Fosaprepitant Tarbis 150 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fosaprepitant Tarbis 150 mg powder for solution for infusion EFG

Read the entire leaflet carefully before you start using 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 adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1 What Fosaprepitant Tarbis is and what it is used for

2 What you need to know before using Fosaprepitant Tarbis

3 How to use Fosaprepitant Tarbis

4 Possible side effects

5 How to store Fosaprepitant Tarbis

6 Contents of the pack and other information

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

Fosaprepitant Tarbis contains the active substance fosaprepitant, which is converted to 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 Tarbis works by blocking signals to this area, thereby reducing nausea and vomiting. Fosaprepitant Tarbis 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 is highly or moderately likely to trigger nausea and vomiting.

2. What you need to know before using Fosaprepitant Tarbis

Do not use Fosaprepitant Tarbis

• 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 these medicines, as treatment must be adjusted before starting 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. Therefore, 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 together with fosaprepitant (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also ‘Do not use Fosaprepitant Tarbis’).

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

• contraceptive medicines, which may include oral contraceptives, contraceptive patches, implants, and certain hormone-releasing intrauterine devices (IUDs), may not work properly when taken together with Fosaprepitant Tarbis. During treatment with Fosaprepitant Tarbis and for up to 2 months after using Fosaprepitant Tarbis, 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 ergotamine-derived alkaloids, such as ergotamine and dihydroergotamine (used to treat migraines),
• warfarin, acenocoumarol (blood thinners; blood tests may be needed),
• 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 infection),
• ketoconazole, except shampoo (used to treat Cushing’s syndrome, a condition in which 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),
• tolbutamide (a medicine used to treat diabetes).

Inform your doctor if you are 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 plan to become pregnant, consult your doctor before using this medicine.

For information regarding contraception, see ‘Other medicines and Fosaprepitant Tarbis’.

It is unknown whether fosaprepitant 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

It should be noted that some people may experience dizziness and numbness after using fosaprepitant. If you feel dizzy or numb, avoid driving or operating machinery 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, which is essentially “sodium-free”.

3. How to use Fosaprepitant Tarbis

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

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

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

• Oral formulations of aprepitant may be prescribed on days 2 and 3 instead 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, 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 instruct 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 using fosaprepitant 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 a severe allergic reaction.
• Reactions at or near the infusion site. The most 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.

Common 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 urge 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, decrease in 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 (a 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 the 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, blood vessel and heart vessel disease,
• decrease in white blood cells, low sodium levels in the blood, weight loss,
• hardening at the injection site.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via 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 Tarbis

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and vial after EXP. The first two digits indicate the month; the following four digits indicate the year.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fosaprepitant Tarbis

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), lactose, sodium hydroxide (E-524) (to adjust pH), and diluted hydrochloric acid (E-507) (to adjust pH).

Appearance of the product and contents of the container

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

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

Each vial contains 150 mg of fosaprepitant.

Pack sizes: 1 and 10 vials.

Only certain pack 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

The 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 solution for infusion

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

The Netherlands: Fosaprepitant Amarox 150 mg poeder voor oplossing voor infusie

Date of the most recent review of this leaflet:

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Instructions for reconstitution and dilution of Fosaprepitant Tarbis 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 along the wall 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 volume from the vial and transfer it 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 Tarbis').

4. Determine the volume to be administered from this prepared infusion bag according to 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 aged 12 years and older, the volume to be administered is calculated as follows:

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

In patients between 6 months and 12 years of age, 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).

5. For volumes less than 150 ml, if necessary, the calculated volume may be transferred to a bag of appropriate size or to a syringe prior to administration by infusion.

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

When the solution and container permit, parenteral medicinal products should be inspected visually for particulate matter or discoloration prior to administration.

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

Discard any unused solution and residual materials. Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.

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