Serious Dermatologic Reactions and HLA-B*1502 Allele
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), reported in patients receiving carbamazepine therapy.
Such reactions are estimated to occur in 1–6 per 10,000 new users of carbamazepine in countries with mainly Caucasian populations; however, risk in some Asian countries estimated to be approximately 10 times higher.
Retrospective, case-control studies in patients of Asian ancestry have demonstrated a strong association between risk of developing SJS and TEN and presence of human leukocyte antigen (HLA)-B*1502, an inherited allelic variant of the HLA-B gene. The HLA-B*1502 allele is found almost exclusively in patients with ancestry across broad areas of Asia.
Screen patients with ancestry in genetically at-risk populations for presence of HLA-B*1502 prior to initiating carbamazepine therapy. Patients testing positive for the allele should not receive carbamazepine therapy unless benefit clearly outweighs risk. (See Serious Dermatologic Reactions and HLA-B*1502 Allele under Cautions.)
Hematologic Effects
Aplastic anemia and agranulocytosis reported.
Risk of aplastic anemia or agranulocytosis in patients receiving carbamazepine appears to be 5–8 times greater than that in general population, but overall risk of these reactions in untreated general population is low (about 6 or 2 cases per million population year for agranulocytosis or aplastic anemia, respectively).
Transient or persistent minor hematologic changes (e.g., decreased leukocyte or platelet counts) are not uncommon, but, in most cases, have not progressed to more serious conditions (e.g., aplastic anemia, agranulocytosis).
Determine baseline hematologic function before initiation of therapy; closely monitor patients exhibiting abnormalities during therapy. Most hematologic changes observed during periodic monitoring are unlikely to signal occurrence of aplastic anemia or agranulocytosis.
Consider discontinuance if evidence of substantial bone marrow depression develops.
REMS:
FDA approved a REMS for carbamazepine to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of carbamazepine and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
CARBAMAZEPINE (kar ba MAZ e peen) is used to control seizures caused by certain types of epilepsy. This medicine is also used to treat nerve related pain. It is not for common aches and pains.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or dropper to measure your medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. If you are administering this medicine down a feeding tube your health care professional will teach you the best way to take this medicine. Do not administer with other liquid medications or foods down the tube.Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.
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.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
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?
Visit your doctor or health care professional for a regular check on your progress. Do not change brands or dosage forms of this medicine without discussing the change with your doctor or health care professional. If you are taking this medicine for epilepsy (seizures) do not stop taking it suddenly. This increases the risk of seizures. Wear a Medic Alert bracelet or necklace. Carry an identification card with information about your condition, medications, and doctor or health care professional.
You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.
Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.
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.
The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.
Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.
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:
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?
Keep out of reach of children.
Store at room temperature below 30 degrees C (86 degrees F). Do not freeze. Protect from light. Throw away any unused medicine after the expiration date.
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.
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