LIBTAYO

Pajjiż: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

CEMIPLIMAB

Disponibbli minn:

SANOFI ISRAEL LTD

Kodiċi ATC:

L01XC33

Għamla farmaċewtika:

CONCENTRATE FOR SOLUTION FOR INFUSION

Kompożizzjoni:

CEMIPLIMAB 50 MG / 1 ML

Rotta amministrattiva:

I.V

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Żona terapewtika:

CEMIPLIMAB

Indikazzjonijiet terapewtiċi:

Cutaneous Squamous Cell Carcinoma LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.Basal Cell Carcinoma LIBTAYO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).

Data ta 'l-awtorizzazzjoni:

2020-07-05

Fuljett ta 'informazzjoni

PATIENT GUIDE
IMPORTANT SAFETY INFORMATION TO MINIMIZE COMPLICATIONS
FROM IMMUNE-MEDIATED ADVERSE REACTIONS
This Patient Guide will help you identify and report side effects from
your treatment with
LIBTAYO
®
(cemiplimab).
IMPORTANT INFORMATION
•
Tell your doctor about all medical conditions that you have and about
all medications
that you are taking before you take LIBTAYO.
•
LIBTAYO can cause serious side effects that can get worse.
•
Report all side effects to your doctor, even if they are not listed in
this Patient Guide.
•
Do not delay in reporting all side effects to your doctor, even if you
are away from
home.
•
Do not attempt to treat any of these side effects yourself without
first consulting your
doctor.
•
Carry the Patient Alert Card with you at all times during treatment.
•
Show the Patient Alert Card to all doctors you see other than the
doctor who prescribed
you LIBTAYO.
LIBTAYO contains an active substance cemiplimab which is anti-PD-1
monoclonal
antibody. LIBTAYO works by helping your immune system fight your
cancer. LIBTAYO
acts on your immune system and may cause inflammation in parts of your
body.
SEEK URGENT MEDICAL ATTENTION IF YOU HAVE ANY OF THE FOLLOWING SIGNS
OR SYMPTOMS, OR IF THEY GET WORSE:
HORMONE GLAND PROBLEMS
•
Headache that will not go away or
unusual headaches
•
Fast heartbeat
•
Increased sweating
•
Feeling more cold or hot than usual
•
Very tired
•
Dizzy or fainting
•
Weight gain or weight loss
•
Feeling more hungry or thirsty than
usual
•
Hair loss
•
Constipation
•
Your voice gets deeper
•
Very low blood pressure
•
Passing water more often than usual
•
Nausea or vomiting
•
Stomach (abdomen) pain
•
Changes in mood or behaviour
(such as decreased sex drive, being
irritable or forgetful)
SYMPTOMS OF TYPE 1 DIABETES OR
DIABETIC KETOACIDOSIS
•
Feeling more hungry or thirsty than
usual
•
Needing to urinate more often
•
Weight loss
•
Feeling tired or feeling sick
•
Stomach pain
•
Fast and deep breathing
•
Confusion
•
Unusu

Karatteristiċi tal-prodott

1
_LIBT350V-9.0_
1. NAME OF THE MEDICINAL PRODUCT
LIBTAYO
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 50 mg of cemiplimab.
Each vial contains 350 mg of cemiplimab in 7 ml.
Cemiplimab is produced by recombinant DNA technology in Chinese
hamster ovary (CHO) cell
suspension culture.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to slightly opalescent, colourless to pale yellow solution The
solution may contain trace
amounts of translucent to white particles in a single-use vial.
Patient safety information card
The marketing of Libtayo is subject to a risk management plan (RMP)
including a 'Patient safety information
card'. The Patient safety information card' emphasizes important
safety information that the patient should be
aware of before and during treatment. Please explain to the patient
the need to review the card before starting
treatment.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Cutaneous Squamous Cell Carcinoma
LIBTAYO as monotherapy is indicated for the treatment of adult
patients with metastatic or locally
advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are
not candidates for
curative surgery or curative radiation.
Basal Cell Carcinoma
LIBTAYO as monotherapy is indicated for the treatment of adult
patients with locally advanced or
metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on
or are intolerant to a
hedgehog pathway inhibitor (HHI).
4.2 Posology and method of administration
Treatment must be initiated and supervised by physicians experienced
in the treatment of cancer.
Posology
_Recommended dose_
_ _
Cutaneous Squamous Cell Carcinoma
The recommended dose is 350 mg cemiplimab every 3 weeks (Q3W)
administered as an intravenous infusion
2
over 30 minutes.
Treatment may be continued until disease progression or unacceptable
toxicity.
Alternatively, a dose of 3 mg/kg every 2 weeks administered as an
intravenous infusion over 30 minutes m