Consumer medicine information

1. Why am I using Fintepla^®?

Fintepla^® contains the active ingredient fenfluramine. Fenfluramine is used to treat seizures associated with 2 forms of childhood epilepsy: Dravet syndrome and Lennox-Gastaut syndrome.
For more information, see Section 1. Why am I using Fintepla^®? in the full CMI.

2. What should I know before I use Fintepla^®?

Do not use Fintepla^® if you or your child have ever had an allergic reaction to fenfluramine or any of the ingredients listed at the end of the CMI, or if you or your child have a heart problem such as valve disease or pulmonary arterial hypertension, or if you or your child have taken medicines called monoamine oxidase inhibitors in the last 2 weeks.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Fintepla^®? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Fintepla^® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Fintepla^®?

• Fintepla^® is an oral solution that is taken twice a day. The required dose will be calculated by your doctor based on your or your child's body weight. Starting at a low dose which may be gradually increased.

5. What should I know while using Fintepla^®?

6. Are there any side effects?

Side effects that need serious medical attention include being agitated, having hallucinations or passing out, fast heartbeat, fever, twitching muscles and being uncoordinated, sleepy or confused, being flushed or hot, shivering or sweating, feeling sick or being sick and diarrhoea. These are symptoms of serotonin syndrome or of taking too much Fintepla^®.
Common side effects include falling, diarrhoea, vomiting, weight loss, constipation, loss of appetite, high temperature, feeling tired, sleepy or weak, chest infection, bronchitis, influenza, ear infection, pneumonia, trembling of the hands, arms or legs, long-lasting seizures, irritability, lethargy, producing a lot of saliva, abnormal behaviour, rapid mood changes, aggression, agitation, insomnia, having problem with coordination of movements, walking and balance and decreased muscle tone.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Warning: valvular heart disease and pulmonary arterial hypertension. See Section 4.4 Special Warnings and Precautions for Use for further detail.
There is an association between serotonergic drugs with 5-HT_2B receptor agonist activity, including fenfluramine (the active ingredient in Fintepla), and valvular heart disease and pulmonary arterial hypertension.
Echocardiogram assessments are required before, during and after treatment with Fintepla.
Fintepla is only available through a controlled access program.

1 Name of Medicine

Fenfluramine hydrochloride.

2 Qualitative and Quantitative Composition

Fintepla oral solution contains 2.2 mg of fenfluramine (as hydrochloride) per mL.
Excipients with known effect. Sucralose, hydroxybenzoates, benzoates, sulfites. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Oral solution. The solution is a clear, colourless, slightly viscous liquid.

4 Clinical Particulars

4.9 Overdose

Only limited data have been reported concerning clinical effects and management of overdose of fenfluramine. Agitation, drowsiness, confusion, flushing, tremor (or shivering), fever, sweating, abdominal pain, hyperventilation, and dilated non-reactive pupils were reported at much higher doses of fenfluramine than those included in the clinical trial program.
Vital functions should be monitored closely, and supportive treatment administered in case of convulsions, arrhythmias, or respiratory difficulties.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Fenfluramine was not genotoxic when tested in the in vitro bacterial reverse mutation test (Ames) and an in vivo micronucleus and comet assay in rats.
Carcinogenicity. Once daily oral administration of fenfluramine to Tg.rasH2 mice (up to 51.8 mg/kg/day) for 26 weeks and to male and female rats (up to 6.9 mg/kg/day) for up to 89 and 97 weeks, respectively, resulted in no evidence of drug-induced tumours in either species. In rats, plasma exposures (AUC) of fenfluramine and norfenfluramine (the major metabolite) at the highest dose tested were approximately 5 and 11 times, respectively, those in humans at the MRHD of 26 mg/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical name: fenfluramine hydrochloride.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFENFLU.gif CAS number. 404-82-0.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/FINTEPST.gif