Kryxana 200mg Tablet contains ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor used to treat certain types of hormone receptor (HR)-positive, HER2-negative breast cancer.

It is used in combination with hormonal therapy for adults with HR-positive, HER2-negative early breast cancer at high risk of recurrence and for locally advanced or metastatic breast cancer. The treatment regimen and dose depend on the stage of breast cancer and the hormonal medicine used alongside ribociclib.

Kryxana should be taken under the supervision of an oncologist. Regular blood tests, liver function tests and ECG monitoring may be required during treatment.

Kryxana 200mg Tablet is used for:

• HR-positive, HER2-negative early breast cancer: As adjuvant treatment in adults with early breast cancer at high risk of recurrence, in combination with an aromatase inhibitor.

• HR-positive, HER2-negative locally advanced or metastatic breast cancer: In combination with an aromatase inhibitor or fulvestrant as endocrine-based treatment.

In premenopausal or perimenopausal women and in men, the hormonal treatment is combined with a luteinising hormone-releasing hormone (LHRH) agonist as appropriate.

Kryxana contains ribociclib, which blocks the activity of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6).

CDK4 and CDK6 help regulate the cell cycle and allow cells to progress from one stage of growth to another. By inhibiting these enzymes, ribociclib can slow the division and multiplication of cancer cells.

Ribociclib is used alongside hormonal therapy because HR-positive breast cancer growth is also driven by hormone signalling.

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

• Strong CYP3A4 inhibitors: Medicines such as clarithromycin, itraconazole, ketoconazole, ritonavir and voriconazole can increase ribociclib levels and the risk of side effects. Their use should generally be avoided or managed with an appropriate dose adjustment.

• Strong CYP3A4 inducers: Medicines such as rifampicin, phenytoin and carbamazepine can reduce ribociclib levels and may reduce its effectiveness. These combinations should generally be avoided.

• QT-prolonging medicines: Ribociclib can prolong the QT interval. Medicines that also prolong the QT interval, including certain anti-arrhythmics and some antibiotics, may increase the risk of abnormal heart rhythms.

• CYP3A4 substrates: Ribociclib can increase the levels of some medicines metabolised by CYP3A4. Your doctor may need to adjust or avoid certain medicines.

• Grapefruit and grapefruit juice: These can increase exposure to ribociclib and should be avoided during treatment.

Tell your doctor before taking any new medicine, including medicines for infections, heart conditions or seizures.

• Store Kryxana 200mg Tablet in its original packaging.

• Protect the tablets from moisture.

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

• No special temperature storage conditions are required for ribociclib tablets under the current product information.

• Do not use tablets if the packaging is damaged or the tablets are broken or cracked.

Take Kryxana 200mg Tablet exactly as prescribed by your oncologist.

The dose depends on the type of breast cancer being treated:

• Early breast cancer: The recommended dose is 400mg once daily, equivalent to two 200mg tablets, for 21 consecutive days followed by 7 days without treatment. This forms a 28-day cycle.

• Advanced or metastatic breast cancer: The recommended dose is 600mg once daily, equivalent to three 200mg tablets, for 21 consecutive days followed by 7 days without treatment.

For early breast cancer, treatment may continue for up to 3 years unless the cancer returns or treatment needs to be stopped because of side effects. For advanced or metastatic breast cancer, treatment generally continues while the medicine is providing clinical benefit and side effects remain manageable.

Take the tablets once daily at approximately the same time, preferably in the morning. They may be taken with or without food.

Swallow the tablets whole with water. Do not crush, chew or split them.

If you vomit after taking a dose or miss a dose, do not take an additional dose on the same day. Take the next prescribed dose at the usual time.

Do not change the dose or stop treatment without medical advice.

Common side effects may include:

• Neutropenia and other changes in blood cell counts

• Infections

• Nausea

• Headache

• Fatigue

• Diarrhoea

• Constipation

• Vomiting

• Hair loss

• Rash or itching

• Cough

• Abnormal liver function tests

• Back pain

• Reduced appetite

The pattern of side effects can vary depending on whether ribociclib is being used for early or advanced breast cancer and which hormonal medicine is given alongside it.

Serious side effects

Seek medical attention promptly if you develop:

• Fever or signs of infection, particularly with a low white blood cell count

• Liver problems, such as yellowing of the skin or eyes, dark urine or severe persistent nausea

• Heart rhythm problems, including fainting, dizziness or a fast or irregular heartbeat

• Lung problems, such as new or worsening cough, shortness of breath or difficulty breathing

• Severe skin reactions, including widespread rash, blistering or peeling of the skin

Your doctor may temporarily interrupt treatment, reduce the dose or discontinue ribociclib if significant side effects occur.

• Take Kryxana exactly as prescribed and follow the 21-days-on, 7-days-off treatment schedule.

• Do not take an extra tablet if you miss a dose or vomit after taking your dose.

• Attend all scheduled blood tests and ECG appointments. Blood counts, liver function and heart rhythm may need regular monitoring.

• Report fever promptly because ribociclib can cause neutropenia and increase the risk of infections.

• Avoid grapefruit and grapefruit juice during treatment.

• Tell your doctor about every medicine, supplement and herbal product you take because ribociclib has several clinically important interactions.

• Report new cough or breathing difficulty promptly because ribociclib can rarely cause interstitial lung disease or pneumonitis.

• Do not stop ribociclib or your accompanying hormonal treatment without consulting your oncologist.