Udenyca (pegfilgrastim-cbqv)

Udenyca may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• skin rash,
• sweating,
• dizziness,
• warmth or tingly feeling,
• wheezing,
• decreased urination,
• tiredness,
• lightheadedness,
• sudden swelling,
• puffiness,
• feeling of fullness,
• fever,
• stomach pain,
• back pain,
• sudden or severe pain in your left upper stomach spreading up to your shoulder,
• easy bruising,
• unusual bleeding,
• purple or red spots under your skin,
• rapid breathing,
• shortness of breath,
• pain while breathing,
• bruising,
• hard lump where the medicine was injected,
• little or no urination,
• pink or dark urine, and
• swelling in your face or lower legs

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Udenyca include:

• bone pain, and
• pain in your arms or legs

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Udenyca. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Patients With Cancer Receiving Myelosuppressive Chemotherapy

The recommended dosage of Udenyca is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administer Udenyca between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Administration

• Udenyca is administered subcutaneously via a single-dose prefilled syringe for manual use.
• Prior to use remove the carton from the refrigerator and allow the Udenyca prefilled syringe to reach room temperature for a minimum of 30 minutes. Discard any prefilled syringe left at room temperature for greater than 48 hours.
• Visually inspect parenteral drug products (prefilled syringe) for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Udenyca if discoloration or particulates are observed.
• The needle cap on the prefilled syringe is not made with natural rubber latex.

Pediatric Patients Weighing Less Than 45 kg

• The Udenyca prefilled syringe is not designed to allow for direct administration of doses less than 0.6 mL (6 mg).
• The syringe does not bear graduation marks which are necessary to accurately measure doses of Udenyca less than 0.6 mL (6 mg) for direct administration to patients.
• Thus, the direct administration to patients requiring dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors. Refer to Table 1.

Table 1: Dosing of Udenyca for pediatric patients weighing less than 45 kg

• Although available data with Udenyca or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production.
• Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not orally absorbed by neonates.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Udenyca and any potential adverse effects on the breastfed child from Udenyca or from the underlying maternal condition.