Infusion-related reaction<\/strong><\/p>\n\n\n\nTell 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.
<\/p>\n\n\n\n
Depending on the severity of the infusion-related reactions, you may need additional treatment to prevent complications and reduce your symptoms, or Empliciti\u2011 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.
<\/p>\n\n\n\n
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”).
<\/p>\n\n\n\n
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).<\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Empliciti is not recommended for use in children and adolescents under 18 years of age.<\/p>\n\n\n\n
Other medicines and Empliciti<\/h2>\n\n\n\n
Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Women using Empliciti<\/strong><\/p>\n\n\n\nIf 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.
<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
- If you are a woman of childbearing potential, you must use effective contraception during treatment with Empliciti and for 120 days after stopping treatment.<\/li>
- Tell your doctor if you become pregnant while using Empliciti.<\/li><\/ul>\n\n\n\n
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.<\/strong>
<\/p>\n\n\n\nIt 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.
<\/p>\n\n\n\n
Men who use Empliciti<\/strong><\/p>\n\n\n\nYou 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.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
Empliciti contains sodium<\/h2>\n\n\n\n
Tell your doctor<\/strong> 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.
<\/p>\n\n\n\n3. How to use Empliciti<\/h2>\n\n\n\n
How much Empliciti is given<\/strong><\/p>\n\n\n\nThe amount of Empliciti you will receive will be calculated based on your body weight.
<\/p>\n\n\n\n
How Empliciti is given<\/strong><\/p>\n\n\n\nYou 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.
<\/p>\n\n\n\n
Empliciti is taken during treatment cycles lasting 28 days (4 weeks), in combination with other medicines used to treat multiple myeloma.<\/p>\n\n\n\n
When given in combination with lenalidomide and dexamethasone, Empliciti should be used as follows:<\/p>\n\n\n\n