Lorlatinib (Lorbrena, Lorviqua)

Lorlatinib at a glance

Lorlatinib is a targeted cancer medicine taken once daily as tablets. Verified brand names are Lorbrena and Lorviqua. It blocks an abnormal growth signal associated with an ALK gene alteration. Your specialist uses appropriate testing and your clinical situation to decide whether this medicine is suitable.

Particular issues include raised cholesterol and triglycerides, swelling, weight gain, nerve symptoms and changes in thinking, mood or speech. Less obvious changes in heart conduction, blood pressure or blood sugar also need monitoring. Serious lung inflammation can occur.

You can take treatment at home, but regular blood tests and appointments remain essential. Tell the team about symptoms early; a pause, a lower dose or supportive treatment may help. Do not change treatment yourself.

How lorlatinib works

ALK, short for anaplastic lymphoma kinase, is a protein involved in cell signalling. An abnormal ALK gene arrangement can produce a continuously active signal that helps cancer cells grow. Lorlatinib is a tyrosine kinase inhibitor, or TKI, designed to block this signalling, including some altered forms associated with resistance to earlier treatment.

Lorlatinib reaches the brain, which can be important when the treatment plan needs to address cancer in the central nervous system. This does not guarantee a response or remove the need for brain imaging when indicated. Effects on normal brain function can also occur during treatment.

Ask the specialist to explain what the ALK result means for your treatment. Lorlatinib is not conventional chemotherapy or checkpoint immunotherapy, although all cancer medicines can affect healthy tissues.

How the team decides whether it is suitable

The decision includes confirmed ALK findings, the pattern of disease, previous treatments, scans, symptoms, other illnesses and your priorities. The presence of a target does not mean every person will benefit in the same way. Additional tests may be needed if the disease has changed.

Tell the team about seizures, depression or other mental-health difficulties, memory problems, unusual behaviour, heart disease, a slow heartbeat, fainting, diabetes, high cholesterol or triglycerides, pancreatitis, liver or kidney disease and previous lung inflammation. A trusted relative or friend may help describe changes that you have not noticed yourself.

Mention allergies and rare inherited problems processing certain sugars. European Lorviqua contains lactose and is unsuitable for people with specified rare disorders such as total lactase deficiency or glucose-galactose malabsorption. This is not the same as assuming every person with common lactose intolerance must avoid it; the pharmacist should check your situation.

Safety and effectiveness below age 18 are not established. Severe kidney or liver impairment requires a reduced starting dose under current US and European information. Dialysis and complex organ problems require specialist assessment rather than a standard self-adjustment.

Before treatment starts

Baseline tests include cholesterol, triglycerides, fasting blood glucose, liver and kidney function and an ECG, which records the heart's electrical activity. Blood pressure should be controlled before treatment. A pregnancy test is needed when relevant. European information also recommends pancreatic enzyme tests, called lipase and amylase, before treatment and as clinically indicated afterwards.

The team reviews every medicine, including vitamins, herbal products, contraceptives, cholesterol tablets, anti-seizure medicines and medicines prescribed by another clinic. Some combinations are prohibited because they can cause serious liver injury; others reduce the effectiveness of lorlatinib or another essential medicine. Do not leave this review until after the first dose.

Discuss your usual mood, sleep, memory and ability to manage everyday tasks. With your agreement, involve someone you trust in recognising changes and knowing whom to contact. This is a practical safety measure, not a prediction that you will experience severe problems.

Before going home, obtain a written dose schedule, blood-test dates and a 24-hour contact number. Ask what to do if a symptom appears between appointments or if you cannot get the next supply on time.

How to take lorlatinib

Tablets, dose and routine

The usual adult starting dose is 100 mg once daily, with or without food, at approximately the same time each day. Tablets come in 25 mg and 100 mg strengths. If side effects require a reduction, the usual steps are 75 mg daily and then 50 mg daily, as prescribed.

