Sirolimus is used with other medications to prevent rejection of a kidney transplant.
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Sirolimus is used together with other medicines to prevent the body from rejecting a transplanted kidney. It belongs to a group of medicines known as immunosuppressive agents.
When a patient receives an organ transplant, the body’s white blood cells will try to get rid of (reject) the transplanted organ. Sirolimus works by preventing the white blood cells from getting rid of the transplanted organ.
Sirolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also reduce the body’s ability to fight infections. You and your doctor should talk about the benefits of this medicine as well as the risks.
Sirolimus is also used to treat lymphangioleiomyomatosis, a rare lung disease that affects predominantly women of childbearing age.
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.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Abdominal or stomach cramps or pain
accumulation of pus
anxiousness, unexplained
backache
black or red, tarry stools
bleeding from the gums or nose
blurred vision
body aches or pain
bone pain
bruising
burning or stinging of the skin
burning while urinating
burning, dry, or itching eyes
burning, tingling, numbness, or pain in the hands, arms, feet, or legs
change in mental status
changes in skin color
chest pain
chills
confusion
convulsions (seizures)
cough
dark or bloody urine
deafness
decreased urine output
decreased vision
difficulty with breathing or swallowing
dilated neck veins
discharge from the eyes
dizziness
drowsiness
dry mouth
earache
excessive tearing
extreme fatigue
eye pain
facial hair growth in females
faintness or lightheadedness when getting up from lying or sitting position
fast, slow, or irregular heartbeat
fever
flushing or redness of the skin, especially on the face and neck
general feeling of discomfort or illness
increased hunger
increased menstrual flow or vaginal bleeding
itching, pain, redness, swelling, tenderness, or warmth on the skin
lack or loss of appetite
large, flat, blue, or purplish patches in the skin
loss of sexual ability, desire, drive, or performance
loss of voice
muscle pain
nasal congestion
nausea or vomiting
numbness or tingling around the lips, hands, or feet
pain in the chest, groin, or legs, especially the calves
painful cold sores or blisters on the lips, nose, eyes, or genitals
pale skin
prolonged bleeding from cuts
rapid heartbeat
rash
red or dark brown urine
redness or swelling in the ear
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
ringing in the ears
runny nose
sensation of pins and needles
severe constipation
severe vomiting
severe, sudden headache
slurred speech
sore throat
sores or white spots on the lips or in the mouth
stomach pain or upset
sudden decrease in the amount of urine
sudden loss of coordination
sudden, severe weakness or numbness in the arm or leg
sudden, unexplained shortness of breath
sweating
swollen, painful, or tender lymph glands in the neck, armpit, or groin
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
tremor
ulcers on the lips or in the mouth
unusual tiredness or weakness
vision changes
weakness or heaviness of the legs
white patches in the mouth or on the tongue
yellow skin and eyes
Less common
Bloating
change in size, shape, or color of existing mole
hoarseness
mole that leaks fluid or bleeds
new mole
pains in the stomach, side or abdomen, possibly radiating to the back
skin ulcer or sores
Incidence not known
Abnormal wound healing
headache
hives or itching
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
nails loose or detached
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
swelling of the arms or legs
yellow nails lacking a cuticle
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Abnormal vision
acne
belching
blistering, crusting, irritation, itching, or reddening of the skin
burning feeling in the chest or stomach
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
constipation
continuing ringing or buzzing or other unexplained noise in the ears
cracked, dry, or scaly skin
crying
decrease in frequency of urination
degenerative disease of the joint
depersonalization
diarrhea
difficulty with moving
difficulty with passing urine (dribbling)
dysphoria
ear pain
enlarged abdomen or stomach
euphoria
excess air or gas in the stomach or intestines
excessive muscle tone, muscle tension or tightness
fear
feeling sad or empty
hearing loss
heartburn
inability to have or keep an erection
increase in heart rate
increased hair growth, especially on the face
increased urge to urinate during the night
indigestion
irritation in the mouth
joint pain or swelling
leg cramps
loss of bladder control
loss of energy or weakness
loss of interest or pleasure
loss of strength
lower abdominal or stomach pain
muscle aches, pain, stiffness, or weakness
nervousness
pain in the back, ribs, arms, or legs
pain or burning in the throat
pain or tenderness around the eyes and cheekbones
paranoia
pelvic pain
quick to react or overreact emotionally
rapid breathing
rapidly changing moods
inflammation, redness, or swelling of the gums or mouth
shaking or trembling
shivering
sleepiness
sunken eyes
swelling
swelling of the scrotum
tender or enlarged gums
tenderness in the stomach area
thickening of the skin
trouble concentrating
trouble sleeping
waking to urinate at night
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
