Empliciti 400 mg polvo para concentrado para solucion para perfusion

Prospect: information for the user

Empliciti 300mg powder for concentrate for solution for infusion

Empliciti 400mg powder for concentrate for solution for infusion

elotuzumab

Read this prospect thoroughly before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor, or pharmacist or nurse.
• If you experience adverse effects, consult your doctor, or pharmacist or nurse, even if they are not listed in this prospect. See section4.

Empliciti contains the active ingredient elotuzumab, which is a monoclonal antibody, a type of protein designed to recognize and bind to a specific target in the body. Elotuzumab binds to the target protein called SLAMF7. SLAMF7 is found in large quantities on the surface of multiple myeloma cells and on certain immune system cells (natural killer cells). When elotuzumab binds to SLAMF7 on multiple myeloma cells or natural killer cells, it stimulates the immune system to attack and destroy multiple myeloma cells.

Empliciti is used to treat multiple myeloma (a cancer of the bone marrow) in adults. It will be administered with lenalidomide and dexamethasone or with pomalidomide and dexamethasone. Multiple myeloma is a cancer of a type of white blood cells called plasma cells. These cells divide uncontrollably and accumulate in the bone marrow. This causes damage to the bones and kidneys.

Empliciti is used if your cancer has not responded or has relapsed after several treatments.

Do not use Empliciti

• if you are allergic to elotuzumab or any of the other ingredients of this medicine (listed in section6). If you are unsure, consult your doctor.

Warnings and precautions

Perfusion-related reaction

Inform your doctor or nurse immediately if you experience any of the perfusion-related reactions listed at the beginning of section4. These adverse effects occur predominantly during or after the perfusion of the first dose. You will be monitored for signs of these effects during and after perfusion.

Depending on the severity of the perfusion-related reactions, you may require additional treatment to prevent complications and reduce your symptoms, or the perfusion of Empliciti may be interrupted. When your symptoms have resolved or improved, the perfusion may be continued more slowly, and the rate may be gradually increased if your symptoms do not recur. Your doctor may decide not to continue treatment with Empliciti if you have a severe perfusion-related reaction.

Before each perfusion of Empliciti, you will be administered medications to reduce perfusion-related reactions (see section3 "How to use Empliciti, Medications administered before each perfusion").

Before starting treatment with Empliciti, you must read the warnings and precautions section of the prospectus for all medications administered in combination with Empliciti, in relation to the information on these medications. When lenalidomide is used, special attention is required for the requirements on pregnancy testing and prevention (see "Pregnancy, and breastfeeding" in this section).

Children and adolescents

Empliciti is not recommended for use in children and adolescents under 18years.

Other medications and Empliciti

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

For women being administered Empliciti

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

You must not use Empliciti if you are pregnant, unless your doctor specifically recommends it. The effects of Empliciti on pregnant women or its potential harm to the fetus are unknown.

• If there is a possibility of becoming pregnant, you must use an effective contraceptive method while being treated with Empliciti and for 120days after completing treatment.
• If you become pregnant while using Empliciti, inform your doctor.

When Empliciti is administered in combination with lenalidomide or pomalidomide, you must follow the pregnancy prevention program for lenalidomide or pomalidomide, respectively (see the prospectus for lenalidomide or pomalidomide).Lenalidomide or pomalidomide is potentially harmful to the fetus.

The passage of elotuzumab into breast milk or any risk to the infant is unknown. Elotuzumab will be administered in combination with lenalidomide or pomalidomide, so breastfeeding should be discontinued due to the use of lenalidomide or pomalidomide.

For men being administered Empliciti

You must use a condom while using Empliciti and for 180days after completing treatment to ensure that your partner does not become pregnant.

Driving and operating machinery

It is unlikely that Empliciti will affect your ability to drive or operate machinery. However, if you experience a perfusion-related reaction (fever, chills, high blood pressure, see section4 "Possible adverse effects"), do not drive, ride a bicycle, or operate machinery until the reaction has resolved.

Empliciti contains sodium

Inform your doctorif you are on a low-sodium diet before using Empliciti.This medication contains 3.92mg of sodium (main component of table salt/for cooking) in each 300mg vial or 5.23mg of sodium in each 400mg vial.This is equivalent to 0.2% or 0.3% of the recommended daily maximum sodium intake for an adult.

