Palbociclib - Oral

Palbociclib is used together with other medicines to treat individuals with certain types of breast cancer that have spread to other parts of the body.

Take Palbociclib 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.

This medicine is available as a tablet or capsule.

If you are taking the tablet, you may take it with or without food. Swallow the tablet whole. Do not chew, crush or split the tablet.

If you are taking the capsule, take it with food or immediately after a meal. Swallow the capsule whole. Do not chew, crush or open the capsule.

Try to take it at the same time each day.

If you vomit after taking this medicine, do not repeat the dose. Take the next dose at your normal scheduled time.

Palbociclib is usually taken for 21 days followed by a 7-day rest period when no medicine is taken. This is a one "cycle" of treatment. Your doctor will tell you how many treatment cycles you will need to complete. Follow your doctor's instructions carefully. Always ask your doctor if you are not sure how to take your medicine.

If you missed a dose of Palbociclib, 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.

Do not take this medicine if you are pregnant or planning to have a baby soon. If you become pregnant while being treated with Palbociclib, alert your doctor immediately. This medicine may cause harm to your unborn child.

It is important that you do not get pregnant while taking this medicine. Both women and their male partners must use proven birth control methods during Palbociclib therapy and for at least 3 weeks (in women) or 14 weeks (in men) after stopping the treatment. You may wish to discuss other reliable methods of birth control with your doctor.

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

Inform your doctor if you have the following conditions:

• moderate to severe liver disease
• moderate to severe kidney disease

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 tests must be done before treatment to know if Palbociclib is suited for you to take.
• Routine blood tests (e.g. complete blood count) 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 for signs and symptoms of blood clot formation, lung problems or infections may also be needed.

Palbociclib may cause any of the following side effects: nausea, vomiting, diarrhoea, decreased appetite, sore or swollen mouth, blurred vision, dry eyes, change in the sense of taste, nosebleed, weakness, hair loss, dry skin and rash.

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

• signs and symptoms of blood clot in the leg veins e.g. pain, swelling and tenderness in your leg accompanied by redness and warmth
• signs and symptoms of blood clot in the lungs e.g. shortness of breath, chest pain, cough which may contain blood
• signs and symptoms of lung inflammation e.g. chest pain, cough with or without mucus, difficulty breathing

This medicine may cause the level of your red blood cells, white blood cells and platelets to drop.

Red blood cells carry oxygen around your body. A fall in the level of red blood cells may make you feel tired and worn out.

White blood cells help your body to fight infections. A fall in the level of your white blood cells may put you at higher risk for infections, such as coughs, colds and flu, which may lead to more serious infections. Avoid crowded places and people who are sick. Inform your doctor if you have a fever, cough, or flu that does not go away.

Platelets help your blood to clot when there is a cut in the skin. A fall in the level of your platelets may put you at risk of bleeding more than usual. Do not take part in activities where you may fall or get injured, such as contact sports. Inform your doctor if you get any unusual bruising (large bruises or several bruises, especially if the bruises appeared on their own) or bleeding that takes a long time to stop (for example, too much bleeding when you floss or brush your teeth).

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:

• medicines to treat fungal infection e.g. itraconazole, ketoconazole
• medicines for HIV infection e.g. indinavir, lopinavir, ritonavir
• medicines used in organ transplant or certain immune disorders e.g. ciclosporin, tacrolimus
• medicines for epilepsy (fits or seizures) e.g. phenytoin, carbamazepine
• certain antibiotics e.g. clarithromycin, telithromycin
• quinidine (medicine for irregular heartbeat)
• fentanyl (strong painkiller)
• 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 Palbociclib.

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.

Protect the tablet from moisture.

Medicines must not be used past the expiry date.