REKAMBYS PROLONGED-RELEASE SUSPENSION FOR INJECTION 300MGML

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Rilpivirine

Disponible desde:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Código ATC:

J05AG05

formulario farmacéutico:

INJECTION, SUSPENSION, EXTENDED RELEASE

Composición:

Rilpivirine 300mg/mL

Vía de administración:

INTRAMUSCULAR

tipo de receta:

Prescription Only

Fabricado por:

Cilag AG

Estado de Autorización:

ACTIVE

Fecha de autorización:

2022-08-11

Ficha técnica

PRODUCT NAME
REKAMBYS
®
(rilpivirine) prolonged-release suspension for injection.
DOSAGE FORMS AND STRENGTHS
Dosage Form
White to off-white, prolonged-release suspension for injection
Strength
Each 3 mL vial contains 900 mg rilpivirine (as rilpivirine free base)
Each 2 mL vial contains 600 mg rilpivirine (as rilpivirine free base)
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
REKAMBYS
®
is indicated, in combination with cabotegravir injection, for the
treatment of
human immunodeficiency virus type
1 (HIV-1) infection in adults who are
virologically
suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral
regimen without present or
past evidence of viral resistance to, and no prior virological failure
with agents of the NNRTI
and INI class (see
_Pharmacological Properties_
).
DOSAGE AND ADMINISTRATION
REKAMBYS
®
should always be co-administered with cabotegravir injection.
Therefore, the
cabotegravir injection prescribing information should be consulted.
Prior to starting REKAMBYS
®
, the healthcare professional should carefully select patients
who agree to the required injection schedule and counsel patients
about the importance of
adherence to scheduled dosing visits to help maintain viral
suppression and reduce the risk of
viral rebound and potential development of resistance associated with
missed doses.
METHOD OF ADMINISTRATION
For gluteal intramuscular (IM) injection use only.
DO NOT INJECT INTRAVENOUSLY.
REKAMBYS
®
should be administered by a healthcare professional.
When administering REKAMBYS
®
, the healthcare professional should take into consideration the
body mass index (BMI) of the patient to ensure that the needle length
is sufficient to reach the
gluteus muscle. REKAMBYS
®
and cabotegravir injections should be administered at separate
gluteal injection sites during the same visit.
POSOLOGY
REKAMBYS
®
may be initiated with an oral lead-in or without (direct to
injection).
The healthcare professional and patient may decide to proceed directly
to REKAMBYS