Amount of Empliciti to administer

The amount of Empliciti to be administered will be calculated based on body weight.

How Empliciti is administered

You will receive Empliciti under the supervision of an experienced healthcare professional. It will be administered intravenously as an infusion over several hours.

Empliciti is used in treatment cycles of 28days in duration (4weeks) in combination with other medications used to treat multiple myeloma.

Empliciti is administered as follows when administered in combination with lenalidomide and dexamethasone:

• In cycles1 and 2, once a week on days1, 8, 15, and 22.
• In cycles3 and subsequent, once every 2weeks on days1 and 15.

Empliciti is administered as follows when administered in combination with pomalidomide and dexamethasone:

• In cycles1 and 2, once a week on days1, 8, 15, and 22.
• In cycles3 and subsequent, once every 4weeks on day1.

Your doctor will continue treating you with Empliciti as long as your condition improves or remains stable and with tolerable side effects.

Medications administered before each infusion

You must receive the following medications before each Empliciti infusion to help reduce possible infusion-related reactions:

• medications to reduce an allergic reaction (an antihistamine)
• medications to reduce inflammation (dexamethasone)
• medications to reduce pain and fever (paracetamol)

If you did not receive a dose of Empliciti

Empliciti is used in combination with other medications for multiple myeloma. If delayed, interrupted, or discontinued, your doctor will decide how to continue your treatment.

If you are administered more Empliciti than you should

As Empliciti will be administered by a healthcare professional, it is unlikely that an overdose will occur. In the unlikely event of an overdose, your doctor will monitor you for adverse effects.

If you interrupt treatment with Empliciti

Interrupting treatment with Empliciti may slow the effect of the medication. Do not interrupt treatment unless you have discussed it with your doctor.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Your doctor will discuss them with you and explain the risks and benefits of your treatment.

In clinical trials with elotuzumab, the following side effects have been reported:

Infusion-related reactions

Empliciti has been associated with infusion-related reactions (see the section"Warnings and precautions").Inform your doctor or nurse immediately if you do not feel well during the infusion.The following list presents characteristic symptoms associated with infusion-related reactions:

• Fever
• Chills
• High blood pressure

Other symptoms may also occur. Your doctor may consider slowing down the infusion of Empliciti or stopping it to manage these symptoms.

Other side effects

Very common (may affect more than1in 10people)

• Fever
• Sore throat
• Pneumonia
• Weight loss
• Low white blood cell count
• Cough
• Common cold
• Headache
• Diarrhea
• Feeling tired or weak

Common (may affect up to1in 10people)

• Chest pain
• Clots in the veins (thrombosis)
• Painful skin rash with blisters (herpes zoster)
• Nocturnal sweating
• Mood changes
• Decreased sensitivity, especially in the skin
• Allergic reactions (hypersensitivity)
• Pain in the mouth/region of the throat/sore throat

Uncommon (may affect up to1 in 100people)

• Potentially life-threatening allergic reaction (anaphylactic reaction)

Inform your doctorif you experience any of the side effects listed above. Do not try to treat the symptoms with other medicines.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the vial label and the outer carton after EXP or CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect it from light.

After reconstitution, the reconstituted solution must be transferred immediately from the vial to the infusion bag.

After dilution, the infusion must be completed within 24 hours after preparation. The product must be used immediately. If not used immediately, the infusion solution can be stored in the refrigerator (2°C-8°C) for up to 24 hours.

Any unused or discarded medication must be disposed of in accordance with local regulations.

Empliciti Composition

• The active ingredient is elotuzumab.

Each vial of powder contains 300 mg or 400 mg of elotuzumab.

After reconstitution, each ml of concentrate contains 25 mg of elotuzumab.

• The other components (excipients) are sucrose, sodium citrate (see section 2 "Empliciti contains sodium"), citric acid monohydrate, and polisorbate 80 (E433).

Appearance of the product and contents of the pack

Empliciti lyophilized powder for concentrate for solution for infusion (lyophilized powder) is presented in a compact or fragmented form, white to off-white in color in a glass vial.

Empliciti is available in packs with 1 vial.

Marketing Authorization Holder

Bristol-Myers Squibb Pharma EEIG
254 Plaza
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Responsible Person

CATALENT ANAGNI S.R.L.
Loc.Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 ANAGNI (FR)
Italy

Swords Laboratories Unlimited Company t/a Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland

Last update of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu. Also, there are links to other websites on rare diseases and orphan medicines.

