Mozobil

Plerixafor injection is used along with a granulocyte-colony stimulating factor (G-CSF) medication such as filgrastim (Neupogen) or pegfilgrastim (Neulasta) to prepare the blood for an autologous stem cell transplant (procedure in which certain blood cells are removed from the body and then returned to the body after chemotherapy and/or radiation) in patients with non-Hodgkin's lymphoma (NHL; cancer that begins in a type of white blood cells that normally fights infection) or multiple myeloma (a type of cancer of the bone marrow). Plerixafor injection is in a class of medications called hematopoeitic stem cell mobilizers. It works by causing certain blood cells to move from the bone marrow to the blood so that they can be removed for transplant.

Before receiving plerixafor injection,

• tell your doctor and pharmacist if you are allergic to plerixafor injection or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had leukemia (cancer that begins in the white blood cells), an abnormally high number of neutrophils (a type of blood cell), or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use birth control to prevent pregnancy during your treatment with plerixafor injection. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving plerixafor injection, call your doctor. Plerixafor injection may harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving plerixafor injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

• easy bruising or bleeding, unusual weakness;
• feeling like you might pass out; or
• pain in your upper stomach, spreading to your shoulder or back.

Less serious side effects may include:

• nausea, vomiting;
• diarrhea, constipation;
• dry mouth, numbness in or around your mouth;
• upset stomach, bloating, gas;
• tired feeling, trouble sleeping;
• headache, dizziness;
• joint or muscle pain;
• increased sweating; or
• itching, rash, or other irritation where the medication was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Mozobil® (plerixafor injection) is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).

• Biological Therapy
• Chemotherapy
• Multiple Myeloma
• Non-Hodgkin's Lymphoma
• Radiation Therapy

Serious side effects have been reported with Mozobil. See the “Mozobil Precautions” section.

Common side effects of Mozobil include the following:

• diarrhea
• nausea
• vomiting
• stomach pain
• fatigue
• injection site reactions (such as pain, redness, hardness, swelling, irritation, itching, bruising, bleeding, numbness, tingling, or rash in the place where Mozobil was injected)
• difficulty falling asleep or staying asleep
• headache
• joint pain
• dizziness

This is not a complete list of Mozobil side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Before taking Mozobil, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Mozobil or to any of its ingredients
• have or have had leukemia
• have or have had an abnormally high number of neutrophils (a type of blood cell)
• have or have had kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Mozobil crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Mozobil.

You should not receive this medication if you are allergic to plerixafor, or if you have leukemia.

To make sure you can safely use plerixafor, tell your doctor if you have kidney disease.

FDA pregnancy category D. Do not receive plerixafor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether plerixafor passes into breast milk or if it could harm a nursing baby. You should not breast-feed while receiving this medication.

Plerixafor is injected under the skin. You will receive this injection in a hospital or clinic setting.

Before receiving plerixafor, you will be given a medication called a granulocyte (GRAN-yoo-loe-site) colony stimulating factor, also called G-CSF. Some examples of a G-CSF are filgrastim (Neupogen), pegfilgrastim (Neulasta), and sargramostim (Leukine).

A G-CSF will cause your bone marrow to produce stem cells and certain white blood cells called granulocytes, which help support your immune system.

Plerixafor works together with the G-CSF by causing stem cells and granulocytes produced in the bone marrow to circulate into your blood stream where they can be collected in blood drawn from your vein.

After your blood is drawn, it will be processed so that the needed stem cells and granulocytes can be separated from other unneeded parts of the blood. These stem cells and granulocytes will then be "transplanted" back into your vein through an IV injection.

To be sure plerixafor is not causing harmful effects, your blood will need to be tested often during your treatment.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Peripheral Blood Progenitor Cell Transplantation.

Used in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells into peripheral blood for collection (e.g., via leukapheresis as CD34+ peripheral blood progenitor cells [PBPCs]) and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma or multiple myeloma.1 2 3 4 5

Plerixafor is used to treat non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). It is used together with granulocyte-colony stimulating factor or G-CSF (e.g., filgrastim, pegfilgrastim) to mobilize hematopoietic stem cells (HSC) for collection and transplantation.

This medicine is available only with your doctor's prescription.

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of plerixafor in the pediatric population.

Geriatric

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

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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:

• Bone marrow cancer or other bone marrow problems (e.g., 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—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

A nurse or other trained health professional may give you this medicine. This medicine is given as a shot under your skin.

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 immediately if any of the following side effects occur:

• Bleeding gums
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• collection of blood under 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
• increased menstrual flow or vaginal bleeding
• irritation
• itching skin
• nosebleeds
• pain
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• redness of the skin
• shortness of breath
• skin rash
• swelling
• unusually warm skin

• Chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• fainting
• fast heartbeat
• swelling around the eyes
• tightness in the chest
• weakness
• wheezing

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:

• Bloated
• diarrhea
• difficulty in moving
• excess air or gas in stomach or intestines
• full feeling
• muscle pain or stiffness
• nausea
• pain in the joints
• passing gas
• sleeplessness
• trouble sleeping
• unable to sleep
• unusual tiredness or weakness
• vomiting

• Acid or sour stomach
• belching
• difficulty having a bowel movement (stool)
• dry mouth
• general feeling of discomfort or illness
• heartburn
• increased sweating
• indigestion
• muscle or bone pain
• pressure in the stomach
• stomach discomfort, upset, or pain
• swelling of abdominal or stomach area

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.

