Consumer medicine information

Empliciti 400 mg Powder for infusion

Elotuzumab

BRAND INFORMATION

Brand name

Empliciti

Active ingredient

Elotuzumab

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Empliciti 400 mg Powder for infusion.

1. Why am I given EMPLICITI?


EMPLICITI contains the active ingredient elotuzumab. EMPLICITI is used to treat multiple myeloma (a cancer of the bone marrow) in adults in combination with other medicines.
For more information, see Section 1. Why am I given EMPLICITI? in the full CMI.

2. What should I know before I am given EMPLICITI?


Do not use if you have ever had an allergic reaction to elotuzumab or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given EMPLICITI? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with EMPLICITI and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How am I given EMPLICITI?

  • You will receive EMPLICITI by infusion under the supervision of an experienced healthcare professional
  • It will be given into a vein (intravenously) as a drip (infusion) over several hours
  • The amount of EMPLICITI you will be given will be calculated based on your body weight

More instructions can be found in Section 4. How am I given EMPLICITI? in the full CMI.

5. What should I know while receiving EMPLICITI?

Things you should do
  • Remind any doctor, dentist, nurses and pharmacist who are treating you that you are being given EMPLICITI.
  • Tell your doctor or nurse immediately if you get any of the infusion reactions, including fever, chills, high blood pressure.
  • Tell your doctor right away if you have any signs and symptoms of an infection, including fever, shortness of breath, flu-like symptoms, pain or burning when you urinate, cough, a painful skin rash.
  • People with multiple myeloma who receive EMPLICITI with lenalidomide and dexamethasone have a risk of developing new cancers. Talk to your doctor about your risk of developing new cancers if you receive EMPLICITI. Your doctor will check you for new cancers during your treatment with EMPLICITI.
  • Tell your doctor if you have signs and symptoms of liver problems, including tiredness, weakness, loss of appetite, yellowing of your skin or eyes, colour changes in your stools, confusion, swelling of the stomach area.
Driving or using machines
  • EMPLICITI is unlikely to affect your ability to drive or use machines. However, if you get an infusion reaction, do not drive, cycle or use machines until the reaction stops.

For more information, see Section 5. What should I know while receiving EMPLICITI? in the full CMI.

6. Are there any side effects?


Serious side effects include infusion reactions. Common side effects include weight decrease, low white blood cell count, cough. Very common side effects include chest pain, night sweats, mood changes, decreased feeling of sensitivity, especially in the skin, painful skin rash with blisters (shingles, herpes zoster), allergic reactions (hypersensitivity).
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Empliciti

Active ingredient

Elotuzumab

Schedule

S4

 

1 Name of Medicine

Elotuzumab.

2 Qualitative and Quantitative Composition

Empliciti 300 mg powder for concentrate for solution for intravenous infusion.
Empliciti 400 mg powder for concentrate for solution for intravenous infusion.
Each vial contains either 300 mg or 400 mg elotuzumab. After reconstitution, each mL of concentrate contains 25 mg elotuzumab.
Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody MuLuc63 grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Purified elotuzumab IgG1 has been shown to have an affinity to SLAMF7 in the range of 30 to 45 nanoM.
Empliciti for injection vials require reconstitution with Sterile Water for Injection, BP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL. After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution has a pH of 5.7-6.3 in Sterile Water for Injection BP and is intravenously administered as an isotonic solution upon further dilution with 0.9% sodium chloride or 5% glucose.
Note. "Qualitative and Quantitative Composition" only relates to the quantity of the therapeutically active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Empliciti is a nonpyrogenic lyophilized powder that is a white to off-white, whole or fragmented cake that is provided in two strengths.
Empliciti for Injection, 400 mg per vial and Empliciti for Injection, 300 mg per vial are single use, sterile, nonpyrogenic lyophilized products.

4 Clinical Particulars

4.9 Overdose

One patient was reported to be overdosed with 23.3 mg/kg of elotuzumab in combination with lenalidomide and dexamethasone. The patient had no infusion reaction, no symptoms, did not require any treatment for the overdose, and was able to continue on elotuzumab therapy.
The maximum tolerated dose has not been determined. In clinical studies, approximately 78 patients were evaluated with elotuzumab at 20 mg/kg without apparent toxic effects.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No genotoxicity data are available for elotuzumab. As a large molecular weight protein, elotuzumab is not expected to interact with DNA or other chromosomal material.
Carcinogenicity. No carcinogenicity data are available for elotuzumab.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

CAS number. CAS number: 915296-00-3.
Chemical structure. Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody. The elotuzumab molecule consists of two identical heavy chain subunits and two identical light chain subunits which are covalently linked through disulfide bridges. The light and heavy chains have masses of 23.4 kDa and 50.6 kDa, respectively. These molecular weights exclude the contributions of glycosylation and other post-translational modifications.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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