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Introduction About XOLIMUS 10 TABLET
XOLIMUS 10 TABLET contains Everolimus which belongs to the group of medicines called Anticancer agents. It is used to manage hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other managements, advanced tumours called neuroendocrine tumours that originate from the stomach, bowels, lung or pancreas, advanced kidney cancer (advanced renal cell carcinoma), where other managements (VEGF-targeted therapy) have not helped stop your disease.
Before taking XOLIMUS 10 TABLET, inform your doctor if you have or ever had liver problems, diabetes, need to receive a vaccine, high cholesterol, recent major surgery or unhealed wound, an infection, hepatitis B, and are about to receive radiation therapy. XOLIMUS 10 TABLET is not recommended to use in children and adolescents (under 18 years of age). Consult your doctor before taking the medicine.
XOLIMUS 10 TABLET should be used with caution in elder patients (65 years and above). XOLIMUS 10 TABLET is generally not recommended for use among pregnant and breastfeeding women. The most common side effects of taking XOLIMUS 10 TABLET are fever, cough, difficulty breathing, wheezing, swelling, feeling of heaviness or tightness, pain. Contact your doctor for advice if any of the symptoms worsen.
Uses Of XOLIMUS 10 TABLET
It is used to manage adult patients with:
- hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other managements (non-steroidal aromatase inhibitors) no longer keep the disease under control
- advanced tumours called neuroendocrine tumours that originate from the stomach, bowels, lung or pancreas
- advanced kidney cancer (advanced renal cell carcinoma)
How XOLIMUS 10 TABLET Works
XOLIMUS 10 TABLET reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.
How to use XOLIMUS 10 TABLET
Take XOLIMUS 10 TABLET as advised by your physician. Swallow the medicine with enough water. Do not crush or chew the XOLIMUS 10 TABLET. The correct dose and duration will be decided by your physician for you depending on your age, body weight, and disease condition.
Side Effects Of XOLIMUS 10 TABLET
Common
- signs of infection (increased temperature, chills)
- signs of inflammation of the lung (fever, coughing, difficulty breathing, wheezing)
- signs of diabetes (excessive thirst, high urine output, increased appetite with weight loss, tiredness)
- bleeding
- severely decreased urine output
- loss of appetite, weight loss
- disturbed taste (dysgeusia)
- headache
- nose bleeds
- cough
- mouth ulcer
- upset stomach
- nausea
- diarrhea
- skin rash, itching (pruritus)
- feeling weak or tired
- anemia (tiredness, breathlessness, dizziness, pale skin, signs of low level of red blood cells)
- edema (swelling of arms, hands, feet, ankles, or other parts of the body)
- hypercholesterolemia (high level of lipids)
- spontaneous bleeding or bruising
- breathlessness
- signs of dehydration (thirst, low urine output, dark urine, dry flushed skin, irritability)
- insomnia
- lymphoedema (signs include swelling of part or all arm, feeling of heaviness, restricted movement, discomfort
- low level of white blood cells, leukopenia, lymphopenia, and/or neutropenia (signs include fever, sore throat, mouth ulcers due to infections)
- inflammation of the inner lining of the mouth, stomach, gut
- dry mouth
- heartburn
- vomiting
- difficulty in swallowing
- abdominal pain
- acne
- hand-foot syndrome (signs include rash and pain on the palms of the hands or soles of feet)
- erythema (reddening of the skin)
- joint pain
- pain in the mouth
- menstruation disorders such as irregular periods
- dry skin, skin exfoliation, skin lesions
- nail disorders, breaking of your nails
- mild loss of hair
- elevated liver enzymes (increased alanine and aspartate aminotransferase)
- elevated creatinine levels
- swelling of the eyelid
- protein in the urine
Uncommon
- hepatitis B reactivation (signs include fever, skin rash, joint pain, and inflammation, as well as tiredness, loss of appetite, nausea, jaundice, pain in the upper right abdomen, pale stools, and dark urine
- heart failure (signs include breathlessness, difficulty breathing when lying down, swelling of the feet or legs)
- swelling and/or pain in one of the legs, usually in the calf, redness, or warm skin in the affected area
- pulmonary embolism (signs include sudden onset of shortness of breath, chest pain, or coughing up blood)
- hypersensitivity (rash, itching, hives, difficulty breathing or swallowing, dizziness)
- weakness, spontaneous bleeding or bruising and frequent infections with signs such as fever
- pancytopenia (chills, sore throat, or mouth ulcers)
- loss of sense of taste (ageusia)
- coughing up blood (hemoptysis)
- amenorrhea (absence of periods)
- chest pain
- abnormal wound healing
- hot flushes
- conjunctivitis (signs include discharge from the eye with itching and redness, pink eye, or red eye)
Rare
- acute respiratory distress syndrome (signs include shortness of breath or rapid breath)
- pure red cell aplasia (signs include tiredness, breathlessness, dizziness, pale skin)
Stop taking XOLIMUS 10 TABLET and contact your doctor immediately if you experience any of the following side effects:
- allergic reaction (signs include difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat (signs of angioedema), and severe itching of the skin, with a red rash or raised bumps)
How To Manage Side Effects
Diarrhea
Drink more fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without taking advice from your doctor.
