eMedicine Specialties > Pediatrics: Genetics and Metabolic Disease > Genetics

Tuberous Sclerosis: Treatment & Medication

Author: Robert A Schwartz, MD, MPH, Professor and Head, Dermatology, Professor of Pathology, Pediatrics, Medicine, and Preventive Medicine and Community Health, UMDNJ-New Jersey Medical School
Coauthor(s): Sergiusz Jozwiak, MD, PhD, Head, Professor, Department of Child Neurology, The Children's Memorial Health Institute of Warsaw, Poland; Robert Pedersen, MD, Chief of Child Neurology, Assistant Professor, Departments of Pediatrics and Neurology, Tripler Army Medical Center
Contributor Information and Disclosures

Updated: Feb 17, 2009

Treatment

Medical Care

  • Medical care is aimed at seizure control using various anticonvulsants. Begin treatment with monotherapy and increase the dose gradually until seizures are well controlled or the dose is limited by adverse effects. If the first drug is ineffective, try a different anticonvulsant agent while the first drug is gradually weaned, rather than directly initiating multidrug therapy. A second anticonvulsant may be added if monotherapy with various medications fails. Treatment is desirable before seizures, representing new indications for antiepileptic therapy in children with tuberous sclerosis complex (TSC).6
  • Lymphangioleiomyomatosis (LAM) may respond to therapy using progesterone and oophorectomy. Therefore, treatment in females with evidence of pulmonary disease should begin with progesterone.
  • Consider inotropic agents in patients with evidence of decreased contractility and cardiomyopathy due to rhabdomyoma.
  • Antihypertensive medication may be required in patients with renal disease and subsequent hypertension. An ACE inhibitor may be the first drug of choice. For more information, see the eMedicine topic Hypertension in the Pediatric Cardiac Disease and Critical Care Medicine Volume.
  • Rapamycin (sirolimus) may be useful in tuberous sclerosis treatment.21 It binds to its intracellular receptor, FK506-binding protein 12 (FKBP12), and inhibits the activity of the mammalian target of rapamycin (mTOR), a serine/threonine kinase involved in numerous cell processes linked to cell growth control. Investigational studies with this agent are in progress.22,11,23

Surgical Care

  • Anticonvulsant medication is the first treatment option, and neurosurgery is rarely required for refractory seizures. The best outcome has been noted in patients with fewer lesions. MRI, EEG, and positron emission tomography (PET) scans to localize the lesions are important prior to neurosurgery. Growth of subependymal giant cell astrocytomas (SEGAs) may result in increased intracranial pressure and hydrocephalus. People with increased intracranial pressure require immediate surgery to remove the obstructing lesions. Ventriculoperitoneal (VP) shunt placement is sometimes required.
  • Partial nephrectomy, enucleation, or renal arterial embolization: Angiomyolipomas may progress and lead to renal failure or bleeding, with resultant hemorrhagic shock. In general, any symptomatic lesion or a lesion larger than 3.5-4 cm should be closely monitored, and surgical treatment should be considered. The goal of surgical treatment is to spare the kidneys as much as possible because new lesions may develop in the future. Therefore, surgical treatment usually consists of enucleation or partial nephrectomy. Renal arterial embolization is an additional treatment option.
  • Oophorectomy and progesterone therapy are believed to have a beneficial impact on LAM in females. In individuals with end-stage lung disease, lung transplantation is sometimes performed, although it is not always successful.
  • Cardiac surgery for the removal of rhabdomyomas is rarely required but is performed when cardiac failure is caused by outflow obstruction. Cardiac rhabdomyomas usually spontaneously regress as the individual ages, thus obviating the need for cardiac surgery in older individuals.
  • Facial angiofibromas may require cosmetic therapy. They were previously treated with repeated dermal abrasion, but laser therapy is currently recognized to have improved efficacy and outcome.

