Warnings and precautions
Talk to your doctor before taking CALQUENCE Tablets if you:
- have recently undergone surgery or are about to undergo surgery. Your doctor may stop treatment with CALQUENCE Tablets before a medical, surgical or dental procedure.
- have a bleeding disorder.
- have an infection.
- have liver problems.
- have or had a liver infection (hepatitis B), so that your doctor can look out for signs of reactivation of this infection, such as fever, chills, weakness, confusion, vomiting and jaundice (yellowing of the skin or eyeballs).
- have or had heart rhythm problems.
- are pregnant or planning to become pregnant.
- are breast-feeding or planning to breast-feed.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking CALQUENCE Tablets. When you take CALQUENCE Tablets, you can have some serious side effects. If you have any of the following, call or see your doctor right away. Your doctor may tell you to decrease your dose, temporarily stop, or completely stop taking CALQUENCE Tablets if you have certain side effects.
- bleeding problems (haemorrhage). Signs and symptoms may include black stools or stools with blood, pink or brown urine, nosebleeds, bruising, unexpected bleeding, vomiting or coughing up blood, dizziness, weakness, confusion, changes in your speech, or headache lasting a long time.
- infections (bacterial, viral, or fungal). Signs and symptoms may include fever or chills, or flu-like symptoms.
- decreased number of blood cell counts. These may be a decreased number of red blood cell counts, decreased number of low white blood cell counts, or decreased number of cells that help blood clot (platelets). Your doctor will check your blood cell counts as needed during treatment with CALQUENCE Tablets.
- second primary cancers. Other cancers may happen during treatment with CALQUENCE Tablets, including cancers of the skin.
- heart rhythm problems (atrial fibrillation or atrial flutter). Signs and symptoms may include fast or abnormal heartbeat, dizziness, feeling faint, chest discomfort, or shortness of breath.
Children and Adolescents
The safety and efficacy of CALQUENCE Tablets has not been established in children or adolescents. Do not give this medicine to children or adolescents aged less than 18 years.
Pregnancy
Talk to your doctor before taking CALQUENCE Tablets if you are pregnant, think you may be pregnant or are planning on having a baby. This is because CALQUENCE Tablets may harm your unborn baby. If you are pregnant, you should not take CALQUENCE Tablets. You should not get pregnant while you are taking this medicine.
Breastfeeding
Before taking CALQUENCE Tablets, tell your doctor if you are breast-feeding. It is not known if CALQUENCE Tablets passes into your breast milk. Do not breast-feed during treatment with CALQUENCE Tablets and for 2 days after your final dose of CALQUENCE Tablets.
Driving and using machines
CALQUENCE Tablets is unlikely to affect the ability to drive and use machines. However, if you feel dizzy, weak or tired while taking CALQUENCE Tablets, take special care when driving or using machines.
Taking other medicines
Tell your doctor and pharmacist if you are taking or have recently taken any other medicines, including medicines not prescribed, herbal medicines, and supplements. CALQUENCE Tablets may make you bleed more easily. This means you should tell your doctor if you take other medicines that increase your risk of bleeding. This includes:
- acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs)
- medicines used to prevent blood clots, such as antiplatelet therapy or blood thinners
Some medicines can affect the levels of CALQUENCE Tablets in your body. Also, CALQUENCE Tablets can affect the way some other medicines work. Tell your doctor if you are taking any of the following:
- antibiotics used to treat bacterial infections (e.g. clarithromycin)
- medicines to treat fungal infections (e.g. posaconazole, ketoconazole, itraconazole, voriconazole)
- medicines used to treat HIV infections (e.g. indinavir)
- medicines used to treat hepatitis C (e.g. telaprevir)
- rifampin, an antibiotic used to treat bacterial infections
- medicines used to prevent seizures or to treat epilepsy (e.g. carbamazepine, phenytoin)
- St. John’s wort, a herbal medicine, used for instance to treat depression
- methotrexate, a medicine used to treat immune disorders
Tell your doctor or pharmacist if you take any of these or any other medicines. The medicines listed here may not be the only ones that could interact with CALQUENCE Tablets.
