Fosaprepitant Accord 150 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fosaprepitant Accord 150 mg powder for solution for infusion EFG

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Fosaprepitant Accord is and what it is used for
2. What you need to know before using Fosaprepitant Accord
3. How to use Fosaprepitant Accord
4. Possible adverse effects
5. Storage of Fosaprepitant Accord
6. Package contents and additional information

1. What Fosaprepitant Accord is and what it is used for

Fosaprepitant Accord contains the active substance fosaprepitant, which is converted into aprepitant in your 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 from 6 months of age, in combination with other medicines, to prevent nausea and vomiting caused by a type of chemotherapy (cancer treatment) that has a high or moderate potential to cause nausea and vomiting.

2. What you need to know before using Fosaprepitant Accord

Do not use Fosaprepitant Accord:

• if you are allergic to fosaprepitant, aprepitant, or polysorbate 80, or to any of the other ingredients of this medicine (listed in section 6);
• with medicines containing pimozide (used to treat psychiatric disorders), terfenadine, and astemizole (used for allergic rhinitis and other allergic conditions), or cisapride (used to treat digestive problems). Inform your doctor if you are taking any of these medicines, as treatment must be adjusted before starting Fosaprepitant Accord.

Warnings and precautions

Talk to 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 plays an important role in eliminating the medicine from the body. Therefore, 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 interact with other medicines both during and after treatment with Fosaprepitant Accord. Some medicines must not be used together with Fosaprepitant Accord (such as pimozide, terfenadine, astemizole, and cisapride), or require dose adjustments (see also ‘Do not use Fosaprepitant Accord’).

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

• hormonal contraceptives, which may include oral contraceptive pills, skin patches, implants, and certain hormone-releasing intrauterine devices (IUDs), may not work properly when taken with Fosaprepitant Accord. During treatment with Fosaprepitant Accord and for up to 2 months after its use, additional non-hormonal contraceptive methods should be used;
• cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants);
• alfentanil, fentanyl (used to treat pain);
• quinidine (used to treat irregular heartbeats);
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer);
• medicines containing ergot alkaloids such as ergotamine and dihydroergotamine (used to treat migraines);
• warfarin, acenocoumarol (blood thinners; blood tests may be required);
• rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections);
• phenytoin (a medicine used to treat seizures);
• carbamazepine (used to treat depression and epilepsy);
• midazolam, triazolam, phenobarbital (medicines used to calm or help sleep);
• St. John’s wort (a herbal preparation used to treat depression);
• protease inhibitors (used to treat HIV infections);
• ketoconazole, except shampoo (used to treat Cushing’s syndrome—when the body produces excess cortisol);
• itraconazole, voriconazole, posaconazole (antifungals);
• nefazodone (used to treat depression);
• diltiazem (a medicine used to treat high blood pressure);
• corticosteroids (such as dexamethasone);
• medicines for anxiety (such as alprazolam); and
• tolbutamide (a medicine used to treat diabetes).

Inform your doctor if you are currently using, have recently used, or might need to use any other medicines or herbal remedies.

Pregnancy and breastfeeding

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

For information regarding contraception, 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 important to inform your doctor before receiving this medicine if you are breastfeeding or plan to breastfeed.

Driving and using machines

Be aware that some people may experience dizziness and numbness after using Fosaprepitant Accord. If you feel dizzy or numb, avoid driving or operating machinery 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 means it is essentially “sodium-free”.

3. How to use Fosaprepitant Accord

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

In children and adolescents (between 6 months and 17 years of age), the recommended dose of Fosaprepitant Accord is based on the patient's age and body weight. Depending on the chemotherapy regimen received, Fosaprepitant Accord may be administered in two different ways:

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

Fosaprepitant Accord is administered on days 1, 2, and 3 (single-day or multi-day chemotherapy)

• Oral formulations of aprepitant may be prescribed on days 2 and 3 instead 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, as an intravenous infusion (a drip) approximately 30 minutes before the start of chemotherapy in adults or 60–90 minutes before the start of chemotherapy 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). If in doubt, consult your doctor or pharmacist.

