Pronunciation:

pler-IX-a-fore

Brand Names:

• Mozobil

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Hematopoietic

Uses of This Medicine:

Plerixafor injection is used in combination with filgrastim to mobilize hematopoietic stem cells (HSC) for collection and transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of plerixafor injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of plerixafor injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving plerixafor.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (eg, leukemia) or
• Enlarged spleen or
• Leukocytosis (high white blood cell count) or
• Thrombocytopenia (low blood platelet count)—Use with caution. May make these conditions worse.

• Kidney disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under your skin.

Your doctor will give you filgrastim once a day for 4 days before receiving this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Male and female patients should use an effective form of birth control during treatment and for 1 week after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

This medicine may enlarge your spleen, which could possibly burst. Check with your doctor right away if you have pain in the upper left part of your stomach or at the tip of your left shoulder.

Tell your doctor right away if you have a slow heartbeat, severe, unusual tiredness or weakness, cold sweats, confusion, or dizziness, faintness, or lightheadedness when getting up from a lying or sitting position after you get the injection.

This medicine may cause a serious allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause diarrhea, nausea, vomiting, or stomach pain in some patients. Ask your doctor or nurse about other ways to control these side effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bleeding gums

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

collection of blood under the skin

coughing up blood

deep, dark purple bruise

difficulty in breathing or swallowing

dizziness

feeling of heat

flushing, redness of the skin

hard lump

headache

hives or welts, itching, skin rash

increased menstrual flow or vaginal bleeding

irritation

nosebleeds

pain

paralysis

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

swelling

unusually warm skin

Rare

Chest tightness

chills

cold sweats

confusion

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

fainting

fast heartbeat

swelling around the eyes

weakness

Incidence not known

Cough

feeling of fullness

pain in the left upper stomach or around the left shoulder

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

stomach pain

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bloated feeling

diarrhea

difficulty in moving

excess air or gas in the stomach or bowels

joint pain

muscle pain or stiffness

nausea

passing gas

trouble sleeping

vomiting

Less common

Belching

bone pain

difficulty having a bowel movement

dry mouth

general feeling of discomfort or illness

heartburn

increased sweating

indigestion

pressure in the stomach

stomach discomfort or upset

swelling of the abdominal or stomach area

Incidence not known

Abnormal dreams and nightmares

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.