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This information is intended solely for healthcare professionals:

Preparation and administration of Empliciti

Dose calculation

Calculate the dose (mg) and determine the number of vials needed for the dose (10 mg/kg or 20 mg/kg) based on the patient's body weight (pc). It may be necessary to use more than one vial of Empliciti to administer the total dose for the patient.

• The total dose of elotuzumab in mg is equal to the patient's body weight in kg multiplied by the dose of elotuzumab (10 or 20 mg/kg).

Reconstitution of the vials

Reconstitute each vial of Empliciti aseptically with a suitable syringe and an 18 gauge or smaller needle, as shown in Table 1. During the administration of the water for injection, a small counter-pressure may be experienced, which is considered normal.

Table 1: Reconstitution instructions

Keep the vial in a vertical position and rotate the vial to dissolve the lyophilized powder. After inverting the vial a few times to dissolve any powder that may be present at the top of the vial or on the stopper. Avoid sudden movement, DO NOT AGITATE. The lyophilized powder should be dissolved in about 10 minutes.

After completely dissolving the remaining solid, leave the reconstituted solution to stand for 5 to 10 minutes. The reconstituted solution is colorless or slightly yellow, clear to very opalescent. In Empliciti, particles and discoloration should be visually inspected before administration. Discard the solution if particles or discoloration are observed.

Preparation of the infusion solution

The reconstituted solution should be diluted with a 9 mg/ml sodium chloride injection (0.9%) or 5% glucose solution to obtain a final infusion concentration range of 1 mg/ml to 6 mg/ml. The volume of the 9 mg/ml sodium chloride injection (0.9%) or 5% glucose solution should be adjusted to not exceed 5 ml/kg of pc in any dose of Empliciti administered.

Calculate the volume (ml) of the diluent (either 9 mg/ml sodium chloride injection (0.9%) or 5% glucose solution) needed to prepare the infusion solution for the patient.

Withdraw the necessary volume from each vial for the calculated dose, up to a maximum of 16 ml from the 400 mg vial and 12 ml from the 300 mg vial. Each vial contains a slight overfill to ensure sufficient volume is withdrawable.

Transfer the withdrawn volumes from all the vials needed according to the calculated dose for the patient into a single infusion bag made of polyvinyl chloride or polyolefin containing the calculated volume of diluent. Mix the infusion solution gently by manual agitation. Do not agitate.

Empliciti is exclusively for intravenous use. Discard any unused portion that remains in the vial.

Administration

The complete infusion of Empliciti should be administered with a set of infusion and a sterile, non-pyrogenic, low-protein binding filter (with a pore size of 0.2-1.2 μm) using an automatic infusion pump.

Empliciti infusion is compatible with:

• PVC and polyolefin containers
• PVC infusion equipment
• In-line filters of polysulfone and nylon with a pore size of 0.2-1.2 μm.

Empliciti infusion 10 mg/kg pc

The administration of Empliciti at a dose of 10 mg/kg pc should be initiated at an infusion rate of 0.5 ml/min. If tolerated well, the infusion rate can be gradually increased as described in Table 2. The maximum infusion rate should not exceed 5 ml/min.

Table 2: Empliciti infusion 10 mg/kg pc

*Continue at this rate until the infusion is complete.

Empliciti infusion 20 mg/kg pc

The administration of Empliciti at a dose of 20 mg/kg pc should be initiated at an infusion rate of 3 ml/min. If the infusion is tolerated well, the infusion rate can be gradually increased as described in Table 3. The maximum infusion rate should not exceed 5 ml/min.

Patients who have increased to 5 ml/min with a dose of 10 mg/kg pc should reduce the rate of the first infusion to 3 ml/min with the dose of 20 mg/kg pc.

Table 3: Empliciti infusion 20 mg/kg pc

*Continue at this rate until the infusion is complete.

The infusion solution of Empliciti should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed a total of 24 hours at 2-8°C and protected from light. Do not freeze the reconstituted or diluted solution. The infusion solution should be stored for a maximum of 8 hours of the total 24 hours at 20-25°C and ambient light. This 8-hour period should be included within the administration period of the medication.

Elimination

Do not store any unused portion of the solution for possible reuse. The elimination of the unused medication and all materials that have been in contact with it will be carried out in accordance with local regulations.