Current guidance also specifies lower starting doses in severe organ impairment: 50 mg daily for severe liver impairment and 75 mg daily for severe kidney impairment. Exact definitions and any interaction-related adjustments require your specialist. These figures explain why prescriptions can differ; they are not instructions to calculate your own dose.

Swallow tablets whole. Do not chew, crush or split them, and do not take a tablet that is cracked or damaged. A 75 mg prescription normally uses three 25 mg tablets rather than cutting a 100 mg tablet. Ask the pharmacist if swallowing is difficult; the reviewed product information does not supply a home liquid or feeding-tube preparation method.

Most schedules are continuous, without a planned weekly break. Treatment duration depends on benefit and tolerability. If side effects or supply problems make regular treatment difficult, contact the team rather than rationing tablets.

Missed dose, vomiting and storage

Take a missed dose when remembered unless the next dose is due within four hours under US instructions. European instructions say to skip when fewer than four hours remain; at exactly four hours, follow your supplied leaflet or pharmacist’s advice. Do not take two doses together to catch up. If uncertain about the exact timing, ask the pharmacist.

If you vomit after a dose, do not take another tablet to replace it. Continue with the next scheduled dose and seek advice if vomiting persists or you cannot drink. An accidental extra dose requires prompt medical advice; bring the pack when seeking help.

Keep tablets in the original packaging, away from children, following the temperature and moisture instructions on your own pack. Do not share treatment or use another person's tablets. Return unused or damaged medicine through the pharmacy's recommended route.

Monitoring during treatment

Cholesterol and triglycerides can rise substantially without symptoms. US guidance specifies testing before treatment, at one and two months, then periodically. European guidance adds a two-week check, with tests at two, four and eight weeks and regularly afterwards. The team chooses a schedule appropriate to your product, results and other risks.

An ECG checks whether electrical signals are moving normally through the heart. US information recommends a baseline ECG and periodic follow-up; European information specifies monthly follow-up, particularly when cardiac risk is present. A heart ultrasound may also be considered for people with relevant risks or symptoms.

Blood pressure is checked after two weeks and at least monthly thereafter. Fasting glucose is checked before treatment and periodically afterwards; people with diabetes may need more frequent home readings or changes to diabetes treatment. Blood counts, liver, kidney and other blood tests are arranged according to the clinical plan.

At visits, mention memory, mood, speech, sleep, swelling, weight change, numbness and walking difficulties. The team may ask someone close to you about changes, with your permission. Scans and clinical assessments determine whether treatment is helping; symptoms alone cannot reliably distinguish treatment effects from the disease or another illness.

Common side effects and practical care

Cholesterol, triglycerides and weight

Blood fats often need treatment with a cholesterol-lowering medicine. This is not a failure of your diet or a reason to stop lorlatinib on your own. The pharmacist must choose a suitable medicine because interactions can make some options less effective. Keep taking prescribed treatment and attend repeat blood tests.

Weight gain can reflect several factors, including fluid retention and appetite changes. Record your weight if asked. A balanced eating plan and manageable activity may help, but rapid weight gain, increasing swelling or breathlessness needs clinical assessment rather than dietary changes alone.

Swelling and nerve symptoms

Swelling can affect the ankles, hands, face or other areas. Report increasing or uncomfortable swelling. Do not start water tablets or strongly restrict fluids yourself. Sudden one-sided leg swelling or new chest symptoms needs urgent assessment for other causes.

Peripheral neuropathy means symptoms from nerves outside the brain and spinal cord. You may notice tingling, numbness, burning, weakness or difficulty with buttons, balance or walking. Report these early. Use well-fitting shoes, check numb skin for injury and avoid testing hot water with an area that has reduced sensation. The team may adjust treatment if daily activities are affected.

Thinking, mood, speech and sleep

You may notice forgetfulness, reduced concentration, difficulty finding words, irritability, anxiety, low mood or a change in sleep. These can feel unsettling. Tell the team even when the change seems mild; do not assume it is simply stress, ageing or an unavoidable part of having cancer.

