INTRODUCTION

BIOMUS 1MG contains Tacrolimus which belongs to the group of medicines called immunosuppressants. It is used with other medicines to help prevent organ rejection in adults who had a kidney, liver or heart transplant. Following an organ transplant, our immune system will try to reject the newly transplanted organ. Tacrolimus controls our body’s immune response and enables it to accept the transplanted organ.

It may also be given during an ongoing rejection of transplanted liver, kidney, heart or other organ, when previous treatment was unable to control your immune response. Tacrolimus acts by inhibiting the activity of T-lymphocytes and cytokines. While taking this medicine, your doctor might recommend you, to do blood test, urine test, heart and eye tests, to set the correct dose.

It should be taken orally on an empty stomach. Avoid drinking alcohol or grapefruit juice while taking this medicine. Limit your exposure to sun and UV light, because immunosuppressants could increase the risk of skin cancer. BIOMUS 1MG must not be taken with cyclosporin. This medicine is not recommended in children and adolescents under 18 years of age.

USES OF BIOMUS 1MG

• Prophylaxis of organ rejection in adults with kidney, liver or heart transplants

HOW BIOMUS 1MG WORKS

Tacrolimus prevents rejection by inhibiting T lymphocyte cells and cytokines, specific cells of the immune system. This in turn controls our body’s immune response and enables it to accept the transplanted organ.

DIRECTIONS FOR USE

Take this medicine on an empty stomach or 2 to 3 hours after a meal or as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose for you depending upon your condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF BIOMUS 1MG

HOW TO MANAGE SIDE EFFECTS

Vomiting:

Try taking this medicine with, or just after meal. Stick to simple meals. Do not eat rich or spicy food.

Bloating:

Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. If the symptoms get worse, contact your doctor.

Constipation: 

Eat fibre rich foods like fresh fruit, vegetables and cereals. Drink plenty of water. Exercise more regularly.

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

Stomach pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• other immunosuppressant drugs (e.g. ciclosporin, mycophenolic acid)
• medicines used to treat viral infections such as HIV (e.g. ritonavir, nelfinavir, saquinavir and cobicistat), hepatitis (telaprevir, boceprevir, ombitasvir, paritaprevir, dasabuvir), human cytomegalovirus (e.g. letermovir), herpes zoaster (e.g. acyclovir)
• macrolide antibiotics (used to treat bacterial infections) e.g. erythromycin, clarithromycin, josamycin, amphotericin B and rifampicin
• antifungal medicines (used to treat fungal infections) e.g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole and isavuconazole
• medicines used to treat stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine)
• medicines used to treat nausea and vomiting (e.g. metoclopramide)
• medicines used to treat heartburn (e.g. cisapride or aluminium-hydroxide)
• medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine, diltiazem, verapamil, amiodarone)
• medicines used to treat elevated cholesterol and triglycerides (e.g. atorvastatin)
• medicines used to treat depression (e.g. nefazodone, St. John’s Wort, or extracts of Schisandra sphenanthera)
• nilotinib and imatinib (used to treat certain cancers)
• contraceptive pill (birth control pills)
• phenytoin or phenobarbital (used to treat epilepsy)
• corticosteroids (used to treat inflammations) e.g. prednisolone and methylprednisolone
• potassium supplements
• diuretics (used to increase urine output) e.g. amiloride, triamterene, or spironolactone
• non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen)
• anticoagulants (used to thin blood) e.g. warfarin, heparin
• oral medicines for diabetes (e.g. metformin)
• vaccinations

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT BIOMUS 1MG

Can BIOMUS 1MG used to treat vitiligo?

No. This medicine is intended only for the prophylaxis of graft rejection.

Can BIOMUS 1MG used to treat acne?

No. This medicine is intended only for the prophylaxis of graft rejection.

Can BIOMUS 1MG cause cancer?

Yes. Limit your exposure to sun and UV light, because immunosuppressants could increase the risk of skin cancer. Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.

REFERENCES

1. KD Tripathi. Immunosuppressant drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 881.

2. Alan M. Krensky, William M. Bennett and Flavio Vincenti. Immunosuppressants, Tolerogens and Immunostimulants. Goodman & Gilman’s: The pharmacological basics of therapeutics. 12th Edition. New York, New York: McGraw-Hill Medical, 2011. Page – 1008-1009.

3. Astellas Pharma Inc. A Study of a Modified-Release Tacrolimus in Stable Pediatric Liver Transplant Patients Based Immunosuppression Regimen. NIH U.S. National library of medicine Clinical trials.gov. [Revised on October 2013] [Accessed 27th October 2020] https://clinicaltrials.gov/ct2/show/NCT00282256

4. David H. Peters, Andrew Fitton, Greg L. Plosker & Diana Faulds. Tacrolimus: A Review of its Pharmacology, and Therapeutic Potential in Hepatic and Renal Transplantation.  Springer Nature Switzerland AG. October 2012. [Accessed 27th October 2020] https://link.springer.com/article/10.2165%2F00003495-199346040-00009

5. Astellas Ireland Co., Ltd. [Revised on March 2020] [Accessed 26th October 2020] https://www.medicines.org.uk/emc/files/pil.7524.pdf

6. Astellas Pharma US, Inc. [Revised on February 2012] [Accessed 26th October 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050709s031lbl.pdf