Before Using

Drug information provided by: Micromedex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sirolimus in children younger than 13 years of age or in children considered to be at high immunologic risk. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sirolimus in the elderly. However, elderly patients are more likely to have liver and heart problems, which may require caution in patients receiving sirolimus.

Pregnancy

Information about this sirolimus-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Mifepristone
  • Posaconazole
  • Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adalimumab
  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Alefacept
  • Amiodarone
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Boceprevir
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Crizotinib
  • Dabrafenib
  • Dronedarone
  • Efavirenz
  • Enzalutamide
  • Eslicarbazepine Acetate
  • Etravirine
  • Fluconazole
  • Infliximab
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Lomitapide
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Nilotinib
  • Pazopanib
  • Phenobarbital
  • Piperaquine
  • Poliovirus Vaccine, Live
  • Primidone
  • Rifampin
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Saquinavir
  • Simeprevir
  • Smallpox Vaccine
  • St John's Wort
  • Tacrolimus
  • Telaprevir
  • Telithromycin
  • Tocophersolan
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amprenavir
  • Aprepitant
  • Cyclosporine
  • Diltiazem
  • Erythromycin
  • Fosphenytoin
  • Micafungin
  • Nevirapine
  • Phenytoin
  • Rifabutin
  • Verapamil

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Ascites (fluid in the abdomen or stomach) or
  • Cancer or
  • Heart disease (e.g., pericardial effusion) or
  • Hyperlipidemia (high amount of cholesterol and fats in the blood) or
  • Lung disease (e.g., bronchitis obliterans organizing pneumonia [BOOP], pleural effusion, pneumonitis, or pulmonary fibrosis) or
  • Peripheral edema (swelling of the hands, ankles, or feet)—Use with caution. May make these conditions worse.
  • Infection (including cytomegalovirus infection)—May decrease body's ability to fight infection.
  • Liver disease—You may require a smaller dose.
  • Liver transplantation or
  • Lung transplantation—Use is not recommended for these conditions.