Proper Use

Drug information provided by: Merative, Micromedex®

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may lead to rejection of your transplanted kidney.

This medicine usually comes with a Medication Guide and patient instructions. Read them carefully and make sure you understand them before taking this medicine. If you have any questions, ask your doctor.

Take this medicine the same way every day. This means take it at the same time and consistently, either with or without food.

Do not change your dose or stop taking this medicine without checking first with your doctor. You may have to take this medicine for the rest of your life to prevent your body from rejecting the kidney transplant.

Sirolimus is usually used along with a corticosteroid (cortisone-like medicine) and cyclosporine. Sirolimus should be taken 4 hours after cyclosporine modified oral solution or cyclosporine modified capsules (Neoral®). If you have any questions about this, ask your doctor.

If you have been taking sirolimus together with cyclosporine for 2 to 4 months after your transplant, your doctor may want you to stop using cyclosporine and increase the dose of sirolimus. However, some patients (eg, black patients or those with transplant rejection in the past) may need to continue using cyclosporine for up to one year after the transplant. Your doctor will tell you if you need to keep taking cyclosporine.

Swallow the tablet whole. Do not crush, break, or chew it. If you are unable to take the tablet form, your doctor will give you an oral liquid and be given instructions on how to take it.

To use the oral liquid:

  • Open the solution bottle and insert the adapter tightly into the bottle.
  • Insert the amber syringe that comes with the bottle to draw the right amount of medicine out of the bottle.
  • Empty the medicine from the syringe into a glass or plastic cup.
  • Mix the medicine with at least 2 ounces (¼ cup or 60 milliliters [mL]) of water or orange juice. Stir the mixture well and drink it immediately.
  • Add at least 4 ounces (½ cup or 120 mL) of additional water or orange juice, stir it well, and drink it to make sure that all of the medicine is taken.
  • If you have been instructed by your doctor to carry your medicine, you may keep your daily dose of sirolimus in a tightly-capped syringe for a maximum of 24 hours at room temperature or in the refrigerator. Throw away the used syringe after each use.

If this medicine gets into your skin, wash it with soap and water right away. If it gets in your eyes, rinse them with water.

You should not eat grapefruit or drink grapefruit juice while you are taking this medicine. Grapefruit and grapefruit juice may cause higher levels of sirolimus in the body. This could result in more unwanted effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (oral solution or tablets):
    • For prevention of kidney transplant rejection:
      • Adults and children 13 years of age and older weighing 40 kilograms (kg) or more—2 milligrams (mg) per day after an initial one-time dose of 6 mg. Some patients may require a dose of up to 5 mg per day after an initial one-time dose of 15 mg. However, the dose is usually not more than 40 mg per day.
      • Children 13 years of age and older weighing less than 40 kg—Dose is based on body size as determined by your doctor. The dose is 1 milligram (mg) per square meter [m(2)] of body surface area once a day after an initial one-time dose of 3 mg per square meter [m(2)] of body surface area.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    • For treatment of lymphangioleiomyomatosis:
      • Adults—At first, 2 milligrams (mg) per day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the tablets at room temperature in a closed container, away from heat, moisture, and direct light.

Store the oral liquid in the refrigerator. Protect it from direct light and moisture. Do not freeze. You may store the oral liquid at room temperature for a short period of time (not more than 15 days). If you see a slight haze or cloudiness in the bottle, leave it out at room temperature and shake it until the haze disappears. Throw away any unused medicine after 30 days.

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