Ribociclib Tablets
Treats hormone receptor-positive HER2-negative breast cancer by inhibiting cyclin-dependent kinases 4 and 6 to halt cancer cell division and slow tumour growth.
- Category
- Oncology Support
- Active ingredient
- Ribociclib
- Route
- Oral use
- Form
- Film-coated tablet
- Strengths
- 200mg
The exact manufacturer offered is confirmed by the fulfilment partner before supply.
Prescription and consultation requirements for Ribociclib Tablets vary by destination and are determined by the fulfilment partner.
Ribociclib Tablets details
- Conditions
- Early Breast Cancer in Combination with An Aromatase Inhibitor for Adjuvant Treatment of Patients with Hormone Receptor-positive, Her2-negative Early Breast Cancer At High Risk of Recurrence · Hormone Receptor-positive, Her2-negative Locally Advanced or Metastatic Breast Cancer in Combination with An Aromatase Inhibitor as Initial Endocrine-based Therapy · Hormone Receptor-positive, Her2-negative Locally Advanced or Metastatic Breast Cancer in Combination with Fulvestrant as Initial Endocrine-based Therapy or Following Prior Endocrine Therapy
- Alternative names
- Kisqali
- Therapeutic class
- Protein kinase inhibitors; Cyclin-dependent kinase inhibitors
- Pharmacological class
- Cyclin-dependent kinase 4 inhibitor; Cyclin-dependent kinase 6 inhibitor
- Dosage forms
- Film-coated tablet
- Administration route
- Oral use
- Supply category
- Prescription-only medicine (POM)
- Storage instructions
- Store below 30°C. Keep in the original package to protect from moisture.
Contraindications
hypersensitivity to the active substance or to any excipient; hypersensitivity to peanut or soya
Precautions and warnings
neutropenia requiring complete blood count monitoring before and during treatment; hepatotoxicity requiring liver function test monitoring before and during treatment; qtc interval prolongation requiring ecg monitoring at baseline and during treatment; interstitial lung disease and pneumonitis presenting as acute respiratory distress; severe cutaneous adverse reactions including stevens-johnson syndrome and drug reaction with eosinophilia and systemic symptoms; infections including pneumonia and sepsis; dose reduction required with concomitant strong cyp3a4 inhibitors; avoid grapefruit and grapefruit juice during treatment; avoid concomitant use with strong cyp3a4 inducers; caution in patients with moderate to severe hepatic impairment; caution in patients with severe renal impairment; embryo-foetal toxicity based on mechanism of action
Minor side effects
neutropenia; leukopenia; nausea; fatigue; diarrhoea; alopecia; vomiting; constipation; headache; back pain; rash; pruritus; decreased appetite; stomatitis; abdominal pain; dyspnoea; cough; pyrexia; dizziness; insomnia; anaemia; thrombocytopenia; urinary tract infection; peripheral oedema; arthralgia; asthenia; abnormal liver function tests; dysgeusia; epistaxis; dry skin; vertigo; lymphopenia
Moderate side effects
febrile neutropenia; severe neutropenia with infection; interstitial lung disease; pneumonitis; qtc prolongation; torsades de pointes; severe hepatotoxicity; hepatic failure; stevens-johnson syndrome; drug reaction with eosinophilia and systemic symptoms; pneumonia; sepsis; venous thromboembolism; acute kidney injury; tumour lysis syndrome; syncope
Serious side effects
signs of febrile neutropenia including fever, chills, sore throat, mouth ulcers, requires immediate medical attention; signs of interstitial lung disease including persistent dry cough, shortness of breath, chest pain, requires immediate medical attention; signs of hepatotoxicity including jaundice, dark urine, right upper abdominal pain, severe fatigue, requires immediate medical attention; signs of severe cutaneous reactions including widespread rash, blistering, facial swelling, fever, requires immediate medical attention; signs of qtc prolongation including palpitations, dizziness, fainting, seizures, requires immediate medical attention; signs of sepsis including high fever, confusion, rapid breathing, rapid heart rate, requires immediate medical attention
Patient summary
Treats hormone receptor-positive HER2-negative breast cancer by inhibiting cyclin-dependent kinases 4 and 6 to halt cancer cell division and slow tumour growth.
Mechanism of action
Ribociclib is a targeted cancer medicine that belongs to a group called cyclin-dependent kinase 4 and 6 inhibitors. Inside breast cancer cells, proteins called cyclin-dependent kinases 4 and 6 help push the cells through their growth cycle so they can divide and multiply. Ribociclib blocks these proteins, effectively halting the cancer cells in their tracks and preventing them from replicating. It is always used together with hormone therapy medicines such as an aromatase inhibitor or fulvestrant, which deprive the cancer cells of the hormones that fuel their growth.
Drug interactions
ketoconazole; itraconazole; voriconazole; posaconazole; clarithromycin; telithromycin; ritonavir; indinavir; nelfinavir; saquinavir; rifampicin; carbamazepine; phenytoin; st. john's wort; tamoxifen; quetiapine; pimozide; ondansetron; amiodarone; disopyramide; procainamide; sotalol; chloroquine; halofantrine; grapefruit juice; midazolam; alfentanil; fentanyl; ciclosporin; tacrolimus; everolimus; sirolimus; simvastatin; atorvastatin; rosuvastatin; warfarin; apixaban; rivaroxaban
Age restrictions
Safety and efficacy in children and adolescents below 18 years have not been established.
Pregnancy and breastfeeding
Ribociclib should not be used during pregnancy unless the clinical condition requires treatment. Women of childbearing potential must use effective contraception during treatment and for at least 21 days after the last dose. Breast-feeding should be discontinued during treatment and for at least 21 days after the last dose. Ribociclib may impair fertility in males.
What you will receive
Ribociclib Tablets is a generic medicine sold under the name of its active ingredient, Ribociclib, rather than under a brand.
- The fulfilment partner confirms the offered manufacturer and product before supply.
- Check the active ingredient, strength, form and pack shown at checkout before confirming an order.