Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
ZTALMY 50 mg/ml Oral suspension
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ganaxolone may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
ZTALMY contains the active substance ganaxolone, a neuroactive steroid that works by attaching to specific receptors and stops the brain from having epileptic seizures. ZTALMY is used to treat a rare epileptic seizure disorder called 'cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder' (CDD) in patients 2 to 17 years of age. If ZTALMY is helping to treat your seizures, it can still continue to be used when you or your child turns 18. ZTALMY is used in combination with other anti-epileptic medicines. This medicine will reduce the number of daily epileptic seizures you or your child may experience. 2.
What you or your child need to know before taking ZTALMY
Do not take ZTALMY if you are allergic to ganaxolone or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking ZTALMY if: •
you or your child feel drowsy ZTALMY can cause drowsiness or sleepiness, or the feeling of being overly calm and relaxed (i.e. feeling sedated). Talk to your doctor or pharmacist before taking ZTALMY if you have any concerns about these effects or if you are taking central nervous system depressants such as other medicines to treat seizures, opioids, antidepressants or alcohol, as these can increase the sleepiness and sedative effects of ZTALMY.
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•
you or your child have had thoughts about harming or killing yourself If you notice unusual changes in your mood or behaviour or have thoughts of harming or killing yourself, contact your doctor straightaway. If you are caring for a child with CDD, look out for any unusual changes in their mood or behaviour or anything they say that could mean they are thinking about self-harming or killing themselves. If you notice any of these, contact your doctor straightaway.
•
you or your child have a history of alcohol or drug addiction ZTALMY has the potential to be abused or used for the wrong purpose. Talk to your doctor or pharmacist before taking ZTALMY if you have a medical history of alcohol or drug abuse.
•
you or your child have severe liver problems Your doctor will monitor you closely during treatment and may reduce your dose of ZTALMY.
Children and adolescents ZTALMY must not be given to children under the age of 2 years since there is no information on use in children below this age. Other medicines and ZTALMY Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines. Taking ZTALMY with certain other medicines may cause side effects, affect how other medicines work or affect how ZTALMY works. Do not start or stop taking other medicines without talking to your doctor or pharmacist first. Tell your doctor if you or your child are taking any of the following medicines, as your dose of ZTALMY may need to be adjusted: –
–
Valproate-containing medicines, which are used to treat epilepsy, they may require your dose of ZTALMY to be lower; Medicines that may reduce how ZTALMY works may require your dose of ZTALMY to be higher: Other antiepileptic or anticonvulsant medicines such as carbamazepine, phenytoin, phenobarbital and primidone; Antibiotics such as rifampicin; St. John's Wort (Hypericum perforatum), a herbal remedy used for mild depression.
The interaction between this medicine and oral contraceptives has not been investigated. Talk to your doctor if you are taking oral contraceptives. ZTALMY with alcohol Alcohol should not be consumed as it can increase the sleepiness and sedative effects of ZTALMY. Pregnancy If you are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. ZTALMY is not recommended if you are pregnant or a women of child-bearing potential and not using contraception. Breast-feeding Do not use ZTALMY whilst breast-feeding unless your doctor decides the benefits of taking ZTALMY outweighs any potential risks. Driving and using machines ZTALMY can make you feel drowsy/sleepy. If affected, do not drive, ride a bicycle or operate a machine until you feel more alert. 2
ZTALMY contains sodium This medicine contains less than 1 mmol sodium (23 mg) per each mL, that is to say, it is essentially 'sodium-free'. ZTALMY contains sodium benzoate and benzoic acid This medicine contains 0.92 mg sodium benzoate and 0.00068 mg benzoic acid in each mL. Sodium benzoate and benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). ZTALMY contains benzyl alcohol This medicine contains 0.00023 mg benzyl alcohol in each mL. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called "gasping syndrome") in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist. Increased risk due to accumulation in young children. Ask your doctor or pharmacist for advice if you are pregnant or breast‐feeding, or if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called 'metabolic acidosis'). ZTALMY contains methyl parahydroxybenzoate and propyl parahydroxybenzoate This medicinal product contains 1.02 mg methyl parahydroxybenzoate and 0.2 mg propyl parahydroxybenzoate in each mL which may cause allergic reactions (possibly delayed). 3.