Nausea And Vomiting
Take this medicine with, or just after meals. Have simple meals. Avoid eating food that is rich in oil or spicy foods.
Stomach Pain
Try to rest and relax. Eat and drink gradually or try to have lesser and more frequent meals. Keep a heating pad on your stomach. Contact your physician if the symptom does not improve.
Warning & Precautions
Pregnancy
Monitoring requiredXOLIMUS 10 TABLET is not recommended for use in pregnant women unless considered clearly necessary. Consult your doctor before taking XOLIMUS 10 TABLET.
Breastfeeding
ContraindicatedXOLIMUS 10 TABLET is generally not recommended for use in breastfeeding women as it may pass through breast milk. Consult your doctor before taking XOLIMUS 10 TABLET.
Driving and Using Machines
Use with CautionDo not drive or operate any machines if you feel tired (fatigue) after taking XOLIMUS 10 TABLET.
Kidney
Use with CautionXOLIMUS 10 TABLET should be taken with caution in patients with kidney problems. Consult your doctor before taking XOLIMUS 10 TABLET.
Liver
Use with CautionXOLIMUS 10 TABLET should be taken with caution in patients with liver problems. Consult your doctor before taking XOLIMUS 10 TABLET.
Allergy
ContraindicatedDo not take XOLIMUS 10 TABLET if you are allergic to Everolimus, or any of the other ingredients of XOLIMUS 10 TABLET.
Use In Pediatrics
ContraindicatedXOLIMUS 10 TABLET is not recommended to use in children and adolescents (under 18 years of age) Consult your doctor before taking [GBKEYWORD].
Use In Geriatrics
Use with CautionXOLIMUS 10 TABLET should be used with caution in elderly patients (above 65 years of age). Consult your doctor before taking XOLIMUS 10 TABLET.
Others
Before taking XOLIMUS 10 TABLET, inform your physician if you:
- have diabetes
- have high cholesterol
- had recent major surgery
- have infection
- have previously had hepatitis B
- have received or are about to receive radiation therapy
Interactions
A. Drug-Drug interactions:
Before taking XOLIMUS 10 TABLET, inform your doctor if you are taking any of the following medicine:
- medicine used to manage fungal infections (Ex. voriconazole, ketoconazole, fluconazole, itraconazole, or and other antifungals)
- medicine used to manage bacterial infections (Ex. clarithromycin, telithromycin, or erythromycin)
- medicines used to manage HIV infection/AIDS (Ex. ritonavir, efavirenz or nevirapine, and other antivirals)
- medicine used to manage heart conditions or high blood pressure (Ex. verapamil or diltiazem)
- medicine used to help regulate heartbeat (Ex. dronedarone)
- medicine used to stop the body from rejecting organ transplants (Ex. ciclosporin)
- medicine used to inhibit the growth of abnormal cells (Ex. imatinib)
- medicine used to manage high blood pressure or other cardiovascular problems (Ex. angiotensin-converting enzyme (ACE) inhibitors
- medicine used to manage tuberculosis (Ex. rifampicin)
- medicine used to manage depression and other conditions (Ex. St. John’s wort)
- medicine used to manage a wide variety of conditions including inflammatory or immune problems (Ex. dexamethasone)
- medicine used to manage epilepsy (Ex. phenytoin, carbamazepine or phenobarbital, and other anti-epileptics)
B. Drug-Food interactions:
Avoid having grapefruit or grapefruit juice while taking XOLIMUS 10 TABLET as it may increase the risk of side effects.
Overdosage:
If you or anyone else accidentally takes too much of XOLIMUS 10 TABLET, consult your doctor immediately or visit the nearby hospital.