4. Possible adverse effects

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

Stop taking Fosaprepitant accord and contact your doctor immediately if you notice any of the following adverse effects, which may be serious and for which you may require urgent medical treatment:

• Hives, rash, itching, difficulty breathing or swallowing, or a severe drop in blood pressure (frequency not known, cannot be estimated from available data): these are signs of an allergic reaction.
• Reactions at or near the infusion site. The more severe reactions at the infusion site have occurred with a certain type of chemotherapy that can burn or blister the skin (vesicant), with adverse effects including pain, swelling, and redness. In some people receiving this type of chemotherapy, skin tissue death (necrosis) has occurred.

Other adverse effects reported are listed below.

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

• constipation, indigestion,
• headache,
• fatigue,
• loss of appetite,
• hiccups,
• increased levels of liver enzymes in the blood.

Uncommon adverse effects (may affect up to 1 in 100 people) are:

• dizziness, drowsiness,
• acne, rash,
• anxiety,
• burping, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• increased need to urinate with pain or burning,
• weakness, general malaise,
• facial/skin redness, hot flushes,
• rapid or irregular heartbeat, increased blood pressure,
• fever with increased risk of infection, decreased red blood cells,
• pain at injection site, redness at injection site, itching at injection site, inflammation of veins at injection site.

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

• difficulty thinking, lack of energy, altered taste,
• skin sensitivity to sunlight, excessive sweating, oily skin, skin sores, itching, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),
• euphoria (feeling of extreme happiness), disorientation,
• bacterial infection, fungal infection,
• severe constipation, stomach ulcer, inflammation of the small intestine and colon, mouth sores, abdominal swelling,
• frequent urge to urinate, urinating more than normal, presence of sugar or blood in urine,
• chest discomfort, swelling, changes in walking pattern,
• cough, mucus in the back of the throat, throat irritation, sneezing, sore throat,
• eye discharge and itching,
• ringing in the ears,
• muscle spasms, muscle weakness,
• excessive thirst,
• slow heartbeat, heart and blood vessel disease,
• decreased white blood cells, low sodium levels in blood, weight loss,
• hardening at the injection site.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosaprepitant Accord

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

Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the month indicated.

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

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Fosaprepitant Accord

• The active substance 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 disodium edetate (E-386), polysorbate 80 (E-433), anhydrous lactose, sodium hydroxide (E-524) (to adjust pH), and concentrated hydrochloric acid (E-507) (to adjust pH).

Appearance of the product and contents of the container

Fosaprepitant Accord is a solid, white to off-white lyophilized powder for infusion solution.

The powder is contained in a clear glass vial with a rubber stopper and a smooth orange aluminium seal.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer

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 under the following names:

Date of the most recent review of this leaflet: February 2022

Up-to-date detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended solely for physicians or healthcare professionals: Reconstitution and dilution instructions for Fosaprepitant Accord 150 mg:

1. Inject 5 ml of sodium chloride 9 mg/ml (0.9%) injection solution into the vial. Ensure that the sodium chloride 9 mg/ml (0.9%) injection solution is added down the side of the vial to avoid foaming. Gently swirl the vial. Avoid shaking or agitating the sodium chloride 9 mg/ml (0.9%) injection solution within the vial.

2. Prepare an infusion bag containing 145 ml of sodium chloride 9 mg/ml (0.9%) injection solution (e.g., by removing 105 ml of sodium chloride 9 mg/ml (0.9%) injection solution from a 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) injection solution).

3. Withdraw the entire contents of the vial and transfer them into the infusion bag containing 145 ml of sodium chloride 9 mg/ml (0.9%) injection solution to obtain 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’).

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

Adults

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

Paediatric patients

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

• Volume to be administered (ml) = recommended dose (mg)

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

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

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

1. If necessary, for volumes less than 150 ml, the calculated volume may be transferred to a suitable-sized bag or syringe prior to infusion administration.

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

When the solution and container permit, parenteral medicines should be visually inspected before administration for particulate matter and discoloration.

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