SYLVANT siltuximab (rmc) 100mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

siltuximab, Quantity: 100 mg

Available from:

Recordati Rare Diseases Australia Pty Ltd

INN (International Name):

siltuximab

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: histidine; polysorbate 80; sucrose

Administration route:

Intravenous Infusion

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Product summary:

Visual Identification: White solid with no meltback; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-08-31

Patient Information leaflet

SYLVANT
®
CMI JAN 2021
1
SYLVANT
®
_Siltuximab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SYLVANT. It does
not contain all the available
information. It does not take the
place of talking to your doctor, nurse
or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING SYLVANT, ASK YOUR DOCTOR
OR PHARMACIST.
Your doctor and pharmacist have
more information.
Keep this information handy. You
can refer to it later if you have any
questions.
Please also refer to Consumer
Medicine Information documents of
other medicines your doctor may
have prescribed for use in
combination with SYLVANT.
WHAT SYLVANT IS
USED FOR
SYLVANT is a prescription
medicine used to treat multicentric
Castleman's disease (MCD) in
patients who do not have human
immunodeficiency virus (HIV) and
human herpesvirus-8 (HHV-8)
infection.
Multicentric Castleman's disease
causes non-cancerous growths
(tumours) to develop in the lymph
nodes in the body. This disease may
also make you feel tired, sweat at
night, have a tingling feeling, and a
loss of appetite.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
_HOW IT WORKS _
SYLVANT contains the active
ingredient siltuximab. SYLVANT
blocks the action of a specific protein
called "interleukin-6", which can
cause inflammation. Blocking this
protein helps to reduce the size of the
affected lymph nodes and reduce the
symptoms of the illness such as
feeling tired. This should help you
carry out your normal daily tasks.
BEFORE YOU USE
SYLVANT
_WHEN YOU MUST NOT USE IT _
DO NOT USE SYLVANT IF YOU KNOW
YOU ARE ALLERGIC TO SILTUXIMAB OR
ANY OF THE OTHER INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include skin rash, itching or
hives on the skin, shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue or
other parts of the body.
DO NOT USE IT AFTER THE EXPIRY DATE
PRINTED ON THE PACK.
DO NOT USE IT IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF BEING
TAMPERED

Summary of Product characteristics

SYLVANT PRODUCT INFORMATION – 05Mar2021
Page 1 of 18
SYLVANT

S
ILTUXIMAB
PRODUCT
INFORMATION
1. NAME OF THE MEDICINE
SYLVANT siltuximab (rmc) 100 mg powder for injection vial
SYLVANT siltuximab (rmc) 400 mg powder for injection vial
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SYLVANT is a chimeric (human murine) immunoglobulin G1k (IgG1k)
monoclonal antibody
against human Interleukin-6 (IL-6) produced in a Chinese Hamster Ovary
(CHO) cell line.
SYLVANT 100 MG POWDER FOR INJECTION
Each single use vial contains 100 mg siltuximab powder for concentrate
for solution for
infusion. After reconstitution, the solution contains 20 mg siltuximab
per 1 mL
SYLVANT 400 MG POWDER FOR INJECTION
Each single use vial contains 400 mg siltuximab powder for concentrate
for solution for
infusion. After reconstitution, the solution contains 20 mg siltuximab
per 1 mL
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Powder for injection, for intravenous infusion
SYLVANT is supplied as a single-use vial containing a lyophilised cake
of white powder for
reconstitution.
4. CLINICAL PARTICULARS
4.1 INDICATIONS
SYLVANT is indicated for the treatment of patients with multicentric
Castleman’s disease
(MCD) who are human immunodeficiency virus (HIV) negative and human
herpesvirus-8
(HHV-8) negative.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dose is 11 mg/kg siltuximab given over 1 hour as an
intravenous infusion
administered every 3 weeks until treatment failure.
Intravenous infusion (IV) of SYLVANT should be administered by
qualified healthcare
professionals. Appropriate personnel and medicinal product should be
available to treat
anaphylaxis if it occurs.
SYLVANT PRODUCT INFORMATION – 05Mar2021
Page 2 of 18
TREATMENT CRITERIA
Haematology laboratory tests should be performed prior to each dose of
SYLVANT therapy
for the first 12 months and every 3 dosing cycles thereafter. The
prescriber should consider
delaying treatment if the treatment criteria outlined in TABLE 1 are
not met, before administeri