ZTALMY- ganaxolone suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ganaxolone (UNII: 98WI44OHIQ) (ganaxolone - UNII:98WI44OHIQ)

Available from:

Marinus Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as ZTALMY, during pregnancy. Encourage women who are taking ZTALMY during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no available data on ZTALMY use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal studies, adverse effects on development were observed in mice (fetal malformations) and rats (neurobehavioral and growth impairment) following exposure during organogenesis (mouse) or throughout gestation and lactation (rat) at maternal exposures lower than that in human adults at the

Product summary:

ZTALMY (ganaxolone) oral suspension (50 mg/mL) is a cherry flavored white to off-white suspension supplied in a 4 fl. oz (135 mL) round natural high density polyethylene (HDPE) bottle with a propylene child-resistant cap containing 110 mL of ZTALMY oral suspension. ZTALMY is packaged in a carton with 1 bottle (NDC 81583-100-01) or in a carton with 5 bottles (NDC 81583-100-05). Store ZTALMY in its original bottle in an upright position at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep the cap tightly closed. Use within 30 days of first opening the bottle, then discard any remainder.

Authorization status:

New Drug Application

Patient Information leaflet

Marinus Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
ZTALMY® (ZUH TAL' MEE)
(GANAXOLONE)
ORAL SUSPENSION, CV
This Medication Guide has been approved by the U.S.
Food and Drug Administration
Issued: 11/2022
What is the most important information I should know about ZTALMY?
ZTALMY can cause serious side effects, including:
1.
ZTALMY may cause sleepiness. Taking ZTALMY with central nervous system
(CNS) depressants
including alcohol may increase sleepiness. Do not drive, operate heavy
machinery, or do other
dangerous activities until you know how ZTALMY affects you or your
child.
2.
Like other antiepileptic drugs, ZTALMY may cause suicidal thoughts or
actions in a very small
number of people, about 1 in 500.
Call a healthcare provider right away if you or your child have any of
these symptoms, especially if
they are new, worse, or worry you:
•
thoughts about suicide or dying
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes in mood,
behaviors, thoughts, or
feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
3.
Do not stop taking ZTALMY without first talking to your healthcare
provider. Stopping a seizure
medicine such as ZTALMY suddenly can cause you or your child to have
seizures more often or
seizures that do not stop (status epilepticus).
Call your healthcare provider between visits as needed, especially if
you are worried about symptoms.
WHAT IS ZTALMY?
•
ZTALMY is a prescription medicine that is used to treat seizures
associated with cyclin-
dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in people 2
years of age

Summary of Product characteristics

ZTALMY- GANAXOLONE SUSPENSION
MARINUS PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZTALMY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZTALMY.
ZTALMY (GANAXOLONE) ORAL SUSPENSION, CV
INITIAL U.S. APPROVAL: 2022
RECENT MAJOR CHANGES
Dosage and Administration (2.3)
6/2023
INDICATIONS AND USAGE
ZTALMY is a neuroactive steroid gamma-aminobutyric acid (GABA) A
receptor positive modulator
indicated for the treatment of seizures associated with
cyclin-dependent kinase-like 5 (CDKL5) deficiency
disorder (CDD) in patients 2 years of age and older. (1)
DOSAGE AND ADMINISTRATION
Administer ZTALMY orally three times daily with food. (2.1)
Titrate ZTALMY gradually according to the recommended schedules. See
full prescribing information.
(2.1)
Dosage for patients weighing 28 kg or less (2.1):
the starting dosage is 6 mg/kg three times daily (18 mg/kg/day)
the maximum dosage is 21 mg/kg three times daily (63 mg/kg/day).
Dosage for patients weighing over 28 kg (2.1):
the starting dosage is 150 mg three times daily (450 mg daily)
the maximum dosage is 600 mg three times daily (1800 mg daily).
Patients with severe hepatic impairment: see full prescribing
information for dosage recommendation.
(2.3)
DOSAGE FORMS AND STRENGTHS
Oral suspension 50 mg/mL (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Somnolence and Sedation: Monitor for somnolence and sedation and
advise patients not to drive or
operate machinery until they have gained sufficient experience with
ZTALMY. Concomitant use with
other CNS depressants or alcohol could potentiate adverse effects.
(5.1)
Suicidal Behavior and Ideation: Monitor patients for suicidal behavior
and thoughts. (5.2)
Withdrawal of Antiepileptic Drugs: ZTALMY should be withdrawn
gradually to minimize the risk of
increased seizure frequency and status epilepticus. (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence of at least 5% for ZTALMY and
at least twice the rate of
pla