Consultations

  • Neurosurgeon: Consult with a neurosurgeon immediately if any suggestion or evidence of increased intracranial pressure is present. Surgery is required to relieve the obstruction and to reduce intracranial pressure. Neurosurgery is rarely required for treatment of epilepsy.
  • Neurologist: A neurologist may be consulted to assist with seizure management and anticonvulsant medication. In addition, a neurologist may assist with obtaining baseline and serial neurologic examinations to assess for neurologic deficits.
  • Cardiologist: Consultation with a cardiologist is recommended so that initial and surveillance echocardiograms can be obtained to assess cardiac rhabdomyomas. Cardiac surgery is rarely required for removal of rhabdomyomas.
  • Ophthalmologist: An ophthalmologist may perform a thorough funduscopic examination to assess for evidence of retinal hamartomas or astrocytomas.
  • Genetic counselor: A genetic counselor is particularly helpful when parents of children with tuberous sclerosis complex are contemplating future pregnancies.
  • Other specialists: A pulmonologist may assist with management of LAM in females with tuberous sclerosis complex. Consult a nephrologist for individuals with symptomatic renal disease. Consultation with a neuropsychologist is helpful in assessing intellectual ability in a child with tuberous sclerosis complex. Neuropsychologists may also assist in management of various behavioral problems, such as autism or pervasive developmental disorder (PDD), schizophrenia, aggressive behavior, or sleep disturbances. Finally, a social worker may assist families and individuals in coping with this chronic disorder.

Diet

  • No specific diet is recommended for most patients.
  • A ketogenic diet is recommended for some patients for seizure control. Patient compliance with this diet may be difficult to obtain because of limited choices and unpleasant tastes.
    • A ketogenic diet is most useful in patients who have seizures that are difficult to control using multidrug therapy.
    • A combination of a ketogenic diet and valproic acid is contraindicated because of the increased risk of hepatotoxicity.
    • Children with tuberous sclerosis complex show high responsiveness to musical stimuli despite otherwise delayed development in language, cognition, and motor skills. The use of music as therapeutic intervention has been suggested.24

Activity

  • Activity is not restricted in patients with tuberous sclerosis complex who do not have a history of seizures.
  • Patients with a history of seizures should avoid certain activities, such as scuba diving and rock climbing.
  • Driving restrictions for people with seizures vary by state, and physicians should be aware of local regulations.

Medication

Anticonvulsant agents

These agents are used to prevent seizures and to terminate clinical and electrical seizure activity. Effective management requires a detailed and accurate classification of seizure types. The goal of treatment is monotherapy, although multidrug therapy is sometimes needed in patients with refractory seizures.


Carbamazepine (Tegretol)

Useful in the treatment of partial and generalized tonic-clonic seizures. Administer a low dose initially, with gradual increases as needed for clinical effect. Therapeutic serum concentration is 4-12 mcg/mL.

Adult

Extended release: 200-400 mg/d PO; may gradually increase by 200-mg increments q2-4wk if needed

Pediatric

10 mg/kg/d PO divided bid/tid; may increase daily dose by 5 mg/kg qwk; not to exceed 30 mg/kg/d

CYP450 1A2, 2C, and 3A3/4 inducer; serum levels may significantly increase within 30 d of danazol coadministration (avoid whenever possible); do not administer within 14 d of MAOIs; cimetidine may increase toxicity, especially if administered in first 4 wk of therapy; carbamazepine may decrease primidone and phenobarbital levels (coadministration may increase carbamazepine levels); rare neurotoxic syndrome consisting of drowsiness, confusion, tremor, and ataxia may develop with concomitant use of lithium

Documented hypersensitivity; history of bone marrow depression; administration of MAOIs within previous 14 d

Pregnancy

D - Fetal risk shown in humans; use only if benefits outweigh risk to fetus

Precautions

Aplastic anemia, neutropenia, hepatitis, and Stevens-Johnson syndrome may develop; high risk of neural tube defects is associated with pregnancy


Valproic acid (Depakene, Depakote)

Useful in the treatment of all seizure types. Although mechanism of action is not established, activity may be related to increased brain levels of GABA or enhanced GABA action. Valproate may potentiate postsynaptic GABA responses, affect potassium channel, or have a direct membrane-stabilizing effect. Therapeutic serum concentration is 50-100 mcg/mL.

