Tepmetko Drug / Drugs Data

Client Drugs Data (CMI) abstract

The complete CMI on the subsequent web page has extra particulars. If you’re frightened about utilizing this drugs,
converse to your physician or pharmacist.
This drugs is new or getting used otherwise. Please report negative effects. See the
full CMI for additional particulars.

Why am I utilizing TEPMETKO?

TEPMETKO accommodates the lively ingredient tepotinib (as hydrochloride monohydrate).
TEPMETKO is used to deal with adults with non-small cell lung most cancers (NSCLC) that has
unfold to different elements of the physique or is superior, and whose tumours have mesenchymal-
epithelial transition (MET) exon 14 skipping alterations.

What ought to I do know earlier than I take advantage of TEPMETKO?

Don’t use when you’ve got ever had an allergic response to TEPMETKO or any of the components
listed on the finish of the CMI.

Discuss to your physician when you’ve got another medical circumstances, take another medicines,
or are pregnant or plan to have a child or are breastfeeding.

What if I’m taking different medicines?

Some medicines could intrude with TEPMETKO and have an effect on the way it works.

How do I take advantage of TEPMETKO?

Really useful dose: 450 mg (two tablets) orally as soon as day by day with meals.

Swallow the pill(s) complete. Don’t break, crush or chew the pill(s).

What ought to I do know whereas utilizing TEPMETKO?

Issues it is best to do

Inform your physician or pharmacist if you’re about to begin on taking any new medicines
whereas utilizing TEPMETKO

Inform your physician in the event you turn out to be pregnant whereas utilizing TEPMETKO

Issues you shouldn’t do

Don’t cease utilizing this drugs abruptly with out telling your physician.

Don’t change the dose except your physician tells you to.

Don’t give this drugs to anybody else, even when their signs appear much like yours.

Driving or utilizing machines

You must take particular care when driving and utilizing machines as chances are you’ll really feel unusually
drained whereas taking TEPMETKO.

Taking care of your drugs

Retailer TEPMETKO tablets under 30°C within the unique package deal to guard from moisture.

Hold this drugs the place youngsters can not attain it.

Don’t use the medication after the expiry date on the label

Are there any negative effects?

Most typical antagonistic reactions had been swelling in your face or different elements of the physique,
nausea, vomiting, diarrhoea. Severe negative effects could embody sudden problem in
respiratory with cough or fever, dark-coloured urine, yellow pores and skin and eyes, lack of
urge for food. For extra info, together with what to do when you’ve got any negative effects,
see Part 6. Are there any negative effects? within the full CMI.
This drugs is topic to further monitoring. It will permit fast identification
of recent security info. You possibly can assist by reporting any negative effects chances are you’ll get.
You possibly can report negative effects to your physician, or immediately at www.tga.gov.au/reporting-problems .

Lively ingredient: tepotinib
(as hydrochloride monohydrate)

This drugs has provisional approval in Australia to deal with grownup sufferers with non-small cell lung most cancers (NSCLC) that
has unfold to different elements of the physique or is superior, and whose tumours have mesenchymal-epithelial
transition (MET) exon 14 skipping alterations. The choice to approve TEPMETKO has
been made based mostly on promising outcomes from preliminary research. Extra proof is required
to be submitted when obtainable to completely affirm the profit and security of the medication
for this use.

 

 

Client Drugs Data (CMI)

This leaflet supplies necessary details about utilizing TEPMETKO. You also needs to converse to your physician or pharmacist if you need additional info
or when you’ve got any issues or questions on utilizing TEPMETKO.

The place to seek out info on this leaflet:

Why am I utilizing TEPMETKO?

TEPMETKO accommodates the lively ingredient tepotinib (as hydrochloride monohydrate). TEPMETKO belongs to anti-cancer medicines known as mesenchymal epithelial transition
(MET) tyrosine kinase inhibitors.

TEPMETKO has provisional approval to deal with
adults with non-small cell lung most cancers (NSCLC) that has unfold to different elements of the
physique or is superior, and whose tumours have mesenchymal epithelial transition (

MET
) exon 14 skipping alterations.

