OPDUALAG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

NIVOLUMAB; RELATLIMAB

可用日期:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

ATC代码:

L01XC17

药物剂型:

CONCENTRATE FOR SOLUTION FOR INFUSION

组成:

RELATLIMAB 4 MG/ML; NIVOLUMAB 12 MG/ML

给药途径:

I.V

处方类型:

Required

厂商:

BRISTOL-MYERS SQUIBB COMPANY, USA

治疗领域:

NIVOLUMAB

疗效迹象:

Opdualag is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

授权日期:

2023-02-07

资料单张

תילגנאב לפוטמל סיטרכ
PATIENT CARD
גלאודפוא
)באמילטלרו באמולובינ(
PATIENT CARD
INFORMATION FOR PATIENTS
Please keep this card with you at all times. Show it to any healthcare
professionals treating you (e.g. doctor, nurse, pharmacist, emergency
department personnel) and inform them that you are receiving treatment
with Opdualag.
IMPORTANT
Opdualag can cause serious immune-related side effects that can
affect different parts of the body. These side effects can occur at
any time, may be delayed and may occur weeks to months after
your last dose of treatment. Some of the following side effects
can be life threatening and need to be addressed immediately:
POSSIBLE SIDE EFFECTS
BODY PART
New or worsening cough, shortness of breath,
breathing difficulties or chest pain.
Lung
Diarrhoea (watery, loose or soft stools) or more
frequent bowel movements than usual; stools that
are black, tarry, sticky or have blood or mucus;
stomach area (abdomen) pain or tenderness.
Stomach
and bowel
(gut)
Yellowing of the skin or the whites of the eyes
(jaundice), nausea or vomiting, pain in the right side
of stomach area (abdomen), dark urine, tiredness,
bleeding or bruising more easily than usual.
Liver
Headaches, increased sweating, weight gain or loss,
fatigue (extreme tiredness), increased hunger or thirst,
needing to urinate more often, hair loss, feeling cold,
constipation, changes in voice, dizziness or fainting,
changes in mood or behaviour, sensitivity to light, eye
problems, rapid heartbeat, having difficulty thinking
clearly, breath that smells sweet or fruity, a sweet
or metallic taste in your mouth, a different odour to
your urine or sweat, feeling sick or being sick, stomach
(abdomen) pain, and deep or fast breathing.
Hormone
glands
(including
diabetes
and diabetic
ketoacidosis)
Decrease in amount of urine, swelling in the ankles,
loss of appetite or blood in urine.
Kidneys
Rash, itching, blistering or peeling skin; painful sores
or ulcers in the mouth.
Skin
New or worsening chest p

产品特点

1
Opdualag_API_Feb2023_Corr_Feb2023
1.
NAME OF THE MEDICINAL PRODUCT
Opdualag
Concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate for solution for infusion contains 12 mg of
nivolumab and 4 mg of relatlimab.
One vial of 20 mL contains 240 mg of nivolumab and 80 mg of
relatlimab.
Nivolumab and relatlimab are human immunoglobulin G4 (IgG4) monoclonal
antibodies produced in
Chinese Hamster Ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
(sterile concentrate).
Clear to opalescent, colourless to slightly yellow liquid that is
essentially free of visible particles.
The solution has a pH of approximately 5.8 and an osmolality of
approximately 310 mOsm/kg.
4.
CLINICAL PARTICULARS
PATIENT SAFETY INFORMATION CARD
The marketing of Opdualag is subject to 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.
4.1
THERAPEUTIC INDICATIONS
Opdualag is indicated for the treatment of adult and pediatric
patients 12 years of age or older with
unresectable or metastatic melanoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and supervised by physicians experienced
in the treatment of cancer.
Posology
The recommended dose for adults and pediatric patients 12 years of age
and older is 480 mg
nivolumab and 160 mg relatlimab every 4 weeks administered as an
intravenous infusion over
30 minutes. This dose is established for pediatric patients 12 years
of age and older weighing at least
30 kg (see section 5.2).
Treatment with Opdualag should be continued as long as clinical
benefit is observed or until treatment
is no longer tolerated by the patient. Dose escalation or reduction is
not recommended. Dosing delay
or