Keep a short record of when a symptom started and how it affects daily life. A family member may notice changes first. The team checks possible causes, reviews other medicines and decides whether lorlatinib needs a pause or reduction. Avoid driving or risky tasks when thinking, judgement, coordination or alertness is affected.

Tiredness, bowel symptoms and other changes

Balance rest with gentle activity. Ask for help with tasks that become difficult and report a sudden worsening of fatigue, especially with faintness or breathlessness. Small meals and prescribed treatments may help nausea or diarrhoea. Persistent diarrhoea, inability to drink or reduced urine needs advice.

Low red blood cells (anaemia) can cause fatigue, pallor or breathlessness; report these promptly. Constipation, rash and muscle or joint aches can also occur. Ask for suitable treatments; medicines bought without a prescription can still interact.

Report blurred or double vision, flashes of light or other new eyesight changes promptly. Sudden loss of vision needs immediate assessment. Avoid driving until the cause and safety have been assessed.

Important side effects to recognise

Severe changes in brain function or mental health

Lorlatinib can cause more serious effects including hallucinations, severe confusion, marked changes in behaviour, seizures and thoughts of self-harm. They can occur early or later during treatment. Seek immediate help if you hear or see things others do not, feel unsafe or have thoughts of harming yourself. If there is immediate danger, use emergency services, stay with a trusted person and do not remain alone while help is arranged.

A seizure, collapse, sudden weakness or severe confusion needs emergency assessment. Do not drive yourself. These symptoms need investigation even if they might also be explained by the cancer or another illness. The team may hold or permanently stop treatment according to severity; a severe event must not be followed by a self-directed restart.

Heart conduction and blood pressure

Lorlatinib can delay electrical conduction between the upper and lower heart chambers, called atrioventricular or AV block. Symptoms may include a slow pulse, dizziness, fainting, unusual tiredness or breathlessness. Some people have no symptoms and changes are found on an ECG. A treatment hold, dose reduction or a pacemaker may be needed.

European information also notes decreases in heart-pumping function in monitored patients, while stating that a causal relationship with lorlatinib cannot be established from the available data. New swelling with breathlessness or difficulty lying flat still needs prompt assessment.

Very high blood pressure may cause severe headache, visual change, chest pain or confusion. Seek urgent help for these symptoms and follow your team's plan for high home readings. Do not wait for a reading if you feel seriously unwell.

Lung inflammation

New or worsening cough, breathlessness or fever can indicate lung inflammation, also called pneumonitis or interstitial lung disease. Infection and cancer-related problems can look similar. Contact the team immediately; lorlatinib should be held while suspected treatment-related lung inflammation is assessed.

US instructions require permanent discontinuation for treatment-related pneumonitis of any severity. European instructions allow a carefully supervised restart at a lower dose after selected mild or moderate cases resolve, but require stopping for severe disease, recurrence or failure to recover within the stated treatment window. Your specialist applies the relevant guidance. Never restart tablets after a lung problem without explicit instructions.

High blood sugar and pancreatic problems

Lorlatinib can raise blood sugar, including in people without known diabetes. Increased thirst, frequent urination, blurred vision or unusual tiredness should be reported. Marked drowsiness, confusion, vomiting or rapid breathing needs emergency assessment. The team may prescribe diabetes treatment and, if control is inadequate, interrupt or stop lorlatinib.

Raised triglycerides and pancreatic enzymes are also relevant to pancreatitis, inflammation of the pancreas. Severe or persistent upper abdominal pain, especially radiating to the back with nausea or vomiting, needs urgent assessment. Do not try to manage it as ordinary indigestion.

Liver injury from a dangerous interaction

Strong enzyme-inducing medicines, such as rifampicin, carbamazepine, phenytoin and St John's wort, must not be combined with lorlatinib. This can cause severe liver injury as well as reducing lorlatinib exposure. The team must arrange an alternative and a sufficient interval before starting treatment when relevant. Do not stop an anti-seizure medicine suddenly on your own.

