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EVEROLIMUS TABLET (ROLIMUS)

Mfd. by :- Cipla Ltd (Fulfilled By : Magicine Pharma)

Everolimus Tablet (Rolimus)

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Magicine Pharma is registered with the Government Of NCT, India, Ministry Of Health in Government of Delhi, India, registration number DL-RAJ-122372 and as a wholesale distributor, department file No. 44208.

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DESCRIPTION

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PACKAGE

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Brand name- Rolimus 

Generics- Everolimus 

Manufacturer- Cipla Ltd.  

Dosage form- Tablet 

Route of Administration- oral 

Strength- 5, 10mg 

Composition- Everolimus 

Packaging- Strip (30 Tablets) 

Indication- Immunosuppressant and for breast cancer, pancreatic cancer, lung cancer and kidney cancer. 

Storage- Store at room temperature (10-30°C) 

Class of drug- Anti-neoplastic (Macrolide Lactams) 

Mechanism of Action 

It belongs to a class of medications called kinase inhibitors.Rolimus treats cancer by inhibiting cancer cells from growing further and by decreasing blood supply to the cancer cells.Rolimus prevents transplant rejection by decreasing the activity of the immune system. 

Side effects- 

Weakness, Sinus inflammation, Infection, Fever, Cough, Fatigue, Stomatitis (Inflammation of the mouth), Otitis media (infection of ear), Diarrhea, Upper respiratory tract infection (UTI). 

Pharmacodynamics 

It is study of drug effects and what the medicine does to the body. 

Rolimus binds with high affinity to the FK506 binding protein-12 (FKBP-12), thereby forming a drug complex that stop the activation of mTOR. This inhibition reduces the activity of growth stages in cancer cells, and subsequently inducing cell growth arrest and apoptosis.  

Pharmacokinetics 

Study of what the body does to the medicine. Rolimus is absorbed rapidly and reaches peak concentration after 1.3-1.8 hours. Steady-state is reached within 7 days. 

Minimum effect concentration (MEC) 

Minimum concentration of medicine in the blood required for producing the therapeutic effects. Its predefined therapeutic MEC is ( 3 ng/mL)   

Minimum toxic concentration (MTC) 

Minimum concentration of medicine in blood above which toxic or adverse effects are precipitated. Its MTC is 8ng/mL 

Bioavailability rate 

After oral administration, the medicine archived approximately 20% bioavailability. 

Shelf life  

Shelf life is the time period over which the concentration of the active medicinal ingredient in the formulation lowers by 10 percent from its value at the time of manufacture. 

Its shelf life is 2years 

Usage 

 Which disease area  

Breast cancer, pancreatic cancer, lung cancer and kidney cancer. 

Substitutes 

Volantis 10mg Tablet-  Dr Reddy'S Laboratories Ltd 

Evertor 10mg Tablet- Biocon Ltd 

Afinitor 10mg Tablet- Novartis India Ltd 

Alternate brands 

Everbliss 10mg Tablet- BDR Pharmaceuticals Internationals Pvt 

Evercan 10mg Tablet- Miracalus Pharma Pvt Ltd 

Rapact 10mg Tablet- Natco Pharma Ltd 

Evelimus 10mg Tablet- Emcure Pharmaceuticals Ltd 

Everotas 10mg Tablet- Intas Pharmaceuticals Ltd 

Precaution 

Do not use the medicine if you are allergic to it. 

. Using this medicine can increase the risk of serious infections or getting certain cancers, such as lymphoma or skin cancer.  