The alterations within the MET gene can result in a dysfunctional protein which might lead
to uncontrolled cell progress and most cancers. By blocking this dysfunctional protein, TEPMETKO
could sluggish or cease the most cancers from rising. It could additionally assist to shrink the most cancers.

What ought to I do know earlier than I take advantage of TEPMETKO?

Warnings

Don’t use TEPMETKO if:

you might be allergic to tepotinib, or any of the components listed on the finish of this
leaflet.

All the time verify the components to ensure you should utilize this drugs.

Examine along with your physician in the event you:

have or have had any new or worsening signs indicative of irritation of the lungs,
e.g. sudden respiratory difficulties, cough or fever

have or have had liver issues

Throughout remedy, chances are you’ll be prone to growing sure negative effects. It is crucial
you perceive these dangers and the way to monitor for them. See further info
below Part 6. Are there any negative effects?

Being pregnant and breastfeeding

Inform your physician in the event you:

are pregnant or in the event you (male or feminine) are planning to have a child. TEPMETKO can
hurt your unborn child.

Females who’re capable of turn out to be pregnant:

Your physician could do a being pregnant take a look at earlier than you begin remedy with TEPMETKO.

You must use efficient contraception (contraception) throughout remedy and for at
least one week after the ultimate dose of TEPMETKO. Discuss to your physician about contraception
strategies that could be best for you.

Males with feminine companions who’re capable of turn out to be pregnant ought to use efficient delivery
management throughout remedy with TEPMETKO and for not less than one week after your closing
dose.

are breastfeeding or intend to breastfeed. It isn’t identified if TEPMETKO passes into
your breast milk. You shouldn’t breastfeed throughout remedy and for not less than one
week after your closing dose.

Use in youngsters and adolescents

The effectiveness of TEMPETKO in youngsters and adolescents below the age of 18 years
has not been established.

What if I’m taking different medicines?

Inform your physician or pharmacist if you’re taking another medicines, together with any
medicines, nutritional vitamins or dietary supplements that you simply purchase with out a prescription out of your pharmacy,
grocery store or well being meals store.

Some medicines could intrude with TEPMETKO and needs to be prevented throughout TEPMETKO remedy.

These embody:

– rifampicin to deal with bacterial infections together with tuberculosis

– phenytoin and carbamazepine to deal with epilepsy

– St. John’s Wort, a natural drugs used to deal with anxiousness or despair

– ketoconazole or itraconazole to deal with fungal infections

Some medicines could not work correctly if you’re taking TEPMETKO.

These embody:

– digoxin to deal with coronary heart circumstances

– metformin to deal with excessive blood glucose ranges

Chances are you’ll want completely different quantities of your medicines, or chances are you’ll must take completely different
medicines.

Your physician could must supervise their results extra intently.

Your physician could have extra info on medicines to watch out with or to keep away from
while utilizing TEPMETKO.

Examine along with your physician or pharmacist if you’re unsure about what medicines, nutritional vitamins
or dietary supplements you’re taking and if these have an effect on TEPMETKO.

How do I take advantage of TEPMETKO?

How a lot to make use of/take TEPMETKO

Your physician will inform you what number of tablets you could take every day.

The same old dose of TEPMETKO is 450 mg (two tablets) taken orally as soon as per day on the
identical time.

Your physician could change your dose throughout remedy. Observe the directions supplied
by your physician.

Don’t change the dose or cease utilizing TEPMETKO except your physician tells you to.

When to make use of/take TEPMETKO

TEPMETKO needs to be taken as soon as per day at about the identical time every day.

How you can take TEPMETKO

Observe all instructions given to you by your physician or pharmacist rigorously.

You must take TEPMETKO pill(s) with meals. Don’t chew, crush or break up the pill(s).

When you neglect to make use of TEPMETKO

TEPMETKO needs to be used commonly on the identical time every day. When you miss your dose
on the common time, take your really useful dose as quickly you keep in mind.

Whether it is nearly time on your subsequent dose (e.g. inside 8 hours), skip the dose you missed
and take your subsequent dose when you’re meant to.

Don’t take a double dose to make up for the dose you missed.

This may occasionally improve the prospect of you getting an undesirable facet impact.