How to take ZTALMY
ZTALMY is given under supervision of a doctor experienced in the treatment of epilepsy. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is an oral suspension (a liquid to be swallowed). Your doctor or pharmacist will tell you how much (in mL) of the oral suspension to take each day, and how many times a day you should take it. Your doctor will calculate the dose according to your body weight. You may start on a low dose that your doctor gradually increases over time. If you have severe hepatic impairment, your doctor will start you on a lower dose and follow a different titration schedule. Patient weighing less than or equal to 28 kg You or your child will gradually have your dose increased over 4 weeks until you receive the recommended maximum daily dose of 63 mg/kg/day given in three separate doses every 8 hours. Patient weighing more than 28 kg You or your child will gradually have your dose increased over 4 weeks until you receive the recommended maximum daily dose of 1 800 mg/day given in three separate doses every 8 hours. It is recommended that you take 3 equal doses throughout the day. However, ZTALMY can make you feel sleepy, and your doctor may decide you should be given a lower dose during the daytime and a higher dose in the evening to avoid any sleepy effects during the daytime. Talk to your doctor if you are unsure of your dose or if you think it may need to be changed.
How to take it
ZTALMY 3
• • • •
Take the medicine with or shortly after meals If possible, try to take with similar types of food (e.g. similar fat content) so you get the same effect each time Do not mix ZTALMY with food or drink To ensure an accurate dose, please use the reusable oral dosing syringes provided in each pack.
Instructions for use Each single-bottle pack is supplied with: One bottle of oral suspension closed with a child resistant cap
Two 12 mL and two 3 mL reusable oral dosing syringes
One bottle adaptor
ZTALMY is also supplied in a pack with five bottles of oral suspension, five 12 mL reusable oral dosing syringes and five bottle adaptors. Please note that the pack containing five bottles of ZTALMY does not include a 3 mL reusable oral dosing syringe. • •
Ask your doctor, pharmacist or nurse if you are not sure how to prepare or take the prescribed dose of ZTALMY. You will receive 12 mL and 3 mL reusable oral dosing syringes in the single-bottle pack. If your dose is 3 mL or less, use the smaller 3 mL syringes to take your medicine. If your dose is more than 3 mL use the larger 12 mL syringes to take your dose. 4
• • • •
Always use the correct reusable oral dosing syringe provided with ZTALMY to make sure you measure the right amount of ZTALMY. Do not use a household spoon. Do not mix ZTALMY with food or drink to administer. Each 3 mL dosing syringe may be used for 16 consecutive days. After 16 days, throw away the used dosing syringe and use the spare syringe contained in the carton. Use ZTALMY within 30 days of first opening the bottle. There is space on the bottle label for you to write down the date for discarding the bottle after opening so you do not forget. After 30 days, discard any ZTALMY that has not been used, and use a new bottle.
Preparing the bottle: 1. Hold the bottle in your hand and shake it up and down well for 1 minute. Always shake the bottle well for 1 minute then let the bottle stand for 1 minute so that any foam that builds up during shaking can settle before measuring and giving each dose of ZTALMY. This helps you measure the correct amount of medicine. NOTE: This step is for each dose of the medicine. 2. Remove the child-resistant cap on the bottle by pushing the cap down whilst turning the cap to the left (anti-clockwise).
3. Puncture and peel off the induction seal from the bottle. NOTE: This step is only for the first use of the bottle.
4. Hold the bottle tight with one hand while pushing the bottle adaptor firmly into the neck of the bottle with the other hand, and make sure it is fully inserted. The adaptor could come off and cause choking if it is not fully inserted. NOTE: Do not remove the press-in bottle adapter from the bottle after it is inserted. 5
Preparing the dose: 5. Insert the tip of the correct reusable oral dosing syringe fully into the bottle adaptor, and with the oral syringe in place, turn the bottle upside down. It is important that you use the correct reusable oral dosing syringe to measure your dose:
- If your dose is 3 mL (150 mg) or less, you should use the smaller 3 mL syringe.
