Package Leaflet: Information for the User

Fosaprepitant Accord 150 mg Powder for Solution for Infusion EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they appear in this leaflet. See section 4

Fosaprepitant Accord 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 Accord works by blocking signals to this area, thereby reducing nausea and vomiting.

Fosaprepitant Accord 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 Accord:

• if you are allergic to fosaprepitant, aprepitant, or to polysorbate 80 or 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 Accord.

Warnings and precautions

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

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 Accord 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 Accord

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

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

• contraceptives that may include birth control pills, skin patches, implants and certain intrauterine devices (IUDs) that release hormones, may not work properly when taken with Fosaprepitant Accord. During treatment with Fosaprepitant Accord and for up to 2 months after using Fosaprepitant Accord, other methods or additional non-hormonal methods of contraception should be used,
• ciclosporin, tacrolimus, sirolimus, everolimus (immunosuppressants),
• alfentanilo, fentanilo (used to treat pain),
• quinidina (used to treat irregular heartbeats),
• irinotecan, etopósido, vinorelbina, ifosfamida (medicines used to treat cancer),
• medicines that contain ergotamine alkaloids, such as ergotamine and dihydroergotamine (used to treat migraines),
• warfarina, acenocumarol (blood thinners; blood tests may be needed),
• rifampicina, claritromicina, telitromicina (antibiotics used to treat infections),
• fenitoína (a medicine used to treat seizures),
• carbamazepina (used to treat depression and epilepsy),
• midazolam, triazolam, fenobarbital (medicines used to calm or to help sleep),
• St. John's Wort (a herbal preparation used to treat depression),
• protease inhibitors (used to treat HIV infections),
• ketoconazol, except shampoo (used to treat Cushing's syndrome - when the body produces an excess of cortisol),
• itraconazol, voriconazol, posaconazol (antifungals),
• nefazodona (used to treat depression),
• diltiazem (a medicine used to treat high blood pressure),
• corticosteroids (such as dexametasona),
• anxiety medicines (such as alprazolam) and
• tolbutamida (a medicine used to treat diabetes)

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 plan to become pregnant, consult your doctor before using this medicine.

For information related to birth control, see ‘Use of Fosaprepitant Accord with other medicines’.

It is unknown whether Fosaprepitant Accord passes into breast milk; 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 your baby or plan to do so.

Driving and operating machines

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

Fosaprepitant Accord contains sodium

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

In adults (18 years of age or older), the recommended dose of Fosaprepitant Accord 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 Accord is based on the patient's age and weight. Depending on the chemotherapy received, Fosaprepitant Accord can be administered in two ways:

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

Fosaprepitant Accord 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 Accord.

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 accord and see 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:

• Hives, itching, difficulty breathing or swallowing, or a severe drop in blood pressure (unknown frequency, cannot be estimated from available data): these are signs of an allergic reaction.
• Reactions at the infusion site or near it. The most severe reactions at the infusion site have occurred with a certain type of chemotherapy that can burn or form blisters on your skin (vesicant) with side effects that include pain, swelling, and redness. In some people who receive this type of chemotherapy, there has been skin tissue death (necrosis)

Other side effects that have been reported are listed below.

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

• Constipation, indigestion,
• Headache,
• Fatigue,
• Loss of appetite,
• Low blood pressure,
• Increased levels of liver enzymes in the blood.

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

• Dizziness, somnolence,
• Acne, hives,
• Anxiety,
• Belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• Increased frequency of urination with pain or burning,
• Weakness, general feeling of illness,
• Face/ skin redness, hot flashes,
• Irregular or rapid heartbeats, increased blood pressure,
• Fever with increased risk of infection, decreased red blood cells,
• Pain at the injection site, redness at the injection site, itching at the injection site, inflammation of the veins at the injection site.

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

• Difficulty thinking, lack of energy, altered taste,
• Sensitivity of the skin to the sun, excessive sweating, oily skin, skin lesions, itching, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),
• Euphoria (extreme feeling of happiness), disorientation,
• Bacterial infection, fungal infection,
• Severe constipation, stomach ulcer, inflammation of the small intestine and colon, mouth sores, abdominal swelling,
• Frequent urination, urinating more than usual, presence of sugar or blood in the urine,
• Chest discomfort, swelling, changes in gait,
• Cough, mucous in the back of the throat, throat irritation, sneezing, sore throat,
• Eye secretion and itching or redness,
• Tinnitus,
• Muscle spasms, muscle weakness,
• Excessive thirst,
• Slow heartbeats, cardiovascular and blood vessel disease,
• Decreased white blood cells, low sodium levels in the blood, weight loss,
• Hardening of the injection site.

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 prospectus. You can also report them directly through theSpanish System of 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 on the vial after CAD.The expiration date is the last day of the month indicated.

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

The reconstituted and diluted solution is stable for 48 hours at 20-25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Fosaprepitant Accord

• The active ingredient is fosaprepitant. Each vial contains fosaprepitant dimeglumine equivalent to 150 mg of fosaprepitant. After reconstitution and dilution, 1 ml of solution contains 1 mg of fosaprepitant (1 mg/ml).
• The other components are edetate disodium (E-386), polysorbate 80 (E-433), anhydrous lactose, sodium hydroxide (E-524) (to adjust the pH) and concentrated hydrochloric acid (E-507) (to adjust the pH).

Appearance of the product and contents of the package

Fosaprepitant Accord is a lyophilized solid of a color between white and off-white for infusion solution.

The powder is included in a transparent glass vial with a rubber stopper and an aluminum cap with a smooth orange finish.

Each vial contains 150 mg of fosaprepitant. Package sizes: 1 vial.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer responsible

LABORATORI FUNDACIÓ DAU

Pol. Ind. Consorci Zona Franca,

c/ C, 12-14,

08040, Barcelona

Spain

Or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice,

Poland

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: February 2022

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/

This information is intended solely for medical professionals or healthcare professionals: Instructions for reconstitution and dilution of Fosaprepitant Accord 150 mg:

1. Inject 5 ml of sodium chloride solution 9 mg/ml (0.9%) into the vial. Ensure that the sodium chloride solution 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 9 mg/ml (0.9%) inside the vial.

1. Prepare a perfusion bag that contains145 mlof sodium chloride solution 9 mg/ml (0.9%) (e.g., by removing 105 ml of sodium chloride solution 9 mg/ml (0.9%) from a 250 ml sodium chloride solution 9 mg/ml (0.9%) perfusion bag).

1. Remove the entire volume from the vial and transfer it into the perfusion bag containing 145 ml of sodium chloride solution 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 Accord’).

1. Determine the volume to be administered from this prepared perfusion bag, based on the recommended dose (see Technical Dossier, see section 4.2).

Adults

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

Pediatric patients

In patients over 12 years old, the volume to be administered is calculated as follows:

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

In patients from 6 months to less than 12 years old, 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 Technical Dossier, see section 4.2).

1. If necessary, for volumes less than 150 ml, the calculated volume can be transferred to a suitable infusion bag or syringe before administration by infusion.

The final reconstituted and diluted solution is stable for 48 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.