RIBOCICLIB
Background and Date of Approval
Ribociclib is an anticancer medication containing the active ingredient ribociclib. It is used primarily in women with hormone receptor-positive, HER2-negative breast cancer that is locally advanced or has metastasized to other parts of the body. It may also be used for the treatment of endometrial cancer in combination with other medications. Ribociclib is generally administered as part of a combination treatment regimen.
The medication works by inhibiting specific proteins involved in the regulation of cell growth and division. By blocking these proteins, ribociclib helps slow or prevent the proliferation of cancer cells. It is not recommended for use in children or adolescents younger than 18 years.
Ribociclib was developed by Novartis Pharmaceuticals and received approval from the U.S. Food and Drug Administration (FDA) on March 13, 2017. Its initial approval was for use with an aromatase inhibitor as first-line endocrine-based therapy in postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
Before starting treatment, patients should inform their healthcare provider about any signs of infection, such as fever, mouth ulcers, or sore throat, as well as any history of liver or heart problems. Allergies to peanut or soya should also be disclosed. Grapefruit and grapefruit juice should be avoided during treatment because they may affect the medication. Ribociclib should not be used in individuals with a known hypersensitivity or allergy to the drug or any of its ingredients.
Uses
Ribociclib is a medication used to treat certain types of breast cancer. Ribociclib is used in combination with other anticancer medications to treat advanced or metastatic (cancer that can spread to other regions of the body) breast cancer. It can also be used in combination with fulvestrant for women who have gone through menopause and have metastatic breast cancer.
How is it administered?
Ribociclib is usually taken orally, with or without food. The tablets should be swallowed whole with a glass of water and not crushed, chewed or broken. The dosage and frequency of Ribociclib will depend on a variety of factors, including the patient's age, weight, overall health, and the type and stage of cancer being treated. It's important to follow the dosing instructions provided by a healthcare provider, and not to adjust the dosage or frequency without consulting with them first.
Side Effects
Ribociclib can cause several side effects, which may vary in severity from person to person. Some common side effects include fatigue, nausea, vomiting, diarrhea, decreased appetite, and hair loss. Other possible side effects may include low white blood cell count, infections, fever, headache, dizziness, and abnormal heart rhythm. In rare cases, it may cause severe allergic reactions or liver damage.
Warnings
Ribociclib comes with several warnings and precautions that patients and healthcare providers should be aware of. It can harm a developing foetus or nursing infant. It can cause liver damage or dysfunction, so it is important to monitor liver function regularly during treatment. It can cause diarrhoea, which can lead to dehydration and electrolyte imbalances. It can also suppress the immune system, increasing the risk of infections.
Precautions
To ensure the safe use of Ribociclib, patients should inform their healthcare provider of any medical conditions they have, disclose all medications they are taking, avoid exposure to sunlight and tanning beds, use sunscreen and wear protective clothing when outdoors, and stay hydrated by drinking plenty of fluids. You should not drink grapefruit juice or eat grapefruits during the treatment with this Tablet. Pregnancy and breastfeeding should be avoided during treatment with this medication can it can cause harm to developing foetus. It is important to follow these precautions to reduce the risk of potential side effects and to ensure that it is effective in treating the intended condition. It can interact with other medications, so it is important to inform your healthcare provider about all your medications, supplements, and herbal products.
Word of Advice
If you have been prescribed Ribociclib or another medication, take it exactly as directed by your healthcare provider. Report any side effects, unusual symptoms, or health concerns promptly, as Ribociclib can cause serious side effects and requires regular monitoring.
Avoid alcohol while taking this medicine and follow all safety precautions recommended by your healthcare provider. Attend all scheduled appointments and follow-up visits so that your treatment response can be monitored and any side effects can be managed appropriately. With proper monitoring, Ribociclib can be an effective treatment for certain types of cancer.
If you miss a dose, take it as soon as you remember unless it is less than 6 hours before your next scheduled dose. If it is within 6 hours of the next dose, skip the missed dose and continue with your usual schedule. Do not take an extra or double dose to make up for a missed one.
Avoid pregnancy and breastfeeding while taking Ribociclib. Use effective contraception during treatment and for at least 3 weeks after your final dose. Stay adequately hydrated and promptly inform your healthcare provider if you experience any concerning reaction or symptoms.
References
Novartis Pharmaceuticals UK Ltd, Electronic medicines compendium (emc), [Revised on 18 Jan 2023], [Accessed on 29th March 2023], https://www.medicines.org.uk/emc/product/8110/smpc Novartis Pharmaceuticals, U. S National Library of Medicine, [ Revised on Dec 2022] [Accessed on 28th March 2023], https://clinicaltrials.gov/ct2/show/NCT03701334 Novartis Pharmaceuticals Corporation, U.S. Food and Drug Administration. Highlights of Prescribing Information: Ribociclib. [Last revised 2017], [Accessed on 29th March 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf Vincent T. DeVita Jr., Theodore S. Lawrence, Steven A. Rosenberg, Cancer Chemotherapy: Principles and Practice Authors, 10th Edition, 2020, 993-994
Frequently Asked Questions
Can Ribociclib cause infertility or affect fertility in women?
Ribociclib may affect fertility in women, and it is recommended to use effective contraception during treatment and for at least 21 days after the last dose of Ribociclib. It is unclear whether Ribociclib can cause permanent infertility in women.
Can men take Ribociclib?
Ribociclib is not approved for use in men and has only been studied in women with advanced breast cancer.
Is Ribociclib used for?
Ribociclib is primarily used to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
Can Ribociclib cure breast cancer?
Ribociclib is not a cure for breast cancer but can help to slow the progression of the disease and improve survival rates in certain cases.
What are the signs and symptoms of liver damage associated with Ribociclib?
Liver damage is a rare but serious side effect of Ribociclib. Signs and symptoms of liver damage may include yellowing of the skin or eyes (jaundice), dark urine, pale stools, abdominal pain, nausea, vomiting, fatigue, or loss of appetite.
Are there any lifestyle changes I should make while taking Ribociclib?
Yes, it is important to maintain a healthy lifestyle while taking Ribociclib, including eating a balanced diet, getting regular exercise, and avoiding smoking and excessive alcohol consumption.
Can Ribociclib be used in combination with other cancer treatments?
Yes, Ribociclib is often used in combination with other cancer treatments, such as chemotherapy, radiation therapy, or hormonal therapy, to treat breast cancer. However, the specific treatment plan may vary depending on the individual patient's condition and response to treatment.
What Foods to Avoid while Taking Ribociclib?
Ribociclib tablets can be taken with or without food. However, do not eat grapefruit (or drink grapefruit juice), pomelos, star-fruit, or Seville oranges during your treatment with Ribociclib. These foods may change the way Kisqali is absorbed into your body.