- If your dose is more than 3 mL (150 mg), you should use the larger 12 mL syringe. 6. Slowly pull back the plunger of the syringe, so the volume (number of mL) of oral suspension needed is drawn into the syringe. Line up the end of the plunger with the volume marking required, as shown opposite. If there is an air bubble in the syringe, push the liquid back into the bottle whilst keeping the bottle upside down, and repeat Step 6 until the bubble has gone.
7. Turn the bottle the right side up, and carefully remove the oral syringe from the adaptor.
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Taking or giving ZTALMY: 8. Place the tip of the oral syringe inside the cheek, and gently push the plunger to release the medicine. Do not push the plunger forcefully or direct the medicine to the back of the mouth or throat.
9. Screw the child resistant cap back on the bottle tightly, by turning the cap to the right (clockwise). You do not need to remove the bottle adaptor; the cap will fit over it.
10. Wash the oral syringe immediately after use. Remove the plunger from the barrel of the syringe, and rinse both parts using room temperature tap water. Warning: Do not use bleach or any other harsh cleaning solutions. Do not wash the oral syringe in a dishwasher. 11. Shake off any water from both syringe parts and allow them to airdry separately until the next use. Make sure both parts are completely dry before placing the plunger back into the syringe barrel for the next 7
use. If both parts are not completely dry before the next dose, use the appropriate spare syringe provided in the pack. When using the 12 mL syringe accompanying each bottle, do not throw away the reusable oral syringes until the bottle is empty. When using the 3 mL syringe, discard after 16 days. 12. Repeat steps 1-3 and 6-12 for each next dose. If you take more ZTALMY than you should If you accidentally take more ZTALMY than you should, tell a doctor or pharmacist immediately, or contact your nearest hospital casualty department, and take the medicine with you. You may feel drowsy or sleepy from taking too much medicine. If you forget to take ZTALMY If you forget to take a dose, the missed dose may be taken up to 4 hours before the next scheduled dose. When the next dose is due in less than 4 hours, it is recommended to skip the dose and continue with the next scheduled dose. If you stop taking ZTALMY Do not reduce the dose or stop taking ZTALMY without first talking to your doctor. Stopping this treatment abruptly could increase your seizures. The doctor will explain how to gradually stop taking ZTALMY. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. You may get the following side effects with this medicine. Tell the doctor if you have any of the following: Very common (may affect more than 1 in 10 people): feeling drowsy or sleepy; fever. Common (may affect more than 1 in 100 people): feeling overly calm or relaxed; feeling excessively tired during the day or sleeping longer than usual at night; lack of energy; drooling; producing more saliva than usual. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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5.
How to store it
ZTALMY
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP. The expiry date refers to the last day of that month. This medicine does not require any special temperature storage conditions. Discard any unused medicine 30 days after first opening. Do not throw away any medicines in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What ZTALMY contains The active substance is ganaxolone. Each mL of oral suspension contains 50 mg of ganaxolone. –
The other ingredients are: hypromellose (E464), polyvinyl alcohol (E1203), sodium lauryl sulfate (E487), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium benzoate (E211), citric acid anhydrous (E330), sodium citrate dihydrate (E331), artificial cherry flavour (including propylene glycol [E1520] and benzyl alcohol [E1519]), sucralose (E955), simethicone emulsion (simethicone, polysorbate 65, methylcellulose, polyethelene, glycolmonostearate, glycerol monostrearate, xanthan gum, benzoic acid [E210], sorbic acid and purified water), purified water (see also section 2 'ZTALMY contains sodium'; 'ZTALMY contains sodium benzoate', 'ZTALMY contains benzoic acid', 'ZTALMY contains benzyl alcohol', and 'ZTALMY contains methyl parahydroxybenzoate and propyl parahydroxybenzoate').
What ZTALMY looks like and contents of the pack ZTALMY is a white to off-white oral suspension. It comes in a plastic bottle which has a plastic child-resistant cap. Each bottle contains 110 mL of oral suspension. ZTALMY is supplied in packs of either: one bottle of oral suspension, two 12 mL and two 3 mL oral dosing syringes, and one bottle adaptor; or five bottles of oral suspension, five 12 mL oral dosing syringes, and five bottle adaptors. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Immedica Pharma AB 113 63 Stockholm Sweden Manufacturer Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dunkalk, A91 P9KD Ireland This leaflet was last revised in: 07/2025
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Frequently asked questions about ZTALMY 50 mg/ml Oral suspension
How do I take ZTALMY 50 mg/ml Oral suspension?