Tell your doctor if you have ever had: 

- problems digesting lactose or galactose (sugar) 

- high cholesterol or triglycerides 

- a heart transplant 

- skin cancer in you or a family member  

Side effects of Everolimus Tablet

         Common side effects 

  • diarrhea 

  • constipation 

  • change the inability to taste food 

  • weight loss 

  • dry mouth 

  • weakness 

  • headache 

  • difficulty falling asleep or staying asleep 

  • nosebleed 

  • dry skin 

  • acne 

  • problems with nails 

  • hair loss 

  • pain in the arms, legs, back or joints 

  • muscle cramps 

  • missed or irregular menstrual periods 

  • heavy menstrual bleeding 

  • difficulty getting or keeping an erection 

  • anxiety 

  • aggression or other changes in behavior 

Serious side effects 

  •  hives 

  • itching 

  • swelling of the hands, feet, arms, legs, eyes, face, mouth, lips, tongue, or throat 

  • hoarseness 

  • difficulty breathing or swallowing 

  • wheezing 

  • flushing 

  • chest pain 

  • extreme thirst or hunger 

  • unusual bleeding or bruising 

  • pale skin 

  • fast or irregular heartbeat 

  • dizziness 

  • seizures 

Dosage 

Missed dose 

If the patient misses a dose of medicine, skip it and continue with the normal schedule. No need to double the dose 

Overdose 

Get the emergency medical treatment and contact your physician

Warnings 

General warning and precautions 

Consult your doctor in case if you experience increased thirst or increased frequency of urination, if you get any infection, suffer from shortness of breath, cough or fever, you need to receive any vaccination after taking Rolimus.. 

Cautions 

Do not chew, crush or break it but swallow the medicine. Rolimus 10mg Tablet may be taken with or without food, but it is better to take it at a fixed time.. 

Q What is Rolimus Tablet?

Rolimus is an immunosuppressant medicine to be used along with other medicines to prevent the body from rejecting a kidney or a liver organ transplant. It is also used to treat certain types of cancers of the breasts, kidneys, pancreas, intestines, lungs, brain, etc. 

Q How Rolimus Tablet works? 

Rolimus treats cancer by inhibiting cancer cells from growing further and by decreasing blood supply to the cancer cells.Rolimus prevents transplant rejection by decreasing the activity of the immune system. 

Q What are the side effects?

Side Effects of Rolimus are Weakness, Sinus inflammation, Infection, Fever, Cough, Fatigue, Stomatitis (Inflammation of the mouth), Otitis media (infection of ear), Diarrhea, Upper respiratory tract infection (UTI). 

Q In what strength it is available?

It is available in 5 and 10mg 

Q What should I avoid while receiving this medicine?

Avoid grape juice and smoking while taking the medication 

Q How to use Rolimus Tablet?

Rolimus 10mg Tablet may be taken with or without food by swallowing, but it is better to take it at a fixed time. 

Q What happens when I miss a dose?

If you miss a dose of medicine, skip it and continue with the normal schedule. No need to double the dose 

Q Does this medicine effects liver function?

Use of Rolimus is not recommended if you have some serious liver-related disorders. 

Q Can I drive after taking this medicine?

Do not drive if you have any symptoms that affect your ability to concentrate and react. 

Q Can I take this medicine during pregnancy?

Rolimus is not safe to use during pregnancy as there is proven evidence of risk to the developing baby.  

Q Can I take this medicine during breast-feeding?

Rolimus is probably not safe to use during breastfeeding. 

Q Can I consume Alcohol while taking this medicine?

It is not known, consult your doctor 

Q Does it affect kidney functions?

There is no affect on the kidney functions 

Q What are the storage conditions?

Store the medicine at room temperature (10-30°C) 

Interactions 

Medicine interaction 

Clarithromycin 

Ritonavir 

Rifampicin 

Phenytoin 

Carbamazepin 

Amlodipine 

Danazol 

Disease interaction 

If the patient is suffering from any of the following diseases, you should not take Rolimus - 

Liver Disease 

Kidney Disease 

Infections 

Pneumonitis 

Lymphoma 

Diabetes Type 2 

Diabetes 

 Alcohol interaction 

Alcohol interaction is unknown, consult your doctor  

Food interaction 

The patient should also avoid grapefruit and grapefruit juice while taking the medicine.  

Contraindications 

It includes Hypersensitivity 

 

Above Content has been reviewed by Professionals