Adult

Typical dosage range: 500 mg PO tid/qid; may increase gradually; not to exceed 60 mg/kg/d

Pediatric

10 mg/kg/d PO divided tid/qid; may increase daily dose by 5-10 mg/kg qwk; not to exceed 60 mg/kg/d divided tid/qid

CYP450 2C9 and 2D6 inhibitors; coadministration with cimetidine, salicylates, felbamate, and erythromycin may increase toxicity; rifampin may significantly reduce valproate levels; in pediatric patients, protein binding and metabolism of valproate decrease when administered concomitantly with salicylates; coadministration with carbamazepine may result in variable changes of carbamazepine concentrations with possible loss of seizure control; may increase diazepam and ethosuximide toxicity (monitor closely); may increase phenobarbital and phenytoin levels, while either may decrease valproate levels; may displace warfarin from protein-binding sites (monitor coagulation tests); may increase zidovudine levels in patients who are seropositive for HIV

Documented hypersensitivity; hepatic disease or dysfunction

Pregnancy

D - Fetal risk shown in humans; use only if benefits outweigh risk to fetus

Precautions

Alopecia, amenorrhea, weight gain, tremor, and liver toxicity may result; Stevens-Johnson syndrome is associated with concomitant use of valproic acid and lamotrigine; higher risk of neural tube defects is associated with pregnancy
Thrombocytopenia and abnormal coagulation parameters have occurred; risk of thrombocytopenia increases significantly at total trough valproate plasma concentrations >110 mcg/mL in females and 135 mcg/mL in males; at periodic intervals and prior to surgery, determine platelet counts and bleeding time before initiating therapy; reduce dose or discontinue therapy if hemorrhage, bruising, or hemostasis/coagulation disorder occurs; hyperammonemia may occur, resulting in hepatotoxicity; monitor patients closely for appearance of malaise, weakness, facial edema, anorexia, jaundice, and vomiting; may cause drowsiness


Lamotrigine (Lamictal)

Useful in the treatment of partial seizures or secondarily generalized seizures. Dose depends on use as monotherapy or as an add-on agent. Dose must be increased slowly.

Adult

Monotherapy: 25 mg/d PO for 2 wk initially; increase to 25 mg PO bid during weeks 3-4; 50-100 mg PO bid as maintenance dose
Add-on agent to valproic acid: 12.5 mg/d PO for 2 wk initially; increase to 25 mg/d PO during weeks 3-4; 50-100 mg PO bid as maintenance dose
Add-on agent to anticonvulsant other than valproic acid: 50 mg/d PO for 2 wk initially; 50 mg PO bid may be administered during weeks 3-4; 100-200 mg PO bid as maintenance dose

Pediatric

Monotherapy: 0.5 mg/kg/d PO for 2 wk initially; increase to 1 mg/kg/d PO for weeks 3-4; 2-8 mg/kg/d as maintenance dose
Add-on agent to valproic acid: 0.2 mg/kg/d PO for 2 wk initially; increase to 0.5 mg/kg/d during weeks 3-4; 1-5 mg/kg/d as maintenance dose
Add-on agent to anticonvulsant other than valproic acid: 2 mg/kg/d PO for 2 wk initially; increase to 5 mg/kg/d for weeks 3-4; 5-15 mg/kg/d as maintenance dose

Acetaminophen increases renal clearance of medication, decreasing effects; similarly, phenobarbital and phenytoin increase lamotrigine metabolism, decreasing lamotrigine levels; administration of valproic acid with lamotrigine increases half-life

Pregnancy

C - Fetal risk revealed in studies in animals but not established or not studied in humans; may use if benefits outweigh risk to fetus

Precautions

Adverse effects include tremor, dizziness, ataxia, diplopia, and rash; Stevens-Johnson syndrome may occur with concomitant use of valproic acid, but risk may be decreased with gradual initiation and increases of lamotrigine; caution in impaired renal or hepatic function

More on Tuberous Sclerosis

Overview: Tuberous Sclerosis
Differential Diagnoses & Workup: Tuberous Sclerosis
Treatment & Medication: Tuberous Sclerosis
Follow-up: Tuberous Sclerosis
Multimedia: Tuberous Sclerosis
References
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Further Reading

