APHEXDA LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION 62 MG/VIAL [SIN17555P]

Product Info

APHEXDA LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION 62 MG/VIAL

[SIN17555P]

Indication

1 INDICATIONS AND USAGE
APHEXDA lyophilized powder for solution for injection 62 mg/vial is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

Dosing

2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing Information

• Premedicate all patients before each dose of APHEXDA to reduce the risk of hypersensitivity and injection site reactions:

  • Administer diphenhydramine (12.5 mg intravenously or 25 mg to 50 mg orally, or another H1-antihistamine), an H2 blocker (e.g., famotidine), and a leukotriene inhibitor (e.g., montelukast) approximately 30 to 60 minutes before injection of APHEXDA.

  • The addition of an analgesic medication (e.g., acetaminophen) to the premedication regimen is recommended.

• Administer filgrastim 10 mcg/kg subcutaneously once daily for 4 days prior to the first dose of APHEXDA and on each day prior to each apheresis.

2.2 Recommended Dosage
The recommended dosage of APHEXDA is 1.25 mg/kg administered via slow (approximately 2 minutes) subcutaneous injection 10 to 14 hours prior to the initiation of the first apheresis. Dosing is based on actual body weight.

A second dose of APHEXDA can be administered 10 to 14 hours before a third apheresis, if necessary.

2.3 Preparation and Administration
Use aseptic technique to prepare and administer APHEXDA:

• More than one vial may be needed for a full dose. Calculate the dose, the total volume of reconstituted APHEXDA solution required, and number of APHEXDA vials required based on patient’s actual body weight.

• Remove the APHEXDA vial(s) from the refrigerator and allow to reach room temperature at 20°C to 25°C (68°F to 77°F) for at least 30 minutes.

• Reconstitute each vial with 2 mL of 0.45% Sodium Chloride Injection, USP at room temperature (20°C to 25°C (68°F to 77°F)) resulting in a concentration of 36.5 mg/mL of APHEXDA and permitting withdrawal of up to 1.7 mL (62 mg). Alternatively, you can reconstitute each vial with 1 mL of Sterile Water for Injection, USP and 1 mL of 0.9% Sodium Chloride Injection, USP.

• Gently swirl and invert for up to 3 minutes slowly until completely dissolved.

• Inspect the reconstituted solution for discoloration and particulate matter. The reconstituted solution should appear clear and colorless. Do not use if the reconstituted solution is discolored, is cloudy, or contains visible particulates.

• If needed, store the reconstituted APHEXDA solution refrigerated at 2°C to 8°C (36°F to 46°F) or at room temperature at 20°C to 25°C (68°F to 77°F) for up to 24 hours protected from light.

• Withdraw the required injection volume of APHEXDA from the vial(s) into an appropriately sized syringe.

• Each injection volume should not exceed 2 mL. Divide doses requiring greater than 2 mL into multiple syringes to allow different injection sites.

Administration

• Administer injection subcutaneously into the abdomen, the back or side of the upper arms, or the thighs. Rotate injection sites. An injection should never be given into scar tissue or areas that are reddened, inflamed, or swollen. If injecting into the abdomen, avoid a 5 cm diameter circle around the navel. If more than one injection is needed for a single dose of APHEXDA, the injection sites should be at least 2 cm apart from previous injection locations. Discard unused portion of the drug.

  • Monitor patients for one hour after administration [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Contraindications

4 CONTRAINDICATIONS
APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].