lorlatinib
Lorviqua · ATC code L01ED05
- Key facts
- Active substance
- lorlatinib
- ATC code
- L01ED05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Lorviqua 25 mg film-coated tablets / Lorviqua 100 mg film-coated tablets
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Information as of
- 2026-10-28
Key facts
Lorlatinib (Lorviqua) is an ALK tyrosine kinase inhibitor used as monotherapy for adults with ALK-positive advanced non-small cell lung cancer.
What it is used for
- Adults with ALK-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.
- Adults with ALK-positive advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK TKI, or after crizotinib and at least one other ALK TKI.
- ALK positivity must be confirmed by a validated test.
Dosing
- 100 mg orally once daily until disease progression or unacceptable toxicity.
- Dose reductions: first to 75 mg once daily, then to 50 mg once daily; stop permanently if 50 mg is not tolerated.
- Hyperlipidaemia is managed with lipid-lowering therapy while continuing the same dose in most cases; see the full text for the modification table (lipids, CNS effects, AV block, pneumonitis, hypertension, hyperglycaemia).
- Missed dose: take it as soon as remembered unless less than 4 hours before the next dose; never take 2 doses together.
- If a strong CYP3A4/5 inhibitor must be used, a dose reduction is recommended.
Contraindications
- Hypersensitivity to lorlatinib or to any of the excipients.
- Concomitant use of strong CYP3A4/5 inducers.
Important warnings
- Increases in serum cholesterol and triglycerides; lipids are checked before starting, 2, 4 and 8 weeks after starting and regularly thereafter.
- Central nervous system effects, including psychotic effects and changes in cognition, mood, mental status or speech.
- PR interval prolongation and AV block have been reported.
- Severe or life-threatening ILD/pneumonitis; worsening respiratory symptoms should be evaluated promptly.
- Hypertension and hyperglycaemia: blood pressure and fasting glucose should be controlled/assessed before and monitored during treatment.
Side effects
- Most frequent: hypercholesterolaemia (79.0%), hypertriglyceridaemia (67.5%), oedema (55.4%), peripheral neuropathy (44.2%), fatigue (30.7%), weight increased (29.8%), arthralgia (27.8%), cognitive effects (27.4%), diarrhoea (22.7%) and mood effects (21.4%).
- Serious adverse reactions occurred in 9.1% of patients, most often cognitive effects and pneumonitis.
Interactions
- Rifampin (a strong CYP3A4/5 inducer) reduced lorlatinib AUC by 85% and caused ALT/AST increases; strong inducers are contraindicated.
- Strong CYP3A4/5 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, ritonavir) and grapefruit may increase lorlatinib levels.
- Lorlatinib can render hormonal contraceptives ineffective and affects CYP3A4/5 substrates.
Pregnancy and breastfeeding
- Pregnancy should be avoided; highly effective non-hormonal contraception is required during treatment and for at least 35 days after completing therapy.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- LorviquaPfizer Europe MA EEIG · EMEA/H/C/004646
Source: European Medicines Agency (EMA), product information
Turkey
- LorviquaPFİZER PFE İLAÇLARI A.Ş. · 7 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Lorviqua
- Liechtenstein
- Lorviqua
- Norway
- Lorviqua
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Lorviqua – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/lorviqua-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.