150 mg powder for infusion solution
fosaprepitant

1. What IVEMEND is and what it is used for

IVEMEND contains the active substance fosaprepitant which is converted to aprepitant in your body and belongs to a group of medicines called “neurokinin 1 (NK 1 ) receptor antagonists”. There is a special area in the brain that controls nausea and vomiting. IVEMEND works by blocking signals to that area, thus reducing nausea and vomiting. IVEMEND is used in adults, adolescents, and children 6 months and older in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) which may trigger severe or moderate 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 any of the other ingredients of this medicine (listed in section 6)
  • together with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever or other allergic conditions), cisapride (used to treat indigestion). Tell your doctor if you are taking these medicines, as treatment must be adjusted before you start using IVEMEND.

Warnings and cautions

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

If you have any liver disease, talk to your doctor before taking this medicine. The liver has an important function in breaking down the drug in the body. Your doctor may therefore need to monitor your liver function.

Children and young people

Do not give IVEMEND to children under 6 months of age or weighing less than 6 kg as it has not been studied in this population.

Other medicines and IVEMEND

IVEMEND can affect other medicines, both during and after treatment with IVEMEND. Some medicines should not be used with IVEMEND (eg pimozide, terfenadine, astemizole, and cisapride), or require dose adjustment of that medicine (see also Do not use IVEMEND).

The effects of IVEMEND or other medicines may be affected if you take IVEMEND with other medicines, including those mentioned below. Tell your doctor or pharmacist if you are taking any of the following medicines:

  • contraceptives such as birth control pills , contraceptive patches , implants , and certain IUDs ( IUDs ) that release hormones (may be less effective if used with IVEMEND. Alternative non-hormonal supplementation methods should be used during ongoing treatment with IVEMEND and for up to 2 months after use of IVEMEND)
  • ciclosporin, tacrolimus, sirolimus, everolimus (immunosuppressive drugs)
  • alfentanil, fentanyl ( painkiller )
  • quinidine (for the treatment of irregular heartbeat)
  • irinotecan, etoposide, vinorelbine, ifosamide (cancer medicine)
  • medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used to treat migraines )
  • warfarin and acenocoumarol (blood thinners, blood tests may be required)
  • rifampicin, clarithromycin, telithromycin ( antibiotics used to treat infections )
  • phenytoin (an antispasmodic)
  • carbamazepine (used to treat depression and epilepsy )
  • midazolam, triazolam, phenobarbital (medicines that are sedative and help you sleep)
  • St. John’s wort (a natural remedy for depression)
  • protease inhibitors (for treatment of HIV – infection s)
  • ketoconazole exemption shampoo (used to treat Cushing’s syndrome – when the body produces too much cortisol )
  • itraconazole, voriconazole, posaconazole (for fungal infections)
  • nefazodone (for the treatment of depression)
  • diltiazem (a medicine used to treat high blood pressure )
  • Corticosteroid is (like dexamethasone)
  • antianxiety drugs (such as alprazolam)
  • tolbutamide (a medicine used in diabetes ).

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

Pregnancy and breastfeeding

This medicine should not be used if you are pregnant unless absolutely necessary. If you are pregnant or breastfeeding, may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

For information on contraceptives, see Other medicines and IVEMEND.

It is not known if IVEMEND passes into breast milk and therefore breastfeeding is not recommended during treatment with this medicine. It is important to tell your doctor if you are breastfeeding or planning to breastfeed before taking this medicine.

Driving and using machines

It should be noted that some people become dizzy and sleepy after using IVEMEND. If you become dizzy or drowsy, avoid driving or using machines after using this medicine (see Possible side effects ).

IVEMEND contains sodium

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

How to use IVEMEND

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

In children and adolescents (6 months up to 17 years), the recommended dose is one of IVEMEND based on the patient’s age and weight. Depending on the chemotherapy treatment, IVEMEND can be given in two ways:

IVEMEND is only given on day 1 (in case of chemotherapy for only one day)

IVEMEND is given on Days 1, 2, and 3 (for chemotherapy for one or more days)

  • Oral preparation of aprepitant may be prescribed on Days 2 and 3 instead of IVEMEND.

The powder must be dissolved and then diluted before use. The solution is given to you by a healthcare professional, a doctor or nurse, via intravenous infusion (drip) about 30 minutes before you start chemotherapy in adults or 60 – 90 minutes before you start chemotherapy in children and adolescents. Your doctor may ask you to take other medicines including a corticosteroid (such as dexamethasone) and a “5HT 3 antagonist” (such as ondansetron) to prevent nausea and vomiting. Ask your doctor or pharmacist if you are unsure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking IVEMEND and contact a doctor immediately if you notice any of the following side effects that may be serious and for which you may need emergency care:

  • hives, rash, itching , difficulty breathing or swallowing, or a severe drop in blood pressure (no known frequency, can not be calculated from the available data) – these are signs of a severe allergic reaction .
  • reactions at the infusion site or near the infusion site. The most serious of these reactions have occurred with a certain type of chemotherapy that can burn your skin or cause blisters (vesicant) with side effects , including pain, swelling and redness . Tissue death ( necrosis ) has occurred in some patients receiving this type of chemotherapy .

Other side effects that have been reported are listed below.

