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Introduction About SIROVA 1MG TABLET
SIROVA 1MG TABLET contains Sirolimus which belongs to the group of medicines called Immunosuppressants. It is used in adults to manage body from rejecting transplanted kidneys along with other immunosuppressant medicines called corticosteroids and initially (first 2-3 months) with ciclosporin.
SIROVA 1MG TABLET is also used to manage sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or reducing lung function. Lymphangioleiomyomatosis (LAM) is a progressive lung disease in women caused by the abnormal growth of smooth muscle cells, most commonly characterized by shortness of breath.
Your doctor will perform tests to monitor SIROVA 1MG TABLET levels in your blood, kidney function, blood fat levels and your liver function, during this management. They may also advise you to limit exposure to sunlight and UV light during SIROVA 1MG TABLET management by covering your skin with clothing and using a sunscreen with a high protection factor as it can increase the risk for skin cancer.
Before taking SIROVA 1MG TABLET inform your doctor if you have liver problem, body mass index more than 30 kg/m2 or if you previously had a failed kidney transplant. Do not drink grapefruit juice while taking SIROVA 1MG TABLET. SIROVA 1MG TABLET is not recommended for use in pregnant and breastfeeding women.
SIROVA 1MG TABLET is not recommended for use in children and adolescents (below 18 years of age). The most common side effects of taking SIROVA 1MG TABLET are pain, fever, headache, stomachache, swelling of body including hands and feet, etc. Contact your doctor if any of the symptoms worsen or persist.
Uses Of SIROVA 1MG TABLET
Used in:
- Adults to manage body from rejecting transplanted kidneys (along with corticosteroids and initially ciclosporin)
- Women having sporadic lymphangioleiomyomatosis (S-LAM)
How SIROVA 1MG TABLET Works
SIROVA 1MG TABLET helps manage organ rejection by inhibiting the activation and multiplication of T-lymphocyte (part of immune system that protects from infection). It does this by inhibiting their reaction to a protein which increases immune response. SIROVA 1MG TABLET also inhibits antibody production.
How to use SIROVA 1MG TABLET
Take SIROVA 1MG TABLET as advised by your physician. Swallow with a glass of water and do not crush, split or chew it. It should be consistently taken, either with or without food.
Your doctor will decide the right dose and duration of SIROVA 1MG TABLET depending upon your age, body weight and disease condition. Do not stop taking SIROVA 1MG TABLET unless your doctor advises you to stop.
Side Effects Of SIROVA 1MG TABLET
Common
- fluid collection around the kidney, abdomen, lungs or heart
- swelling of the body, even hands and feet
- joint pain, fever, headache
- increased blood pressure
- stomach pain, diarrhea, constipation, nausea
- low red blood cells, white blood cells and blood platelets
- increased fat, blood sugar, low blood potassium and phosphorus, increased lactate dehydrogenase and creatinine in the blood
- acne, rashes
- urinary tract infection
- bacterial, viral or fungal infections including pneumonia
- diabetes
- abnormal tests of liver function
- raised protein in the urine
- menstrual disorders, ovarian cysts
- slow healing of wound
- rapid heart rate
- infections (including life-threatening infections)
- blood clots in the limbs or lungs
- mouth sores
- kidney damage with or without rash (hemolytic uremic syndrome)
- deterioration of bone
- nose bleeds
- skin cancer
- inflammation of the pancreas
- shingles
- cytomegalovirus infection
- weight loss
Uncommon
- cancer of the lymph tissue
- bleeding from the lung
- protein in the urine, occasionally severe and associated with swelling
- scarring in the kidney
- excess fluid collecting in the tissues due to irregular lymph function
- low blood platelets, with or without rash (thrombocytopenic purpura)
- serious allergic reactions causing peeling of the skin
- tuberculosis, Epstein-Barr virus infection
- infectious diarrhea with clostridium difficile
- serious liver damage
Rare
- excess protein in the air sacs of the lungs that may interfere with breathing
- serious allergic reactions affecting blood vessels
Stop taking SIROVA 1MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- serious allergic reaction (swollen face, tongue, back of the mouth, difficulties in breathing, skin peeling off)
- kidney damage (bruising, rash, changes in urine, changes in behavior or any others that are serious, unusual or prolonged)
- skin, mouth, stomach, intestines, lungs and urinary tract infections
How To Manage Side Effects
Nausea or vomiting:
Take SIROVA 1MG TABLET with or just after meals. Stick to simple meals. Avoid eating spicy food. Drink clear or ice-cold drinks. Eat light, bland foods and avoid fried, oily or sweet foods. If symptom persists, contact your doctor.
Headache:
Apply hot or cold-water bag on your head. Take enough rest in a quiet environment and don’t involve yourself in any exertional activities. Apply pain relieving balm on the forehead. If symptom persists, contact your doctor.
Constipation:
Eat a lot of fiber rich foods such as fresh fruits, vegetables and cereals and drink enough water. Exercise more regularly. If symptom persists, contact your doctor.
Diarrhea:
Drink lots of water or fruit juice to keep yourself hydrated. If symptom persists, contact your doctor.
Warning & Precautions
Pregnancy
SIROVA 1MG TABLET is not recommended for use if you are pregnant or planning to have a baby unless clearly necessary. Consult your doctor before taking it.
