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Before Using
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 below 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 geriatrics-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
| 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
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.
- 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.
- Amiodarone
- Bacillus of Calmette and Guerin Vaccine, Live
- Carbamazepine
- Clarithromycin
- Efavirenz
- Etravirine
- Fluconazole
- Itraconazole
- Ketoconazole
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Phenobarbital
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- St John's Wort
- Tacrolimus
- 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
- Cyclosporine
- Diltiazem
- Erythromycin
- Micafungin
- Nevirapine
- Phenytoin
- Rifabutin
- Rifampin
- Saquinavir
- Telithromycin
- 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Cancer or
- Hyperlipidemia (high amount of cholesterol and fats in the blood) or
- Lung disease (e.g., pneumonitis or pulmonary fibrosis)—Sirolimus can make these conditions worse.
- Chickenpox (including recent exposure) or
- Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body.
- Infection—Sirolimus decreases the body's ability to fight infection.
- Liver transplantation—or
- Lung transplantation—Sirolimus is not recommended in liver or lung transplant patients.
