough
- Diarrhea
- Edema
- Fever
- Increased creatine kinase level
- Urinary tract infection
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Impaired wound healing
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Pralsetinib
Safety and effectiveness not established in age < 12 years. May impact bone and tooth development.
May impact bone development; monitor patients with open growth plates for development of growth plate abnormalities.
- 1 Day – 12 Years
- Safety and effectiveness not established in age < 12 years. May impact bone and tooth development.
- May impact bone development; monitor patients with open growth plates for development of growth plate abnormalities.
- 12 Years – 18 Years
- Safety and effectiveness not established in age < 12 years. May impact bone and tooth development.
- May impact bone development; monitor patients with open growth plates for development of growth plate abnormalities.
Pralsetinib
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible
Contraindicated
Pralsetinib
Insuff human data avail; not rec during tx and for 1 wk after last dose
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Insuff human data avail; not rec during tx and for 1 wk after last dose |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| RET fusion-positive metastatic NSCLC | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| C39.9 | Malignant neoplasm of lower respiratory tract, part unspecified |
| RET fusion-positive thyroid cancer | |
| C73 | Malignant neoplasm of thyroid gland |
| 0-9 | A-Z |
|---|---|
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| C39.9 | Malignant neoplasm of lower respiratory tract, part unspecified |
| C73 | Malignant neoplasm of thyroid gland |
Formulary Reference Tool