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Keywords

tuberous sclerosis, tuberous sclerosis complex, TSC, Bourneville disease, neurocutaneous disease, mental retardation, epilepsy, facial angiofibromas, cortical tubers, subependymal nodules, SEN, subependymal giant cell astrocytomas, SEGA, hypomelanotic lesions, Fitzpatrick patches, ash-leaf spots, cardiac rhabdomyomas, renal angiomyolipomas, hamartomas, confetti lesions, shagreen patches, fibrous plaques, periungual fibromas, renal cysts, angiomyolipomas, spontaneous pneumothorax, cor pulmonale, phalangeal cysts, status epilepticus, bronchopneumonia

autism, pervasive developmental disorder, PDD, outflow obstruction, cardiomyopathy, arrhythmia, polycystic kidney disease, PKD, lymphangioleiomyomatosis, LAM, pulmonary cysts, phalangeal cysts, sclerotic lesions, hydrocephalus, sleep disorder, hyperactivity, schizophrenia, cafe au lait spots

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Contributor Information and Disclosures

Author

Robert A Schwartz, MD, MPH, Professor and Head, Dermatology, Professor of Pathology, Pediatrics, Medicine, and Preventive Medicine and Community Health, UMDNJ-New Jersey Medical School
Robert A Schwartz, MD, MPH is a member of the following medical societies: Alpha Omega Alpha, American Academy of Dermatology, American College of Physicians, and Sigma Xi
Disclosure: Nothing to disclose.

Coauthor(s)

Sergiusz Jozwiak, MD, PhD, Head, Professor, Department of Child Neurology, The Children's Memorial Health Institute of Warsaw, Poland
Sergiusz Jozwiak, MD, PhD is a member of the following medical societies: Sigma Xi
Disclosure: Nothing to disclose.

Robert Pedersen, MD, Chief of Child Neurology, Assistant Professor, Departments of Pediatrics and Neurology, Tripler Army Medical Center
Robert Pedersen, MD is a member of the following medical societies: American Academy of Pediatrics and Child Neurology Society
Disclosure: Nothing to disclose.

Medical Editor

Erawati V Bawle, MD, FAAP, FACMG, Division of Genetic and Metabolic Disorders, Children's Hospital of Michigan; Professor (Clinician-Educator), Department of Pediatrics, Wayne State University School of Medicine
Erawati V Bawle, MD, FAAP, FACMG is a member of the following medical societies: American Academy of Pediatrics, American College of Medical Genetics, American Medical Association, and American Society of Human Genetics
Disclosure: Nothing to disclose.

Pharmacy Editor

Mary L Windle, PharmD, Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy, Pharmacy Editor, eMedicine
Disclosure: Pfizer Inc Stock Investment from financial planner; Avanir Pharma Stock Investment from financial planner ; WebMD Salary and stock Employment and investment from financial planner

Managing Editor

Leonard G Feld, MD, PhD, MMM, FAAP, Sara H Bissell and Howard C Bissell Endowed Chair in Pediatrics, Chief Medical Officer, Levine Children's Hospital, Carolinas Medical Center
Leonard G Feld, MD, PhD, MMM, FAAP is a member of the following medical societies: American Academy of Pediatrics, American College of Physician Executives, American Society of Nephrology, American Society of Pediatric Nephrology, International Society of Nephrology, and Juvenile Diabetes Foundation International
Disclosure: Nothing to disclose.

CME Editor

Paul D Petry, DO, FACOP, FAAP, Consulting Staff, Freeman Pediatric Care, Freeman Health System
Paul D Petry, DO, FACOP, FAAP is a member of the following medical societies: American Academy of Osteopathy, American Academy of Pediatrics, American College of Osteopathic Pediatricians, and American Osteopathic Association
Disclosure: Nothing to disclose.

Chief Editor

Bruce Buehler, MD, Professor, Department of Pediatrics, Pathology and Microbiology, Executive Director, Hattie B Munroe Center for Human Genetics and Rehabilitation, University of Nebraska Medical Center
Bruce Buehler, MD is a member of the following medical societies: American Academy for Cerebral Palsy and Developmental Medicine, American Academy of Pediatrics, American Association on Mental Retardation, American College of Medical Genetics, American College of Physician Executives, American Medical Association, and Nebraska Medical Association
Disclosure: Nothing to disclose.

 
 
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