ZTALMY 50 mg/ml Oral suspension comes as oral solution containing 50mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in ZTALMY 50 mg/ml Oral suspension?
The active substance in ZTALMY 50 mg/ml Oral suspension is ganaxolone.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for ZTALMY 50 mg/ml Oral suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get ZTALMY 50 mg/ml Oral suspension without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ganaxolone
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
ZTALMY is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 to 17 years of age. ZTALMY may be continued in patients 18 years of age and older.
4.2. Posology and method of administration
Treatment should be initiated and supervised by physicians with experience in the treatment of epilepsy.
Posology
Children and adolescents
ZTALMY should be titrated gradually to achieve individual clinical response and tolerability. Any patient not tolerating the dosing steps shown in the tables below, can be maintained at the lower dose for additional days before advancing to the next dose. If the next dose is still not tolerated, patients can drop back to the previous lower dose.
It is recommended that the total daily dose is administered in 3 equal doses throughout the day. If this is not tolerated by a patient, the dose can be adjusted to manage symptoms (e.g., somnolence), provided that the total daily dose is administered.
Patients weighing ≤ 28 kg
The recommended maximum daily dose is 63 mg/kg/day given in three separate doses (every 8 hours). A minimum dose of 33 mg/kg/day is generally required.
The recommended titration schedule for patients weighing 28 kg or less is shown below:
Week
Dose
(given 3 times a day)
mL/kg per single dose
Total daily dose
Week 1
6 mg/kg
0.12
18 mg/kg
Week 2
11 mg/kg
0.22
33 mg/kg
Week 3
16 mg/kg
0.32
48 mg/kg
Week 4 – ongoing
21 mg/kg
0.42
63 mg/kg
Patients weighing > 28 kg
The recommended maximum daily dose is 1 800 mg per day given in three separate doses (every 8 hours). A minimum dose of 900 mg/day is generally required.
The recommended titration schedule for patients weighing more than 28 kg is shown below:
Week
Dose
(given 3 times a day)
mL per single dose
Total daily dose
Week 1
150 mg
3
450 mg
Week 2
300 mg
6
900 mg
Week 3
450 mg
9
1 350 mg
Week 4 – ongoing
600 mg
12
1 800 mg
Adults
The efficacy and safety of treatment initiation with ZTALMY in patients aged over 17 years have not yet been established. In adolescents in whom a clear treatment benefit has been demonstrated, treatment may be continued into adulthood. However, treatment initiation in adults is not recommended as efficacy and safety have not yet been established in this population (see sections 5.1 and 5.2)
Discontinuation
If ZTALMY must be discontinued, the dose should be decreased gradually. For patients weighing 28 kg or less, the decrease in total daily dose should be 15 mg/kg every four days. For patients weighing more than 28 kg, the decrease in total daily dose should be 450 mg every four days. ZTALMY may be stopped immediately and without down-titration in the case of an emergency, however, a down-titration is recommended to minimize the risk of increased seizure frequency and status epilepticus.
Missed doses
Missed doses may be taken up to 4 hours before the next scheduled dose. When the next dose is due in less than 4 hours, it is recommended to skip the dose and to continue with the next scheduled dose.
Special populations
Elderly
There is no information on the use of ZTALMY in patients with CDD who are 65 years of age and over. Doses in elderly patients should be chosen carefully based on clinical status and concomitant medicinal products. Close clinical monitoring is recommended when initiating treatment in the elderly.
Renal impairment
ZTALMY can be administered to patients with mild, moderate, or severe renal impairment without dose adjustment. There is no experience in patients with end-stage renal disease. It is not known if ZTALMY is dialysable (see section 5.2).
Hepatic impairment
Dose adjustment is not required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment (see section 4.4).