Common side effects (may affect less than 1 user in 10) are:

Uncommon side effects (may affect less than 1 in 100 people) are:

  • dizziness, drowsiness
  • acne , skin rash
  • anxiety
  • belching, nausea, vomiting, heartburn, stomach pain, dry mouth , gas in the stomach
  • increased painful or burning urination
  • weakness, general malaise,
  • facial or skin redness, hot flashes
  • rapid or irregular heartbeat, high blood pressure
  • fever with increased risk of infection , decreased number of red blood cells
  • pain at the infusion site, redness and itching at the infusion site, inflammation of the veins at the injection site.

Rare side effects (may affect less than 1 in 1,000 people) are:

  • difficulty thinking, lack of energy, taste change
  • skin sensitivity to sunlight, increased sweating, oily skin, skin ulcers, itchy rash, Stevens-Johnson syndrome / toxic epidermal necrolysis (rare severe skin reaction)
  • euphoria (extreme happiness), disorientation
  • bacterial infection, fungal infection
  • severe constipation, stomach ulcers , inflammation of the small intestine and colon, ulcers in the mouth, bloating in the stomach
  • frequent urination, increased urine output, the presence of sugar or blood in the urine
  • feeling of discomfort in the chest, swelling, altered gait
  • cough, mucus in the back of the throat, irritation of the throat, sneezing, sore throat
  • watery and itchy eyes
  • tinnitus
  • muscle spasms, muscle weakness
  • increased thirst
  • slow heartbeat, cardiovascular disease
  • decreased white blood cell count , low sodium levels in the blood, weight loss
  • hardening at the infusion site

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store IVEMEND

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

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The first 2 digits indicate the month, the following 4 digits indicate the year.

Store in a refrigerator (2 ° C – 8 ° C).

The dissolved and diluted drug 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 no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

Content declaration

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

What the medicine looks like and contents of the pack

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

The powder is packed in a transparent glass bottle with a rubber stopper and an aluminum closure with a gray plastic snap cap.

One vial contains 150 mg of fosaprepitant. Pack size: 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme BVWaarderweg 392031 BN HaarlemNetherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgique / België / BelgienMSD BelgiumTel: +32 (0) 27766211dpoc_belux@merck.com LithuaniaUAB Merck Sharp & DohmeTel. +370 5278 02 47msd_lietuva@merck.com
BulgariaMark Harp and Doom Bulgaria BulgariaTel: +359 2 819 3737info-msdbg@merck.com Luxembourg / LuxemburgMSD BelgiumTel: +32 (0) 27766211dpoc_belux@merck.com
Czech RepublicMerck Sharp & Dohme IDEA, Inc., org.sl.Tel .: +420 233 010 111dpoc_czechslovak@merck.com HungaryMSD Pharma Hungary Kft.Tel .: +36 1 888 53 00hungary_msd@merck.com
DenmarkMSD Danmark ApSTel: +45 4482 4000dkmail@merck.com MaltaMerck Sharp & Dohme Cyprus LimitedTel: 8007 4433 (+356 99917558)malta_info@merck.com
GermanyMSD Sharp & Dohme GmbHTel: 0800 673 673 673 (+49 (0) 89 4561 2612)e-mail@msd.de The NetherlandsMerck Sharp & Dohme BVTel: 0800 9999000(+31 23 5153153)medicalinfo.nl@merck.com
EestiMerck Sharp & Dohme OÜTel .: +372 6144 200msdeesti@merck.com NorwayMSD (Norway) ASTel: +47 32 20 73 00msdnorge@msd.no
EladMSD Α.Φ.Β.Ε.Ε.:Ηλ: +30 210 98 97 300dpoc_greece@merck.com AustriaMerck Sharp & Dohme Ges.mbHTel: +43 (0) 1 26 044msd-medizin@merck.com
SpainMerck Sharp & Dohme de España, SATel: +34 91 321 06 00msd_info @ merck.com PolandMSD Polska Sp.z ooTe: +48 22 549 51 00msdpolska@merck.com
FranceMSD FranceTel: +33 (0) 1 80 46 40 40 PortugalMerck Sharp & Dohme, LdaTel: +351 21 4465700inform_pt@merck.com
CroatiaMerck Sharp & Dohme dooTel: + 385 1 6611 333croatia_info@merck.com RomaniaMerck Sharp & Dohme Romania SRLTel: + 4021 529 29 00msdromania@merck.com
IrelandMerck Sharp & Dohme Ireland ( Human Health) LimitedTel: +353 (0) 1 2998700medinfo_ireland@merck.com SloveniaMerck Sharp & Dohme, innovative zdravila dooTel: + 386 1 5204201msd_slovenia@merck.com
Iceland .Vistor hf.Phone: +354 535 7000 Slovak RepublicMerck Sharp & Dohme, sroTel .: +421 2 58282010dpoc_czechslovak@merck.com
ItalyMSD Italia SrlTel: +39 06 361911medicalinformation.it@merck.com Finland / FinlandMSD Finland OyPuh / Tel: +358 (0) 9 804650info@msd.fi
ΚύπροςMerck Sharp & Dohme Cyprus Limited:Ηλ: 80000 673 (+357 22866700)cyprus_info@merck.com SwedenMerck Sharp & Dohme (Sweden) ABTel: +46 77 5700488medicinskinfo@merck.com
LatviaSIA “Merck Sharp & Dohme Latvija”.Tel: +371 67364 224msd_lv@merck.com United Kingdom (Northern Ireland)Merck Sharp & Dohme Ireland ( Human Health) LimitedTel: +353 (0) 1 2998700medinfoNI@msd.com

Muhammad Nadeem

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