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Empliciti (elotuzumab) – Package leaflet - L01XC

Updated on site: 06-Oct-2017

Medication nameEmpliciti
ATC CodeL01XC
Substanceelotuzumab
ManufacturerBristol-Myers Squibb

Package leaflet: Information for the user

Empliciti 300 mg powder for concentrate for solution for infusion

Empliciti 400 mg powder for concentrate for solution for infusion

elotuzumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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, or pharmacist or nurse.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Empliciti is and what it is used for

2.What you need to know before you use 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 recognise and attach to a specific target substance in the body. Elotuzumab attaches to a target protein called SLAMF7. SLAMF7 is found in large amounts on the surface of multiple myeloma cells and on certain cells of your immune system (natural killer cells). When elotuzumab binds to SLAMF7 on the multiple myeloma 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. It is used in combination with lenalidomide and dexamethasone. Multiple myeloma is a cancer of a type of white blood cell called plasma cells. These cells divide out of control and collect in the bone marrow. This results in damage to the bones and kidneys.

Empliciti is used when you have already had at least one multiple myeloma treatment before. One of these treatments may include bone marrow transplantation.

2. What you need to know before you use Empliciti

You should not be given Empliciti:

if you are allergic to elotuzumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”). Talk to your doctor if you are not sure.

Warnings and precautions Infusion reaction

Tell your doctor or nurse straight away if you get any of the infusion reactions listed at the top of section 4. These side effects mostly occur during or after the infusion of the first dose. You will be monitored for signs of such effects during and after the infusion.

Depending on the seriousness of the infusion reactions, you may require additional treatment to prevent complications and reduce your symptoms, or your infusion of Empliciti may be interrupted. When the symptoms go away or improve, the infusion can be continued more slowly and speeded up gradually if the symptoms do not recur. Your doctor may decide not to continue Empliciti treatment if you have a strong infusion reaction.

Before each infusion of Empliciti, you will be given medicines to reduce infusion reaction (see section 3 “How to use Empliciti, Medicines given before each infusion”).

Before starting treatment with Empliciti, you must also read the package leaflet warnings and precautions of all medicines to be taken in combination with Empliciti for information related to these medicines. When lenalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see “Pregnancy and breast-feeding” in this section).

Children and adolescents

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

Other medicines and Empliciti

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

Pregnancy and breast-feeding

For women taking Empliciti

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not use Empliciti if you are pregnant, unless your doctor specifically recommends it. The effects of Empliciti in pregnant women or its possible harm to an unborn baby are unknown.

You must use effective contraception while you are being treated with Empliciti, if there is any chance you could become pregnant.

If you become pregnant while using Empliciti, tell your doctor.

When Empliciti is given in combination with lenalidomide, you must follow the pregnancy prevention programme for lenalidomide (see package leaflet for lenalidomide). Lenalidomide is expected to be harmful for an unborn baby.

It is not known, whether elotuzumab passes into breast milk or if there is any risk to the breast-fed infant. Elotuzumab will be given in combination with lenalidomide and breast-feeding should be stopped because of the use of lenalidomide.

For men taking Empliciti

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

Driving and using machines

Empliciti is unlikely to affect your ability to drive or use machines. However, if you get an infusion reaction (fever, chills, high blood pressure see section 4 “Possible side effects”), do not drive, cycle or use machines until the reaction stops.

Empliciti contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium free’.

3.How to use Empliciti

How much Empliciti is given

The amount of Empliciti you will be given will be calculated based on your body weight. The recommended dose is 10 mg of elotuzumab per kilogram of 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 taken in treatment cycles that are 28 days (4 weeks) long in combination with lenalidomide and dexamethasone.

In cycles 1 and 2, Empliciti is administered once weekly on days 1, 8, 15, and 22.

In cycles 3 and beyond, Empliciti is administered once every 2 weeks on days 1 and 15. Your doctor will continue to treat you with Empliciti for as long as the disease improves or remains stable and side effects are tolerable.

You will also be given lenalidomide and dexamethasone together with Empliciti.

Medicines given before each infusion

You must receive the following medicines before each infusion of Empliciti to help reduce possible infusion reactions:

medicine to reduce an allergic reaction (an anti-histamine)

medicine to reduce inflammation (dexamethasone)

medicine 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 your treatment should be continued.

If you are given too much Empliciti

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

If you stop using Empliciti

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

If you have any further questions on 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 will explain the risks and benefits of your treatment.

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

Infusion reactions

Empliciti has been associated with infusion reactions (see section 2 “Warnings and precautions”). Tell your doctor or nurse straight away if you feel unwell during infusion. Below is a list of typical symptoms associated with infusion reactions:

Fever

Chills

High blood pressure

Other symptoms may occur as well. Your doctor may consider slowing 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

Painful skin rash with blisters (shingles, zona)

Weight decrease

Low white blood cell count

Cough

Common cold

Headache

Diarrhoea

Feeling tired or weak

Common (may affect up to 1 in 10 people)

Chest pain

Blood clots in the veins (thrombosis)

Night sweats

Mood changes

Decreased sensitivity, especially in the skin

Allergic reactions (hypersensitivity)

Pain in the mouth/throat region/sore throat

Uncommon (may affect up to 1 in 100 people)

Sudden life-threatening allergic reaction (anaphylactic reaction)

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

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.How to store 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 vial label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Store in the original package in order to protect from light.

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

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

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

6. Contents of the pack and other information

What Empliciti contains

The active substance is elotuzumab.

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

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

The other ingredients (excipients) are sucrose, sodium citrate (see section 2 “Empliciti contains sodium”), citric acid monohydrate, and polysorbate 80.

