EMPLICITI 400 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Empliciti 300mg powder for concentrate for solution for infusion

Empliciti 400mg powder for concentrate for solution for infusion

elotuzumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Empliciti and what is it used for

Empliciti contains the active substance 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 cells of our immune system (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 the multiple myeloma cells.

Empliciti is used to treat multiple myeloma (a type of bone marrow cancer) in adults. You will be given Empliciti along with lenalidomide and dexamethasone or along with pomalidomide and dexamethasone. Multiple myeloma is a cancer of a type of white blood cell called plasma cells. These cells divide without control 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 come back after several treatments.

2. What you need to know before you use Empliciti

Do not use Empliciti

• if you are allergic to elotuzumab or any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor.

Warnings and precautions

Infusion-related reaction

Tell your doctor or nurse immediately if you experience any infusion-related reactions, including those listed at the beginning of section 4. These side effects mostly occur during or after the infusion of the first dose. You will be monitored for signs of these effects during and after the infusion.

Depending on the severity of the infusion-related reactions, you may need additional treatment to prevent complications and reduce your symptoms, or the infusion of Empliciti may be interrupted. When the symptoms disappear or improve, the infusion can be continued more slowly, and the speed of the infusion can be gradually increased if the symptoms do not recur. Your doctor may decide not to continue treatment with Empliciti if you have a strong infusion-related reaction.

Before each infusion of Empliciti, you will be given medications to reduce infusion-related reactions (see section 3 "How to use Empliciti, Medications given before each infusion").

Before starting treatment with Empliciti, you must read the warnings and precautions sections of the package leaflet of all the medications given in combination with Empliciti, regarding the information on these medications. When lenalidomide is used, special attention is required to 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 18 years of age.

Other medicines and Empliciti

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

Pregnancy and breastfeeding

For women who are given Empliciti

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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

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

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

It is not known whether elotuzumab passes into breast milk or if there is any risk to the breastfed baby. Elotuzumab is given in combination with lenalidomide or pomalidomide, so breastfeeding should be discontinued due to the use of lenalidomide or pomalidomide.

For men who are given Empliciti

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

Driving and using machines

It is unlikely that Empliciti will affect your ability to drive or use machines. However, if you experience an infusion-related reaction (fever, chills, high blood pressure, see section 4 "Possible side effects"), do not drive, ride a bicycle, or use machines until the reaction has stopped.

Empliciti contains sodium

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

3. How to use Empliciti

Amount of Empliciti to be given

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

How Empliciti is given

You will receive Empliciti under the supervision of an experienced healthcare professional. It will be given into a vein (intravenously) as a drip (infusion) over several hours.

Empliciti is used in 28-day treatment cycles (4 weeks) in combination with other medicines used to treat multiple myeloma.

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

• In cycles 1 and 2, once a week on days 1, 8, 15, and 22.
• In cycles 3 and later, once every 2 weeks on days 1 and 15.

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

• In cycles 1 and 2, once a week on days 1, 8, 15, and 22.
• In cycles 3 and later, once every 4 weeks on day 1.

Your doctor will continue to treat you with Empliciti while your disease improves or remains stable and with tolerable side effects.

Medicines given before each infusion

You will be given the following medicines before each Empliciti infusion to help reduce infusion-related reactions:

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

If you miss a dose of Empliciti

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

If you are given too much Empliciti

As Empliciti will be given by a healthcare professional, it is unlikely that too much will be given. In the unlikely event of an overdose, your doctor will monitor you for side effects.

If you stop treatment with Empliciti

Stopping treatment with Empliciti may reduce the effect of the medicine. Do not stop treatment unless you have discussed it with your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss these 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 section 2 "Warnings and precautions"). Tell your doctor or nurse immediately if you do not feel well during the infusion.The following is a list of characteristic symptoms associated with infusion-related reactions:

• Fever
• Chills
• High blood pressure

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

Other side effects

Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

• Chest pain
• Blood clots in the veins (thrombosis)
• Painful skin rash with blisters (shingles)
• Night sweats
• Mood changes
• Decreased sensitivity, especially in the skin
• Allergic reactions (hypersensitivity)
• Pain in the mouth/throat area/sore throat

Uncommon (may affect up to 1 in 100 people)

• Sudden, potentially life-threatening allergic reaction (anaphylactic reaction)

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

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Empliciti

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 label of the vial and the carton after EXP or CAD. The expiry date is the last day of the month stated.

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

Do not freeze.

Store in the original package to protect from light.

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

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

Any unused or discarded medicine should be disposed of in accordance with local regulations.

6. Container Contents and Additional Information

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 polysorbate 80 (E433).

Product Appearance and Container Contents

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

Empliciti is available in packs with 1 vial.

Marketing Authorization Holder

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

Manufacturer

CATALENT ANAGNI S.R.L. Loc. Fontana del Ceraso snc Strada Provinciale 12 Casilina, 4103012 ANAGNI (FR) Italy

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

Date of Last Revision of this Prospectus:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

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This information is intended only 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 body weight (bw). More than one vial of Empliciti may be necessary to administer the total dose to the patient.

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

Reconstitution of Vials

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

Table1:Reconstitution Instructions

Maintain the vial in a vertical position and move the solution by rotating the vial to dissolve the lyophilized powder. Then, invert the vial a few times to dissolve any powder that may be present on the top of the vial or on the stopper. Avoid sudden movement, DO NOT SHAKE. The lyophilized powder should be dissolved within 10 minutes.

After completely dissolving the remaining solid, let the reconstituted solution 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 inspected visually 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 (0.9%) sodium chloride injectable solution 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 (0.9%) sodium chloride injectable solution or 5% glucose solution should be adjusted to not exceed 5 ml/kg of bw in any Empliciti dose administered.

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

Withdraw from each vial the volume needed 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 extractable volume.

Transfer the withdrawn volumes from all necessary vials 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 gently by manual agitation. Do not shake.

Empliciti is for intravenous use only. Discard any unused portion remaining in the vial.

Administration

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

Empliciti infusion is compatible with:

• PVC and polyolefin containers
• PVC infusion equipment
• Online filters of polyethersulfone and nylon with a pore size of 0.2 μm to 1.2 μm.

Empliciti 10 mg/kg bw Infusion Rate

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

Table2:Empliciti 10 mg/kg bw Infusion Rate

• Continue at this rate until the infusion is complete

Empliciti 20 mg/kg bw Infusion Rate

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

Patient who have increased to 5 ml/min with a 10 mg/kg bw dose should decrease the infusion rate of the first infusion to 3 ml/min with the 20 mg/kg bw dose.

Table3:Empliciti 20 mg/kg bw Infusion Rate

• Continue at this rate until the infusion is complete.

The Empliciti infusion solution should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed a total of 24 hours at 2°C - 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°C - 25°C and ambient light. This 8-hour period should be included within the administration period of the medicinal product.

Disposal

Do not store any unused portion for possible reuse. Disposal of the unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations.