300 mg and 400 mg powder for concentrate for infusion solution
elotuzumab
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 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 certain cells in the immune system (natural killer cells). When elotuzumab binds to SLAMF7 on the multiple myeloma cells or the natural killer cells, it stimulates the immune system to attack and destroy the multiple myeloma cells.
Empliciti is used to treat multiple myeloma ( bone marrow cancer ) in adults. Empliciti will be given to you with lenalidomide and dexamethasone or with pomalidomide and dexamethasone. Myeloma is a cancer of a type of white blood cell called a plasma cell. These cells divide uncontrollably and accumulate in the bone marrow. This leads to damage to the skeleton and kidneys.
Empliciti is used if your cancer has not responded to previous treatment or has returned after a certain number of previous treatments.
2. What you need to know before using Empliciti
Do not use Empliciti
- if you are allergic to elotuzumab or any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”). Talk to your doctor if you are not sure.
Warnings and cautions
Infusion-related reaction
Tell your doctor or nurse immediately if you get any of the infusion-related reactions listed at the top of section 4. These side effects occur mainly during or after infusion one of the first dose. You will be monitored for signs of such effects during and after infusion one.
Depending on the severity of the infusion-related reactions, you may need additional treatment to prevent complications and reduce your symptoms, or Empliciti‑ infusion may be discontinued. When the symptoms disappear or improve, the infusion can continue a little slower and increase gradually if the symptoms do not return. Your doctor may decide not to continue your Empliciti treatment if you have a severe infusion-related reaction.
Before each infusion of Empliciti, you will be given medicines to reduce infusion-related reactions (see section 3 “How to use Empliciti, medicines given before each infusion”).
Before starting treatment with Empliciti, you must also read the section warnings and precautions in the package leaflet of all medicines taken in combination with Empliciti, to get information about these medicines. When using lenalidomide, you must pay special attention to pregnancy testing and the need to use contraception (see “Pregnancy and breast-feeding” in this section).
Children and young people
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 taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Women using 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 using this medicine.
You should not use Empliciti if you are pregnant unless your doctor explicitly recommends it. It is unknown what effect Empliciti has on pregnant women or whether it could harm the unborn baby.
- If you are a woman of childbearing potential, you must use effective contraception during treatment with Empliciti and for 120 days after stopping treatment.
- Tell your doctor if you become pregnant while using Empliciti.
When Empliciti is given in combination with lenalidomide or pomalidomide, you must follow the pregnancy prevention program for lenalidomide and pomalidomide respectively (see the package leaflet for lenalidomide or pomalidomide). Lenalidomide and pomalidomide are expected to harm the fetus.
It is not known if elotuzumab passes into breast milk or if there is any risk to breastfeeding infants. Elotuzumab will be given in combination with lenalidomide or pomalidomide and breast-feeding will be discontinued due to the use of lenalidomide or pomalidomide.
Men who use Empliciti
You should use a condom during your treatment with Empliciti and for 180 days after stopping treatment to ensure that 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 disappears.
Empliciti contains sodium
Tell your doctor if you have been prescribed a low-salt diet (low in sodium) before being treated with Empliciti. This medicine contains 3.92 mg sodium (the main ingredient in table salt/table salt) per 300 mg vial or 5.23 mg sodium per 400 mg vial. This corresponds to 0.2% and 0.3%, respectively, of the highest recommended daily intake of sodium for an adult.
3. How to use Empliciti
How much Empliciti is given
The amount of Empliciti you will receive will be calculated based on your body weight.
How Empliciti is given
You will receive Empliciti under the supervision of experienced healthcare professionals. It will be given via a vein ( intravenously ) as a drip ( infusion ) for several hours.
Empliciti is taken during treatment cycles lasting 28 days (4 weeks), in combination with other medicines used to treat multiple myeloma.
When given in combination with lenalidomide and dexamethasone, Empliciti should be used as follows:
- In cycles 1 and 2 once a week on days 1, 8, 15, and 22.
- In cycle 3 and later once every two weeks on days 1 and 15.
When given in combination with pomalidomide and dexamethasone, Empliciti should be used as follows:
- In cycles 1 and 2, once a week on days 1, 8, 15, and 22.
- In cycle 3 and later, once every four weeks on day 1.
Your doctor will treat you with Empliciti as long as the disease improves or is stable and the side effects are tolerable.
Medicines are given before each infusion
You must receive the following medicines before each infusion of Empliciti, to help reduce any infusion-related reactions:
- drugs to reduce an allergic reaction (an antihistamine )
- medicines to reduce inflammation (dexamethasone)
- drugs to reduce pain and fever ( paracetamol )
If you miss a dose of Empliciti
Empliciti is used in combination with other drugs for multiple myeloma. If any of the medicines in the treatment are delayed, discontinued, or discontinued, your doctor will decide how to continue your treatment.
If you get too much Empliciti
Because Empliciti is given to you by healthcare professionals, you are unlikely to receive too much. In the unlikely event of an overdose, your doctor will monitor you to rule outside effects.
If you stop using Empliciti
If your Empliciti treatment is stopped, this may interrupt 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 product, 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 this with you and will explain the risks and benefits of the treatment.
The following side effects have been reported in clinical trials with elotuzumab:
Infusion- related reactions
Treatment with 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 typical symptoms associated with infusion-related reactions:
- Fever
- Overindulge
- High blood pressure
Other symptoms may also occur. Your doctor may consider reducing the infusion rate of Empliciti or discontinuing it to manage these symptoms. Other side effects are
Very common (may affect more than 1 in 10 people)
- Fever
- Sore throat
- Pneumonia
- Weight loss
- Low white blood cell count
- Cough
- 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, zona)
- Night sweats
- Mood swings
- Decreased sensitivity, especially in the skin
- Allergic reactions (hypersensitivity)
- Pain in the mouth/throat / 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.
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 expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C ‑ 8 ° C).
Do not freeze.
Store in the original package. Sensitive to light.
After reconstitution, the reconstituted solution should be immediately transferred from the vial to the infusion bag.
After dilution, the infusion must be completed within 24 hours of reconstitution. The medicine should be used immediately. If the infusion solution is not used immediately, it can be stored in a refrigerator (2 ° C ‑ 8 ° C) for up to 24 hours.
Any unused product or waste material should be disposed of by local requirements.
6. Contents of the packaging and other information
Content declaration
- 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 ingredients (excipients) are sucrose, sodium citrate (see section 2 “Empliciti contains sodium”), citric acid monohydrate, and polysorbate 80 (E433).
What the medicine looks like and the contents of the pack
Empliciti powder for concentrate for solution for infusion (powder for concentrate) is a white to off-white, whole or decomposed cake, in a glass bottle.
Empliciti is available in packs containing 1 vial.
Marketing Authorisation Holder
Marketing Authorisation Holder
Bristol ‑ Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
CATALENT ANAGNI SRL
Loc. Fontana del Ceraso snc
Strada Provinciale Casilina, 41
03012 ANAGNI (FR)
Italy
Swords Laboratories to Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine:
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