Mozobil (plerixafor)

The recommended adult dosage of plerixafor is 0.24 mg/kg (based on actual body weight) daily for up to 4 consecutive days. Plerixafor is given concomitantly with filgrastim as part of the hematopoietic stem cell mobilization regimen. Treatment with plerixafor should only begin after the patient has received the initial 4 doses of filgrastim. Plerixafor should be administered in the evening, approximately 11 hours prior to a scheduled apheresis session; the filgrastim dose should be administered in the morning prior to apheresis.

Dosage may be increased according to changes in weight, but the maximum dosage should not exceed 40 mg once daily.

Plerixafor is administered by subcutaneous injection. The drug is available in single-use vials; any unused portion should be discarded.

In vitro studies indicate that plerixafor is not a substrate, inhibitor, or inducer of cytochrome P-450 (CYP) isoenzymes. Therefore, interactions with plerixafor and other drugs involving CYP isoenzymes are unlikely.

At in vitro concentrations similar to those achieved clinically, plerixafor did not act as a substrate or inhibitor of P-glycoprotein.

Because plerixafor is excreted principally by the kidneys, concurrent administration of drugs that reduce renal function or compete for active tubular secretion may potentially increase concentrations of plerixafor or the coadministered drug. The effects of coadministration of plerixafor with drugs that are excreted by the kidneys or known to affect renal function have not been established.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

The manufacturer states there are no contraindications to the use of plerixafor.

• Lactation
• Leukemia

• Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
• Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Nontraumatic splenic rupture
• Pregnancy

• Kidney disease with likely reduction in glomerular filtration rate (GFr)
• Thrombocytopenic disorder

The most common adverse events (occurring in at least 5% of patients in controlled clinical trials) reported with the combination of plerixafor and filgrastim included diarrhea, nausea, injection site reactions, fatigue, headache, arthralgia, dizziness, vomiting, flatulence, and insomnia.

Rare or Very Rare

• Anaphylaxis
• Dyspnea
• Hypotension
• Hypoxia
• Leukocytosis
• Nontraumatic splenic rupture
• Splenomegaly
• Thrombocytopenic disorder

More Frequent

• Arthralgia
• Diarrhea
• Dizziness
• Fatigue
• Flatulence
• Headache disorder
• Injection site sequelae
• Nausea
• Vomiting

Less Frequent

• Abdominal distension
• Acute abdominal pain
• Constipation
• Dyspepsia
• Erythema
• Hyperhidrosis
• Hypoesthesia
• Hypokalemia
• Hypomagnesemia
• Insomnia
• Malaise
• Musculoskeletal pain
• Myalgia
• Xerostomia

Rare or Very Rare

• Dream disorder
• Nightmares
• Orthostatic hypotension
• Periorbital edema
• Syncope
• Urticaria

No enhanced messaging available.

Safety and efficacy not established in pediatric patients younger than 18 years of age.

Category D. (See Users Guide). (See Fetal/Neonatal Morbidity and Mortality, under Cautions: Warnings/Precautions.)

It is not known if plerixafor is distributed into human milk. Because many drugs are distributed into human milk and because of the potential for serious adverse effects of plerixafor in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into the account the importance of the drug to the woman.

No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity cannot be ruled out.