WYOST Solution for injection Ref.[109628] Active ingredients: Denosumab

2.1 Important Administration Instructions

Wyost is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.

2.2 Multiple Myeloma and Bone Metastasis from Solid Tumors

The recommended dose of Wyost is 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen.

Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia [see Warnings and Precautions (5.3)].

2.3 Giant Cell Tumor of Bone

The recommended dose of Wyost is 120 mg administered every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen.

Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia [see Warnings and Precautions (5.3)].

2.4 Hypercalcemia of Malignancy

The recommended dose of Wyost is 120 mg administered every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen.

2.5 Preparation and Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Wyost is a clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution. Do not use if the solution is discolored or cloudy or if the solution contains visible particles or foreign particulate matter.

Prior to administration, Wyost may be removed from the refrigerator and brought to room temperature (up to 25°C/77°F) by standing in the original container. This generally takes 15 to 30 minutes. Do not warm Wyost in any other way [see How Supplied/Storage and Handling (16)].

Use a 27-gauge needle to withdraw and inject the entire contents of the vial. Do not re-enter the vial. Discard vial after single-dose or entry.

There is no experience with overdosage of denosumab products.

Store Wyost in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze. Once removed from the refrigerator, Wyost must not be exposed to temperatures above 25°C/77°F or direct light and must be used within 30 days. Discard Wyost if not used within the 30 days. Do not use Wyost after the expiry date printed on the label.

Protect Wyost from direct light and heat. Avoid vigorous shaking of Wyost.