EmpliCiti 400 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

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 questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Empliciti is and what it is 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 amounts 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 your immune system to attack and destroy the multiple myeloma cells.

Empliciti is used to treat multiple myeloma (a cancer of the bone marrow) in adults. Empliciti will be given to you in combination with lenalidomide and dexamethasone or in combination 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 bones and kidneys.

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

2. What you need to know before using Empliciti

Do not use Empliciti

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

Warnings and precautions

Infusion-related reactions

Immediately inform your doctor or nurse if you experience any of the infusion-related reactions listed at the beginning of section 4. These adverse effects mostly occur during or after the first infusion. 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 require additional treatment to prevent complications and reduce your symptoms, or the Empliciti infusion may be interrupted. Once symptoms have disappeared or improved, the infusion may be resumed at a slower rate, gradually increasing the rate if symptoms do not recur. Your doctor may decide to discontinue treatment with Empliciti if you experience a severe infusion-related reaction.

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

Before starting treatment with Empliciti, you must read the warnings and precautions sections of the package leaflets of all medicines administered in combination with Empliciti, regarding information about these medicines. When lenalidomide is used, special attention must be paid to pregnancy testing and prevention requirements (see "Pregnancy and breastfeeding" in this section).

Children and adolescents

Use of Empliciti is not recommended in children and adolescents under 18 years of age.

Other medicines and Empliciti

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

For women receiving Empliciti

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

You must not use Empliciti if you are pregnant unless specifically advised by your doctor. The effects of Empliciti in pregnant women and its potential harm to the fetus are unknown.

• If you are capable of becoming pregnant, you must use an effective method of contraception during treatment with Empliciti and for 120 days after treatment ends.
• If you become pregnant while using Empliciti, inform your doctor immediately.

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

It is unknown whether elotuzumab is excreted in human milk or if there is any risk to the breastfed infant. Elotuzumab is administered in combination with lenalidomide or pomalidomide; therefore, breastfeeding must be discontinued due to the use of lenalidomide or pomalidomide.

For men receiving Empliciti

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

Driving and using machines

It is unlikely that Empliciti will affect your ability to drive or operate machinery. 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 operate machinery until the reaction has resolved.

Empliciti contains sodium

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

3. How to use Empliciti

Amount of Empliciti to be administered

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 given into a vein (intravenously) as an 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 administered 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 administered 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 treating you with Empliciti for as long as your disease improves or remains stable and adverse effects are tolerable.

Medicines given before each infusion

You should receive the following medicines before each Empliciti infusion to help reduce possible 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 missed a dose of Empliciti

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

If you are given more Empliciti than you should have

Since 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 down the medicine's effect. Do not interrupt treatment unless discussed with your doctor.

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

4. Possible adverse effects

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

The following adverse effects have been reported in clinical trials with elotuzumab:

Infusion-related reactions

Empliciti has been associated with infusion-related reactions (see section 2 "Warnings and precautions"). Inform your doctor or nurse immediately if you feel unwell 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 or stopping the Empliciti infusion to manage these symptoms.

Other adverse 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 (herpes zoster)
• Night sweats
• Mood changes
• Decreased sensation, 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)

Inform your doctor immediately if you experience any of the adverse effects listed above. Do not attempt to treat the symptoms with other medicines.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 outer carton after EXP or CAD. The expiry date refers to the last day of the month indicated.

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

Do not freeze.

Keep in the original packaging to protect from light.

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

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

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

6. Contents of the pack and other information

Composition of Empliciti

• The active substance 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).

Presentation of the product and contents of the pack

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

Empliciti is available in packs containing 1 vial.

Marketing Authorisation 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, 4
03012 ANAGNI (FR)
Italy

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

Date of the most recent revision of this summary:

Detailed information on this medicine 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.

This information is intended for healthcare professionals only:

Preparation and administration of Empliciti

Dose calculation

Calculate the dose (mg) and determine the number of vials required for the dose (10 mg/kg or 20 mg/kg) based on body weight (BW). More than one vial of Empliciti may be needed to administer the total dose for the patient.

• The total dose of elotuzumab in mg equals 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 using a syringe of appropriate size and an 18-gauge or smaller needle, as shown in Table 1. A slight back pressure may be experienced during the administration of water for injections, which is considered normal.

Table 1: Reconstitution instructions

Keep the vial in an upright position and swirl the solution by rotating the vial to dissolve the lyophilized powder. Then invert the vial several times to dissolve any powder that may be present at the top of the vial or on the stopper. Avoid vigorous movement; DO NOT SHAKE. The lyophilized powder should dissolve within approximately 10 minutes.

After complete dissolution of the residual solid, allow the reconstituted solution to stand for 5 to 10 minutes. The reconstituted solution is colorless or slightly yellow, clear to very opalescent. For 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 must be diluted with either a 9 mg/mL (0.9%) sodium chloride injection solution or 5% glucose injection solution to achieve a final infusion concentration between 1 mg/mL and 6 mg/mL. The volume of the 9 mg/mL (0.9%) sodium chloride or 5% glucose injection solution must be adjusted so that it does not exceed 5 mL/kg of body weight for any administered dose of Empliciti.

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

Withdraw from each vial the volume required 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 vials required according to the patient's calculated dose into a single infusion bag made of polyvinyl chloride or polyolefin containing the calculated volume of diluent. Gently mix the infusion 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 must be administered using 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 sets
• in-line filters made of polyethersulfone and nylon with a pore size of 0.2 μm to 1.2 μm.

Empliciti 10 mg/kg body weight infusion rate

Administration of Empliciti at a dose of 10 mg/kg body weight 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 must not exceed 5 mL/min.

Table 2: Empliciti 10 mg/kg body weight infusion rate

• Continue at this rate until the infusion is complete

Infusion rate of Empliciti 20 mg/kg body weight

Administration of Empliciti at a dose of 20 mg/kg body weight 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.

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

Table 3: Infusion rate of Empliciti 20 mg/kg body weight

• 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 prior to use are the responsibility of the user and normally should not 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 may be stored for a maximum of 8 hours of the total 24 hours at 20 °C ‑ 25 °C under ambient light. This 8-hour period should be included within the drug administration period.

Disposal

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