Pierre Fabre Pharmaceuticals, Inc.
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Pierre Fabre Pharmaceuticals, Inc. Drugs
Initiate treatment at ages 5 weeks to 5 months.
The recommended starting dose of HEMANGEOL is 0.15 mL/kg (0.6 mg/kg) (see Table 1) twice daily, taken at least 9 hours apart. After 1 week, increase the daily dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks of treatment, increase the dose to 0.4 mL/kg (1.7 mg/kg) twice daily and maintain this for 6 months. Readjust the dose periodically as the child’s weight increases.
To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding. Skip the dose if the child is not eating or is vomiting [see Warnings and Precautions (5.1)].
Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases [see Warnings and Precautions (5.2)].
If hemangiomas recur, treatment may be re-initiated [see Clinical Studies (14)].
HEMANGEOL is supplied with an oral dosing syringe for administration. Administration directly into the child’s mouth is recommended. Nevertheless, if necessary, the product may be diluted in a small quantity of milk or fruit juice, given in a baby’s bottle.
Table 1. Dose Titration According to WeightWeek 1
Week 3 (maintenance)
Volume administeredtwice a day twice a day twice a day
2 to <2.5
2.5 to <3
3 to <3.5
3.5 to <4
4 to <4.5
4.5 to <5
5 to <5.5
5.5 to <6
6 to <6.5
6.5 to <7
7 to <7.5
7.5 to <8
8 to <8.5
8.5 to <9
9 to <9.5
9.5 to <10
10 to <10.5
10.5 to <11
11 to <11.5
11.5 to <12
4.6 mL12 to <12.5 1.8 mL 3.6 mL 4.8 mL
2.1 Recommended Dose
In Combination with Cisplatin 100 mg/m2The recommended dose of NAVELBINE is 25 mg/m2 administered as an intravenous injection or infusion over 6 to 10 minutes on Days 1, 8, 15, and 21 of a 28 day cycle in combination with cisplatin 100 mg/m2 on Day 1 only of each 28 day cycle.
In Combination with Cisplatin 120 mg/m2The recommended dose of NAVELBINE is 30 mg/m2 administered as an intravenous injection or infusion over 6 to 10 minutes once a week in combination with cisplatin 120 mg/m2 on Days 1 and 29, then every 6 weeks.
Single-AgentThe recommended dose of NAVELBINE is 30 mg/m2 administered intravenously over 6 to 10 minutes once a week.
2.2 Dose Modifications
[see Warnings and Precautions (5.1)]
Hold or decrease the dose of NAVELBINE in patients with decreased neutrophil counts using the following schema.
Neutrophils on Day of Treatment (Cells/mm3)
Percentage of Starting Dose of NAVELBINE
1,000 to 1,499
Do not administer NAVELBINE.
Repeat neutrophil count in one week.
If three consecutive weekly doses are held becauseNeutrophil count is < 1,000 cells/mm3, discontinue NAVELBINE
Note : For patients who experience fever and/or sepsis while neutrophil count is < 1,500 or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of NAVELBINE should be:
1,000 to 1,499
Do not administer NAVELBINE. Repeat neutrophil count in one week.
[see Warnings and Precautions (5.2) and Use in Specific Populations(8.6)]
Reduce NAVELBINE dose in patients with elevated serum total bilirubin concentration according to the following schema:
Serum total bilirubin concentration (mg/dl)
Percentage of Starting Dose of NAVELBINE
2.1 to 3.0
Concurrent Hematologic Toxicity and Hepatic Impairment
In patients with both hematologic toxicity and hepatic impairment, administer the lower of the doses based on the corresponding starting dose of NAVELBINE determined from the above schemas.
[see Warnings and Precautions (5.5)]
Discontinue NAVELBINE for NCI CTCAE Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation.
2.3 Preparation and Administration
Preparation of NAVELBINE
Dilute NAVELBINE in either a syringe or intravenous bag using one of the recommended solutions.
Dilute to a concentration between 1.5 and 3 mg/mL. The following solutions may be used for dilution:5% Dextrose Injection, USP 0.9% Sodium Chloride Injection, USP
Dilute to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:5% Dextrose Injection, USP 0.9% Sodium Chloride Injection, USP 0.45% Sodium Chloride Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP Ringer's Injection, USP Lactated Ringer's Injection, USP
Diluted NAVELBINE may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl chloride bags at 5° to 30°C (41° to 86°F).
Administer diluted NAVELBINE over 6 to 10 minutes into the side port of a free-flowing intravenous line followed by flushing with at least 75 to 125 mL of one of the solutions.
NAVELBINE must only be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any NAVELBINE is injected.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, NAVELBINE should not be administered.
Management of Suspected ExtravasationIf NAVELBINE leakage into surrounding tissue occurs or is suspected, immediately stop administration of NAVELBINE and initiate appropriate management measures in accordance with institutional policies [see Warnings and Precautions (5.4)].
2.4 Procedures for Proper Handling and Disposal
Handle and dispose NAVELBINE consistent with recommendations for the handling and disposal of hazardous drugs1.
Exercise caution in handling and preparing the solution of NAVELBINE. The use of gloves is recommended. If the solution of NAVELBINE contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.
Avoid contamination of the eye with NAVELBINE. If exposure occurs, flush the eyes with water immediately and thoroughly.
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