Abemaciclib - Oral

Abemaciclib is used on its own or together with other medicines to treat certain types of breast cancer for those who have failed previous therapy or whose tumour has spread to other parts of the body.

Take Abemaciclib exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

You may take this medicine with or without food. Try to take it at the same time each day.

Swallow it whole. Do not divide, chew or crush the tablet.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the treatment timeframe depending on your condition and response to the medication.

Abemaciclib must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.

If you miss a dose or vomit after taking Abemaciclib, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

If you often forget to take your medicine, let your doctor and pharmacist know.

Inform your doctor if you have the following conditions:

• severe liver disease
• severe kidney disease

It is important that you do not get pregnant while being treated with this medicine. You must use proven birth control methods during Abemaciclib therapy and 3 weeks after stopping the treatment. You may wish to discuss birth control methods with your doctor or pharmacist.

Do not breastfeed while you are being treated with this medicine and for 3 weeks after the last dose.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy test and hepatitis B virus screening must be done before treatment, to know if this medicine is suited for you to take.
• Routine tests (e.g. complete blood count, platelet counts, liver function test) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring of signs and symptoms of diarrhoea and dehydration may also be needed.

Abemaciclib may cause dizziness or tiredness. If affected, do not drive or take part in any activity in which you need to be alert.

Other side effects include any of the following: headache, nausea, vomiting, abdominal pain, constipation, mouth sore, fever, decreased appetite, joint pain, muscle weakness, altered taste, hair loss, dry skin, skin rash or itch.

You may experience diarrhoea while being treated with this medicine. Drink lots of water to replace the fluids lost. However, if you have severe diarrhoea or diarrhoea accompanied by severe stomach cramps or bloody stools, alert your doctor immediately.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• frequent sore throat, mouth sores, fever, chills or sweating
• signs and symptoms of lung problems e.g. difficulty breathing, new or worsening of cough, fever
• signs and symptoms of blood clots e.g. shortness of breath, chest pain, cough which may contain blood; pain, swelling and tenderness in your leg accompanied by redness and warmth
• yellowing of the skin or eyes, stomach pain, dark coloured urine, tiredness, swelling in the legs and ankles

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Inform your doctor and pharmacist if you are taking any of these medicines:

• clarithromycin (certain antibiotic)
• medicines to treat fungal infection e.g. itraconazole, ketoconazole, posaconazole, voriconazole
• medicines for HIV infection e.g. lopinavir, ritonavir
• medicines for epilepsy (fits or seizures) e.g. carbamazepine, phenytoin
• rifampicin (medicine to treat TB [lung infection known as tuberculosis])
• St. John's wort (herbal medicine)

This list does not include all medicines that may interact with Abemaciclib.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Avoid excessive consumption of grapefruit or grapefruit juice (more than 1 litre a day).

Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.

As this is a cancer medicine, always return any unused or expired tablet to the clinic, hospital or pharmacy for disposal. Do not throw it away in the household waste.