Risk of developing potentially fatal, hepatic injury (e.g., hepatitis); should not be used for unlabeled indications.
Females, patients >35 years of age, and those receiving other drugs (especially estrogens) concomitantly are at greatest risk.
Risk of symptomatic hepatitis (fatal and nonfatal) may be dose dependent; incidence much higher at dosages ≥800 mg daily than at dosages ≤400 mg daily. Even intermittent, short courses at higher dosages associated with increased risk. Use lowest possible effective dose.
Overt hepatitis most frequently observed between 3rd and 12th month of therapy.
Frequently monitor hepatic function. (See Hepatic Effects under Cautions.)
If benefits are not evident within 45 days, discontinue therapy.
This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your condition will be monitored carefully while you are receiving this medicine.
You may get drowsy or dizzy. Muscle weakness may occur. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. Be careful walking down stairs. Use caution to reduce the risk of dizzy or fainting spells or falls. Alcohol can make you more drowsy. Avoid alcoholic drinks.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
drowsy, dizzy
loss of appetite
muscle weakness for up to 48 hours after treatment
slurred speech
trouble sleeping
unusually weak or tired
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.