Plerixafor

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of plerixafor, there are no specific foods that you must exclude from your diet when receiving this medication.

• Keep this and all medicines out of the reach of children.
• Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to plerixafor.

Contraindications

• No known contraindications.1

Warnings/Precautions

Tumor Cell Mobilization

Possible mobilization of leukemic cells with subsequent contamination of the final apheresis product.1 Plerixafor is not recommended as part of a hematopoietic stem cell mobilization regimen in patients with leukemia.1

Possible mobilization of tumor cells from the marrow into the peripheral circulation with unintentional collection into the apheresis product.1 Effect of potential reinfusion of tumor cells has not been well studied.1

Hematologic Effects

Increase in peripheral leukocytes (e.g., increase in hematopoietic stem or CD34+ cells) with concomitant administration of plerixafor and filgrastim.1 Monitor total WBC count, including neutrophil count.1 If peripheral neutrophil count is >50,000 cells/mm3, use clinical judgment when considering administering plerixafor.1

Thrombocytopenia reported.1 Monitor platelet counts in patients receiving plerixafor who then undergo subsequent apheresis.1

Splenomegaly and Splenic Rupture

Splenomegaly (i.e., increased spleen weights), associated with extramedullary hematopoiesis, observed in animals receiving prolonged (2–4 weeks) therapy with higher than recommended doses (fourfold higher than recommended human doses).1 Effect of plerixafor on spleen size not established in humans.1 However, splenomegaly and splenic rupture reported in patients who received filgrastim (or pegfilgrastim) alone for the treatment of neutropenia or in conjunction with autologous stem cell transplantation.7 8 9 10

Patients receiving plerixafor/filgrastim therapy who experience left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity (and possible rupture).1

Fetal /Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryolethality demonstrated in rats.1 Avoid pregnancy during therapy.1 If used during pregnancy or if patient becomes pregnant while receiving the drug, apprise of potential fetal hazard.1

Specific Populations

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Not known whether plerixafor is distributed into milk.1 Discontinue nursing or the drug, taking into the account the importance of the drug to the woman.1

Safety and efficacy not established in pediatric patients <18 years of age.1 11

No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Clearance may be decreased; dosage adjustments necessary in patients with moderate to severe renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Diarrhea,1 nausea,1 injection site reactions,1 fatigue, 1 headache,1 arthralgia,1 dizziness,1 vomiting,1 flatulence,1 insomnia.1

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Eye or eyelid swelling.
• Very bad dizziness or passing out.
• Shortness of breath.
• Any unexplained bruising or bleeding.
• Enlarged spleens have happened with plerixafor. This may lead to rupture of the spleen. Call your doctor right away if you have left upper stomach pain or shoulder pain.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling tired or weak.
• Headache.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Stomach pain.
• Gas.
• Joint pain.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about plerixafor, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about plerixafor. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using plerixafor.

Review Date: October 4, 2017

• AMD3100
• LM3100

• Mozobil

Clearance is reduced in patients with renal impairment. When compared to patients with normal renal function, the mean AUC was increased 7% in patients with mild renal impairment (CrCl 51 to 80 mL/minute), 32% for moderate renal impairment (CrCl 31 to 50 mL/minute), and 39% with severe renal impairment (CrCl <31 mL/minute).

CBC with differential and platelets; signs/symptoms of hypersensitivity (during, for 30 minutes after administration, and until clinically stable); signs/symptoms of splenomegaly

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience loss of strength and energy, headache, injection site irritation, nausea, vomiting, abdominal pain, diarrhea, flatulence, or joint pain. Have patient report immediately to prescriber signs of enlarged or ruptured spleen (left upper abdominal pain or left shoulder pain), eye or eyelid edema, severe dizziness, passing out, shortness of breath, bruising, or bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Dosing Based on Actual Patient Body Weight:
-83 kg or Less:
20 mg fixed dose or 0.24 mg/kg subcutaneously once in the evening, approximately 11 hours prior to initiation of each apheresis

-Greater than 83 kg and Less than 160 kg:
0.24 mg/kg subcutaneously once in the evening, approximately 11 hours prior to initiation of each apheresis

Duration of Therapy: Up to 4 consecutive days

Maximum Dose: 40 mg/day

Comments:
-The drug volume to be administered should be calculated using the following equation: 0.012 x actual patient body weight (kg) = administration dose (mL)
-The dosing has been calculated based on actual patient body weight up to 175% of ideal body weight; dosing and treatment of patients weighing more than 175% of ideal body weight have not been investigated.
-Granulocyte-colony stimulating factor (G-CSF) 10 mcg/kg should be administered once daily in the morning for 4 consecutive days prior to the first dose of this drug and on each morning prior to apheresis.

Use: Indicated in combination with G-CSF to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma.

-Hemodialysis: Insufficient data available to make dosage recommendation.
-Peritoneal dialysis: Data not available