The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of Lupin Healthcare and Zentiva Pharma’s generic raltegravir medicines to treat HIV.
The 600 mg film‑coated tablet is indicated for use in adults and paediatric patients with a minimum body weight of 40kg.
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A recommended dosage of 1,200mg raltegravir will be taken as two 600mg tablets once daily.
Raltegravir is an antiviral medication that inhibits the HIV integrase enzyme, crucial for the virus’s replication in the body’s cells.
When combined with other medicines, raltegravir lowers the HIV viral load in the blood and enhances the CD4-cell count.
The MHRA’s endorsement of the generic versions is supported by studies conducted in healthy volunteers, aimed at establishing bioequivalence to the original branded medication.
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By GlobalDataBioequivalence implies that generic medicines produce identical levels of the active substance in the body as the reference drug.
The efficacy and potential side effects of generic raltegravir are expected to mirror those of the reference medicine.
The MHRA has committed to maintain vigilant oversight of raltegravir’s safety and effectiveness.
Patients are advised to consult their healthcare provider if they encounter adverse effects, including any not listed in the product information leaflets.
MHRA Innovative Medicines deputy director Shirley Hopper stated: “Ensuring timely access to generic medicines is a key priority for us.
“Appropriate data have been provided to assure us that these medicines are the same as, and considered interchangeable with, an already licensed reference medicine, Isentress.
“As with all products, we will keep the safety of raltegravir under close review.”