When you use an excessive amount of TEPMETKO

When you assume that you’ve got used an excessive amount of TEPMETKO, chances are you’ll want pressing medical consideration.

You must instantly:

telephone the Poisons Data Centre
(by calling
13 11 26), or

contact your physician, or

go to the Emergency Division at your nearest hospital.

You must do that even when there are not any indicators of discomfort or poisoning.

What ought to I do know whereas utilizing TEPMETKO?

Issues it is best to do

Name your physician right away in the event you:

are about to begin on taking any new medicines.

turn out to be pregnant throughout remedy with TEPMETKO.

expertise allergic reactions, together with shortness of breath, wheezing or problem
respiratory, swelling of the face, lips, tongue or different elements of the physique, rash, itching
or hives on the pores and skin.

expertise any negative effects as listed in Part 6. Your physician could hold or change
your dose throughout remedy. In case your situation worsens, your physician could cease your remedy
briefly or completely relying in your situation.

Remind any physician, dentist or pharmacist you go to that you’re utilizing TEPMETKO.

TEPMETKO could intrude with the results of some laboratory assessments.

Issues you shouldn’t do

Don’t cease utilizing this drugs abruptly except your physician tells you to.

Don’t give TEPMETKO to anybody else, even when their circumstances appear much like yours.

Don’t change the dose with out checking along with your physician.

Driving or utilizing machines

You must take particular care when driving and utilizing machines as chances are you’ll really feel unusually
drained whereas taking TEPMETKO.

Taking care of your drugs

Hold your tablets within the pack in a dry cool place the place the temperature stays under
30°C. Don’t take away the tablets from the carton pack.

Observe the directions within the carton on the way to maintain your drugs correctly.

Retailer it in a cool dry place away from moisture, warmth or daylight; for instance, do
not retailer it:

within the toilet or close to a sink, or

within the automotive or on window sills.

Hold it the place younger youngsters can not attain it.

When to discard your drugs

In case your physician tells you to cease taking this drugs or the expiry date has handed,
ask your pharmacist what to do with any drugs that’s left over.

Eliminating any undesirable drugs

When you not want to make use of this drugs or it’s outdated, take it to any pharmacy
for protected disposal.

Don’t use this drugs after the expiry date.

Are there any negative effects?

All medicines can have negative effects. When you do expertise any negative effects, most of
them are minor and non permanent. Nonetheless, some negative effects may have medical consideration.

See the data under and, if you could, ask your physician or pharmacist in the event you
have any additional questions on negative effects.

Much less severe negative effects

Severe negative effects

Relying on the severity of your situation, your physician could cut back your dose or ask
you to cease the remedy briefly or completely.

Inform your physician or pharmacist in the event you discover the rest that could be making you
really feel unwell.

Different negative effects not listed right here could happen in some folks.

Reporting negative effects

After you could have acquired medical recommendation for any negative effects you expertise, you may
report negative effects to the Therapeutic Items Administration on-line at www.tga.gov.au/reporting-problems . By reporting negative effects, you may assist present extra info on the protection of
this drugs.

All the time be sure you converse to your physician or pharmacist earlier than you resolve to cease
taking any of your medicines.

Product particulars

This drugs is barely obtainable with a physician’s prescription.

What TEPMETKO accommodates

Lively ingredient

(predominant ingredient)

Tepotinib (as hydrochloride monohydrate)

Different components

(inactive components)

Mannitol, colloidal anhydrous silica, crospovidone, magnesium stearate, microcrystalline
cellulose

Movie coating: Hypromellose, lactose monohydrate, macrogol 3350, triacetin, pink iron
oxide, titanium dioxide

Potential allergens

Not relevant

Don’t take this drugs if you’re allergic to any of those components.

What TEPMETKO seems like

TEPMETKO is white-pink, oval, biconvex film-coated pill with embossment “M” on one
facet and plain on the opposite facet (Aust R 370977). Every pack accommodates 60 tablets.

Who distributes TEPMETKO

Merck Healthcare Pty Ltd

Suite 1, Degree 1, Constructing B

11 Talavera Highway, Macquarie Park

NSW 2113

Australia

This leaflet was ready in January 2022.

A001-0122

https://www.news-medical.internet/medication/Tepmetko.aspx