Synopsis
| Drug | : | Everolimus |
| Pharmacological Category | : | Anti-cancer agents |
| Therapeutic Indication | : | Hormone receptor-positive advanced breast cancer in postmenopausal women, advanced tumours called neuroendocrine tumours that originate from the stomach, bowels, lung or pancreas, advanced kidney cancer (advanced renal cell carcinoma) |
| Dosage Forms | : | Tablet |
More Information
- Keep XOLIMUS 10 TABLET out of reach of children
- Store at a temperature below 25°C
FAQs About XOLIMUS 10 TABLET
Q: Is there any food to avoid while taking XOLIMUS 10 TABLET?
A: Avoid having grapefruit or grapefruit juice while taking XOLIMUS 10 TABLET as it may increase the risk of side effects. Consult your physician for advice before taking XOLIMUS 10 TABLET.
Q: Can I stop taking XOLIMUS 10 TABLET if I feel my condition is improved?
A: Do not stop taking XOLIMUS 10 TABLET even if you feel improved because the condition may become worsen. Consult your doctor before stopping XOLIMUS 10 TABLET.
Q: How to take XOLIMUS 10 TABLET?
A: Take XOLIMUS 10 TABLET as advised by your physician. Swallow the medicine with enough water. Do not crush or chew the medicine. The correct dose and duration will be decided by your physician for you depending on your age, body weight, and disease condition.
Q: How do XOLIMUS 10 TABLET works?
A: XOLIMUS 10 TABLET reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.
Q: Can I take XOLIMUS 10 TABLET along with antiepileptics?
A: Antiepileptics like phenytoin, phenobarbital, or carbamazepine will affect the efficacy of XOLIMUS 10 TABLET. Consult your doctor before taking XOLIMUS 10 TABLET.
Q: Is it safe to use XOLIMUS 10 TABLET in children?
A: XOLIMUS 10 TABLET is not recommended to use in children and adolescents (under 18 years of age) Consult your doctor before taking XOLIMUS 10 TABLET.
Q: XOLIMUS 10 TABLET is safe for pregnant and breastfeeding women?
A: XOLIMUS 10 TABLET is generally not recommended for use in pregnant and breastfeeding women unless considered clearly necessary. Consult your doctor before taking XOLIMUS 10 TABLET.
References
1. Alan M. Krensky, Jamil R. Azzi, and David A. Hafler. Immunosuppressants and Tolerogens. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. New York McGraw Hill Medical 2018. Page – 638-653.
2. David N. Franz, Elena Belousova, Steven Sparagana, E. Martina Bebin, Michael D. Frost, Rachel Kuperman, et.al. Long-Term Use of Everolimus in Patients with Tuberous Sclerosis Complex: Results from the EXIST-1 Study. Journal of Plos one. June 2018. [Accessed on 11th June 2022] https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0158476
3. Katarzyna Bobeff, Karolina Krajewska, Dobromila Baranska, Katarzyna Kotulska, Sergiusz Jozwiak, Wojciech Mlynarski and Joanna Trelinska. Maintenance Therapy With Everolimus for Subependymal Giant Cell Astrocytoma in Patients With Tuberous Sclerosis –Results From the EMINENTS Study. Journal of Frontiers in Neurology. April 2021. [Accessed on 11th June 2022] https://www.frontiersin.org/articles/10.3389/fneur.2021.581102/full
4. Peri M, Fazio N. Clinical Evaluation of Everolimus in the Treatment of Neuroendocrine Tumor of the Lung: Patient Selection and Special Considerations. Systematic and Critical Review of the Literature. Journal of lung cancer: targets and therapy. June 2020. [Accessed on 11th June 2022] https://www.dovepress.com/clinical-evaluation-of-everolimus-in-the-treatment-of-neuroendocrine-t-peer-reviewed-fulltext-article-LCTT
5. Ajay Dhakal, Roby Antony Thomas, Ellis G Levine, Adam Brufsky, Kazuaki Takabe, Matthew G Hanna, et.al. Outcome of Everolimus-Based Therapy in Hormone-Receptor-Positive Metastatic Breast Cancer Patients After Progression on Palbociclib. SAGE Journals (July 2020). [Accessed on 11th June 2022] https://journals.sagepub.com/doi/full/10.1177/1178223420944864
6. Novartis Pharmaceuticals UK Limited. Electronic Medicines Compendium (EMC). [Revised in January 2022] [Accessed 11th June 2022] https://www.medicines.org.uk/emc/files/pil.6658.pdf
7. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed 11th June 2022] https://www.medicines.org.uk/emc/files/pil.11084.pdf
8. Novartis Pharmaceuticals Corporation. US Food and Drug Administration. [Revised in July 2012] [Accessed on 11th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s016lbl.pdf
Useful Diagnostic Tests
- Complete Blood Count
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