Empliciti 300 mg and 400 mg powder for concentrate for solution for infusion

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

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 related reaction

Tell your doctor or nurse straight away if you get any of the infusion related 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 related 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 related reaction.

Before each infusion of Empliciti, you will be given medicines to reduce infusion related 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 and for 120 days after stopping treatment, 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 or pomalidomide, you must follow the pregnancy prevention programme for lenalidomide or pomalidomide respectively (see package leaflet for lenalidomide or pomalidomide). Lenalidomide and pomalidomide are 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 or pomalidomide and breast-feeding should be stopped because of the use of lenalidomide or pomalidomide.

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 related 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

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

How much Empliciti is given

The amount of Empliciti you will 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 taken in treatment cycles that are 28 days (4 weeks) long in combination with other medicines used to treat multiple myeloma.

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

• In cycles 1 and 2, once weekly on days 1, 8, 15, and 22.
• In cycles 3 and beyond, once every 2 weeks on days 1 and 15.

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

• In cycles 1 and 2, once weekly on days 1, 8, 15, and 22.
• In cycles 3 and beyond, once every 4 weeks on day 1.

Your doctor will continue to treat you with Empliciti for as long as the disease improves or remains stable and side effects are tolerable.

Medicines given before each infusion

You must receive the following medicines before each infusion of Empliciti to help reduce possible infusion related 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.

Other side effects

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

• Fever
• Sore throat
• Pneumonia
• 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)
• Painful skin rash with blisters (shingles, zona)
• 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Malta

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

What Empliciti contains

• The active substance is elotuzumab.
  Each vial of powder 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 (E433).

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

Manufacturer

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