Motixafortide

Motixafortide is a prescription medication used in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

• Motixafortide is available under the following different brand names: Aphexda

Common side effects of Motixafortide include:

• injection-site reactions included pain, erythema, pruritus, bruising, discomfort, induration, mass, nodule, rash, swelling, and urticaria

Serious side effects of Motixafortide include:

• vomiting
• injection-site reaction
• hypersensitivity reaction
• injection site cellulitis
• hypokalemia, and hypoxia

Rare side effects of Motixafortide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 62 mg/single-dose vial

Multiple myeloma

Adult dosage

• Filgrastim dosing
  • Administer filgrastim 10 mcg/kg SC once a day for 4 days before the first dose of Motixafortide and on each day before each apheresis
• Premedication
  • Premedicate before each dose of motixafortide to reduce the risk of hypersensitivity and injection-site reactions
• Regimen includes
  • Administer the following approximately 30 to 60 minutes before motixafortide injection
  • Diphenhydramine (12.5 mg IV or 25 to 50 mg orally, or another H1-antihistamine), and
  • H2 blocker (eg, famotidine), and
  • Leukotriene inhibitor (eg, montelukast)
  • An analgesic medication (e.g., acetaminophen) is also recommended
• Motixafortide dosing
  • Dosing is on actual body weight
    • 1.25 mg/kg SC (over approximately 2 minutes) 10 to 14 hours before initiating the first apheresis
    • A second dose can be administered 10 to 14 hours before the third apheresis, if necessary

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Motixafortide has no noted severe interactions with any other drugs
• Motixafortide has no noted serious interactions with any other drugs
• Motixafortide has no noted moderate interactions with any other drugs
• Motixafortide has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity to motixafortide

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Motixafortide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Motixafortide?”

Cautions

• Anaphylactic shock and hypersensitivity reactions
  • Anaphylactic shock reported
  • Time to anaphylactic shock was between 5 and 30 minutes after drug administration
  • Pruritus, flushing, urticaria, rash, erythema, vomiting, nausea, and chills were also reported
  • Premedicate all patients before each dose with a triple-drug premedication regimen that includes an H1- antihistamine, an H2 blocker, and a leukotriene inhibitor
• Patients receiving concomitant negative chronotropic drugs (e.g., beta-blockers) may be at greater risk for hypotension in case of a hypersensitivity reaction
• When appropriate, replace beta-blockers with nonchronotropic drugs
• Administer only in a setting where personnel and therapies are immediately available for the treatment of anaphylaxis and other systemic reactions
• Monitor for signs or symptoms of hypersensitivity reactions for 1 hour following administration
• Injection-site reactions
  • Injection-site reactions reported
  • Symptoms included pain, erythema, pruritus, bruising, discomfort, induration, mass, nodule, rash, swelling, and urticaria
  • Premedicate with an analgesic medication (e.g., acetaminophen) before each dose
  • Use analgesic medication and local treatments post-dose, as needed
• Tumor cell mobilization in patients with leukemia
• When used for hematopoietic stem cell (HSC) mobilization, Motixafortide may cause mobilization of leukemic cells and subsequent contamination of the apheresis product
• Therefore, it is not intended for HSC mobilization and harvest in patients with leukemia
• Leukocytosis
  • Administration in conjunction with filgrastim increases circulating leukocytes as well as HSC populations
  • Monitor white blood cell counts during use
  • Potential for tumor cell mobilization
  • When used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in leukapheresis product
  • The effect of potential reinfusion of tumor cells has not been well-studied
• Embryo-fetal toxicity
  • Based on its mechanism of action, can cause fetal harm when administered to pregnant women

Pregnancy and Lactation

• Based on its mechanism of action, can cause fetal harm when administered to pregnant women
• Advise pregnant women of potential risk to the fetus
• Verify pregnancy status in women of reproductive potential before initiating
• Contraception
  • Advise women of reproductive potential to use effective contraception during treatment and for 8 days after the final dose
• Lactation
  • Data are not available on the presence of motixafortide in human milk, its effects on breastfed children, or milk production
  • Advise women not to breastfeed during treatment and for 8 days after the final dose