Prospect: information for the user

Fosaprepitant Tarbis 150 mg powder for solution for infusion EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

1 What is Fosaprepitant Tarbis and for what it is used

2. What you need to know before starting to use Fosaprepitant Tarbis

3. How to use Fosaprepitant Tarbis

4. Possible adverse effects

5. Storage of Fosaprepitant Tarbis

6. Contents of the package and additional information

Fosaprepitant Tarbis contains the active ingredient fosaprepitant, which is converted into aprepitant in the body. It belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists". The brain has a specific area that controls nausea and vomiting. Fosaprepitant Tarbis works by blocking signals to this area, thereby reducing nausea and vomiting. Fosaprepitant Tarbis is used in adults, adolescents, and children aged 6 months and older,in combination with other medicines, to prevent nausea and vomiting caused by a type of chemotherapy (cancer treatment) that triggers strong or moderate nausea and vomiting.

Do not use Fosaprepitant Tarbis

• if you are allergic to fosaprepitant, aprepitant or to polysorbate 80 or to any of the other ingredients of this medicine (listed in section 6).
• with medicines that contain pimozide (used to treat psychiatric disorders), terfenadine and astemizol (used to treat allergic rhinitis and other allergic disorders), cisaprida (used to treat digestive problems). Inform your doctor if you are taking these medicines as the treatment needs to be modified before starting to use fosaprepitant.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use fosaprepitant.

Before treatment with this medicine, inform your doctor if you have liver disease, as the liver is important for eliminating the medicine from the body. Your doctor may need to monitor your liver function.

Children and adolescents

Do not give fosaprepitant to children under 6 months of age or weighing less than 6 kg, as the use of this medicine has not been studied in this population.

Other medicines and Fosaprepitant Tarbis

Fosaprepitant may affect other medicines both during and after treatment with fosaprepitant. There are some medicines that should not be used with fosaprepitant (such as pimozide, terfenadine, astemizol and cisaprida) or that require a dose adjustment (see also ‘Do not use Fosaprepitant Tarbis’).

The effects of fosaprepitant or of other medicines may be influenced if you take fosaprepitant with other medicines, including the following. Consult your doctor or pharmacist if you are taking any of the following medicines:

Inform your doctor if you are using, have used recently or may need to use any other medicine or herbal remedy.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy unless it is clearly necessary. If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

For information related to birth control, see ‘Other medicines and Fosaprepitant Tarbis’.

The passage of fosaprepitant into breast milk is unknown; therefore, breastfeeding is not recommended during treatment with this medicine. It is essential to inform your doctor before receiving this medicine if you are breastfeeding or plan to do so.

Driving and operating machines

Some people experience dizziness and drowsiness after using fosaprepitant. If you feel dizzy or drowsy, avoid driving or operating machines after using this medicine (see ‘Possible side effects’).

Fosaprepitant Tarbis contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is, essentially “sodium-free”.

In adults (18 years of age or older), the recommended dose of fosaprepitant is 150 mg of fosaprepitant on day 1 (chemotherapy day).

In children and adolescents (6 months to 17 years of age), the recommended dose of fosaprepitant is based on the patient's age and weight. Depending on the chemotherapy received, fosaprepitant may be administered in one of two ways:

Fosaprepitant is administered only on day 1 (single-day chemotherapy)

Fosaprepitant is administered on days 1, 2, and 3 (chemotherapy of one or multiple days)

• On days 2 and 3, oral presentations of aprepitant may be prescribed in place of Fosaprepitant Tarbis.

The powder is reconstituted and diluted before use. The infusion solution is administered by a healthcare professional, such as a doctor or nurse, via intravenous infusion (drip) approximately 30 minutes before chemotherapy begins in adults or 60 – 90 minutes before chemotherapy begins in children and adolescents. Your doctor may ask you to take other medications to prevent nausea and vomiting, including corticosteroids (such as dexamethasone) and a 5-HT3 antagonist (such as ondansetron). In case of doubt, consult your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking fosaprepitant and consult your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

Other side effects that have been reported are detailed below.

