ROLIMUS

DESCRIPTION

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Category:

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

         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..