Fosaprepitant Accord

Package leaflet: Information for the user

Fosaprepitant Accord 150 mg powder for solution for infusion

Generic medicine
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any 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.

Contents of this leaflet

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

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

Fosaprepitant Accord 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 Accord works by blocking the signals sent to that area, thereby reducing nausea and vomiting. Fosaprepitant Accord is used in adults in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) containing cisplatin (highly emetogenic chemotherapy) and by moderately emetogenic chemotherapy (such as cyclophosphamide, doxorubicin, and epirubicin).

2. What you need to know before using Fosaprepitant Accord

Do not use Fosaprepitant Accord:

• if you are allergic to fosaprepitant, aprepitant, polysorbate 80, or any of the other ingredients (listed in section 6).
• with medicines containing pimozide (a substance used to treat psychiatric disorders), terfenadine and astemizole (used for hay fever and other allergies), or cisapride (used to treat digestive problems). Inform your doctor if you are taking any of these medicines, as your treatment must be changed before starting Fosaprepitant Accord.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Fosaprepitant Accord.
Before treatment with this medicine, inform your doctor if you have liver disease, as the liver is important for metabolizing the medicine in the body. Your doctor may therefore need to monitor your liver function.
Children and adolescents
Do not administer Fosaprepitant Accord to children and adolescents under 18 years of age, as it has not been studied in this population.
Other medicines and Fosaprepitant Accord
Fosaprepitant Accord may affect other medicines both during and after treatment with Fosaprepitant Accord. There are certain medicines that must not be taken with Fosaprepitant Accord (such as pimozide, terfenadine, astemizole, and cisapride) or that require dose adjustment (see also “Do not use Fosaprepitant Accord”).
The effects of Fosaprepitant Accord or other medicines may be altered if Fosaprepitant Accord is used together with other medicines, including those listed below. Inform your doctor or pharmacist if you are taking any of the following medicines:

• contraceptives, which may include birth control pills, contraceptive patches, implants, and certain hormone-releasing intrauterine devices (IUDs); these may not work effectively when taken together with Fosaprepitant Accord. During treatment with Fosaprepitant Accord and for up to 2 months after its use, an additional non-hormonal method of contraception or an alternative non-hormonal contraceptive method should be used,
• cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),
• alfentanil, fentanyl (used to treat pain),
• quinidine (used to treat irregular heartbeat),
• irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),
• medicines containing ergot alkaloids such as ergotamine, dihydroergotamine (used to treat migraine),
• warfarin, acenocoumarol (anticoagulants; 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 induce sedation or help with sleep),
• St. John’s wort (a herbal remedy used to treat depression),
• protease inhibitors (used to treat HIV infections),
• ketoconazole except shampoo (used to treat Cushing's syndrome, characterized by excessive cortisol production),
• 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), and
• tolbutamide (a medicine used to treat diabetes)

Inform your doctor if you are taking, have recently taken, or might take any other medicines or herbal remedies.
Pregnancy and breastfeeding
You must not use this medicine during pregnancy unless absolutely necessary. If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
For information on contraception, see “Other medicines and Fosaprepitant Accord”.
It is not known whether Fosaprepitant Accord is excreted in human milk; therefore, breastfeeding is not recommended during treatment with this medicine. It is important that you inform your doctor if you are breastfeeding or intend to breastfeed before taking this medicine.
Driving and using machines
You should be aware that some people may experience dizziness or feel drowsy after using Fosaprepitant Accord. If you feel dizzy or drowsy, you should avoid driving or operating machinery after using this medicine (see “Possible side effects”).
Fosaprepitant Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to use Fosaprepitant Accord

The recommended dose of Fosaprepitant Accord is 150 mg of fosaprepitant on Day 1 (the day of chemotherapy).
The powder is reconstituted and diluted before use. The infusion solution will be administered by a healthcare professional, such as a doctor or nurse, through an intravenous infusion (by drip) 30 minutes before starting chemotherapy. Your doctor will ask you to take other medicines, including a corticosteroid (such as dexamethasone) and a "5-HT* antagonist" (such as ondansetron) to prevent nausea and vomiting. If you have any doubts, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Fosaprepitant Accord and seek immediate medical attention if you experience any of the
following side effects, which may be serious and require urgent medical treatment:

• hives, skin rash, itching, difficulty breathing or swallowing, or a severe drop in blood pressure (frequency not known, cannot be estimated from the available data); these are signs of an allergic reaction.

Other side effects reported are listed below.
Common side 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 side effects (may affect up to 1 in 100 people) are:

• dizziness, insomnia,
• acne, skin rash,
• anxiety,
• belching, nausea, vomiting, heartburn, stomach pain, dry mouth, passing of gas,
• increased pain or burning during urination,
• weakness, general feeling of being unwell,
• 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 the vein at injection site.

Rare side 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 lesions, itchy skin rash, 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, intestinal gas,
• frequent urination, increased volume of urine passed, presence of sugar or blood in urine,
• chest discomfort, swelling, change 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,
• slowed heart rate, heart and blood vessel disease,
• decrease in white blood cells, decrease in blood sodium levels, weight loss,
• hardening at infusion site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Fosaprepitant Accord

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 after EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
The reconstituted and diluted solution is stable for 48 hours at 20–25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fosaprepitant Accord contains

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

Description of the appearance of Fosaprepitant Accord and contents of the pack
Fosaprepitant Accord is a white to off-white lyophilised powder for infusion solution.
The powder is contained in a clear glass vial closed with a rubber stopper and an aluminium seal with an orange tear-off cap.
Each vial contains 150 mg of fosaprepitant. Pack: 1 vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
Harrow, Middlesex
HA1 4HF
United Kingdom
or
LABORATORI FUNDACIÓ DAU
Pol. Ind. Consorci Zona Franca, c/ C, 12-14
Barcelona, 08040,
Spain
or
Wessling Hungary Kft.
Fòti ùt 56.,
Budapest 1047,
Hungary

The following information is intended for medical or healthcare personnel only:
Instructions for reconstitution and dilution of Fosaprepitant Accord 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 down the side wall of the vial to prevent foaming. Gently rotate the vial. Avoid shaking and avoid spraying the sodium chloride 9 mg/mL (0.9%) injection solution into the vial.
2. Prepare an infusion bag filled with 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. Aspirate the entire volume from the vial and transfer it into an infusion bag containing 145 mL of sodium chloride 9 mg/mL (0.9%) injection solution to obtain a total volume of 150 mL. Gently invert the bag 2–3 times (see “How to use Fosaprepitant Accord”). The final reconstituted and diluted solution is stable for 48 hours at 20–25°C.

Medicinal products for parenteral use should be visually inspected before administration, wherever possible, to check for the presence of particulate matter or discoloration, provided that the solution and container permit.
The appearance of the reconstituted solution is identical to that of the diluent.