Yulareb 50 mg/100 mg/150 mg/200 mg Film-Coated Tablets

YULAREB is a cancer medicine containing the active substance abemaciclib and is used:

• in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer with a high risk of coming back.
• in combination with an aromatase inhibitor as the first endocrine-based therapy to treat women who have gone through menopause (postmenopausal), and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has worsened or that has spread to other parts of the body (metastatic).
• in combination with fulvestrant to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has worsened or that has spread to other parts of the body (metastatic) and whose disease has progressed after endocrine therapy.
• In pre- or perimenopausal women, the treatment should be combined with a Luteinising hormone-releasing hormone (LHRH) agonist (a medicine that cause the ovaries to stop making oestrogen and progesterone).
• alone to treat post-menopausal women with HR-positive, HER2-negative breast cancer that has worsened or that has spread to other parts of the body (metastatic) and whose disease has progressed after endocrine therapy and prior chemotherapy.

When YULAREB is used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, also read the Patient Information of the prescribed product. Ask your healthcare provider if you are not sure.

Do not take YULAREB if you are hypersensitive (allergic) to abemaciclib or any of the other ingredients of YULAREB (listed in section 6). If you are currently taking a medicine containing ketoconazole (a medicine used to treat fungal infections). If you are pregnant or are breastfeeding your infant.

Warnings and precautions

Take special care with YULAREB:

• if you develop diarrhoea, it may lead to dehydration and infection.
• if you have fever, chills, or any other signs of an infection.
• if you have liver problems.
• if you are pregnant or plan to become pregnant. YULAREB can harm your unborn baby.
• if you are breastfeeding or plan to breastfeed.
• if you develop pain, swelling and tenderness in one of your legs (usually the calf) contact your health care professional.
• if you have been diagnosed with interstitial lung disease (symptoms may include changes in skin colour, confusion, cough, shortness of breath).
• if you are also receiving hormone therapies, as this can cause blood clots in your arteries.

Other medicines and YULAREB

Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines). Your dose of YULAREB might need to be changed if you are also using other medicines that affect the breakdown of YULAREB such as, clarithromycin (an antibiotic), rifampicin (used in treatment of tuberculosis), digoxin (used for heart disorders). Do not use ketoconazole while taking YULAREB.

YULAREB with food and drink

YULAREB may be taken with or without food. Avoid grapefruit and grapefruit juice.

Pregnancy, breastfeeding and fertility

YULAREB can harm your unborn baby and you must not take it while you are pregnant or trying to become pregnant. If you are able to become pregnant, your healthcare provider must do a pregnancy test before you start treatment with YULAREB. Females who can become pregnant should use effective birth control during treatment with YULAREB and for at least 3 weeks after the last dose of YULAREB. Do not breastfeed during treatment with YULAREB and for at least 3 weeks after the last dose of YULAREB. YULAREB may impair fertility in males. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Driving and using machines

The adverse effects of YULAREB may impair your driving ability and your ability to handle machines, e.g., dizziness, diarrhoea, vomiting.

YULAREB contains lactose

Patients with the rare hereditary conditions of lactose or galactose intolerance should not take YULAREB.

YULAREB contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Do not share medicines prescribed for you with any other person. Always take YULAREB exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your healthcare provider may change your dose if needed. Do not stop taking YULAREB or change the dose without talking to your healthcare provider. YULAREB may be taken with or without food.

Swallow YULAREB tablets whole. Do not chew, crush, or split the tablets before swallowing. Do not take YULAREB tablets if they are broken, cracked, or damaged.

If you take more YULAREB than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take YULAREB

If you miss or vomit a dose of YULAREB, take your next dose at your regular time. Do not take 2 doses of YULAREB at the same time to make up for the missed dose.

YULAREB can have side effects. Not all side effects reported for YULAREB are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking YULAREB, please consult your doctor, pharmacist or other healthcare professional for advice. Contact your doctor immediately if you experience any of the following:

• Symptoms such as chills or fever. These could be a sign of low white blood cell counts (which may affect more than 1 in 10 people) and should be treated immediately. If you have cough, fever and difficulty breathing or chest pain, this could be a sign of lung infection. Serious or life-threatening infections are uncommon (may affect up to 1 in 100 people).
• Painful swollen leg, chest pain, shortness of breath, rapid breathing or rapid heart rate as these can be signs of blood clots in the vein (which may affect up to 1 in 10 people).
• Diarrhoea (which may affect more than 1 in 10 people).

Refer to Section 2 for more information on any of the possible effects listed above. Other side effects with YULAREB may include:

Very common side effects

(may affect more than 1 in 10 people):

• nausea (feeling sick), vomiting
• infections
• reduction in red blood cells (anaemia) (pale skin, tiredness, noticeable heartbeats, shortness of breath)
• decreased appetite
• inflammation or sore mouth
• alteration in sense of taste
• hair loss, rash, itching
• tiredness
• dizziness
• reduction in white blood cell counts (leukopenia)
• reduction in platelet count (thrombocytopenia)
• headache
• abnormalities in liver blood tests

Common side effects

(may affect up to 1 in 10 people):

• watering eyes
• muscular weakness
• dry skin
• inflammation of the lungs which causes breathlessness, cough and raised temperature
• indigestion or upset stomach, abdominal pain
• nail disorders such as breaking or splitting of nails

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of YULAREB. Alternatively, report suspected adverse reactions to the company at [email protected].

Store at or below 30 °C. Store all medicines out of reach of children. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).