Drug Interaction:
Drug interactions-
Nephrotoxic drugs-
because plerixafor is primarily eliminated by the kidneys, coadministration of plerixafor
with drugs that reduce renal function or compete for active tubular secretion may increase
serum concentration of plerixafor or the coadministered drug
Indication:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Plerixafor injection 20mg/ml 31-01-2012
In combination with Granulocyte colony stimulating factor (G-CSF)
to enhance mobilasation of Hematopoietic stem cells to peripheral
blood for collection and subsequent Autologous Hematopoeitic stem
cells transportation in patients with non-Hodhkins Lymphoma whose
cells mobilise poorly
Peripheral Stem Collection and Transportation
Adverse Reaction:
Adverse reactions-
CNS- dizziness 11% fatigue 27% headache 22% insomnia 7%
GI- diarrhea 37% flatulance 7% nausea 34% vomiting 10%
Miscellaneous- arthalgia 13% injection site reactions 34%
Contra-Indications:
Special Precautions-
Leukemia- for the purpose of HSC mobilization , plerixafor may cause mobilization of leukemic cells and subsequent contamination of the apherisis product. Therfore, plexiafor is not intended for HSC mobilzation and harvest with leukemia
Hematologic effects-
Leukocytosis- administration of plerixafor in conjunction with G-CSF increases circulating
leukocytes as well as HSC population . Monitor white blood cells counts during plerixafor use.
Thrombocytopenia- thrombocytopenia has been observed in patients receiving plerixafor.
Monitor platelet counts in all patients who receive plerixafor and undergo apheresis.
Tumor cell mobilization- when plerixafor is used in combination with G-CSF for HSC mobilaztion,tumor cells may be released from marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells have not been well studied.
Renal function inpairment- in patients with moderate to severe renal impairment CrCl of 50mL/min or less ) reduce the dose of plerixafor by one third to 0.16mg/kg
Pregnancy- if this drug is used during pregnancy or if the patients becomes pregnant while taking the drug apraise the patient of the potential hazard to the fetus.
Lactation- decide whether to discontinue breast feeding or the drug depending on the importance of the drug to the mother.
Children- the safety and effectiveness of the children have not been established in controlled clinical studies
Elderly- dosage adjustments in elderly with a CrCl of 50mL/ml or less is recommended
Monitoring- monitor white cell counts during plerixafor use. Excercise clinical judgement when adminstering plerixafor to patients with counts with peripheral blood neurophil counts
higher than 50.000/mcl
Dosages/ Overdosage Etc:
In combination with Granulocyte colony stimulating factor (G-CSF)
to enhance mobilasation of Hematopoietic stem cells to peripheral
blood for collection and subsequent Autologous Hematopoeitic stem
cells transportation in patients with non-Hodhkins Lymphoma whose
cells mobilise poorly
Indication-
Peripheral Stem Collection and Transportation
Dosage-
Maxomum dose 40mg/day
usual dosage -0.24mg/body weight by subcutaneous injection.
Begin treatment with plerixafor after the patient has received G-CSF once daily for 4 days.
Administer plerixafor approitately 11 hours prior to initiation of apheresis for up to 4 consecutive
days.
Patient Information:
1. Advice patients of the signs and symptoms of potential systemic reactions such as urticaria,
periorbital swelling, dyspnea, or hypoxia during and following plerixafor injection.
2.Instruct patients to inform a health care provider immediately if symptoms of vasovagal reactions
such as ortostatic hypotension or syncope occur during or shortly after their plerixafor injection.
3. In patients experiencing itching, rash, or reacion at the site of injection , instruct them to notify
a health care provider because these symptoms have been treated with nonprescription
medications during clinical trials
4. Inform patients that plerixafor may cause GI disorders, including diarrhea, nausea, vomiting,
flatulence and abdominal pain. Tell patients how to manage specific GI disorders and to
inform their healthcare provider events occur following perixafor injection.
5. Advice women with repoductive potential to use contraceptives methods during perixafor use.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Plerixafor is hematopoietic stem cell mobilizer, is an inhibitor of CXCR4 chemokine receptor and blocks binding of its cognate ligand stromal cell-derived factor -1 alpha ( SDF -1 alpha) and CXCR4 are recognized to play a role in the trafficking and homing of human HScs to the marrow compartment.
Pharmacokinetics-
Peak plasma concentration at approximetely 30 to 60 minutes after a subcutaneous dose
Major route of elimination is urinary.
Following a 0.24mg/kg dose in healthy volunteers with normal renal function,
approximately 70% of dose was excreted in the urine as a parent drug during first
24 hours following administration.
The terminal half-life ranged from 3 and 5 hours
The distribution half-life was estimated to be 0.3 hrs and the terminal population
half-life was 5.3 hrs in patients with normal renal function.
Pregnancy and lactation:
Pregnancy-
If the drug is used during pregnancy or if the patients becomes pregnant while taking
the drug apraise the patient of the potential hazard to the fetus.
Lactation-
Decide whether to discontinue breast feeding or the drug depending on the importance
of the drug to the mother.
Children-
The safety and effectiveness of the children have not been established in controlled clinical
studies
Elderly-
Dosage adjustments in elderly with a CrCl of 50mL/ml or less is recommended
Manufacturer Details