Leqvio (carbamazepine)

Dosage of carbamazepine must be carefully and slowly adjusted according to individual requirements and response. Therapy should be initiated with a low dosage and increased gradually. Once a therapeutic effect has been achieved, efforts should be made to reduce the dosage to the minimum effective dosage.

When transferring patients from conventional, immediate-release formulations to extended-release capsules or tablets, the same total daily dosage should be administered in 2 divided doses. Following the transition, patients should be closely monitored and dosage adjusted as necessary. Because a given dose of carbamazepine administered as the oral suspension will produce higher peak concentrations of the drug than when administered as tablets, therapy with the oral suspension should be initiated with low, frequent doses (e.g., 50 mg 4 times daily for children 6-12 years of age) and increased slowly to reduce the risk of adverse effects (e.g., sedation). When transferring patients from therapy with oral tablets to the oral suspension, the total daily dose administered as tablets should be divided into smaller, more frequent doses of the suspension (e.g., transfer from twice-daily divided dosing of tablets to thrice (3 times)-daily divided dosing of the suspension).

Carbamazepine is usually administered orally; however, an IV preparation is available for temporary (i.e., no longer than 7 days) use in the management of seizure disorders in adults when oral administration is not feasible.

Patients who are currently receiving or beginning therapy with carbamazepine and/or any other anticonvulsant for any indication should be closely monitored for the emergence or worsening of depression, suicidal thoughts or behavior (suicidality), and/or any unusual changes in mood or behavior. (See Cautions: Nervous System Effects and see Cautions: Precautions and Contraindications.)

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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There are no contraindication contraindications for this drug.

• Pregnancy

• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Severe hepatic disease

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Less Frequent

• Angioedema

Rare or Very Rare

• Anaphylaxis
• Hypersensitivity drug reaction

More Frequent

• Arthralgia
• Bronchitis
• Diarrhea
• Dyspnea
• Injection site sequelae
• Pain in extremities
• Urinary tract infection

Less Frequent

• Skin rash
• Urticaria

Rare or Very Rare

• Pruritus of skin

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Safe use of carbamazepine during pregnancy has not been established. Adverse fetal effects have been observed in reproduction studies in rats. Although several reports suggest an association between use of anticonvulsants in pregnant, epileptic women and an increased incidence of birth defects in children born to these women, a causal relationship to many of these drugs has not been established. However, epidemiologic data suggest that an association between carbamazepine use during pregnancy and certain congenital abnormalities such as spina bifida may exist. Other congenital anomalies and developmental disorders (e.g., craniofacial defects, cardiovascular malformations, anomalies involving various body systems) also have been reported in association with carbamazepine use.

Anticonvulsants should not be discontinued in pregnant women in whom the drugs are administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases, when the severity and frequency of the seizure disorder are such that discontinuance of therapy does not pose a serious threat to the patient, discontinuance of the drugs may be considered prior to and during pregnancy; however, it cannot be said with any certainty that even minor seizures do not pose some hazard to the fetus. Clinicians should carefully weigh these considerations in treating or counseling epileptic women of childbearing potential. Because carbamazepine can cause fetal harm when administered to pregnant women, the benefits of therapy must be weighed against the risks in women of childbearing potential. If carbamazepine is used during pregnancy, or if the patient becomes pregnant while receiving the drug, the patient should be apprised of the potential hazard to the fetus. Tests to detect fetal abnormalities using currently accepted procedures should be considered part of routine prenatal care in women of childbearing potential receiving carbamazepine.

There have been a few cases of seizures and/or respiratory depression in neonates born to women receiving carbamazepine concomitantly with other anticonvulsant agents. A few cases of vomiting, diarrhea, and/or decreased feeding also have been reported in neonates born to women receiving carbamazepine; these symptoms may represent a neonatal withdrawal syndrome.

Women who are pregnant while receiving carbamazepine should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 888-233-2334. Information on the registry also can be found on the website https://www.aedpregnancyregistry.org.

Carbamazepine and its epoxide metabolite (carbamazepine 10,11-epoxide (CBZ-E)) are distributed into milk. Safe use of carbamazepine during lactation has not been established. Because of the potential for serious adverse reactions from carbamazepine in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. Following daily oral administration of carbamazepine in nursing women, the milk-to-maternal plasma ratio of carbamazepine is about 0.4 and that of CBZ-E is about 0.5; it is estimated that neonates may receive about 2-5 and 1-2 mg of carbamazepine and CBZ-E, respectively, daily.

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