SETOFILM Orodispersible film Ref.[27891] Active ingredients: Ondansetron

SETOFILM is only indicated for oral use. Please refer to the relevant SmPC for other dosage forms of ondansetron.

SETOFILM may be recommended in patients with an enhanced risk of aspiration. It can be useful for patients that experience difficulties in swallowing, e.g., children or the elderly.

Method of administration

• SETOFILM orodispersible film should be removed from each individual sachet taking care not to damage the film.
• Open the sachet only at the tear tag and tear this off slowly. Do not cut the sachet.
• Before use check the film for damage. Only undamaged films should be used.
• The patients' mouth should be empty and their fingers dry before placing SETOFILM orodispersible film on to the tongue.
• The film should disintegrate on the tongue without water in a few seconds (in saliva which should be subsequently swallowed).

Posology

4.2.1 Chemotherapy and radiotherapy induced nausea and vomiting

Adults

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge.

Emetogenic chemotherapy and radiotherapy:

Ondansetron can be given either by rectal, oral, intravenous or intramuscular administration.

SETOFILM is an oral formulation. The recommended oral dose is 8mg 1 to 2 hours before treatment, followed by 8mg orally 12 hours later.

To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with SETOFILM should be continued for up to 5 days after a course of treatment. The recommended oral dosage is 8mg to be taken twice daily.

Highly emetogenic chemotherapy (e.g. high dose cisplatin):

Ondansetron can be given either by oral, rectal, intravenous or intramuscular administration.

SETOFILM is an oral formulation. The recommended oral dose is 24 mg taken together with oral dexamethasone sodium phosphate 12mg, 1 to 2 hours before treatment.

To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with SETOFILM should be continued for up to 5 days after a course of treatment. The recommended oral dosage is 8mg to be taken twice daily.

Paediatric Population

Chemotherapy induced nausea and vomiting (CINV):

The dose for CINV can be calculated based on body surface area (BSA) or weight – see table 1 below. Weight – based dosing results in higher total daily doses compared to BSA based dosing. (See sections 4.4 and 5.1)

There are no data from controlled clinical trials on the use of ondansetron in the prevention of delayed or prolonged CINV or on the use of ondansetron for radiotherapy-induced nausea and vomiting (RINV) in children.

Ondansetron should be administered immediately before chemotherapy as a single intravenous dose. The intravenous dose must not exceed 8 mg.

Oral dosing can commence twelve hours later and may be continued for up to 5 days. See Table 1 below.

The total daily dose must not exceed adult dose of 32 mg.

Table 1. BSA and weight based dosing for Chemotherapy:

^a The intravenous dose must not exceed 8 mg.
^b The total daily dose must not exceed adult dose of 32 mg
^* SETOFILM is an oral preparation only, and is not available in an intravenous formulation
^** SETOFILM is only available in films of 4mg and 8mg. It is not possible to divide the film to obtain a 2mg dosage.

Elderly

Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration is required.

Prescribers intending to use ondansetron in the prevention of delayed nausea and vomiting associated with chemotherapy or radiotherapy in adults, adolescents or children should take into consideration current practice and appropriate guidelines.

4.2.2 Post-operative nausea and vomiting (PONV)

Adults

Prevention of Post-operative nausea and vomiting (PONV):

For the prevention of post-operative nausea and vomiting, the recommended oral dose is 16mg given 1 hour prior to anaesthesia.

Alternatively, use 8 mg one hour prior to anaesthesia followed by two further doses of 8 mg at eight hourly intervals.

Treatment of established Post-operative nausea and vomiting (PONV):

For the treatment of established PONV, intravenous or intramuscular administration is recommended.

Paediatric population

Post-operative nausea and vomiting:

For the prevention and treatment of PONV, slow intravenous injection is recommended.

Alternatively, for administration in children weighing ≥40kg SETOFILM can be administered orally as a 4 mg dose, one hour prior to anaesthesia, followed by one further dose of 4 mg after 12 hours.

There are no data on the use of ondansetron for the treatment of PONV in children under 2 years of age.

Elderly

There is limited experience in the use of ondansetron in the prevention and treatment of PONV in the elderly; however ondansetron is well tolerated in patients over 65 years receiving chemotherapy.

Special populations – both indications

Patients with renal impairment

No alteration of daily dosage or frequency of dosing, or route of administration are required.

Patients with hepatic impairment

Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8mg should not be exceeded.

Patients with poor sparteine/debrisoquine metabolism

The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.

Little is known at present about over-dosage with ondansetron, however, a limited number of patients received overdoses. Manifestations that have been reported include visual disturbances, severe constipation, hypotension and vaso-vagal episodes with transient second degree AV block. In all instances, the events resolved completely.

Ondansetron prolongs QT interval in a dose-dependent manner. ECG monitoring is recommended in cases of overdose.

There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.

The use of ipecacuanha to treat overdose with ondansetron is not recommended, as patients are unlikely to respond due to the anti-emetic action of ondansetron itself.

Paediatric population

Peadiatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeded estimated ingestion of 4 mg/kg) in infants and children aged 12 months to 2 years.

3 years.

Keep the sachet tightly closed in order to protect from moisture.

The primary packaging material is a sachet, which will be opened and removed before application. The material is a composite foil composed of kraft paper (outer layer), LDPE, aluminium foil and Surlyn (inner layer).

Pack size of 2, 4, 6, 10, 30 and 50.

Not all pack sizes may be marketed.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.