Yellow eyes or skin, dark urine, marked loss of appetite or unusual abdominal pain needs prompt advice. A pharmacist should review any newly prescribed medicine before you take it.

Other medicines and vaccinations

The interaction review is especially important with lorlatinib. Strong CYP3A enzyme inducers are prohibited. Strong inhibitors, including some antifungal and antiviral medicines, should generally be avoided or require a specialist dose change. Grapefruit and grapefruit juice should be avoided. Separating doses by a few hours does not reliably remove these interactions.

Current US guidance also advises avoiding fluconazole and moderate enzyme inducers where possible, with specific prescriber-led dose changes if unavoidable. European wording differs for some of these medicines. Do not apply a dose change found online without the oncology pharmacist checking the current local instructions.

Lorlatinib can reduce levels of other medicines, making them less effective. Important examples include hormonal contraceptives, some blood thinners, transplant medicines, certain pain medicines and heart medicines. Cholesterol treatment must also be selected with interactions in mind. Give every prescriber and your dentist an up-to-date list and the cancer team's contact details.

Ask before vaccinations. Non-live vaccines may be appropriate, although protection may be reduced depending on your overall treatment and immune function. Live vaccines require specific advice; do not use a generic fixed waiting period after treatment as a substitute for an individual plan.

Everyday life and caregiver support

A consistent daily routine, dose reminders and a written medicine list can help. If memory is affected, ask someone you trust to check the schedule with you. Do not take another tablet simply because you cannot remember whether a dose was taken; seek advice.

Changes in mood or behaviour can strain relationships. Explain to those close to you that a new change deserves medical review. Agree beforehand who can contact the team if they notice you behaving differently. Support should respect your preferences and independence while making it easier to obtain help.

Avoid driving, machinery, heights or other hazardous activities if you are dizzy, drowsy, confused, unsteady or affected by vision or concentration changes. Discuss driving after a seizure directly with the medical team. Alcohol may worsen judgement or drowsiness; ask about its use with your medicines.

Plan travel around blood tests and keep medicines protected according to the pack instructions. Ask for dietitian, physiotherapy or psychological support when symptoms interfere with daily life. Reporting a side effect helps your team keep treatment safe and give you the support you need.

Fertility, pregnancy and breastfeeding

Lorlatinib may harm a developing baby and can make hormonal contraception ineffective. If you can become pregnant, US information advises effective non-hormonal contraception during treatment and for at least six months afterwards. European information specifies highly effective non-hormonal contraception during treatment and for at least thirty-five days afterwards; if a hormonal method is unavoidable, a condom must be added.

For men with partners who can become pregnant, US information specifies effective contraception during treatment and for at least three months after the final dose. European instructions specify at least fourteen weeks and include condoms; condoms are also required when the partner is pregnant. These are genuine regional differences. Ask for a written plan for your product rather than choosing the shortest interval.

Do not breastfeed during treatment or for seven days after the last dose under both reviewed labels. Male fertility may be affected based on animal findings; ask about sperm preservation before treatment if relevant. Effects on female fertility are uncertain.

If pregnancy occurs or is suspected, contact the team promptly for individual advice. Do not stop contraception because periods become irregular, and do not change cancer treatment without medical guidance.

After a treatment pause or completion

Keep follow-up appointments for blood fats, glucose, blood pressure, heart findings and any unresolved neurological symptoms. Cholesterol or diabetes medicines may need adjustment as treatment changes, but do not stop them automatically with the last lorlatinib tablet.

Only restart after a pause when the team confirms the dose and timing. Some complications require permanent stopping. Continue reproductive precautions for the full prescribed interval, and return unused medicine safely.

Ask how response will be monitored and whom to contact if new symptoms appear. Support for memory, mood, nerve symptoms or mobility may still be useful after treatment changes.

Frequently asked questions