Ribociclib 200 mg film-coated tablets

What Ribociclib is used for:

• Ribociclib is used in women with a type of breast cancer called hormone receptor-positive,
• Human epidermal growth factor receptor 2-negative breast cancer that is locally advanced or has spread to other parts of the body (metastatic).
• It is used in combination with an aromatase inhibitor or fulvestrant, which are used as hormonal anticancer therapies.
• Ribociclib works by blocking proteins called cyclin-dependent kinases 4 and 6, which are important for the growth and division of cells.
• Blocking these proteins can slow down the growth of cancer cells and delay the progression of your cancer.

Do not take Ribociclib:

• if you are allergic to Ribociclib, peanut, soya or any of the other ingredients of this medicine.

Warnings & Precautions:

• Talk to your doctor or pharmacist before taking Ribociclib:
• If you have a fever, sore throat or mouth ulcers due to infections (signs of a low level of white blood cells).
• If you have any problems with your liver or have previously had any type of liver disease.
• If you have or have had heart disorders or heart rhythm disorders.

Possible Side Effects: 

• These include tiredness, pale skin, sore throat, runny nose, fever, painful and frequent urination, reduced appetite, shortness of breath,
• Difficulty breathing, back pain, nausea (feeling sick), diarrhea or constipation, vomiting, mouth sores with gum inflammation (stomatitis),
• Abdominal (belly) pain, upset stomach, indigestion, heartburn (dyspepsia), hair loss or hair thinning (alopecia), rash, itching (pruritus),
• Tiredness (fatigue), weakness (asthenia), fever (pyrexia), headache, swollen hands, ankles or feet (peripheral oedema),
• Dizziness or light headedness, cough, sore throat, abdominal pain, spontaneous bleeding or bruising (signs of a low level of blood platelets), watering eyes, dry eyes,
• Reduced level of calcium in the blood, which may sometimes lead to cramps, reduced level of phosphate in the blood, strange taste in the mouth (dysgeusia), abnormal kidney blood test result, skin reddening (erythema) and spinning sensation (vertigo).

Other medicines and Ribociclib:

• Tell your doctor or pharmacist if you are taking: 
• Tamoxifen, another medicine for the treatment of breast cancer.
• Some medicines used to treat fungal infections, such as ketoconazole.
• Some medicines used to treat HIV/AIDS such as ritonavir, saquinavir, indinavir, lopinavir.
• Some medicines used to treat seizures or fits (anti-epileptics) such as carbamazepine and phenytoin.
• St. John’s Wort (also known as Hypericum perforatum) - a herbal product used to treat depression and other conditions.
• Some medicines used to treat heart rhythm problems or high blood pressure such as amiodarone, disopyramide, procainamide, quinidine, sotalol and verapamil.
• Antimalarials such as chloroquine.
• Antibiotics such as clarithromycin, telithromycin, moxifloxacin, rifampicin, ciprofloxacin, levofloxacin and azithromycin.
• Some medicines used for sedation or anaesthesia such as midazolam.
• Some medicines used as antipsychotics such as haloperidol.
• Medicines used to treat angina such as bepridil.
• Methadone, used to treat pain or addiction to opioids.
• Medicines like intravenous ondansetron, used to prevent nausea and vomiting caused by chemotherapy (treatment with cancer medicines).

How to take Ribociclib:

• Do not exceed the recommended dose prescribed by your doctor.
• The recommended starting dose of Ribociclib is 600 mg (3 tablets of 200 mg) once daily.
• Your doctor will tell you exactly how many tablets of Ribociclib to take.
• In certain situations, your doctor may instruct you to take a lower dose of Ribociclib, e.g. 400 mg (2 tablets of 200 mg) once daily or 200 mg (1 tablet of 200 mg) once daily.
• A treatment cycle lasts 28 days. Take Ribociclib once a day only on days 1 to 21 of a 28-day cycle.
• The outer carton of the Ribociclib pack includes a “calendar tool” which allows you to track your daily Ribociclib dose by marking off a circle for every tablet you take over the 28-day cycle.
• You should not take Ribociclib on days 22 to 28 of the cycle.
• It is very important to follow your doctor’s instructions.
• If you get certain side effects your doctor may ask you to take a lower dose, interrupt your treatment with Ribociclib, or stop it permanently.
• Take Ribociclib once daily at the same time each day, preferably in the morning. This will help you to remember to take your medicine.
• Ribociclib tablets should be swallowed whole (tablets should not be chewed, crushed or split before swallowing).
• Do not take a tablet that is broken, cracked or otherwise damaged.
• You should take Ribociclib once daily every day at the same time, preferably in the morning. You may take it with or without food.

How long to take Ribociclib:

• Take Ribociclib once a day on days 1 to 21 of a 28-day cycle.
• Continue Ribociclib treatment for as long as your doctor tells you to.

How to store Ribociclib:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and the blister.
• The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not take this medicine if you notice any damage to the packaging or if there are any signs of tampering.