For patients with severe hepatic impairment (Child-Pugh C) the initial target dose should be one-third the recommended target dose. The dose titration should be performed as detailed in the table(s) below.
The dose in patients with severe hepatic impairment weighing 28 kg or less is shown below:
Week
Dose
(given 3 times a day)
mL/kg per single dose
Total daily dose
Week 1
2 mg/kg
0.04
6 mg/kg
Week 2
3.7 mg/kg
0.07
11 mg/kg
Week 3
5.3 mg/kg
0.11
16 mg/kg
Week 4 – ongoing
7 mg/kg
0.14
21 mg/kg
The dose in patients with severe hepatic impairment weighing more than 28 kg is shown below:
Week
Dose
(given 3 times a day)
mL per single dose
Total daily dose
Week 1
50 mg
1
150 mg
Week 2
100 mg
2
300 mg
Week 3
150 mg
3
450 mg
Week 4 – ongoing
200 mg
4
600 mg
Higher or lower doses may be considered in patients with severe hepatic impairment based on individual clinical response and tolerability.
Paediatric population
There is no relevant use of ZTALMY in infants below 6 months of age. The safety and efficacy of ZTALMY in children aged less than 2 years have not yet been established. No data are available.
Method of administration
Oral use only. No data are available on the feasibility of administration through an enteral feeding tube.
ZTALMY must be taken with or shortly after meals and each dose should be administered with similar types of food, if possible (see section 5.2). Do not mix with food or drinks prior to administration.
ZTALMY should only be administered using the reusable oral dosing syringes provided in each pack for a more accurate dose administration.
Each 12 mL reusable oral syringe is graduated in 0.25 mL increments (each 0.25 mL increment corresponds to 12.5 mg ganaxolone) and each 3 mL reusable oral dosing syringe is graduated in 0.1 mL increments (each 0.1 mL increment corresponds to 5 mg ganaxolone). The calculated dose should be rounded to the nearest graduated increment. If the calculated dose is 3 mL (150 mg) or less, the smaller 3 mL oral syringe should be used. If the calculated dose is more than 3 mL (150 mg) the larger 12 mL oral syringe should be used.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Somnolence and sedation
ZTALMY causes somnolence and sedation (see sections 4.5 and 4.8).
Other Central Nervous System (CNS) depressants, including concomitantly used anti-seizure medicinal products, opioids, antidepressants, and alcohol, could potentiate the somnolence and sedation effect.
Suicidal behaviour and ideation
Suicidal behaviour and ideation have been reported in patients treated with anti-epileptic drugs (AEDs) in several indications. A meta-analysis of randomised placebo-controlled trials with AEDs has shown a small increased risk of suicidal behaviour and ideation. The mechanism of this risk is not known. The available data do not exclude the possibility of an increased risk with ganaxolone.
Patient's caregivers should be advised to monitor for signs of suicidal behaviour and ideation, or self-harm behaviour during treatment and when changes in the treatment regimen become necessary. Caregivers should be advised to seek medical advice should any signs of suicidal behaviour and ideation, or self-harm emerge.
Alcohol use
In animal models, ganaxolone has been shown to potentiate the effects of alcohol. Patients should not use alcohol during treatment (see section 4.5).
CYP3A4 inducers
Concomitant use with strong cytochrome P450 (CYP) 3A4 inducers e.g. carbamazepine, phenobarbital, phenytoin, primidone, rifampicin and St John's Wort should be avoided as they can reduce ganaxolone exposure (see section 4.5).
Hepatic impairment
An increase in ganaxolone exposure was seen in patients with severe hepatic impairment (Child-Pugh C) (see section 5.2). A dosage adjustment is recommended in these patients (see section 4.2).
Abuse
ZTALMY has potential for abuse (see section 5.3).
Dependence
It was not possible to assess physical dependence during clinical trials with ganaxolone; animal studies suggest that abrupt discontinuation of ganaxolone may cause withdrawal symptoms (see sections 5.1 and 5.3). It is therefore recommended that ganaxolone be tapered according to the dosage recommendations unless symptoms warrant immediate discontinuation (see section 4.2).
Excipients with known effect
This medicinal product contains less than 1 mmol sodium (23 mg) per each daily dose, that is to say essentially 'sodium-free'.
