Brand Names: Ztalmy, generics
Ganaxolone (ga KNAX oe lone) has been approved by the FDA to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
You/your child’s epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.
Ganaxolone is available as an oral suspension taken orally with food three times per day.
If your child had a previous allergic reaction such as hives, itching or trouble breathing, to corticotropin or pork products, then your child should not take corticotropin.
There are other considerations that may influence whether your child should take corticotropin. Tell your health care provider if your child:
Do not stop taking corticotropin suddenly unless directed to do so by a health care provider.
Corticotropin should be stopped gradually to avoid the risk of not producing enough cortisol. Steroid medicine may be needed to protect your child’s body until the adrenal gland recovers and works properly. Your child should not stop using corticotropin suddenly unless your child’s health care provider tells your child to stop the medicine because of a serious side effect.
Tell your child’s health care provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking corticotropin with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your child’s health care provider.
Corticotropin is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by corticotropin can be very serious, and even life threatening. It is important to be informed about these serious reactions, and to be aware of their symptoms.
The most common side effects that were reported in studies of corticotropin are: increased risk of infections, convulsions, hypertension (high blood pressure), irritability, and pyrexia (fever).
Taking corticotropin may make your child more susceptible to new infection, worsen infections already present, or cause an infection to become active like TB. Call your health care provider if your child develops a fever, cough, vomiting, diarrhea, other signs of illness or flu, and an open cuts or sores on their body.
Stopping corticotropin treatment may cause decreased production of a hormone called cortisol in your child’s body. Steroid medications may need to be taken to protect the body until the adrenal gland recovers and works properly. Talk with your health care provider about when and how to slowly stop giving injections to avoid serious side effects. Call your health care provider right away if your child has the following symptoms: appears weak, loses weight/decreased appetite, appears tired/lacks energy, looks pale, has stomach pain, or appears sick with fever. Do not stop giving corticotropin injections without talking to your health care provider.
After prolonged therapy, your child may produce too much cortisol which can cause symptoms of Cushing’s syndrome. Symptoms may include: increased upper body fat around the neck, but not the arms and legs; weight gain; a rounded face; thin skin, easy bruising, and stretch marks on thighs, belly and trunk; slowed growth rates; or weak bones (osteoporosis).
Corticotropin can cause elevated blood pressure, increases in salt and water retention, and hypokalemia (potassium loss). Your child may need dietary salt restrictions and potassium supplementation. If your child has hypertension (high blood pressure), congestive heart failure, or renal insufficiency (poor kidney function), then caution should be used when treating with corticotropin.
Taking corticotropin may mask symptoms of other underlying disease/disorders. Your child should be monitored during and after corticotropin treatment for signs of infection, abnormal cardiac (heart) function, hypertension (high blood pressure), change in body weight, and fecal blood loss.
Corticotropin can cause gastric ulcers and bleeding. There is an increased risk of gastrointestinal perforation (holes in stomach or intestines) in patients with certain gastrointestinal disorders. Signs and symptoms may be masked by the treatment. Tell your health care provider if your child has pain in the stomach area, vomits blood, or has bloody or black stools.
Your child may experience behavior and mood changes during corticotropin treatment. Symptoms range from euphoria, insomnia (trouble sleeping), irritability (especially in infants), mood swings, personality changes, severe depression, and psychotic manifestations. Stopping corticotropin treatment will reverse these symptoms.
Patients with symptoms of diabetes and myasthenia gravis may be worsened with corticotropin treatment.
Extended use of corticotropin may produce posterior subcapsular cataracts (eye opacity), glaucoma, and enhance infections of the eye.
Neutralizing antibodies may develop against corticotropin with chronic administration, potentially leading to a loss of endogenous ACTH (normal adrenocorticotropic hormone inside the body) and corticotropin activity. There is also an increased risk of hypersensitivity which has been reported in postmarketing settings. Use in patients with sensitivity to porcine (pig) proteins is contraindicated. Monitoring for sensitivities during treatment should be considered.
Taking corticotropin may result in an enhanced effect in patients with hypothyroidism (underactive thyroid) or liver cirrhosis (liver scarring).
Long-term use of corticotropin may result in negative effects on your child’s growth and physical development. Appetite changes increase as the treatment period increases. Once treatment is stopped, the effects are reversible. Pediatric patient growth and development should be carefully monitored during prolonged therapy.
Corticotropin treatment effects on calcium regulation and osteoblast (bone cell) function may result in decreased bone formation and increased bone reabsorption. Osteoporosis (weak or brittle bones) may occur at any age. Bone density should be monitored for patients on long term therapy.
Live or live attenuated vaccinations is contraindicated in patients taking corticotropin. While killed or inactivated vaccines may be given, the responses cannot be predicted. Caution should be used for patients given any other immunization after corticotropin treatment (especially high dosages) due to the potential for neurological complications and lack of antibody response.