Frequent side effects(may affect up to 1 in 10 people) are:

Infrequent side effects(may affect up to 1 in 100 people) are:

Rare side effects(may affect up to 1 in 1,000 people) are:

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial after CAD. The first 2 numbers indicate the month; the following 4 numbers indicate the year.

Store in refrigerator between 2°C and 8°C.

The reconstituted and diluted solution is stable for 24 hours at 20-25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

Composition of Fosaprepitant Tarbis

The active ingredient is fosaprepitant. Each vial contains fosaprepitant dimeglumine equivalent to 150 mg of fosaprepitant. After reconstitution and dilution, 1 ml of the solution contains 1 mg of fosaprepitant (1 mg/ml).

The other components are: Edetate disodium (E-386), polysorbate 80 (E-433), lactose, sodium hydroxide (E-524) (to adjust the pH) and diluted hydrochloric acid (E-507) (to adjust the pH).

Appearance of the product and contents of the package

Fosaprepitant Tarbis is a white to off-white lyophilized cake or powder for solution for infusion.

The powder is contained in a transparent glass vial with a rubber stopper and an aluminum seal with a plastic flip-top cap.

Each vial contains 150 mg of fosaprepitant.

Package sizes: 1 and 10 vials.

Only some package sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany:Fosaprepitant Amarox 150 mg Powder for the Preparation of an Infusion Solution

Spain: Fosaprepitant Tarbis 150 mg powder for solution for infusion EFG

Netherlands: Fosaprepitant Amarox 150 mg powder for solution for infusion

Date of the last review of this leaflet:

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Instructions for reconstitution and dilution of Fosaprepitant Tarbis 150 mg:

1. Inject 5 ml of sodium chloride solution for injection 9 mg/ml (0.9 %) into the vial. Ensure that the sodium chloride solution for injection 9 mg/ml (0.9 %) is added to the vial along the wall of the vial to avoid foam formation. Gently move the vial. Avoid agitating and shaking the sodium chloride solution for injection 9 mg/ml (0.9 %) inside the vial.

2. Prepare an infusion bag that contains145 mlof sodium chloride solution for injection 9 mg/ml (0.9 %) (e.g., by removing 105 ml of sodium chloride solution for injection 9 mg/ml (0.9 %) from a 250 ml sodium chloride solution for injection 9 mg/ml (0.9 %) infusion bag).

3. Remove the entire volume from the vial and transfer it into the infusion bag containing 145 ml of sodium chloride solution for injection 9 mg/ml (0.9 %) toobtain a total volume of 150 ml and a final concentration of 1 mg/ml. Gently invert the bag 2-3 times (see ‘How to use Fosaprepitant Tarbis’).

4. Determine the volume to be administered from this prepared infusion bag, in accordance with the recommended dose (see the Summary of Product Characteristics, section 4.2).

Adults

The entire volume of the prepared infusion bag (150 ml) should be administered.

Pediatric patients

In patients aged 12 years or older, the volume to be administered is calculated as follows:

• The volume to be administered (ml) is equal to the recommended dose (mg)

In patients aged 6 months to 12 years, the volume to be administered is calculated as follows:

• Volume to be administered (ml) = recommended dose (mg/kg) x weight (kg)

• Nota: Do not exceed the maximum doses (see the Summary of Product Characteristics, section 4.2).

5. For volumes less than 150 ml, if necessary, the calculated volume can be transferred to an appropriate infusion bag or syringe before administration by infusion.

The final reconstituted and diluted solution is stable for 24 hours at 20- 25°C.

When the solution and the container permit, a visual inspection of parenteral medicines should be performed before administration to check for the presence of particles or discoloration.

The appearance of the reconstituted solution is the same as the appearance of the diluent used.

Dispose of any remaining solution and residual material. The disposal of unused medicinal product and all materials that have been in contact with it should be carried out in accordance with local regulations.

The medicinal product should not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see the Summary of Product Characteristics, section 6.2).