Leaflet: information for the user

IVEMEND 150mg powder for solution for infusion

fosaprepitant

Read this 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, consult your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section4.

1.What is IVEMEND and what it is used for

2.What you need to know before starting to use IVEMEND

3.How to use IVEMEND

4.Possible side effects

5.Storage of IVEMEND

6.Contents of the pack and additional information

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

Do not use IVEMEND

• if you are allergic to fosaprepitant, aprepitant or 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 conditions), 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 IVEMEND.

Warnings and precautions

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

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 IVEMEND 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 IVEMEND

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

The effects of IVEMEND or other medicines may be influenced if you take IVEMEND 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 IVEMEND. During treatment with IVEMEND and for up to 2 months after using IVEMEND, 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 required),
• 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),
• 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 are planning to become pregnant, consult your doctor before using this medicine.

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

The passage of IVEMEND 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 taking IVEMEND. If you feel dizzy or drowsy, avoid driving or operating machines after taking this medicine (see ‘Possible side effects’).

IVEMEND 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 and older), the recommended dose of IVEMEND 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 IVEMEND is based on the patient's age and weight. Depending on the chemotherapy received, IVEMEND can be administered in two ways:

IVEMEND is administered only on day 1 (single-day chemotherapy).

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

• Days 2 and 3 may be prescribed oral presentations of aprepitant in place of IVEMEND.

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 IVEMEND 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 (frequency unknown, cannot be estimated from available data): these are signs of a severe allergic reaction.
• Reactions at the infusion site or near it.Severe reactions at the infusion site have occurred with a certain type of chemotherapy that can burn or form blisters on the 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 1in 10people) are:

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

Rare side effects (may affect up to 1in 100people) 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,
• Redness of the face/skin, 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 of the injection site, itching at the injection site, inflammation of the veins at the injection site.

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

If you experienceany type ofside 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 thenational notification system included in theAppendix V. 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 first 2 numbers indicate the month; the following 4 numbers indicate the year.

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

The reconstituted and diluted solution is stable for 24 hours at 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 IVEMEND

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

Appearance of the product and contents of the pack

IVEMEND is a white to off-white powder for solution for infusion.

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

Each vial contains 150mg of fosaprepitant. Pack sizes: 1vial or 10vials.

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder.

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

Instructions for reconstitution and dilution of IVEMEND 150mg:

1.Inject 5ml of sodium chloride 9mg/ml (0,9%) solution for injection into the vial. Ensure that the sodium chloride 9mg/ml (0,9%) solution for injection 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 9mg/ml (0,9%) solution for injection within the vial.

2.Prepare an infusion bag that contains145mlof sodium chloride 9mg/ml (0,9%) solution for injection (e.g., by removing 105ml of sodium chloride 9mg/ml (0,9%) solution for injection from a 250ml sodium chloride 9mg/ml (0,9%) solution for injection bag).

3.Withdraw the entire volume from the vial and transfer it into the infusion bag that contains 145ml of sodium chloride 9mg/ml (0,9%) solution for injection toobtain a total volume of 150ml and a final concentration of 1mg/ml. Gently invert the bag 2‑3times (see ‘How to use IVEMEND’).

4.Determine the volume to be administered from this prepared infusion bag, in accordance with the recommended dose (see the SmPC or Package Leaflet, section4.2).

Adults

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

Pediatric patients

In patients aged 12years and above, 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 6months to 12years, 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 SmPC or Package Leaflet, section4.2).

5.For volumes less than 150 ml, if necessary, 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 24hours at 25ºC.

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 in accordance with local requirements.

The medicinal product should not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see the SmPC or Package Leaflet, section6.2).