Immunosuppression may result in increased susceptibility to infection and possible development of lymphoma or other malignancies.
Only clinicians experienced in immunosuppressive therapy and management of renal transplant patients should prescribe sirolimus.
Patients should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources; the clinician responsible for maintenance therapy should have complete information for patient follow-up.
Use Not Recommended in Liver or Lung Transplant Patients
Safety and efficacy of sirolimus as immunosuppressive therapy not established in liver or lung transplant patients; such use is not recommended. (See Excess Mortality, Graft Loss, and Hepatic Artery Thrombosis in Liver Transplant Patients under Cautions and see Bronchial Anastomotic Dehiscence in Lung Transplant Patients under Cautions.)
REMS:
FDA approved a REMS for sirolimus to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth with a glass of water. Do not cut, crush or chew this medicine. Follow the directions on the prescription label. If you take the medicine with food, always take it with food. Do not take the medicine with grapefruit juice. If you are also taking cyclosporine, take this medicine at least 4 hours after taking your dose of cyclosporine. Take your medicine at regular intervals. You must take the medicine at the same time each day. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 13 years of age for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can, and call your doctor or health care professional. Call your doctor or health care professional if you vomit after a dose.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor for regular checks on your progress. You will need frequent blood checks.
This medicine can cause your cholesterol or lipid levels to go up. You may need treatment for high cholesterol.
If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.
This medicine may increase your risk of getting some cancers. Talk with your doctor.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
Women who are able to have children should use effective birth control before, during, and for 12 weeks after stopping this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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