• It is used to raise the number of stem cells.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you are 65 or older, use Mozobil with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking this medicine.
• If you are pregnant or you get pregnant while taking Mozobil, call your doctor right away.

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 Mozobil. This may lead to rupture of the spleen. Call your doctor right away if you have left upper stomach pain or shoulder pain.

The following serious adverse reactions are discussed elsewhere in the labeling:

• Anaphylactic shock and hypersensitivity reactions [see Warnings and Precautions (5.1)]
• Potential for tumor cell mobilization in leukemia patients [see Warnings and Precautions (5.2)]
• Increased circulating leukocytes and decreased platelet counts [see Warnings and Precautions (5.3)]
• Potential for tumor cell mobilization [see Warnings and Precautions (5.4)]
• Potential for splenic enlargement [see Warnings and Precautions (5.5)]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reactions (≥ 10%) reported in patients who received Mozobil in conjunction with G-CSF regardless of causality and more frequent with Mozobil than placebo during HSC mobilization and apheresis were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting.

Safety data for Mozobil in combination with G-CSF were obtained from two randomized placebo-controlled studies (301 patients) and 10 uncontrolled studies (242 patients). Patients were primarily treated with Mozobil at daily doses of 0.24 mg/kg SC. Median exposure to Mozobil in these studies was 2 days (range 1 to 7 days).

In the two randomized studies in patients with NHL and MM, a total of 301 patients were treated in the Mozobil and G-CSF group and 292 patients were treated in the placebo and G-CSF group. Patients received daily morning doses of G-CSF 10 micrograms/kg for 4 days prior to the first dose of Mozobil 0.24 mg/kg SC or placebo and on each morning prior to apheresis. The adverse reactions that occurred in ≥ 5% of the patients who received Mozobil regardless of causality and were more frequent with Mozobil than placebo during HSC mobilization and apheresis are shown in Table 2. 

In the randomized studies, 34% of patients with NHL or MM had mild to moderate injection site reactions at the site of subcutaneous administration of Mozobil. These included erythema, hematoma, hemorrhage, induration, inflammation, irritation, pain, paresthesia, pruritus, rash, swelling, and urticaria.

Mild to moderate allergic reactions were observed in less than 1% of patients within approximately 30 min after Mozobil administration, including one or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnea (n = 1) or hypoxia (n = 1). Symptoms generally responded to treatments (e.g., antihistamines, corticosteroids, hydration or supplemental oxygen) or resolved spontaneously.

Vasovagal reactions, orthostatic hypotension, and/or syncope can occur following subcutaneous injections. In Mozobil oncology and healthy volunteer clinical studies, less than 1% of subjects experienced vasovagal reactions following subcutaneous administration of Mozobil doses ≤ 0.24 mg/kg. The majority of these events occurred within 1 hour of Mozobil administration. Because of the potential for these reactions, appropriate precautions should be taken.

Other adverse reactions in the randomized studies that occurred in < 5% of patients but were reported as related to Mozobil during HSC mobilization and apheresis included abdominal pain, hyperhidrosis, abdominal distention, dry mouth, erythema, stomach discomfort, malaise, hypoesthesia oral, constipation, dyspepsia, and musculoskeletal pain.

Hyperleukocytosis: In clinical trials, white blood cell counts of 100,000/mcL or greater were observed, on the day prior to or any day of apheresis, in 7% of patients receiving Mozobil and in 1% of patients receiving placebo. No complications or clinical symptoms of leukostasis were observed.

Post-marketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been reported from post-marketing experience with Mozobil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Anaphylactic reactions, including anaphylactic shock

Psychiatric disorders: Abnormal dreams and nightmares

Carton contains one vial of

Mozobil®
(plerixafor injection)

24 mg/1.2 mL
(20 mg/mL)

For single use only

Rx only

See package insert
for dosage
and administration

genzyme

Do not receive Mozobil without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not receive Mozobil if you are allergic to plerixafor, or if you have leukemia.

Before you take Mozobil, tell your doctor if you have kidney disease.

Mozobil is given as an injection in a hospital or clinic setting.

Before receiving Mozobil, you will be given another medication that will help your bone marrow produce stem cells and certain white blood cells that help support your immune system.

To be sure this medication is not causing harmful effects, your blood will need to be tested often.

Applies to plerixafor: subcutaneous solution

Along with its needed effects, plerixafor (the active ingredient contained in Mozobil) 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 immediately if any of the following side effects occur while taking plerixafor:

• Bleeding gums
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• collection of blood under 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
• increased menstrual flow or vaginal bleeding
• irritation
• itching skin
• nosebleeds
• pain
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• redness of the skin
• shortness of breath
• skin rash
• swelling
• unusually warm skin

• Chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• fainting
• fast heartbeat
• swelling around the eyes
• tightness in the chest
• weakness
• wheezing

Some side effects of plerixafor 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:

• Bloated
• diarrhea
• difficulty in moving
• excess air or gas in stomach or intestines
• full feeling
• muscle pain or stiffness
• nausea
• pain in the joints
• passing gas
• sleeplessness
• trouble sleeping
• unable to sleep
• unusual tiredness or weakness
• vomiting

• Acid or sour stomach
• belching
• difficulty having a bowel movement (stool)
• dry mouth
• general feeling of discomfort or illness
• heartburn
• increased sweating
• indigestion
• muscle or bone pain
• pressure in the stomach
• stomach discomfort, upset, or pain
• swelling of abdominal or stomach area