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Vocabria

Vocabria

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig

Marketer:

GlaxoSmithKline
Concise Prescribing Info
Contents
Cabotegravir
Indications/Uses
Tab In combination w/ rilpivirine tab for the short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen w/o present or past evidence of viral resistance to, & no prior virological failure w/, agents of the NNRTI & integrase inhibitor class as: oral lead-in to assess tolerability prior to administration of long-acting cabotegravir + rilpivirine inj; oral therapy for adults who will miss planned dosing w/ cabotegravir + rilpivirine inj. Susp for inj In combination w/ rilpivirine inj for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen w/o present or past evidence of viral resistance to, & no prior virological failure w/, agents of the NNRTI & integrase inhibitor class.
Dosage/Direction for Use
Tab Oral lead-in 30 mg cabotegravir + 25 mg rilpivirine once daily during mth 1 (at least 28 days). Oral dosing for missed cabotegravir inj Mthly IM dosing: 1st dose should be taken 1 mth (±7 days) after the last inj doses of cabotegravir & rilpivirine. May be used to replace up to 2 consecutive mthly inj visits. Every-2-mth IM dosing: 1st dose should be taken 2 mth (±7 days) after the last inj doses of cabotegravir & rilpivirine. May be used to replace one every-2-mth inj visit. Susp for inj Mthly IM dosing Initiation inj: 600 mg cabotegravir + 900 mg rilpivirine at mth 2, on the final day of oral lead-in therapy. Continuation inj: 400 mg cabotegravir + 600 mg rilpivirine mthly at mth 3 onwards. Patients may be given inj up to 7 days before or after the date of mthly inj schedule. Every-2-mth IM dosing Initiation inj: 600 mg cabotegravir + 900 mg rilpivirine at mth 2 (on the final day of oral lead-in therapy) & mth 3. Continuation inj: 600 mg cabotegravir + 900 mg rilpivirine beginning at mth 5 onwards. Patients may be given inj up to 7 days before or after the date of the every-2-mth inj schedule. Switching from mthly to every-2-mth IM dosing Single 600 mg inj 1 mth after the last 400 mg continuation inj & then 600 mg every 2 mth thereafter. Switching from every-2-mth to mthly IM dosing Single 400 mg inj 2 mth after the last 600 mg continuation inj & then 400 mg mthly thereafter.
Administration
Tab: May be taken with or without food.. When Vocabria tab is taken at the same time as rilpivirine tab: Should be taken with food.
Contraindications
Hypersensitivity. Concomitant use w/ rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin or phenobarb.
Special Precautions
Immediately discontinue if hypersensitivity develops. Take into account the baseline factors associated w/ increased risk of virological failure (archived rilpivirine resistance mutations, HIV-1 subtype A6/A1 or BMI ≥30 kg/m2) before starting the regimen. Reports of hepatotoxicity. Monitoring of liver chemistries is recommended. Discontinue treatment if hepatotoxicity is suspected. Not recommended to initiate in patients w/ hepatitis B co-infection. Monitoring of liver function is recommended in patients w/ hepatitis C co-infection. Residual risk of HIV transmission; risk of immune reactivation syndrome; opportunistic infections. Concomitant use w/ medicinal products that may reduce cabotegravir exposure. May impair ability to drive or operate machinery. Patients w/ end-stage renal disease on renal replacement therapy. Patients w/ severe hepatic impairment (Child-Pugh score C). Pregnancy. Do not breast-feed. Childn & adolescents <18 yr. Tab Take polyvalent cation-containing antacids at least 2 hr before or 4 hr after taking Vocabria tab. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains <1 mmol Na (23 mg) per tab (essentially Na-free). Susp for inj Avoid inadvertent inj into a blood vessel. Always co-administer w/ rilpivirine inj at separate gluteal inj sites. Adopt an alternative, fully suppressive antiretroviral regimen no later than 1 mth after the final mthly inj or 2 mth after the final every-2-mth inj to minimise the risk of developing viral resistance following treatment discontinuation. May remain in systemic circulation for up to ≥12 mth after treatment discontinuation. Concomitant use w/ rifabutin is not recommended.
Adverse Reactions
Headache; pyrexia. Depression, anxiety, abnormal dreams, insomnia; dizziness; nausea, vomiting, abdominal pain, flatulence, diarrhoea; rash; myalgia; fatigue, asthenia, malaise; increased wt. Susp for inj Inj site pain & discomfort, nodule, induration. Inj site swelling, erythema, pruritus, bruising, warmth, haematoma.
Drug Interactions
Decreased plasma conc w/ strong UGT1A1 or UGT1A9 inducers. May inhibit OAT1/3 substrate drugs (eg, methotrexate). Significantly decreased plasma conc w/ metabolic inducers (eg, carbamazepine, oxcarbazepine, phenytoin, phenobarb); rifampicin, rifapentine. Tab Decreased oral absorption w/ antacids (eg, Mg, Al, Ca). Susp for inj Decreased plasma conc w/ rifabutin.
MIMS Class
Antivirals
ATC Classification
J05AJ04 - cabotegravir ; Belongs to the class of integrase inhibitors. Used as direct acting antiviral in the systemic treatment of viral infections.
Presentation/Packing
Form
Vocabria FC tab 30 mg
Packing/Price
30's
Form
Vocabria PR susp for inj 600 mg/3 mL
Packing/Price
1's
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