Consumer medicine information

Jemperli 500 mg/10 mL Concentrate for infusion

Dostarlimab

BRAND INFORMATION

Brand name

Jemperli

Active ingredient

Dostarlimab

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Jemperli 500 mg/10 mL Concentrate for infusion.

1. What is JEMPERLI and what is it used for?


JEMPERLI contains the active ingredient dostarlimab. JEMPERLI is used to treat endometrial cancer.
For more information, see Section 1. What is JEMPERLI and what is it used for? in the full CMI.

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


Do not use if you have ever had an allergic reaction to JEMPERLI 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 JEMPERLI? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with JEMPERLI 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 will JEMPERLI be given to me?


JEMPERLI will be given to you in a hospital or clinic under the supervision of a doctor experienced in cancer treatment. More instructions can be found in Section 4. How will JEMPERLI be given to me? in the full CMI.

5. What should I know while using JEMPERLI?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using JEMPERLI.
  • Seek medical attention if you think you may be having an allergic reaction.
  • If you miss an appointment, contact your doctor or hospital immediately to reschedule.
  • Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
  • Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
  • If you are breast-feeding tell your doctor before treatment.
Things you should not do
  • Do not stop using this medicine suddenly.
  • It is very important that you do not miss a dose of this medicine.
  • Do not breast feed during treatment.
Driving or using machines
  • JEMPERLI is unlikely to affect your ability to drive and use machines. However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines.
Looking after your medicine
  • JEMPERLI will be given to you in a hospital or clinic and the healthcare professionals will be responsible for its storage.

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

6. Are there any side effects?


Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects can be serious, and you need to know what symptoms to look out for. JEMPERLI can cause serious side effects due to inflammation. If you develop symptoms of inflammation, you must tell your doctor or nurse as soon as possible. Your doctor may give you other medicines to prevent more serious complications and reduce your symptoms. Your doctor may decide that you should miss a dose of JEMPERLI or stop your treatment altogether.
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

Jemperli

Active ingredient

Dostarlimab

Schedule

S4

 

1 Name of Medicine

Dostarlimab.

2 Qualitative and Quantitative Composition

Each mL of concentrate for solution for infusion contains 50 mg of dostarlimab.
One vial of 10 mL concentrate for solution for infusion contains 500 mg of dostarlimab (50 mg/mL).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).
Dostarlimab is a clear to slightly opalescent colourless to yellow solution, free from visible particles.

4 Clinical Particulars

4.9 Overdose

If overdose is suspected, the patient should be monitored for any signs or symptoms of adverse reactions or effects, and appropriate standard of care measures should be instituted immediately.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No studies have been performed to assess the potential of dostarlimab for genotoxicity.
Carcinogenicity. No studies have been performed to assess the potential of dostarlimab for carcinogenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDOSTAR.gif CAS number. 2022215-59-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/JEMPERST.gif