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Drug overview for APHEXDA (motixafortide acetate):
Generic name: MOTIXAFORTIDE ACETATE
Drug class: CXCR4 Chemokine Receptor Antagonists
Therapeutic class: Hematological Agents
Motixafortide acetate, a C-X-C motif chemokine receptor 4 (CXCR4) inhibitor, is a hematopoietic stem cell mobilizer.
No enhanced Uses information available for this drug.
Generic name: MOTIXAFORTIDE ACETATE
Drug class: CXCR4 Chemokine Receptor Antagonists
Therapeutic class: Hematological Agents
Motixafortide acetate, a C-X-C motif chemokine receptor 4 (CXCR4) inhibitor, is a hematopoietic stem cell mobilizer.
No enhanced Uses information available for this drug.
DRUG IMAGES
APHEXDA 62 MG VIAL
The following indications for APHEXDA (motixafortide acetate) have been approved by the FDA:
Indications:
Peripheral mobilization of hematopoietic stem cells
Professional Synonyms:
None.
Indications:
Peripheral mobilization of hematopoietic stem cells
Professional Synonyms:
None.
The following dosing information is available for APHEXDA (motixafortide acetate):
Dosage of motixafortide acetate is expressed in terms ofmotixafortide.
Administer motixafortide by slow subcutaneous injection. Administer filgrastim 10 mcg/kg subcutaneously once daily for 4 days prior to the first dose of motixafortide and on each day prior to each apheresis. Motixafortide acetate is available as a lyophilized powder in a single-dose vial; each vial contains 62 mg of motixafortide.
Store unopened vials of motixafortide at 2-8degreesC in the original carton to protect from light. Reconstitute motixafortide lyophilized powder before each use. (See Reconstitution under Dosage and Administration.) Prior to administration, withdraw the required volume from the reconstituted motixafortide vial(s) into an appropriately sized syringe.
Administer injection in the abdomen, the back or side of the upper arms, or the thighs. Rotate injection sites. Do not inject 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 1 injection is needed for a single dose, the injection sites should be >=2 cm apart from previous injection locations. Each injection volume should not exceed 2 mL.
Divide doses requiring >2 mL into multiple syringes to allow different injection sites. Discard unused portions of the drug. Monitor patients for 1 hour after administration.
Store unopened vials of motixafortide at 2-8degreesC in the original carton to protect from light. Reconstitute motixafortide lyophilized powder before each use. (See Reconstitution under Dosage and Administration.) Prior to administration, withdraw the required volume from the reconstituted motixafortide vial(s) into an appropriately sized syringe.
Administer injection in the abdomen, the back or side of the upper arms, or the thighs. Rotate injection sites. Do not inject 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 1 injection is needed for a single dose, the injection sites should be >=2 cm apart from previous injection locations. Each injection volume should not exceed 2 mL.
Divide doses requiring >2 mL into multiple syringes to allow different injection sites. Discard unused portions of the drug. Monitor patients for 1 hour after administration.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| APHEXDA 62 MG VIAL | Maintenance | Adults inject 1.25 mg/kg by subcutaneous route once 10 to 14 hours prior to initiation of apheresis |
No generic dosing information available.
The following drug interaction information is available for APHEXDA (motixafortide acetate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for APHEXDA (motixafortide acetate):
Drug contraindication overview.
*History of serious hypersensitivity reactions to motixafortide.
*History of serious hypersensitivity reactions to motixafortide.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Leukemia |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Pregnancy |
There are 0 moderate contraindications.
The following adverse reaction information is available for APHEXDA (motixafortide acetate):
Adverse reaction overview.
The most common adverse effects (incidence >20%) of motixafortide include injection site reactions, injection site pain, injectionsite erythema, injection site pruritus, pruritus, flushing, and back pain.
The most common adverse effects (incidence >20%) of motixafortide include injection site reactions, injection site pain, injectionsite erythema, injection site pruritus, pruritus, flushing, and back pain.
There are 5 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Injection site sequelae |
Hypoxia Injection site infection Leukocytosis |
| Rare/Very Rare |
|---|
|
Anaphylaxis |
There are 17 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Back pain Erythema Flushing Injection site erythema Injection site pain Pruritus of skin Skin rash Urticaria |
Chills Dizziness Fever Hypertension Hypokalemia Nausea Paresthesia Tremor Vomiting |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for APHEXDA (motixafortide acetate):
Safety and effectiveness of motixafortide have not been established in pediatricpatients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Motixafortide can cause fetal harm when administered during pregnancy, based on the mechanism of action of the drug. There are no available data on motixafortide use in pregnant women to inform the risk of embryo-fetal toxicity. Animalmodels link dysfunction in CXCR4/SDF-1 signaling to adverse outcomes in mammalianembryo-fetal development and suggest risk to normal placental development.
No animal studies have been performed to assess the effect of motixafortide onreproduction and fetal development. Verify pregnancy status in females of reproductive potential prior to initiating motixafortide. Apprise patients of the potential hazard to the fetus if motixafortide is used during pregnancy.
No animal studies have been performed to assess the effect of motixafortide onreproduction and fetal development. Verify pregnancy status in females of reproductive potential prior to initiating motixafortide. Apprise patients of the potential hazard to the fetus if motixafortide is used during pregnancy.
It is unknown whether motixafortide distributes into human milk, or affects milk production or the breast-fed child. Because of the potential seriousadverse reactions in the breast-fed child, advise females that breast-feeding is notrecommended during treatment and for 8 days after the last dose of motixafortide.
In the GENESIS trial, 33.8% of patients were >=65 years of age, and1.25% were >=75 years of age. No overall differences in safety oreffectiveness were observed between these geriatric patients and younger adults.
The following prioritized warning is available for APHEXDA (motixafortide acetate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for APHEXDA (motixafortide acetate)'s list of indications:
| Peripheral mobilization of hematopoietic stem cells | |
| Z52.011 | Autologous donor, stem cells |
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