Source: Health Products Regulatory Authority (ZA) Publisher: Eurolab (Pty) Ltd., Woodmead Office Park, 3 Stirrup Lane, Van Reenens Avenue, Woodmead, 2144
NAVILIN (Vinorelbine tartrate) is indicated in the palliative treatment of advanced inoperable non-small cell lung cancer (NSCLC) as a single medicine or in combination. Combination therapy proves to be more effective than monotherapy. NAVILIN is also indicated for the treatment of patients with metastatic breast cancer who have failed anthracycline first-line monotherapy for metastatic disease or who have relapsed within 6 months of anthracyclinebased adjuvant therapy.
First three administrations: The recommended dose is 60 mg/mm² of body surface area, administered once weekly.
Further administrations: Beyond the third administration, it is recommended to increase the dose of NAVILIN to 80 mg/m² once weekly, except in patients for whom the neutrophil count dropped once below 500/mm³ or more than once between 500 and 1000/ mm³ during the first three administrations at 60 mg/m².
The following table gives the dose required for appropriate ranges of body surface area (BSA):
| BSA (m²) | 60 mg/m² Dose (mg) | 80 mg/m² Dose (mg) |
|---|---|---|
| 0,95 to 1 1,05 to 1,14 1,15 to 1,24 1,25 to 1,34 1,35 to 1,44 1,45 to 1,54 1,55 to 1,65 1,65 to 1,74 1,74 to 1,84 1,85 to 1,94 ≥1,95 | 60 70 70 80 80 90 100 100 110 110 120 | 80 90 100 100 110 120 130 140 140 150 160 |
For the administration given at 80 mg/m², if the neutrophil count is below 500/mm³, the administration should be delayed until recovery and the dose definitely reduced from 80 to 60 mg/m² per week. Clinical experience has not identified relevant differences in responses in the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Even for patients with BSA>2 m² the total dose should never exceed 160 mg per week.
For oral use only.
NAVILIN soft capsules should be swallowed with water without chewing or sucking the capsule. It is recommended to take the capsules with some food.
In case of overdosage, the patient must be closely monitored for the appearance of severe granulocytopenia with an increased risk of serious secondary infections, fever, paralytic ileus and hepatic disorders.
General supportive measures together with blood transfusion, growth factors, and broadspectrum antibiotic therapy should be instituted as deemed necessary by the doctor. A close monitoring of hepatic function recommended.
There is no known antidote for overdosage of NAVILIN.
36 months.
Store at 2-8°C (in a refrigerator). Keep in the outer carton until required for use.
KEEP OUT OF REACH OF CHILDREN.
NAVILIN is packed in PVC/PVDC-Al blister with child-resistant safety paper layer. The blister is further packed in an outer carton.
Pack size: 1 capsule.
Any unused product or waste material should be returned to the pharmacist for safe disposal in accordance with local requirements.
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