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CABOTEGRAVIR, 200mg/ml, prolonged-release, 3ml, vial

https://msf.oodin.sh/cat/product/89290
STD DINJCABO6VP

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
6.4.2.4 - Integrase inhibitors
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
J05AJ04
Anatomical Therapeutic Chemical Classification according to WHOCC
PMF
The order of this product needs to be justified and is only acceptable under certain conditions.
1525
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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CABOTEGRAVIR prolonged-released

Therapeutic Action

Antiretroviral, Integrase Strand Transfer Inhibitor (INSTI)

Prolonged-release suspension for injection

Indications

Pre-exposure prophylaxis (PrEP) of HIV infection in at-risk adults and adolescents weighing at least 35 kg.

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Instructions for use

Single-dose vial containing 600 mg cabotegravir in 3 ml.

Hold the vial firmly, and vigorously shake for a full 10 seconds. Invert the vial and confirm the suspension is uniform. If the suspension is not uniform, shake the vial again. Small air bubbles are normal.

Must be given as slow IM injection into the ventrogluteal site (recommended) or the dorsogluteal sites.

Use a 5 ml Luer-lock syringe (SINSSYLL05-) and two Luer needles (one for drawing up the suspension and one for the IM injection). Some manufacturers provide a pack containing one adaptor, one syringe and one injection needle along with the cabotegravir vial. In such case, refer to the manufacturer's instructions.

Posology: one injection every month for the first 2 months, then once every 2 months.

Perform HIV-1 testing prior to each injection.

Prolonged-release cabotegravir is indicated for pre-exposure prophylaxis (PrEP) as part of an overall HIV-1 infection prevention strategy, including adherence to the administration schedule and safer sex practices (e.g., condoms use).

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Precautions for Use

Do not administer by IV route.

Contraindicated in unknown or positive HIV-1 status.

Contraindicated in patients receiving:

  • anticonvulsants: carbamazepine, oxcarbazepine, phenytoin or phenobarbital
  • antimycobacterials: rifampicin, rifapentine

The safety of cabotegravir use in pregnant or breastfeeding women has not been evaluated. It should only be used during pregnancy or breastfeeding if the expected benefit justifies the potential risk to the foetus or infant.

Storage

  • Below 25ºC
  • Do not freeze.
  • Once the suspension is drawn into the syringe, use the product immediately.