What Empliciti looks like and contents of the pack

Empliciti powder for concentrate for solution for infusion (powder for concentrate) is a white to off white whole or fragmented cake provided in a glass vial.

Empliciti is available in packs containing 1 vial.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

Manufacturer

Bristol-Myers Squibb S.r.l. Loc. Fontana del Ceraso 03012 Anagni (FR)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

N.V. Bristol-Myers Squibb Belgium S.A.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tél/Tel: + 32 2 352 76 11

Tel: +370 52 369140

България

Luxembourg/Luxemburg

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. N.V. Bristol-Myers Squibb Belgium S.A.

Teл.: + 359 800 12 400

Tél/Tel: + 32 2 352 76 11

Česká republika

Magyarország

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: + 420 221 016 111

Tel.: + 36 1 301 9700

Danmark

Malta

Bristol-Myers Squibb

BRISTOL-MYERS SQUIBB S.R.L.

Tlf: + 45 45 93 05 06

Tel: + 39 06 50 39 61

Deutschland

Nederland

Bristol-Myers Squibb GmbH & Co. KGaA

Bristol-Myers Squibb B.V.

Tel: + 31 (0)30 300 2222

 

Eesti

Norge

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd

Tel: +372 640 1030

Tlf: + 47 67 55 53 50

Ελλάδα

Österreich

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb GesmbH

Τηλ: + 30 210 6074300

Tel: + 43 1 60 14 30

España

Polska

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Tel: + 34 91 456 53 00

Tel.: + 48 22 5796666

France

Portugal

Bristol-Myers Squibb SARL

Bristol-Myers Squibb Farmacêutica Portuguesa,

Tél: + 33 (0)1 58 83 84 96

S.A.

 

Tel: + 351 21 440 70 00

Hrvatska

România

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

TEL: +385 1 2078 508

Tel: + 40 (0)21 272 16 00

Ireland

Slovenija

Bristol-Myers Squibb Pharmaceuticals Ltd

Bristol-Myers Squibb spol. s r.o.

Tel: + 353 (1 800) 749 749

Tel: +386 1 2355 100

Ísland

Slovenská republika

Vistor hf.

Bristol-Myers Squibb spol. s r.o.

Sími: + 354 535 7000

Tel: + 421 2 59298411

Italia

Suomi/Finland

BRISTOL-MYERS SQUIBB S.R.L.

Oy Bristol-Myers Squibb (Finland) Ab

Tel: + 39 06 50 39 61

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb AB

Τηλ: + 357 800 92666

Tel: + 46 8 704 71 00

Latvija

United Kingdom

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd

Tel: +371 67708347

Tel: + 44 (0800) 731 1736

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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The following information is intended for healthcare professionals only:

Preparation and administration of Empliciti

Calculating the dose

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

The total elotuzumab dose in mg = the patient’s weight in kg x 10.

Preparing the infusion

Aseptically reconstitute each Empliciti vial with a syringe of adequate size and an 18 gauge or smaller needle as shown in Table 1. A slight back pressure may be experienced during administration of the water for injections, which is considered normal.

Table 1:

Reconstitution instructions

 

 

Strength

 

Amount of water for

Final volume of

Post-reconstitution

 

 

injections, required for

reconstituted Empliciti in

concentration

 

 

reconstitution

the vial

 

300 mg vial

13.0 mL

13.6 mL

25 mg/mL

400 mg vial

17.0 mL

17.6 mL

25 mg/mL

Hold the vial upright and swirl the solution by rotating the vial to dissolve the lyophilised cake. Then invert the vial a few times in order to dissolve any powder that may be present on top of the vial or the stopper. Avoid vigorous agitation, DO NOT SHAKE. The lyophilised powder should dissolve in less than 10 minutes.

After the remaining solids are completely dissolved, allow the reconstituted solution to stand for 5 to 10 minutes. The reconstituted solution is colourless to slightly yellow and clear to very opalescent. Empliciti should be inspected visually for particulate matter and discolouration prior to administration. Discard the solution if any particulate matter or discolouration is observed.

Once the reconstitution is completed, withdraw the necessary volume for the calculated dose from each vial, up to a maximum of 16 mL from 400 mg vial and 12 mL from 300 mg vial. Dilute the reconstituted solution with 230 mL of either sodium chloride

9 mg/mL (0.9%) solution for injection or 5% glucose injection into an infusion bag made of polyvinyl chloride or polyolefin. The volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection should be adjusted so as not to exceed 5 mL/kg of patient weight at any given dose of Empliciti.

Administration

The entire 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 sets

polyethersulfone and nylon in-line filters with pore sizes of 0.2 μm to 1.2 μm.

Empliciti should be initiated at an infusion rate of 0.5 mL/min. If well tolerated, the infusion rate may be increased stepwise as described in Table 2. The maximum infusion rate should not exceed

5 mL/min.

Table 2:

Infusion rate for Empliciti

 

 

Cycle 1, Dose 1

Cycle 1, Dose 2

Cycle 1, Dose 3 and 4

 

 

 

 

 

and all subsequent Cycles

 

 

 

 

 

Time interval

Rate

Time interval

Rate

Rate

 

 

 

 

 

 

0 - 30 min

 

0.5 mL/min

0 - 30 min

3 mL/min

 

30 - 60 min

 

1 mL/min

≥ 30 min

4 mL/min*

5 mL/min*

≥ 60 min

 

2 mL/min*

-

-

 

*Continue this rate until infusion is completed, approximately 1 hour based on patient weight.

The Empliciti infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than

24 hours at 2°C − 8°C protected from light. Do not freeze the reconstituted or diluted solution. The solution for infusion may be stored for a maximum of 8 hours of the total 24 hours at 20°C − 25°C and room light. This 8-hour period should be inclusive of the product administration period.

Disposal

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.

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