Indications

Anfran Injection is used for the treatment of nausea and vomiting caused by cytotoxic chemotherapy and radiotherapy.

Anfran Injection is also used for the prevention and treatment of postoperative nausea and vomiting.

Contraindications

Hypersensitivity to any component of the preparation.

Dosage and Administration

Anfran may be administered orally, allowing for convenient administration and dosing.

The preparation supplied in ampoules must not be stored after opening. Once opened, the ampoule should be used immediately as a single dose, either by injection or infusion, and any remaining solution should be discarded.

Anfran ampoules must not be autoclaved.

Chemotherapy- and radiotherapy-induced nausea and vomiting

Adults

The emetogenic potential of chemotherapy and radiotherapy varies depending on the dosage and combination of the treatment regimens used for cancer therapy.

The daily dose of Anfran Injection ranges from 8 mg to 32 mg and should be selected as follows:

Emetogenic chemotherapy and radiotherapy

The recommended intravenous or intramuscular dose is 8 mg administered by slow injection immediately before treatment.

To prevent delayed or prolonged vomiting after the first 24 hours, oral administration is recommended.

Highly emetogenic chemotherapy

In patients receiving highly emetogenic chemotherapy (e.g., cisplatin), Anfran may be administered immediately before treatment as a single 8 mg intravenous or intramuscular dose.

Doses greater than 8 mg and up to 32 mg should only be administered by intravenous infusion after dilution in 50–100 ml of an appropriate infusion solution (e.g., normal saline or another suitable infusion solution – see Pharmacological Properties), infused over no less than 15 minutes.

Alternatively, Anfran may be administered as a single 8 mg slow intravenous or intramuscular injection immediately before chemotherapy, followed by two additional 8 mg intravenous or intramuscular doses at intervals of 2–4 hours, or by continuous intravenous infusion at a rate of 1 mg/hour for up to 24 hours.

The dosage regimen should be selected according to the severity of the emetogenic challenge.

To enhance the antiemetic effect of Anfran during highly emetogenic chemotherapy, a single intravenous dose of 20 mg dexamethasone sodium phosphate may be administered immediately before chemotherapy.

Oral administration is recommended after the first 24 hours to prevent delayed or prolonged vomiting.

Children and adolescents (6 months–17 years)

In children with a body surface area of 0.6–1.2 m², Anfran is administered as a single intravenous dose of 5 mg/m² immediately before chemotherapy, followed 12 hours later by an oral dose of 4 mg. Oral treatment with 4 mg twice daily may be continued for up to 5 days after completion of chemotherapy.

In children with a body surface area greater than 1.2 m², Anfran is administered as an initial intravenous dose of 8 mg immediately before chemotherapy, followed 12 hours later by an oral dose of 8 mg. Oral treatment with 8 mg twice daily may be continued for up to 5 days after completion of chemotherapy.

Alternatively, in children aged 6 months and older, Anfran may be administered as a single intravenous dose of 0.15 mg/kg (not exceeding 8 mg) immediately before chemotherapy. This dose may be repeated every 4 hours for a total of three doses. Oral treatment with 4 mg twice daily may be continued for up to 5 days after completion of chemotherapy. The adult dosage should not be exceeded.

Elderly

Anfran is well tolerated in patients over 65 years of age. No adjustment of dose, dosing frequency, or route of administration is required.

Postoperative nausea and vomiting

Adults

For the prevention of postoperative nausea and vomiting, the recommended dose of Anfran is a single 4 mg slow intravenous or intramuscular injection administered at the induction of anesthesia.

For the treatment of postoperative nausea and vomiting, a single 4 mg slow intravenous or intramuscular injection is recommended.

Children

For the prevention and treatment of postoperative nausea and vomiting in pediatric patients undergoing surgery under general anesthesia, Anfran may be administered by slow intravenous injection at a dose of 0.1 mg/kg, up to a maximum dose of 4 mg, before or during induction of anesthesia, or after surgery.

Elderly

There is limited experience with the use of Anfran for the prevention and treatment of postoperative nausea and vomiting in elderly patients. However, Anfran is well tolerated in patients over 65 years of age receiving chemotherapy.

Patients with renal impairment

No adjustment of the daily dose, dosing frequency, or route of administration is required.

Patients with severe hepatic impairment

In patients with moderate or severe hepatic impairment, the clearance of Anfran is significantly reduced and the elimination half-life is markedly prolonged. In such patients, the total daily dose should not exceed 8 mg.

Patients with poor sparteine/debrisoquine metabolism

The elimination half-life of Anfran is not altered in patients who are poor metabolizers of sparteine and debrisoquine. Therefore, repeated dosing in such patients results in drug exposure similar to that observed in the general population. No adjustment of the daily dose or dosing frequency is required.

Overdose

There is limited information regarding overdose with Anfran. In most reported cases, the symptoms were similar to those observed with the recommended doses (see Adverse Reactions).

There is no specific antidote for Anfran. Therefore, in cases of suspected overdose, appropriate symptomatic and supportive treatment should be provided.

The use of ipecacuanha is not recommended in cases of Anfran overdose, as patients are unlikely to respond because of the antiemetic effect of Anfran.

Dosage Form

2 ml (4 mg ondansetron hydrochloride) or 4 ml (8 mg ondansetron hydrochloride) solution for injection in amber glass ampoules.

5 or 10 ampoules, together with the package leaflet, are packed in a cardboard box.

Storage Conditions

Store below 25°C, protected from light and out of the reach of children.

Shelf Life

The expiry date is indicated on the package.

Do not use after the expiry date.

Dispensing Conditions

Prescription only.