TEPMETKO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TEPOTINIB AS HYDROCHLORIDE HYDRATE

Available from:

MERCK SERONO LTD

ATC code:

L01EX21

Pharmaceutical form:

FILM COATED TABLETS

Composition:

TEPOTINIB AS HYDROCHLORIDE HYDRATE 225 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MERCK HEALTHCARE KGAA, GERMANY

Therapeutic area:

TEPOTINIB

Therapeutic indications:

TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harbouring a MET tyrosine kinase receptor exon 14 (METex14) skipping mutation.

Authorization date:

2022-02-28

Patient Information leaflet

Patient leaflet in accordance with the Pharmacists’
Regulations (Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Tepmetko
Film-coated tablets
Active ingredient:
Each film-coated tablet of Tepmetko contains: tepotinib 225 mg.
Inactive ingredients and allergens in this medicine: see section 2
under ‘Important
information about some of this medicine’s ingredients’, and
section 6 ‘Additional
information’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
Keep this leaflet handy, you may need to read it again.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
What is this medicine intended for
Tepmetko is used to treat adults with metastatic non-small cell lung
cancer (NSCLC)
harbouring a MET tyrosine kinase 14 (METex14) skipping mutation.
Therapeutic group: protein kinase inhibitors.
This mutation in the MET gene can lead to a dysfunctional protein,
which can lead to
uncontrolled cell growth and cancer. By blocking this dysfunctional
protein, Tepmetko may
slow or stop the cancer from growing. It may also help to shrink the
tumour.
2.
Before using this medicine
Do not use this medicine if:
•
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients in this medicine (see section 6).
Special warnings about using this medicine
Before treatment with Tepmetko, tell your doctor if:
you have any other diseases or if you have allergies.
_ _
Lung or breathing problems
Tepmetko may cause sudden breathing difficulties that may be
associated with fever and
cough. Talk to your doctor right away, if you develop new symptoms or
your current
symptoms get worse (see also section 4). Your doctor may prescribe a
different medicine
and tell you to stop your Tepmetko treatment.
Contraception

Summary of Product characteristics

Prescribing Information
TEPMETKO
Composition
_Active substances _
Tepotinib as tepotinib hydrochloride hydrate
_Excipients _
_Core:_ mannitol, microcrystalline cellulose, crospovidone, magnesium
stearate, colloidal silicon dioxide
_Film:_ hypromellose, titanium dioxide, lactose monohydrate,
polyethylene glycol, triacetin, red iron oxide
Pharmaceutical form and active substance quantity per unit
Each film-coated tablet contains 225 mg Tepotinib (as 250 mg tepotinib
hydrochloride hydrate).
Indications/Uses
Tepmetko is indicated for the treatment of adult patients with
metastatic non-small cell lung cancer
(NSCLC) harbouring a _MET_ tyrosine kinase receptor exon 14
(_MET_ex14) skipping mutation.
Dosage/Administration
Treatment must be initiated and supervised by a physician experienced
in the use of anticancer therapies.
_MET_ex14 skipping alterations should be confirmed by a validated test
method, using nucleic acids isolated
from plasma or tumour specimens.
Tepmetko is for oral use.
_Usual dosage _
The recommended dose of Tepmetko is 450 mg tepotinib (2 film-coated
tablets) taken once daily.
_Duration of treatment _
Treatment should continue as long as clinical benefit is observed.
_Dose adjustment following undesirable effects _
Recommended dose adjustments for Tepmetko for undesirable effects are
provided in Table 1.
_Table 1: Dose adjustments following undesirable effects _
Adverse Reaction
Severity
Dose Adjustment
Interstitial Lung Disease
(ILD) /ILD-like reactions
(see section _Warnings _
_and Precautions)_
Any grade
Withhold Tepmetko if ILD is
suspected.
Permanently discontinue Tepmetko if
ILD is confirmed.
Increased ALT and/or
AST without increased
total bilirubin (
see
section _Warnings and _
_Precautions_)
Grade 3
Withhold Tepmetko until recovery to
baseline ALT/AST.
If recovered to baseline within 7 days,
then resume Tepmetko at the same
dose; otherwise resume Tepmetko at
a reduced dose.
Grade 4
Permanently discontinue Tepmetko.
_Table 1: Dose adjustments following undesirable effects _
Adverse Reaction