Breastfeeding
Patients taking SIROVA 1MG TABLET should discontinue breastfeeding as it is not known if it is excreted in the breastmilk. Consult your doctor before taking it.
Driving and Using Machines
SIROVA 1MG TABLET is not known to affect your ability to drive or use machines.
Kidney
SIROVA 1MG TABLET should be used with caution in patients who are at a high risk of kidney rejection or have previously had a failed kidney transplant. Consult your doctor before taking it.
Liver
SIROVA 1MG TABLET should be used with caution in patients with liver disease. Consult your doctor before taking it.
Allergy
Do not take SIROVA 1MG TABLET if you are allergic to Sirolimus or any of the other ingredients of this medicine.
Others
Before taking SIROVA 1MG TABLET, inform your doctor if you:
- have a body mass index (BMI) greater than 30 kg/m² (increased risk of abnormal wound healing)
- have intolerance to certain sugars
Use in Pediatrics:
SIROVA 1MG TABLET is not recommended for use in children and adolescents (below 18 years of age). Consult your child’s doctor for advice.
Use in Geriatrics:
SIROVA 1MG TABLET should be used with caution in elderly patients above 65 years of age. Consult your doctor before taking it.
Interactions
A. Drug - Drug interactions:
Before taking SIROVA 1MG TABLET, inform your doctor if you are taking any of the following medicines:
- any other immunosuppressant medicines (Ex. tacrolimus, everolimus)
- medicines used to manage infections (Ex. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, rifampicin, ketoconazole, voriconazole)
- medicines used for heart problems (Ex. enalapril, nicardipine, verapamil, diltiazem, simvastatin, fenofibrate)
- medicines used for fits (Ex. carbamazepine, phenobarbital, phenytoin)
- medicines to manage ulcers or other gut disorders (Ex. cisapride, cimetidine, metoclopramide)
- bromocriptine (used in Parkinson’s disease and various hormonal disorders)
- danazol (used to manage gynaecological disorders)
- medicines used for HIV and hepatitis C (Ex. ritonavir, indinavir, boceprevir, telaprevir, letermovir)
- St. John’s Wort (used in depression)
- live vaccines
B. Drug - Food interaction:
Do not drink grapefruit juice while taking SIROVA 1MG TABLET.
Overdosage:
If you or anyone else accidentally take too much of SIROVA 1MG TABLET, consult your doctor immediately or visit the nearby hospital.
Synopsis
| Drug | : | Sirolimus |
| Pharmacological Category | : | mTOR Inhibitors |
| Therapeutic Indication | : | Prevention of transplant rejection |
| Dosage Forms | : | Tablet |
More Information
- Keep SIROVA 1MG TABLET out of reach of children
- Store SIROVA 1MG TABLET below 25°C
FAQs About SIROVA 1MG TABLET
Does SIROVA 1MG TABLET affect male fertility?
Decreased sperm count has been associated with the use of SIROVA 1MG TABLET and it usually returns to normal once management is discontinued. Consult your doctor for further queries.
What if I miss a dose of SIROVA 1MG TABLET?
If you miss a dose of SIROVA 1MG TABLET, take it as soon as you remember. However, skip that dose if it's almost time for the next one. Do not take SIROVA 1MG TABLET two times to make up for the missed dose. Remember to always take SIROVA 1MG TABLET and ciclosporin approximately 4 hours apart.
Can I stop taking SIROVA 1MG TABLET on my own?
Do not stop taking SIROVA 1MG TABLET unless your doctor tells you to, as doing so might increase the risk of losing your transplant. Consult your doctor for further queries.
What are the precautionary measures to follow while taking SIROVA 1MG TABLET?
Do not drink grapefruit juice while taking SIROVA 1MG TABLET. Inform your doctor if you have liver problem, body mass index more than 30 kg/m2, intolerance to certain sugars or had a previously failed kidney transplant. Patients should also tell if they are pregnant, breast-feeding or allergic to anything.
Can SIROVA 1MG TABLET be given to children?
No. SIROVA 1MG TABLET is used for adults and not recommended for children and adolescents below 18 years of age. Consult your child’s doctor for advice. The physician will determine a proper dose or select a suitable alternative management for your child.
References
1. KD Tripathi. Immunosuppressant Drugs. Essentials of medical pharmacology. Eighth Edition. 2019. Page – 941.
2. Augustine JJ, Bodziak KA, Hricik DE. Use of sirolimus in solid organ transplantation. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. 2007. [Accessed on 20th June 2022]. https://pubmed.ncbi.nlm.nih.gov/17335296/
3. C G Groth, L Bäckman, J M Morales, R Calne, H Kreis, P Lang, J L Touraine, K Claesson, J M Campistol, D Durand, L Wramner, C Brattström, B Charpentier. Sirolimus (rapamycin)-based therapy in human renal transplantation. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. April 1999. [Accessed on 20th June 2022]. https://pubmed.ncbi.nlm.nih.gov/10221490/
4. Pfizer Ireland Pharmaceuticals. Electronic Medicines Compendium (EMC). [Revised in July 2021] [Accessed on 20th June 2022]. https://www.medicines.org.uk/emc/files/pil.1368.pdf
5. Wyeth Pharmaceuticals Inc. U.S. Food & Drug Administration. [Revised in July 2011] [Accessed on 20th June 2022]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021083s059,021110s076lbl.pd
Useful Diagnostic Tests
- Blood tests
- Kidney function test
- Liver function test
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