Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible (see section 4.2).
The therapy should be initiated by a doctor experienced in the management of HIV infection (see also section 4.4).
For patients starting therapy with Zerit, the duration should be limited to the shortest time possible followed by a switch to an alternative appropriate therapy whenever possible. Patients continuing treatment with Zerit should be assessed frequently and switched to an alternative appropriate therapy whenever possible (see section 4.4).
The recommended oral dosage is:
| Patient weight | Zerit dosage |
|---|---|
| <60 kg | 30 mg twice daily (every 12 hours) |
| ≥60 kg | 40 mg twice daily (every 12 hours) |
The recommended oral dosage is:
| Patient age and/or weight | Zerit dosage |
|---|---|
| From birth* to 13 days old | 0.5 mg/kg twice daily (every 12 hours) |
| At least 14 days old and <30 kg | 1 mg/kg twice daily (every 12 hours) |
| ≥30 kg | adult dosing |
* The reduced posology in neonates from 0 to 13 days is based on average study data and may not correspond to invidual variation in kidney maturation.
Dosing recommendations are not available for neonates with a gestational age <37 weeks.
The powder formulation of Zerit should be used for infants under the age of 3 months. Adult patients that have problems swallowing capsules should ask their doctor about the possibility of changing to the powder formulation of this medicine.
Instructions for preparation, see section 6.6.
If symptoms of peripheral neuropathy develop (usually characterised by persistent numbness, tingling, or pain in the feet and/or hands) (see section 4.4), patients should be switched to an alternative treatment regimen, if appropriate. In the rare cases when this is inappropriate, dose reduction of stavudine may be considered, while the symptoms of peripheral neuropathy are under close monitoring and satisfactory virological suppression is maintained. The possible benefits of a dose reduction should be balanced in each case against the risks – which may result from this measure (lower intracellular concentrations).
Zerit has not been specifically investigated in patients over the age of 65.
No initial dosage adjustment is necessary.
The following dosages are recommended:
| Patient weight | Zerit dosage (according to creatinine clearance) | |
|---|---|---|
| 26-50 ml/min | ≤ 25 ml/min (including dialysis dependence*) | |
| <60 kg | 15 mg twice daily | 15 mg every 24 hours |
| ≥60 kg | 20 mg twice daily | 20 mg every 24 hours |
* Patients on haemodialysis should take Zerit after the completion of haemodialysis, and at the same time on non-dialysis days.
Since urinary excretion is also a major route of elimination of stavudine in paediatric patients, the clearance of stavudine may be altered in paediatric patients with renal impairment. Although there are insufficient data to recommend a specific dosage adjustment of Zerit in this patient population, a reduction in the dose and/or an increase in the interval between doses proportional to the reduction for adults should be considered. There are no dosage recommendations for paediatric patients under the age of 3 months with renal impairment.
For optimal absorption, Zerit should be taken on an empty stomach (i.e. at least 1 hour prior to meals) but, if this is not possible, it may be taken with a light meal.
Experience in adults treated with up to 12 times the recommended daily dosage revealed no acute toxicity. Complications of chronic overdosage could include peripheral neuropathy and hepatic dysfunction. The mean haemodialysis clearance of stavudine is 120 ml/min. The contribution of this to the total elimination in an overdose situation is unknown. It is not known whether stavudine is removed by peritoneal dialysis.
2 years.
Store below 25°C (aclar/alu blisters).
Do not store above 30°C (HDPE bottles).
Store in the original package.
HDPE bottles with child resistant screw cap (60 hard capsules per bottle).
Aclar/aluminum blisters with 14 hard capsules per card and 4 cards (56 hard capsules) per carton.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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