FOSAPREPITANT HIKMA 150 mg POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you use Fosaprepitant Hikma

Do not use Fosaprepitant Hikma:

• with medicines that contain pimozide (used to treat psychiatric disorders), terfenadine, and astemizole (used for allergic rhinitis and other allergic disorders), cisapride (used to treat digestive problems). Inform your doctor if you are taking these medicines, as treatment needs to be modified before starting this medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use fosaprepitant.

Before treatment with this medicine, tell your doctor if you have liver disease, because the liver is important for removing the medicine from the body. Therefore, your doctor may need to monitor your liver condition.

Children and adolescents

Do not give fosaprepitant to children under 6 months of age or weighing less than 6 kg, because the use of this medicine has not been studied in this population.

Other medicines and Fosaprepitant Hikma

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

The effects of fosaprepitant or other medicines may be influenced if you take fosaprepitant with other medicines, including those listed below. Talk to your doctor or pharmacist if you are taking any of the following medicines:

• contraceptive medicines that may include birth control pills, skin patches, implants, and certain intrauterine devices (IUDs) that release hormones, may not work properly when taken with fosaprepitant. During treatment with fosaprepitant and up to 2 months after using fosaprepitant, other non-hormonal methods or additional 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 that contain ergot-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 plant-based 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 too much cortisol),
• itraconazole, voriconazole, posaconazole (antifungals),
• nefazodone (used to treat depression),
• diltiazem (a medicine used to treat high blood pressure),
• corticosteroids (such as dexamethasone),
• anxiety medicines (such as alprazolam),
• tolutamide (a medicine used to treat diabetes).

Tell your doctor if you are using, have recently used, or might use any other medicine or herbal remedy.

Pregnancy and breast-feeding

This medicine should not be used during pregnancy unless clearly necessary. If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

For information on birth control, see ‘Other medicines and Fosaprepitant Hikma’.

It is not known if fosaprepitant passes into breast milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important to inform your doctor before receiving this medicine if you are breast-feeding or plan to breast-feed.

Driving and using machines

It should be taken into account that some people experience dizziness and drowsiness after using fosaprepitant. If you feel dizzy or drowsy, avoid driving or using machines after using this medicine (see ‘Possible side effects’).

Fosaprepitant Hikma contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose, so it is essentially “sodium-free”.

3. How to use Fosaprepitant Hikma

In adults (from 18 years of age), the recommended dose of Fosaprepitant Hikma is 150 mg of fosaprepitant on day 1 (day of chemotherapy).

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

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

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

• On days 2 and 3, oral formulations of aprepitant may be prescribed instead of fosaprepitant.

The powder is reconstituted and diluted before use. The infusion solution is administered by a healthcare professional, such as a doctor or nurse, by intravenous infusion (a drip) approximately 30 minutes before chemotherapy starts in adults or 60-90 minutes before chemotherapy starts in children and adolescents. Your doctor may ask you to take other medicines 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.

4. Possible side effects

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

Stop taking Fosaprepitant and contact your doctor immediately if you notice any of the following side effects, which can be serious and 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 the injection site (ISR) or near the injection site. The most severe ISR has occurred with a certain type of chemotherapy that can burn or blister the skin (vesicant) with side effects such as pain, swelling, and redness. Tissue death (necrosis) has occurred in some people receiving this type of chemotherapy.

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,

• fatigue,
• loss of appetite,
• hypo,
• increased levels of liver enzymes in the blood.

Uncommon side 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 need to urinate with pain or discomfort,
• weakness, general feeling of being unwell,
• flushing of the face/skin, hot flushes,
• rapid or irregular heartbeat, increased blood pressure,
• fever with increased risk of infection, decreased red blood cells,
• pain at the injection site, redness at the injection site, itching at the injection site, inflammation of the veins at the injection site.

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

• difficulty thinking, lack of energy, altered taste,
• sensitivity of the skin to sunlight, excessive sweating, oily skin, skin ulcers, itching, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),
• euphoria (extreme feeling of happiness), disorientation,
• bacterial infection, fungal infection,
• severe constipation, stomach ulcers, inflammation of the small intestine and colon, mouth ulcers, abdominal swelling,
• frequent need to urinate, urinating more than usual, presence of sugar or blood in the urine,
• chest discomfort, swelling, changes in walking,
• cough, mucous 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, disease of the blood vessels and blood,
• low white blood cell count, low sodium levels in the blood, weight loss,
• hardening of the injection site.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosaprepitant Hikma

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 expiry date is the last day of the month shown.

Store in a refrigerator (2°C - 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 no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Fosaprepitant Hikma

• 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 ingredients are disodium edetate (E-386), polysorbate 80 (E-433), lactose monohydrate, sodium hydroxide (E-524) (for pH adjustment) and/or hydrochloric acid (E-507) (for pH adjustment).

Appearance and pack size

Fosaprepitant Hikma is a white to off-white powder for solution for infusion.

The powder is enclosed in a transparent glass vial with a rubber stopper and an aluminum seal.

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

Marketing Authorisation Holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó 8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria: Fosaprepitant Hikma 150 mg Pulver zur Herstellung einer Infusionslösung

Germany: Fosaprepitant Hikma 150 mg Pulver zur Herstellung einer Infusionslösung

Italy: Fosaprepitant Hikma 150 mg powder for solution for infusion

Portugal: Fosaprepitant Hikma

Spain: Fosaprepitant Hikma 150 mg powder for solution for infusion EFG

Date of last revision of this leaflet:September 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Instructions for reconstitution and dilution of Fosaprepitant Hikma 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 to the vial along the vial wall to avoid foaming. Gently move the vial. Avoid shaking and agitating the injection solution in the vial.
2. Prepare an infusion bag containing 145 mlof 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. Remove 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 mlwith a final concentration of 1 mg/ml. Gently invert the bag 2-3 times (see ‘How to use Fosaprepitant Hikma’).
4. Determine the volume to be administered from this prepared infusion bag, according to the recommended dose (see Summary of Product Characteristics, section 4.2).

Adults

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

Pediatric patients

In patients from 12 years of age, the volume to be administered is calculated as follows:

• The volume to be administered (ml) is equal to the 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) x weight (kg)

• Note: Do not exceed the maximum doses (see Summary of Product Characteristics, section 4.2).

1. For volumes less than 150 ml, if necessary, the calculated volume can be transferred to a smaller bag or a syringe before administration by infusion.

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

When the solution and container permit, a visual inspection of parenteral medicines should be performed before administration to check for particles or discoloration.

The appearance of the reconstituted solution is the same as the appearance of the diluent used.

Discard any remaining solution and residual material. The disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.

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