Consumer medicine information

Retevmo 80 mg Capsules

Selpercatinib

BRAND INFORMATION

Brand name

Retevmo

Active ingredient

Selpercatinib

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Retevmo 80 mg Capsules.

1. Why am I taking RETEVMO?


RETEVMO contains the active ingredient selpercatinib. RETEVMO is used to treat a type of lung cancer (non-small cell lung cancer (NSCLC)) in adults, caused by an abnormal RET gene.
For more information, see Section 1. Why am I taking RETEVMO? in the full CMI.

2. What should I know before I take RETEVMO?


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

3. What if I am taking other medicines?


Some medicines may interfere with RETEVMO 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 do I take RETEVMO?


Your doctor will prescribe the right dose for you. The maximum doses are: 1) for patients with less than 50 kg body weight: 120 mg twice a day; 2) for patients with 50 kg body weight or greater: 160 mg twice a day.
More instructions can be found in Section 4. How do I take RETEVMO? in the full CMI.

5. What should I know while taking RETEVMO?

Things you should do
  • You and your partner should use an effective method of birth control (contraception) to avoid becoming pregnant while taking RETEVMO and for at least one week after your final dose.
  • Tell your doctor straight away if you experience any signs of bleeding or liver problems.
  • You will need to have regular blood tests, blood pressure checks and ECG testing.
  • Remind any doctor, dentist or pharmacist you visit that you are using RETEVMO.
Things you should not do
  • Do not take RETEVMO to treat any other complaints unless your doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not stop taking your medicine, or change the dosage, without checking with your doctor.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how RETEVMO affects you.
  • RETEVMO may make you feel tired or dizzy.
Looking after your medicine
  • Keep your capsules in the original pack until it is time to take them.
  • This medicine does not require any special storage conditions.

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

6. Are there any side effects?


Potential side effects include swelling, diarrhoea, tiredness, dry mouth, abdominal pain, constipation, rash, nausea, headache, vomiting, dizziness, decreased appetite, fever. Serious potential side effects include severe or life threatening inflammation of the lungs, raised liver enzymes, high blood pressure, bleeding, heart rhythm changes (which prolong the QT interval), low thyroid hormone levels (characterised by weight gain, feeling cold, tiredness that worsens or does not go away, constipation), allergic reactions (characterised by fever, rash, and muscle and joint pain), accumulation of fluid in the lung and in the abdominal area.
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

Retevmo

Active ingredient

Selpercatinib

Schedule

S4

 

1 Name of Medicine

Selpercatinib.

2 Qualitative and Quantitative Composition

Retevmo 40 mg immediate release hard capsule. Each immediate release capsule contains 40 mg selpercatinib.
Retevmo 80 mg immediate release hard capsule. Each immediate release capsule contains 80 mg selpercatinib.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Retevmo 40 mg immediate release hard capsule. Grey, opaque capsule imprinted with "Lilly 3977" and "40 mg" in black ink.
Retevmo 80 mg immediate release hard capsule. Blue, opaque capsule imprinted with "Lilly 2980" and "80 mg" in black ink.

4 Clinical Particulars

4.9 Overdose

Symptoms of overdose have not been established. In the event of suspected overdose, supportive care should be provided.
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. Selpercatinib did not cause mutations in a bacterial mutagenicity assay and was negative in an in vitro micronucleus assay in human peripheral blood lymphocytes. Selpercatinib is not genotoxic at therapeutic doses. In an in vivo micronucleus assay in rats, selpercatinib was positive at concentrations > 7 times the Cmax at the human dose of 160 mg twice daily.
Carcinogenicity. Long-term studies to assess the carcinogenic potential of selpercatinib have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The empirical formula for selpercatinib is C29H31N7O3 and it has the following structural formula.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSELPER.gif CAS number. 2152628-33-4.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes

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