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Prescription medicine

Motixafortide

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Motixafortide used for?
The FDA-approved label (Aphexda, Gamida Cell Inc., June 4, 2026) says: “APHEXDA 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Motixafortide have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Motixafortide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Motixafortide been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Motixafortide?
2 companies list prescription products of Motixafortide in the FDA NDC Directory, including Gamida Cell Inc. and BioLineRx USA Inc.

What Motixafortide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

APHEXDA 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. …

— FDA label: Aphexda, Gamida Cell Inc., effective June 4, 2026. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsInjection, powder, lyophilized, for solution
RouteSubcutaneous
Prescription products2 in the FDA NDC Directory
Brand namesAphexda

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA217159
APHEXDA
Ayrmid PharmaSeptember 8, 2023 1, latest March 11, 2026
2026: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)2664901, 2664906
SPL set ID of the quoted labele704b2db-f119-40ba-9346-9229e3281c9e
FDA labels (SPL)1
FDA applicationsNDA217159
Active ingredients (FDA)MOTIXAFORTIDE ACETATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Aphexda, Gamida Cell Inc., effective June 4, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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