Dosage Information

The recommended dosage of RADICAVA and RADICAVA ORS is as follows:

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RADICAVA: an intravenous infusion of 60 mg administered over a 60-minute period

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RADICAVA ORS: 105 mg (5 mL) taken orally or via feeding tube in the morning after overnight fasting [see Dosage and Administration (2.3)]

Administer RADICAVA or RADICAVA ORS according to the following schedule:

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An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period

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Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods

Preparation and Administration Information for RADICAVA Injection

RADICAVA is for intravenous infusion only.

Preparation

Do not use if the oxygen indicator has turned blue or purple before opening the package. Once the overwrap package is opened, use within 24 hours [see How Supplied/Storage and Handling(16.1,16.2)].

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Administration

Administer each 60 mg dose of RADICAVA injection as two consecutive 30 mg intravenous infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 mL per minute]).

Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction [see Warnings and Precautions (5.1, 5.2)].

Other medications should not be injected into the infusion bag or mixed with RADICAVA.

Preparation and Administration Information for RADICAVA ORS Oral Suspension

See the Instruction for Usefor further preparation and administration details.

Preparation

Prior to opening the bottle, turn it upside down (invert) and shake vigorously up and down for at least 30 seconds.

Administration

RADICAVA ORS can be administered by mouth or via feeding tube (see Feeding Tube Administration).

RADICAVA ORS should be taken in the morning on an empty stomach after overnight fasting. Food should not be consumed for 1 hour after administration except water [see Clinical Pharmacology (12.3)]. See Table 1 for specific fasting conditions.

Administer RADICAVA ORS using a 5 mL oral syringe that comes with the product. A household teaspoon is not an adequate measuring device.

Dispose of any RADICAVA ORS that is not used within 15 days after opening the bottle or within the 30 days from the date of shipment indicated on the carton pharmacy label, which ever happens first.

Feeding Tube Administration

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Nasogastric (NG) tubes or percutaneous endoscopic gastrostomy (PEG) tubes made of silicone, polyvinyl chloride (PVC), or polyurethane can be used

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Before and after administration, use a catheter-tip syringe to flush the tube with at least 1 ounce (30 mL) of water

Switching from RADICAVA to RADICAVA ORS

Patients treated with 60 mg of RADICAVA intravenous infusion may be switched to 105 mg (5 mL) RADICAVA ORS using the same dosing frequency. Upon switching to RADICAVA ORS, patients should follow RADICAVA ORS dosing recommendations with regards to food consumption [see Dosage and Administration (2.3)].