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LORBRENA (lorlatinib)
- ALK positive non-small cell lung cancer
100 mg tablet
- 1 tablet (100 mg) by oral route once daily at the same time eachday
25 mg tablet
- 2 tablets (50 mg) by oral route once daily at the same time eachday
ALK positive non-small cell lung cancer
- 2 tablets (50 mg) by oral route once daily at the same time eachday
- 3 tablets (75 mg) by oral route once daily at the same time eachday
- 1 tablet (100 mg) by oral route once daily at the same time eachday
- None
Contraindicated
- axitinib
- bedaquiline
- Bosulif
- bosutinib
- enzalutamide
- guanfacine
- Inlyta
- Intuniv Er
- Olysio
- simeprevir
- Sirturo
- Tenex
- Xtandi
Severe
Moderate
- None
- Lactating mother
Contraindicated
- Atrioventricular block
- Interstitial pneumonitis
- Pregnancy
- Suicidal ideation
Severe
Moderate
- Hypercholesterolemia
- Hypertriglyceridemia
- Seizure disorder
LORBRENA (lorlatinib)
- ALK positive non-small cell lung cancer
- Abnormal hepatic function tests
- Anemia
- Increased alanine transaminase
- Increased aspartate transaminase
- Acute confusion
- Arthralgias
- Diarrhea
- Dyspnea
- Edema
- Elevated serum lipase
- Fatigue
- Hypoalbuminemia
- Mood changes
- Peripheral neuropathy
- Weight gain
More Frequent
Severe
Less Severe
- Atrioventricular block
- Interstitial pneumonitis
- Pneumonia
- Seizure disorder
- Altered mental status
- Aphasia
- Back pain
- Dysarthria
- Fever
- Hallucinations
- Hyperlipidemia
- Hypertriglyceridemia
- Limb pain
- Myalgias
- Skin rash
- Sleep disorder
- Upper respiratory infection
- Visual changes
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Acute myocardial infarction
- Acute respiratory distress syndrome
- Pulmonary edema
- Suicidal ideation
- Thromboembolic disorder
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Lorlatinib
No pediatric safety and efficacy.
- 1 Day – 18 Years
- No pediatric safety and efficacy.
Lorlatinib
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible.
Contraindicated
Lorlatinib
Manufacturer rec avoid breastfeeding during tx and 7 days 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 | Manufacturer rec avoid breastfeeding during tx and 7 days 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
Lorlatinib
Neuro/Psych-Risk of changes in cognitive function, mood, speech, mental status and sleep. Monitor and hold/reduce dose, as needed.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | N | Y | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
| ALK positive non-small cell lung cancer | |
| 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 |
| 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 |
Formulary Reference Tool