IVEMEND 150 mg powder for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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 containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell your doctor if you are taking these medicines since the treatment must be modified before you start using IVEMEND.

Talk to your doctor, pharmacist, or nurse before using IVEMEND.

Before treatment with this medicine, tell your doctor if you have liver disease because the liver is important in breaking down the medicine in the body. Your doctor may therefore have to monitor the condition of your liver.

Do not give IVEMEND to children under 6 months of age or who weigh less than 6 kg, because it has not been studied in this population.

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

The effects of IVEMEND or other medicines might be influenced if you take IVEMEND together with other medicines including those listed below. Please talk to your doctor or pharmacist if you are taking any of the following medicines:

• birth control medicines which can include birth control pills, skin patches, implants, and certain Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with IVEMEND. Another or additional non-hormonal form of birth control should be used during treatment with IVEMEND and for up to 2 months after using IVEMEND,
• ciclosporin, tacrolimus, sirolimus, everolimus (immunosuppressants),
• alfentanil, fentanyl (used to treat pain),
• quinidine (used to treat an irregular heart beat),
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),
• medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating 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 produce calmness or help you sleep),
• St. John’s Wort (an 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 an excess of cortisol),
• itraconazole, voriconazole, posaconazole (antifungals),
• nefazodone (used to treat depression),
• diltiazem (a medicine used to treat high blood pressure),
• corticosteroids (such as dexamethasone),
• anti-anxiety medicines (such as alprazolam),
• tolbutamide (a medicine used to treat diabetes).

Tell your doctor about any other medicines or herbal medicines you are taking, have recently taken, or might take.

This medicine should not be used during pregnancy unless clearly necessary. If you are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.

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

It is not known whether IVEMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important to tell your doctor if you are breast-feeding or are planning to breast-feed before receiving this medicine.

It should be taken into account that some people get dizzy and get sleepy after using IVEMEND. If you get dizzy or get sleepy, avoid driving or using machines after using this medicine (see ‘Possible side effects’).

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

• Hives, rash, itching, difficulty breathing or swallowing, or a serious decrease of blood pressure (frequency not known, cannot be estimated from the available data); these are signs of a serious allergic reaction.
• Infusion site reactions (ISR) at or near the infusion site. Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin (vesicant) with side effects, including pain, swelling and redness. Death of skin tissue (necrosis) has happened in some people getting this type of chemotherapy medicine.

Other side effects that have been reported are listed below.

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

• constipation, indigestion,
• headache,
• tiredness,
• loss of appetite,
• hiccups,
• increased amount of liver enzymes in your blood.

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

• dizziness, sleepiness,
• acne, rash,
• anxiousness,
• burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind,
• increased painful or burning urination,
• weakness, generally feeling unwell,
• reddening of the face/skin, hot flush,
• fast or irregular heartbeats, blood pressure increased,
• fever with increased risk of infection, lowering of red blood cells,
• infusion site pain, infusion site redness, infusion site itching, infusion site vein inflammation.

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

• difficulty thinking, lack of energy, taste disturbance,
• sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, itching rash, 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, sores in mouth, bloating,
• frequent urination, passing more urine than normal, presence of sugar or blood in urine,
• chest discomfort, swelling, change in the manner of walking,
• cough, mucus in back of throat, throat irritation, sneezing, sore throat,
• eye discharge and itching,
• ringing in the ear,
• muscle spasms, muscle weakness,
• excessive thirst,
• slow heartbeat, heart and blood vessel disease,
• lowering of white blood cells, low sodium levels in the blood, weight loss,
• hardening of site of infusion.

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is fosaprepitant. Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant. After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml).
• The other ingredients are: disodium edetate (E386), polysorbate 80 (E433), lactose anhydrous, sodium hydroxide (E524) (for pH adjustment) and/or hydrochloric acid diluted (E507) (for pH adjustment).

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 or 10 vials.

Not all pack sizes may be marketed.

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