Lorbriqua 100mg Tablet 15's is used for:

• ALK-positive metastatic non-small cell lung cancer (NSCLC): It is used to treat adults whose NSCLC has spread to other parts of the body and has been confirmed to be ALK-positive.

Before starting treatment, testing is performed to confirm that the tumour has an ALK alteration suitable for treatment with Lorlatinib.

Lorbriqua 100mg Tablet contains Lorlatinib, which blocks the activity of ALK, a protein that can help certain cancer cells grow and survive when it is abnormally activated.

By inhibiting ALK signalling, Lorlatinib can slow or stop the growth and spread of ALK-positive cancer cells. It can also act against certain ALK alterations that may develop during treatment with other ALK-targeted medicines.

Lorbriqua can interact with medicines that affect Cytochrome P450 3A (CYP3A), an enzyme that helps the body break down many medicines.

• Strong CYP3A inducers: Medicines such as rifampicin can significantly reduce Lorlatinib levels and may cause serious liver toxicity. These medicines should not be taken with Lorbriqua.

• Moderate CYP3A inducers: These may reduce Lorlatinib levels and should generally be avoided. If their use cannot be avoided, your doctor may adjust the Lorlatinib dose.

• Strong CYP3A inhibitors: Medicines such as itraconazole can increase Lorlatinib levels. Their use should generally be avoided or the Lorlatinib dose may need to be reduced.

• Fluconazole: Concomitant use should generally be avoided. If it cannot be avoided, your doctor may reduce the Lorlatinib dose.

• Other medicines affected by Lorlatinib: Lorlatinib can reduce the levels of certain CYP3A and P-glycoprotein (P-gp) substrates, which may reduce their effectiveness.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins and herbal supplements you take before starting Lorbriqua.

• Store Lorbriqua 100mg Tablet below 30°C.

• Keep it out of the sight and reach of children.

• Do not use the tablets after the expiry date printed on the pack.

• Do not use the medicine if the pack is damaged or shows signs of tampering.

• Store the tablets in their original pack as directed by your pharmacist.

Take Lorbriqua 100mg Tablet exactly as prescribed by your doctor.

The usual recommended dose is 100mg once daily, with or without food. Take it at approximately the same time each day.

Swallow the tablet whole with water. Do not chew, crush or split the tablet. Do not take a tablet that is broken, cracked or otherwise damaged.

If you miss a dose, take it when you remember unless your next dose is due within 4 hours. Do not take two doses at the same time to make up for a missed dose.

If you vomit after taking Lorbriqua, do not take an additional tablet. Take the next dose at the usual scheduled time.

Your doctor may reduce the dose to 75mg once daily and then to 50mg once daily if you develop certain side effects. Do not change the dose or stop treatment on your own.

Common side effects

• Swelling or oedema

• Weight gain

• Peripheral neuropathy

• Changes in thinking or memory

• Fatigue

• Diarrhoea

• Shortness of breath

• Joint pain

• High cholesterol

• High triglycerides

• Mood changes

• Cough

• Nausea

• Constipation

• Vomiting

• Headache

• Dizziness

• High blood pressure

• Vision changes

• Muscle pain

• Back pain

• Reduced appetite

• Fever

• Rash

Some of these effects may be detected through blood tests, particularly increases in cholesterol, triglycerides, blood sugar or liver enzymes.

Serious side effects

• Central nervous system effects: Seizures, severe changes in thinking, confusion, hallucinations, significant mood changes or changes in speech may occur.

• Interstitial lung disease/pneumonitis: This can cause serious or life-threatening inflammation of the lungs.

• Heart rhythm problems: Lorbriqua can cause atrioventricular (AV) block, which affects the electrical conduction of the heart.

• Severe liver toxicity: The risk is particularly important when Lorlatinib is taken with strong CYP3A inducers.

• Severe hyperlipidaemia: Marked increases in cholesterol or triglycerides may require treatment or a change in the Lorbriqua dose.

• Severe hypertension: Blood pressure can become significantly elevated during treatment.

• Severe hyperglycaemia: Lorbriqua can cause or worsen high blood sugar.

• Severe allergic reactions: Seek urgent medical attention if you develop swelling, breathing difficulty or other signs of a serious allergic reaction.

Contact your doctor promptly if you develop new breathing problems, severe neurological or mood changes, fainting, chest symptoms, severe headache or other unusual symptoms.

• Take Lorbriqua 100mg Tablet at the same time each day to maintain a consistent treatment schedule.

• Do not stop treatment or change the dose without your oncologist's advice.

• Your doctor may regularly monitor cholesterol and triglyceride levels, as increases are common with Lorlatinib.

• Blood pressure and blood sugar should also be monitored during treatment.

• Your doctor may perform an ECG to monitor your heart rhythm, particularly if you have cardiac risk factors.

• Report new or worsening cough, breathlessness or fever immediately because these may indicate lung inflammation.

• Tell your doctor about every medicine, supplement or herbal product you take before starting or while receiving Lorbriqua.

• Avoid grapefruit or grapefruit juice unless your doctor specifically advises that it is safe, as grapefruit can affect the metabolism of Lorlatinib.

• If you develop cognitive, mood, speech or sleep changes, inform your doctor rather than adjusting the dose yourself.