This medicinal product contains 0.92 mg sodium benzoate and 0.00068 mg benzoic acid in each mL. Benzoate salt and benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
This medicinal product contains 0.00023 mg benzyl alcohol in each mL. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist. Increased risk due to accumulation in young children. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding, or if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
This medicinal product contains 1.02 mg methyl parahydroxybenzoate and 0.2 mg propyl parahydroxybenzoate in each mL. Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
4.5. Interaction with other medicinal products and other forms of interaction
CYP3A4 inducers
Coadministration with a strong CYP3A4 inducer will decrease ganaxolone exposure.
Concomitant use of rifampicin decreased the AUC0-inf of ganaxolone by approximately 57-68%. Enzyme inducing antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital, and primidone) and St. John's Wort may result in similarly lower plasma exposures of ganaxolone. In patients on a stable dose of ganaxolone or in patients initiating or increasing the dose of concomitant enzyme-inducing antiepileptic drugs or St. John's Wort a dose increase may be necessary; however, do not exceed the maximum daily dose (see section 4.4).
CYP3A4 inhibitors
Coadministration of ganaxolone with itraconazole, a strong CYP3A4 inhibitor, increased the ganaxolone AUC by 17% in healthy subjects (the Cmax was unchanged). The changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
UGT inhibitors
Ganaxolone is a substrate for UGT1A3, UGT1A6, UGT1A9, and UGT2B15. No formal drug-drug interaction studies have been conducted with ganaxolone in combination with UGT inhibitors such as valproate. Dose reduction of ganaxolone and/or the UGT inhibitor may be necessary when given in combination.
Oral contraceptives
The potential interaction of ganaxolone with oral contraceptives has not been investigated.
Ethanol interaction
Concomitant use with CNS depressants (including alcohol) may increase the risk of sedation and somnolence (see section 4.4). Patients should be prohibited from drinking alcohol during treatment.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited data on the use of ganaxolone in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
ZTALMY is not recommended during pregnancy and in woman of childbearing potential not using contraception.
Breast-feeding
Ganaxolone and its metabolites are excreted in human milk. Based on an average milk intake, the calculated maximum relative infant dose of ganaxolone is approximately 1% of the maternal dose. The effect of ganaxolone on breastfed newborns/infants is unknown, A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue ZTALMY taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There are no human data on the effect of ganaxolone on fertility. Animal studies are insufficient with respect to fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
ZTALMY has a moderate to major influence on the ability to drive and use machines because it may cause somnolence, sedation and sedation-related adverse reactions, such as fatigue and ataxia, and other CNS-related events such as dizziness (see section 4.4). Patients should be advised not to drive or use machines (see section 4.8).
4.8. Undesirable effects
Summary of the safety profile
The most commonly reported adverse drug reactions in clinical trials in patients with CDD include somnolence (29.4%) and pyrexia (23.5%).
Tabulated list of adverse reactions
Adverse reactions reported with ganaxolone in a clinical trials in patients with CDD with an average exposure duration of 411.5 days (N = 102) are listed in the table below by System Organ Class and frequency.
The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
System organ class
Very common
Common
Nervous system disorders
Somnolence
Sedation
Hypersomnia
Lethargy
Drooling
Gastrointestinal disorders
Salivary hypersecretion
General disorders and administration site conditions
Pyrexia
Description of selected adverse reactions
Somnolence and sedation
ZTALMY can cause somnolence and sedation. In a placebo-controlled study for CDD, the incidence of somnolence and sedation was 31.4%, and 3.9% respectively in patients treated with ZTALMY, compared with 15.7%, and 3.9% respectively in patients treated with placebo. These adverse reactions appear early in treatment and are dose-related; symptoms may decrease with continued treatment.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is limited clinical trial experience regarding overdose. Adverse events of the central nervous system (e.g., somnolence, sedation) have been reported to be dose dependent.
In the event of overdose, the patient should be observed and appropriate symptomatic treatment given, including monitoring of vital signs.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- ZtalmyGanaxolonum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about ZTALMY 50 mg/ml Oral suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.