Aphexda

Generic name: Motixafortide
Dosage form: subcutaneous injection
Drug class: Hematopoietic stem cell mobilizer

Usage of Aphexda

Aphexda is used in the treatment of multiple myeloma, a cancer that forms in plasma cells. Aphexda (motixafortide) is a medication used to increase the number of circulating stem cells before they are collected for a stem cell transplant. Aphexda is called a hematopoietic stem cell mobilizer and is used together with filgrastim, which is a G-CSF (granulocyte colony-stimulating factor).

Aphexda (motixafortide) works by blocking the receptor CXCR4, which increases stem cells in the circulation, available for collection. Aphexda is from the class of medicines called CXCR4 antagonist.

Aphexda became an FDA-approved medicine on September 11, 2023, to be used in conjunction with filgrastim (G-CSF) to mobilize hematopoietic stem cells into the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. FDA approval was based on positive results from the 2-part, Phase 3 GENESIS trial (NCT 03246529), which was a randomized, double-blind, placebo-controlled study comparing how effective Aphexda plus filgrastim was compared to placebo plus filgrastim.

Aphexda side effects

The most common Aphexda side effects that affected 20% or more of patients include:

injection site reactions 73% which included pain (53%), redness (27%), itching (24%)

general itching 38%

flushing 33%

back pain 21%.

Serious of Aphexda include:

anaphylactic shock and hypersensitivity reactions

injection site reactions

tumor cell mobilization in patients with leukemia

leukocytosis

potential for tumor cell mobilization

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Aphexda

You should not take this medicine if you are allergic to the active ingredient motixafortide or any of the inactive ingredients

Pregnancy

Aphexda can cause fetal harm when administered to pregnant women. Women of reproductive potential should use effective contraception during treatment with this medicine and for 8 days after the final dose. Women of reproductive potential should have a negative pregnancy test before starting treatment.

Breastfeeding

Breastfeeding is not recommended during the treatment with Aphexda and for 8 days after the final dose.

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How to use Aphexda

Aphexda vial should be reconstituted with 2 mL of 0.45% sodium chloride for injection (or 1 mL water for injection + 1 mL 0.9% sodium chloride for injection). This yields a clear solution of 36.5 mg/mL motixafortide, pH 5.8 to 7.5.

The recommended Aphexda dosage is 1.25 mg/kg administered via slow (approximately 2 minutes) subcutaneous injection.

Dosing is based on actual body weight.

Aphexda dose should be given 10 to 14 hours prior to the initiation of the first apheresis.

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

Warnings

Anaphylactic Shock and Hypersensitivity Reactions: Aphexda may cause serious allergic reactions. You will be given medication before treatment to help prevent allergic reactions. You will have treatment in a setting where personnel and therapies are available for immediate treatment if you have an anaphylactic reaction or a hypersensitivity reaction

Injection Site Reactions: You may have a reaction at the injection site therefore, pain premedication (e.g., acetaminophen) is recommended.

Tumor Cell Mobilization in Patients with Leukemia: This medicine may mobilize leukemic cells and should not be used in leukemia patients.

Leukocytosis: Increased circulating leukocytes have been observed. Your white blood cell counts will be monitored during treatment.

Potential for Tumor Cell Mobilization: Tumor cells may be released from marrow during hematopoietic stem cell mobilization with Aphexda and filgrastim. The effect of reinfusion of tumor cells is unknown.

Embryo-fetal Toxicity: Aphexda can cause fetal harm. Women of reproductive potential should use effective contraception.

What other drugs will affect Aphexda

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Not all possible interactions are listed here.

Disclaimer

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