Ivemend 150 mg powder for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

IVEMEND 150 mg powder for solution for infusion

fosaprepitant

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 IVEMEND is and what it is used for
2. What you need to know before using IVEMEND
3. How to use IVEMEND
4. Possible adverse effects
5. How to store IVEMEND
6. Contents of the pack and other information

1. What IVEMEND is and what it is used for

IVEMEND 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. IVEMEND works by blocking signals to this area, thereby reducing nausea and vomiting. IVEMEND 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 strongly or moderately triggers nausea and vomiting.

2. What you need to know before using IVEMEND

Do not use IVEMEND

• 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 modified before starting IVEMEND.

Warnings and precautions

Talk to 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 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 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. Some medicines must not be used together with IVEMEND (such as pimozide, terfenadine, astemizole, and cisapride), or require dose adjustments (see also 'Do not use IVEMEND').

The effects of IVEMEND or of other medicines may be altered if you take IVEMEND 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 with IVEMEND. During treatment with IVEMEND and for up to 2 months after using IVEMEND, alternative or additional non-hormonal methods of contraception 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 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),
• 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 products.

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 'Other medicines and IVEMEND'.

It is unknown whether IVEMEND 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 IVEMEND. If you feel dizzy or numb, avoid driving or operating machinery after using this medicine (see 'Possible side effects').

IVEMEND contains sodium

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

3. How to use IVEMEND

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

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

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

IVEMEND 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 IVEMEND.

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 to 90 minutes before the start of chemotherapy in children and adolescents. Your doctor may also 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 experiences them.

Stop taking IVEMEND and contact your doctor immediately if you experience 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, death of the skin tissue (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,
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, flatulence,
• increased urge to urinate with pain or stinging,
• weakness, general malaise,
• facial/skin flushing,
• 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 (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 gait,
• 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,
• 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 effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of IVEMEND

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 following 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 25 °C.

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

6. Contents of the container and other information

Composition of IVEMEND

• 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/or diluted hydrochloric acid (E 507) (to adjust pH).

Appearance of the product and contents of the container

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Instructions for reconstitution and dilution of IVEMEND 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 IVEMEND').

4. Determine the volume to be administered from this prepared infusion bag according to the recommended dose (see the Package Leaflet or 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 doses (see the Package Leaflet or Summary of Product Characteristics, section 4.2).

1. For volumes less than 150 ml, if necessary, the calculated volume may be transferred to a suitably sized infusion bag or syringe prior to administration by infusion.

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

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

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 medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.

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