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Rolimus 5mg Tablet 10'S

Patanjali Pharma (15.9 km)

₹6670

INTRODUCTION ROLIMUS 5MG TABLET contains Everolimus which belongs to the group of medicines called Anticancer agents. It is used to treat hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other treatments, advanced tumours called neuroendocrine tumours that orig...

INTRODUCTION

ROLIMUS 5MG TABLET contains Everolimus which belongs to the group of medicines called Anticancer agents. It is used to treat hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other treatments, advanced tumours called neuroendocrine tumours that originate from the stomach, bowels, lung or pancreas, advanced kidney cancer (advanced renal cell carcinoma), where other treatments (VEGF-targeted therapy) have not helped stop your disease.

Before taking ROLIMUS 5MG 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. ROLIMUS 5MG TABLET is not recommended to use in children and adolescents (under 18 years of age). Consult your doctor before taking the medicine.

ROLIMUS 5MG TABLET should be used with caution in elder patients (65 years and above). ROLIMUS 5MG TABLET is generally not recommended for use among pregnant and breastfeeding women. The most common side effects of taking ROLIMUS 5MG 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 ROLIMUS 5MG TABLET

It is used to treat adult patients with:

  • hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other treatments (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 ROLIMUS 5MG TABLET WORKS

ROLIMUS 5MG TABLET reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.

DIRECTIONS FOR USE

Take ROLIMUS 5MG TABLET as advised by your physician. Swallow the medicine with enough water. Do not crush or chew the ROLIMUS 5MG 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 ROLIMUS 5MG 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 ROLIMUS 5MG 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 required

ROLIMUS 5MG TABLET is not recommended for use in pregnant women unless considered clearly necessary. Consult your doctor before taking ROLIMUS 5MG TABLET.

BREASTFEEDING
Contraindicated

ROLIMUS 5MG TABLET is generally not recommended for use in breastfeeding women as it may pass through breast milk. Consult your doctor before taking ROLIMUS 5MG TABLET.

DRIVING AND USING MACHINES
Use with Caution

Do not drive or operate any machines if you feel tired (fatigue) after taking ROLIMUS 5MG TABLET.

KIDNEY
Use with Caution

ROLIMUS 5MG TABLET should be taken with caution in patients with kidney problems. Consult your doctor before taking ROLIMUS 5MG TABLET.

LIVER
Use with Caution

ROLIMUS 5MG TABLET should be taken with caution in patients with liver problems. Consult your doctor before taking ROLIMUS 5MG TABLET.

ALLERGY
Contraindicated

Do not take ROLIMUS 5MG TABLET if you are allergic to Everolimus, or any of the other ingredients of ROLIMUS 5MG TABLET.

USE IN PEDIATRICS
Contraindicated

ROLIMUS 5MG 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 Caution

ROLIMUS 5MG TABLET should be used with caution in elderly patients (above 65 years of age). Consult your doctor before taking ROLIMUS 5MG TABLET.

OTHERS

Before taking ROLIMUS 5MG 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 ROLIMUS 5MG TABLET, inform your doctor if you are taking any of the following medicine:

  • medicine used to treat fungal infections (Ex. voriconazole, ketoconazole, fluconazole, itraconazole, or and other antifungals)
  • medicine used to treat bacterial infections (Ex. clarithromycin, telithromycin, or erythromycin)
  • medicines used to treat HIV infection/AIDS (Ex. ritonavir, efavirenz or nevirapine, and other antivirals)
  • medicine used to treat 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 treat high blood pressure or other cardiovascular problems (Ex. angiotensin-converting enzyme (ACE) inhibitors
  • medicine used to treat tuberculosis (Ex. rifampicin)
  • medicine used to treat depression and other conditions (Ex. St. John’s wort)
  • medicine used to treat a wide variety of conditions including inflammatory or immune problems (Ex. dexamethasone)
  • medicine used to treat epilepsy (Ex. phenytoin, carbamazepine or phenobarbital, and other anti-epileptics)

B. Drug-Food interactions:

Avoid having grapefruit or grapefruit juice while taking ROLIMUS 5MG TABLET as it may increase the risk of side effects.

Overdosage:

If you or anyone else accidentally takes too much of ROLIMUS 5MG 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 ROLIMUS 5MG TABLET out of reach of children
  • Store at a temperature below 25°C

FAQs ABOUT ROLIMUS 5MG TABLET

Q: Is there any food to avoid while taking ROLIMUS 5MG TABLET?

A: Avoid having grapefruit or grapefruit juice while taking ROLIMUS 5MG TABLET as it may increase the risk of side effects. Consult your physician for advice before taking ROLIMUS 5MG TABLET.

Q: Can I stop taking ROLIMUS 5MG TABLET if I feel my condition is improved?

A: Do not stop taking ROLIMUS 5MG TABLET even if you feel improved because the condition may become worsen. Consult your doctor before stopping ROLIMUS 5MG TABLET.

Q: How to take ROLIMUS 5MG TABLET?

A: Take ROLIMUS 5MG 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 ROLIMUS 5MG TABLET works?

A: ROLIMUS 5MG TABLET reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.

Q: Can I take ROLIMUS 5MG TABLET along with antiepileptics?

A: Antiepileptics like phenytoin, phenobarbital, or carbamazepine will affect the efficacy of ROLIMUS 5MG TABLET. Consult your doctor before taking ROLIMUS 5MG TABLET.

Q: Is it safe to use ROLIMUS 5MG TABLET in children?

A: ROLIMUS 5MG TABLET is not recommended to use in children and adolescents (under 18 years of age) Consult your doctor before taking ROLIMUS 5MG TABLET.

Q: ROLIMUS 5MG TABLET is safe for pregnant and breastfeeding women?

A: ROLIMUS 5MG TABLET is generally not recommended for use in pregnant and breastfeeding women unless considered clearly necessary. Consult your doctor before taking ROLIMUS 5MG 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

AUTHOR DETAILS

Written By Dr. Janet.C, Pharm.D
Last updated on 23 Mar 2023 | 06:01 PM(IST)

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