What should I watch for?
You may need blood work done while you are taking this medicine.
This medicine is available only through a special program. Doctors, pharmacies, and patients must meet all of the conditions of the program. Your health care provider will help you get signed up with the program if you need this medicine. Through the program you will only receive up to a 28 day supply of the medicine at one time. You will need a new prescription for each refill.
This medicine can cause birth defects. Do not get pregnant while taking this drug. Females with child-bearing potential will need to have 2 negative pregnancy tests before starting this medicine. Pregnancy testing must be done every 2 to 4 weeks as directed while taking this medicine. Use 2 reliable forms of birth control together while you are taking this medicine and for 4 weeks after you stop taking this medicine. If you think that you might be pregnant talk to your doctor right away. Do not breast-feed an infant while taking this medicine.
Men must use a latex condom during sexual contact with a woman while taking this medicine and for 4 weeks after you stop taking this medicine. A latex condom is needed even if you have had a vasectomy. Contact your doctor right away if your partner becomes pregnant. Do not donate sperm while taking this medicine and for 4 weeks after you stop taking this medicine.
Do not give blood while taking the medicine and for 4 weeks after completion of treatment to avoid exposing pregnant women to the medicine through the donated blood.
Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.
Common and Rare Side Effects
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
Black, tarry stools
bleeding gums
blood in the urine or stools
chills
convulsions
decreased urine
difficult or labored breathing
increased thirst
irregular heartbeat
loss of appetite
lower back or side pain
mood changes
muscle pain or cramps
nausea or vomiting
numbness or tingling in the hands, feet, or lips
painful or difficult urination
pale skin
pinpoint red spots on the skin
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
tightness in the chest
unusual bleeding or bruising
unusual tiredness or weakness
Less common
Chest discomfort
confusion
difficulty with speaking
double vision
headache
inability to move the arms, legs, or facial muscles
inability to speak
pain or discomfort in the arms, jaw, back or neck
slow speech
sweating
Incidence not known
blistering, peeling, or loosening of the skin
clay-colored stools
dark-colored urine
depressed mood
difficulty having a bowel movement (stool)
dizziness or lightheadedness
dry skin and hair
fainting
fast heartbeat
feeling cold
general feeling of tiredness or weakness
hoarseness or husky voice
itching or rash
joint pain, stiffness, or swelling
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
muscle cramps and stiffness
pain, redness, or swelling in the arm or leg
red skin lesions, often with a purple center
red, irritated eyes
sensitivity to heat
slowed heartbeat
stomach pain, continuing
sudden shortness of breath or troubled breathing
swelling of the feet or lower legs
trouble sleeping
unpleasant breath odor
vomiting of blood
weight gain or loss
yellow eyes or skin
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 or decreased touch sensation
bloody nose
blurred vision
body aches or pain
bruising
burning while urinating
burning, numbness, tingling, or painful sensations
change in taste
cough-producing mucus
difficulty with moving
drowsiness or tiredness
ear congestion
fast, slow, irregular, pounding, or racing heartbeat or pulse
flushing or redness of the skin
increased sweating or night sweats
irritability
itching, pain, redness, swelling, tenderness, or warmth on the skin
lack or loss of strength
large, flat, blue or purplish patches in the skin
loose stools
loss of interest or pleasure
muscle spasms, stiffness, or twitching
pain or tenderness around the eyes and cheekbones
seizures
shivering
tender, swollen glands in the neck
trembling
trouble concentrating
trouble swallowing
unsteadiness or awkwardness
upper abdomen or stomach pain
voice changes
weakness in the arms, hands, legs, or feet
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
