Lorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. MedsAcross supplies Lorlatinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Source: US FDA prescribing information
Lorlatinib is a kinase inhibitor with in vitro activity against ALK and ROS1 as well as TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK. Lorlatinib demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors. In mice subcutaneously implanted with tumors harboring EML4 fusions with either ALK variant 1 or ALK mutations, including the G1202R and I1171T mutations detected in tumors at the time of disease progression on ALK inhibitors, administration of lorlatinib resulted in antitumor activity. Lorlatinib also demonstrated anti-tumor activity and prolonged survival in mice implanted intracranially with EML4-ALK-driven tumor cell lines.
Source: US FDA prescribing information
Recommended dosage: 100 mg orally once daily. Severe Hepatic Impairment: 50 mg orally once daily. Renal Impairment: 75 mg orally once daily.
Source: US FDA prescribing information
LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity. Concomitant use with strong CYP3A inducers.
Source: US FDA prescribing information
• Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA. • Central Nervous System (CNS) Effects: CNS effects include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Withhold and resume LORBRENA at same or reduced dose or permanently discontinue LORBRENA based on severity. • Hyperlipidemia: Initiate or increase the dose of lipid-lowering agents. Withhold and resume LORBRENA at same or reduced dose based on severity. • Atrioventricular Block: Withhold and resume LORBRENA at same or reduced dose based on severity. • Interstitial Lung Disease/Pneumonitis: Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis.
Source: US FDA prescribing information
The following adverse reactions are described elsewhere in the labeling: • Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers • Central Nervous System Effects • Hyperlipidemia • Atrioventricular Block • Interstitial Lung Disease/Pneumonitis • Hypertension • Hyperglycemia Most common (incidence ≥20%) adverse reactions and Grade 3–4 laboratory abnormalities are edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects, hypercholesterolemia, hypertriglyceridemia, and cough.
Source: US FDA prescribing information
• Strong CYP3A Inducers: Contraindicated. • Moderate CYP3A Inducers: Avoid concomitant use. If concomitant use cannot be avoided, increase the LORBRENA dose. • Strong CYP3A Inhibitors: Avoid concomitant use, reduce LORBRENA dose if concomitant use cannot be avoided. • Fluconazole: Avoid concomitant use, reduce LORBRENA dose if concomitant use cannot be avoided. • Certain CYP3A Substrates: Avoid concomitant use with CYP3A substrates for which minimal concentration changes may lead to serious therapeutic failures. • Certain P-gp Substrates: Avoid concomitant use with P-gp substrates for which minimal concentration changes may lead to serious therapeutic failures.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Lorlatinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Lorbrena 25 mg tabletOral | Pfizer Laboratories | US FDA | Available on request |
| Lorbrena 100 mg tabletOral | Pfizer Laboratories | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Lorlatinib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Lorlatinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Lorlatinib, including Lorbrena.
Yes. The US FDA first approved Lorlatinib on 2 November 2018, according to Drugs@FDA.
Yes. Lorlatinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Lorlatinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Lorlatinib is classified under ATC code L01ED05 (Lorlatinib).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.